WorldWideScience

Sample records for rights drug testing

  1. Human rights vs. Public safety -- When can you test your workers for drugs?

    Energy Technology Data Exchange (ETDEWEB)

    Kossowan, B. L.

    2002-06-01

    Legislative and regulatory aspects of drug testing of employees vs. public safety are discussed. While in Canada federal and provincial laws concerning human rights take precedence over public safety issues, laws and regulations vary from province to province, therefore there is good reason for concern about uncertainty. To compound the uncertainty, certain relevant laws of the United States are different (generally more stringent than corresponding Canadian laws), consequently there is the possibility that certain American companies might feel justified in refusing to do business with Canadian firms that do not follow their rigid standards. The conclusion is that while the situation may be clear enough in a legal situation, it does not always work equally well in practice. Unfortunately, at the present time there is not a whole lot of guidance available for companies to manage the workplace in a practical sense.

  2. Drug Testing

    Science.gov (United States)

    ... testing, substance abuse testing, toxicology screen, tox screen, sports doping tests What is it used for? Drug screening is used to find out whether or not a person has taken a certain drug or drugs. It ... Sports organizations. Professional and collegiate athletes usually need to ...

  3. The Right to Privacy at the Workplace, Part 3: Employee Alcohol- and Drug-Testing Programs.

    Science.gov (United States)

    Mendelson, Susan R.; Libbin, Anne E.

    1988-01-01

    The third in a series of four articles, this discusses the legal implications of the use of medical tests to prevent drug and alcohol abuse in the workplace and to reduce absenteeism, tardiness, reduced productivity, and accidents that result from employee substance abuse. Cites recent cases. (JOW)

  4. Choosing the right laboratory: a review of clinical and forensic toxicology services for urine drug testing in pain management.

    Science.gov (United States)

    Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L

    2015-01-01

    Urine drug testing (UDT) services are provided by a variety of clinical, forensic, and reference/specialty laboratories. These UDT services differ based on the principal activity of the laboratory. Clinical laboratories provide testing primarily focused on medical care (eg, emergency care, inpatients, and outpatient clinics), whereas forensic laboratories perform toxicology tests related to postmortem and criminal investigations, and drug-free workplace programs. Some laboratories now provide UDT specifically designed for monitoring patients on chronic opioid therapy. Accreditation programs for clinical laboratories have existed for nearly half a century, and a federal certification program for drug-testing laboratories was established in the 1980s. Standards of practice for forensic toxicology services other than workplace drug testing have been established in recent years. However, no accreditation program currently exists for UDT in pain management, and this review considers several aspects of laboratory accreditation and certification relevant to toxicology services, with the intention to provide guidance to clinicians in their selection of the appropriate laboratory for UDT surveillance of their patients on opioid therapy.

  5. RIGHT MEDICATION RELATED TO DRUG CENTRALIZED IN RSUD SIDOARJO

    Directory of Open Access Journals (Sweden)

    Aprilia Aprilia

    2017-02-01

    Full Text Available Introduction. Centralized drug is a management of the entire drug which is entirely done by nurses to administration to patients. Right medication is the process of right drug administration which is done by nurses based on 6 rights of medication, and wary of side effects. The purpose of this study was to analyze the corelation between centralized drug, team leadership, and nurse`s knowledge with right medication among nurses. Methods.The design of the study was descriptive corelational with cross-sectional approach. The population was inpatient nurses in RSUD Sidoarjo. Total sample was 114 respondents was selected by purposive sampling. The independent variables in this study: centralized drug, team leadership, and nurse`s knowledge. The dependent variable was right medication. Data were collected by using questionnares for independent variables and dependent variable. Data were analyzed by using Binary Logistic Regression with degree of significance α>0,05. Results. Binary Logistic Regression test showed non significance level between centralized drug with right medication (P=0.501, team leadership with right medication (P=0.874, and nurses`s knowledge with right medication (P=0.243. Discussion. This study concluded centralized drug, team leadership, and nurse`s knowledge were good. But, there are nurses that have negative value at right medication, however right medication in RSUD Sidoarjo has majority positive value. Keywords: centralized drug, right medication

  6. Workplace drug testing in Europe.

    Science.gov (United States)

    Verstraete, A G; Pierce, A

    2001-09-15

    Not much information is available on workplace drug testing (WDT) in Europe. There is no specific legislation and there are no generally accepted guidelines. Many companies establish a drug policy with little or no provisions for drug testing. Often, testing is performed on-site by occupational physicians, with little or no quality control, no systematic confirmation of positives, no chain of custody and no adulteration testing. In some parts of Europe, e.g. in the United Kingdom and some Scandinavian countries, WDT is increasing in importance, but it is not as widespread as in USA. The most frequently performed tests are amphetamines, cannabinoids, cocaine, opiates and alcohol. The percentage of positives is variable, but seems to decrease with the years following the introduction of WDT. Cannabis is the drug that is most frequently found.Recently, the European Workplace Drug Testing Society (EWDTS) was founded, with the aims to ensure that WDT in Europe is performed to a defined quality standard and in a legally secured way and to provide an independent forum for all aspects of WDT.A working group in the United Kingdom has recently finalised the United Kingdom laboratory guidelines for legally defensible WDT and discussions are under way with the EWDTS to establish common guidelines. Many efforts will be needed to establish WDT as an accepted part of a company policy on drugs: establishing and maintaining the confidence in the results of the laboratory, establishing the legal status of WDT, preserving the privacy and rights of the employees, proving the cost-effectiveness of WDT in a European context, finding a balance between strict guidelines and enough flexibility to tailor testing to the changing needs. It is hoped that the exchange of experience between different countries will contribute to reaching these goals.

  7. Profit-driven drug testing.

    Science.gov (United States)

    Collen, Mark

    2012-01-01

    Random drug testing of people being treated for chronic pain has become more common. Physicians may drug test patients on opioid therapy as a result of concerns over prosecution, drug misuse, addiction, and overdose. However, profit motive has remained unexplored. This article suggests profits also drive physician drug-testing behavior and evidence is offered, including an exploration of Medicare reimbursement incentives and kickbacks for drug testing.

  8. Drug policy, harm and human rights: a rationalist approach.

    Science.gov (United States)

    Stevens, Alex

    2011-05-01

    It has recently been argued that drug-related harms cannot be compared, so making it impossible to choose rationally between various drug policy options. Attempts to apply international human rights law to this area are valid, but have found it difficult to overcome the problems in applying codified human rights to issues of drug policy. This article applies the rationalist ethical argument of Gewirth (1978) to this issue. It outlines his argument to the 'principle of generic consistency' and the hierarchy of basic, nonsubtractive and additive rights that it entails. It then applies these ideas to drug policy issues, such as whether there is a right to use drugs, whether the rights of drug 'addicts' can be limited, and how different harms can be compared in choosing between policies. There is an additive right to use drugs, but only insofar as this right does not conflict with the basic and nonsubtractive rights of others. People whose freedom to choose whether to use drugs is compromised by compulsion have a right to receive treatment. They retain enforceable duties not to inflict harms on others. Policies which reduce harms to basic and nonsubtractive rights should be pursued, even if they lead to harms to additive rights. There exists a sound, rational, extra-legal basis for the discussion of drug policy and related harms which enables commensurable discussion of drug policy options. Copyright © 2011 Elsevier B.V. All rights reserved.

  9. People who use drugs, HIV, and human rights.

    Science.gov (United States)

    Jürgens, Ralf; Csete, Joanne; Amon, Joseph J; Baral, Stefan; Beyrer, Chris

    2010-08-07

    We reviewed evidence from more than 900 studies and reports on the link between human rights abuses experienced by people who use drugs and vulnerability to HIV infection and access to services. Published work documents widespread abuses of human rights, which increase vulnerability to HIV infection and negatively affect delivery of HIV programmes. These abuses include denial of harm-reduction services, discriminatory access to antiretroviral therapy, abusive law enforcement practices, and coercion in the guise of treatment for drug dependence. Protection of the human rights of people who use drugs therefore is important not only because their rights must be respected, protected, and fulfilled, but also because it is an essential precondition to improving the health of people who use drugs. Rights-based responses to HIV and drug use have had good outcomes where they have been implemented, and they should be replicated in other countries. Copyright 2010 Elsevier Ltd. All rights reserved.

  10. Colombian drugs policy. The dose for personal and health rights

    Directory of Open Access Journals (Sweden)

    Juan Camilo Fischer Rodríguez

    2013-07-01

    Full Text Available This article is a review of Colombian law on drugs, with special emphasis on the so-called dose for personal and health rights that relate to the use of legal or illegal drugs. A brief contextualization of international treaties on drugs is presented, as well as presenting some cases representing the current debate on trade control measures and use of illegal drugs. The article argues that in the international and Colombian debate there are no homogeneous positions, and the repressive policies towards illegal drug use coexist with approaches from the public health that point to the recognition of the rights of people who use legal or illegal substances.

  11. Active drug users - struggling for rights and recognition in Denmark

    DEFF Research Database (Denmark)

    Anker, Jørgen

    This paper examines the strategic dilemmas and the self-representation of the Drug Users’ Union in Denmark. The paper explores how a group of drug users on the one hand seeks to struggle for the rights of drug users and one the other hand seeks to gain legitimacy and access to public funding...... and support. It reveals how the organisation attempts to advance a more balanced image of drug users as persons who are able to run an effective organisation while they also claim the right to use drugs....

  12. Implications of Drug Testing Cheerleaders

    Science.gov (United States)

    Trachsler, Tracy A.; Birren, Genevieve

    2016-01-01

    With the untimely death of a University of Louisville cheerleader due to an accidental drug overdose in the summer of 2014, the athletic department representatives took steps to prevent future incidents by adding cheerleaders to the randomized drug testing protocols conducted at the university for the student-athletes involved in National…

  13. International Guidelines on Human Rights and Drug Control: A Tool for Securing Women's Rights in Drug Control Policy.

    Science.gov (United States)

    Schleifer, Rebecca; Pol, Luciana

    2017-06-01

    Discrimination and inequality shape women's experiences of drug use and in the drug trade and the impact of drug control efforts on them, with disproportionate burdens faced by poor and otherwise marginalized women. In recent years, UN member states and UN drug control and human rights entities have recognized this issue and made commitments to integrate a 'gender perspective' into drug control policies, with 'gender' limited to those conventionally deemed women. But the concept of gender in international law is broader, rooted in socially constructed and culturally determined norms and expectations around gender roles, sex, and sexuality. Also, drug control policies often fail to meaningfully address the specific needs and circumstances of women (inclusively defined), leaving them at risk of recurrent violations of their rights in the context of drugs. This article explores what it means to 'mainstream' this narrower version of gender into drug control efforts, using as examples various women's experiences as people who use drugs, in the drug trade, and in the criminal justice system. It points to international guidelines on human rights and drug control as an important tool to ensure attention to women's rights in drug control policy design and implementation.

  14. Human Rights and Wrongs in Iran's Drug Diplomacy with Europe

    DEFF Research Database (Denmark)

    Christensen, Janne Bjerre

    2017-01-01

    Europe has a strong interest in and a history of assisting Iran in controlling inflows of drugs from Afghanistan. But due to Iran's increasing use of the death penalty in drug trafficking cases, Europe has terminated its cooperation. Based on interviews with Iranian policy......-makers and representatives of both human rights organizations and the United Nations Office on Drugs and Crime (UNODC), this article presents Denmark's withdrawal of drug control funding in 2013 as a case study, analyzing the dilemmas and trajectories of joint Iranian-European drug diplomacy and the prospects...

  15. Statins: Are These Cholesterol-Lowering Drugs Right for You?

    Science.gov (United States)

    Statins: Are these cholesterol-lowering drugs right for you? Find out whether your risk factors for heart disease make you a ... risk prediction. In addition to your cholesterol numbers, these risk calculators also ask about your age, race, ...

  16. IMPLEMENTATION OF DRUG ADDICTS RIGHT TO HEALTH PROTECTION (SEPARATE ASPECTS).

    Science.gov (United States)

    Shevchuk, O; Rzhevska, O; Korop, O; Pyliuha, L

    2018-03-01

    The purpose of the research is to analyze specific problems of the realization of the right to protect the health of people who take narcotic drugs or psychotropic substances. To achieve this goal, statistics have been analyzed on the number of people using narcotic drugs or psychotropic substances (including drug-addicted children) placed on medical records and the number of their applications for medical care. It has been found out that people in this category often face a denial of medical care that causes extremely strong physical and mental suffering. The analysis of the understanding of the legal design of the «right to health care» in the scientific literature, national legislation and international legal documents was made. State institutions and local authorities providing «the right to health care» of people taking narcotic or psychotropic drugs are singled out. The absence of grounds for restricting the right to protect the health of people who take narcotic or psychotropic drugs who are not registered is justified. In the course of the research, it was found out that people who take narcotic drugs or psychotropic substances are more likely than other patients to need medical assistance and, when requesting the right to health care, face a number of problems that require immediate solution: incomplete provision of quality free medical care; unimplementation of rehabilitation programs for such categories of patients; the lack of the right of children who take narcotic drugs or psychotropic substances to make their own decisions at the age of 14 and apply to public health institutions for the treatment of drug addiction; violations of the continuity of SMT programs and their absence in penal institutions for drug dependent people. It was proposed to introduce a number of changes in the relevant normative legal acts.

  17. The rights of drug treatment patients: Experience of addiction treatment in Poland from a human rights perspective.

    Science.gov (United States)

    Klingemann, Justyna

    2017-05-01

    Drug dependence is a recognized medical condition and therefore, right to health applies in the same way to drug dependence as it does to any other health condition. The human rights in patient care framework - which refers to the application of basic human rights principles in the delivery of health care services - was used to explore the experiences of equality in the dignity and rights protected by Polish law within four different specialist drug treatment settings in Poland. The views of patients and staff were examined and compared. Focus group interviews were conducted in 12 drug treatment facilities: three inpatient therapeutic communities, three outpatient programs, three opioid substitution programs and three harm reduction programs (drop-in/needle exchange/support). Interviews were conducted with a total of 43 staff and 73 patients. All interviews were audio-recorded with participants' prior consent and transcribed verbatim. Data were analysed according to the problem-centred interview methodology, using CAQDA. Patients described instances of abuse of their rights regarding dignity, privacy, confidentiality, personalized treatment, and respect of patient's time, right to information and to complain. Those accounts were complemented by the perspective of professionals working in drug treatment. Patients of Polish opioid substitution programs reported experiencing more humiliation and disenfranchisement than patients in other drug treatment settings. Drug testing and control, fuelled by prejudices of health professionals, are leading to discriminatory practices in substitution treatment and damaging the chances of therapeutic success. The concept of epistemic injustice illuminates the reasons behind discrimination against patients on opioid substitution programs, who are seen as continuously sick and their illness perceived as a mark of moral, social and epistemic failure. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. STD Testing: What's Right for You

    Science.gov (United States)

    ... testing for specific sexually transmitted infections. Chlamydia and gonorrhea Get screened annually if: You're a sexually ... in sexual activity against your will Chlamydia and gonorrhea screening is done either through a urine test ...

  19. Right to experimental treatment: FDA new drug approval, constitutional rights, and the public's health.

    Science.gov (United States)

    Leonard, Elizabeth Weeks

    2009-01-01

    On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.

  20. Organizational adoption of preemployment drug testing.

    Science.gov (United States)

    Spell, C S; Blum, T C

    2001-04-01

    This study explored the adoption of preemployment drug testing by 360 organizations. Survival models were developed that included internal organizational and labor market factors hypothesized to affect the likelihood of adoption of drug testing. Also considered was another set of variables that included social and political variables based on institutional theory. An event history analysis using Cox regressions indicated that both internal organizational and environmental variables predicted adoption of drug testing. Results indicate that the higher the proportion of drug testers in the worksite's industry, the more likely it would be to adopt drug testing. Also, the extent to which an organization uses an internal labor market, voluntary turnover rate, and the extent to which management perceives drugs to be a problem were related to likelihood of adoption of drug testing.

  1. A Model for Random Student Drug Testing

    Science.gov (United States)

    Nelson, Judith A.; Rose, Nancy L.; Lutz, Danielle

    2011-01-01

    The purpose of this case study was to examine random student drug testing in one school district relevant to: (a) the perceptions of students participating in competitive extracurricular activities regarding drug use and abuse; (b) the attitudes and perceptions of parents, school staff, and community members regarding student drug involvement; (c)…

  2. Formulation and stability testing of photolabile drugs.

    Science.gov (United States)

    Tønnesen, H H

    2001-08-28

    Exposure of a drug to irradiation can influence the stability of the formulation, leading to changes in the physicochemical properties of the product. The influence of excipients of frequently used stabilizers is often difficult to predict and, therefore, stability testing of the final preparation is important. The selection of a protective packaging must be based on knowledge about the wavelength causing the instability. Details on drug photoreactivity will also be helpful in order to minimize side-effects and/or optimize drug targeting by developing photoresponsive drug delivery systems. This review focuses on practical problems related to formulation and stability testing of photolabile drugs.

  3. 21 CFR 516.31 - Scope of MUMS-drug exclusive marketing rights.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Scope of MUMS-drug exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.31 Scope of MUMS-drug exclusive...

  4. Experiences with urine drug testing by police among people who inject drugs in Bangkok, Thailand.

    Science.gov (United States)

    Hayashi, Kanna; Ti, Lianping; Buxton, Jane A; Kaplan, Karyn; Suwannawong, Paisan; Wood, Evan; Kerr, Thomas

    2014-03-01

    Thailand has relied on drug law enforcement in an effort to curb illicit drug use. While anecdotal reports suggest that Thai police frequently use urine toxicology to identify drug users, little is known about the prevalence or impacts of this practice among people who inject drugs (IDU). Therefore, we sought to examine experiences with urine drug testing by police among IDU in Bangkok. Data were derived from a community-recruited sample of IDU in Bangkok participating in the Mitsampan Community Research Project between July and October 2011. We assessed the prevalence and correlates of being subjected to urine toxicology testing by police using multivariate Poisson regression. In total, 438 IDU participated in this study, with 293 (66.9%) participants reporting having been tested for illicit drugs by police. In multivariate analyses, reports of drug testing by police were independently and positively associated with younger age (adjusted prevalence ratio [APR]: 1.28), a history of methamphetamine injection (APR: 1.22), a history of incarceration (APR: 1.21), having been in compulsory drug detention (APR: 1.43), avoiding healthcare (APR: 1.15), and HIV seropositivity (APR: 1.19), and negatively associated with access to voluntary drug treatment (APR: 0.82) (all p<0.05). A high proportion of IDU in Bangkok were subjected to drug testing by police. Young people and methamphetamine injectors were more likely to have been tested. The findings indicate that drug testing by police is associated with the compulsory drug detention system and may be interfering with IDU's access to healthcare and voluntary drug treatment. These findings raise concern about the widespread practice of drug testing by police and its associated impacts. Copyright © 2013 Elsevier B.V. All rights reserved.

  5. Chemical dependency and drug testing in the workplace.

    Science.gov (United States)

    Osterloh, J D; Becker, C E

    1990-05-01

    Urine testing for drug use in the workplace is now widespread, with the prevalence of positive drug tests in the work force being 0% to 15%. The prevalence of marijuana use is highest, and this can be reliably tested. Though it is prudent to rid the workplace of drug use, there is little scientific study on the relationship of drug use and workplace outcomes, such as productivity and safety. Probable-cause testing and preemployment testing are the most common applications. Random testing has been less accepted owing to its higher costs, unresolved legal issues, and predictably poor test reliability. Legal issues have focused on the right to policy, discrimination, and the lack of due process. The legal cornerstone of a good program is a policy that is planned and agreed on by both labor and management, which serves both as a contract and as a procedure in which expectations and consequences are known. The National Institute on Drug Abuse is certifying laboratories doing employee drug testing. Testing methods when done correctly are less prone to error than in the past, but screening tests can be defeated by adulterants. Although the incidence of false-positive results is low, such tests are less reliable when the prevalence of drug abuse is also low.

  6. Health and human rights concerns of drug users in detention in Guangxi Province, China.

    Directory of Open Access Journals (Sweden)

    J Elizabeth Cohen

    2008-12-01

    Full Text Available BACKGROUND: Although confinement in drug detoxification ("detox" and re-education through labor (RTL centers is the most common form of treatment for drug dependence in China, little has been published about the experience of drug users in such settings. We conducted an assessment of the impact of detention on drug users' access to HIV prevention and treatment services and consequent threats to fundamental human rights protections. METHODS AND FINDINGS: Chinese government HIV and anti-narcotics legislation and policy documents were reviewed, and in-depth and key informant interviews were conducted with 19 injection drug users (IDUs and 20 government and nongovernmental organization officials in Nanning and Baise, Guangxi Province. Significant contradictions were found in HIV and antinarcotics policies, exemplified by the simultaneous expansion of community-based methadone maintenance therapy and the increasing number of drug users detained in detox and RTL center facilities. IDU study participants reported, on average, having used drugs for 14 y (range 8-23 y and had been confined to detox four times (range one to eight times and to RTL centers once (range zero to three times. IDUs expressed an intense fear of being recognized by the police and being detained, regardless of current drug use. Key informants and IDUs reported that routine HIV testing, without consent and without disclosure of the result, was the standard policy of detox and RTL center facilities, and that HIV-infected detainees were not routinely provided medical or drug dependency treatment, including antiretroviral therapy. IDUs received little or no information or means of HIV prevention, but reported numerous risk behaviors for HIV transmission while detained. CONCLUSIONS: Legal and policy review, and interviews with recently detained IDUs and key informants in Guangxi Province, China, found evidence of anti-narcotics policies and practices that appear to violate human rights

  7. Health and human rights concerns of drug users in detention in Guangxi Province, China.

    Science.gov (United States)

    Cohen, J Elizabeth; Amon, Joseph J

    2008-12-09

    Although confinement in drug detoxification ("detox") and re-education through labor (RTL) centers is the most common form of treatment for drug dependence in China, little has been published about the experience of drug users in such settings. We conducted an assessment of the impact of detention on drug users' access to HIV prevention and treatment services and consequent threats to fundamental human rights protections. Chinese government HIV and anti-narcotics legislation and policy documents were reviewed, and in-depth and key informant interviews were conducted with 19 injection drug users (IDUs) and 20 government and nongovernmental organization officials in Nanning and Baise, Guangxi Province. Significant contradictions were found in HIV and antinarcotics policies, exemplified by the simultaneous expansion of community-based methadone maintenance therapy and the increasing number of drug users detained in detox and RTL center facilities. IDU study participants reported, on average, having used drugs for 14 y (range 8-23 y) and had been confined to detox four times (range one to eight times) and to RTL centers once (range zero to three times). IDUs expressed an intense fear of being recognized by the police and being detained, regardless of current drug use. Key informants and IDUs reported that routine HIV testing, without consent and without disclosure of the result, was the standard policy of detox and RTL center facilities, and that HIV-infected detainees were not routinely provided medical or drug dependency treatment, including antiretroviral therapy. IDUs received little or no information or means of HIV prevention, but reported numerous risk behaviors for HIV transmission while detained. Legal and policy review, and interviews with recently detained IDUs and key informants in Guangxi Province, China, found evidence of anti-narcotics policies and practices that appear to violate human rights and imperil drug users' health.

  8. Drug Testing in Schools: Implications for Policy.

    Science.gov (United States)

    Bozeman, William C.; And Others

    1987-01-01

    Public concern about substance abuse, fueled by political and media attention, is causing school administrators to consider a variety of approaches beyond traditional drug education. No procedures, methods, or rules regarding drug testing should be established in the absence of clear school board policy, and no policy decisions should be made…

  9. Doing the right things and doing things right : inpatient drug surveillance assisted by clinical decision support

    NARCIS (Netherlands)

    Helmons, Pieter J.; Suijkerbuijk, Bas O.; Nannan Panday, Prashant V.; Kosterink, Jos G. W.

    Increased budget constraints and a continuous focus on improved quality require an efficient inpatient drug surveillance process. We describe a hospital-wide drug surveillance strategy consisting of a multidisciplinary evaluation of drug surveillance activities and using clinical decision support to

  10. 75 FR 59105 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Federal Drug Testing...

    Science.gov (United States)

    2010-09-27

    ... 2105-AE03 Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Federal Drug... the Federal workplace drug testing program but also pointed out that ``* * * the Department of.... Executive Order 12866 and Regulatory Flexibility Act This Interim Final Rule is not significant for purposes...

  11. Preemptive Genotyping for Personalized Medicine: Design of the Right Drug, Right Dose, Right Time – Using Genomic Data to Individualize Treatment Protocol

    Science.gov (United States)

    Bielinski, Suzette J.; Olson, Janet E.; Pathak, Jyotishman; Weinshilboum, Richard M.; Wang, Liewei; Lyke, Kelly J.; Ryu, Euijung; Targonski, Paul V.; Van Norstrand, Michael D.; Hathcock, Matthew A.; Takahashi, Paul Y.; McCormick, Jennifer B.; Johnson, Kiley J.; Maschke, Karen J.; Rohrer Vitek, Carolyn R.; Ellingson, Marissa S.; Wieben, Eric D.; Farrugia, Gianrico; Morrisette, Jody A.; Kruckeberg, Keri J.; Bruflat, Jamie K.; Peterson, Lisa M.; Blommel, Joseph H.; Skierka, Jennifer M.; Ferber, Matthew J.; Black, John L.; Baudhuin, Linnea M.; Klee, Eric W.; Ross, Jason L.; Veldhuizen, Tamra L.; Schultz, Cloann G.; Caraballo, Pedro J.; Freimuth, Robert R.; Chute, Christopher G.; Kullo, Iftikhar J.

    2014-01-01

    Objective To report the design and implementation of the Right Drug, Right Dose, Right Time: Using Genomic Data to Individualize Treatment Protocol that was developed to test the concept that prescribers can deliver genome guided therapy at the point-of-care by using preemptive pharmacogenomics (PGx) data and clinical decision support (CDS) integrated in the electronic medical record (EMR). Patients and Methods We used a multivariable prediction model to identify patients with a high risk of initiating statin therapy within 3 years. The model was used to target a study cohort most likely to benefit from preemptive PGx testing among Mayo Clinic Biobank participants with a recruitment goal of 1000 patients. Cox proportional hazards model was utilized using the variables selected through the Lasso shrinkage method. An operational CDS model was adapted to implement PGx rules within the EMR. Results The prediction model included age, sex, race, and 6 chronic diseases categorized by the Clinical Classifications Software for ICD-9 codes (dyslipidemia, diabetes, peripheral atherosclerosis, disease of the blood-forming organs, coronary atherosclerosis and other heart diseases, and hypertension). Of the 2000 Biobank participants invited, 50% provided blood samples, 13% refused, 28% did not respond, and 9% consented but did not provide a blood sample within the recruitment window (October 4, 2012 – March 20, 2013). Preemptive PGx testing included CYP2D6 genotyping and targeted sequencing of 84 PGx genes. Synchronous real-time CDS is integrated in the EMR and flags potential patient-specific drug-gene interactions and provides therapeutic guidance. Conclusion These interventions will improve understanding and implementation of genomic data in clinical practice. PMID:24388019

  12. Results of workplace drug testing in Norway

    Directory of Open Access Journals (Sweden)

    Hilde Marie Erøy Lund

    2011-12-01

    Full Text Available Workplace drug testing is less common in Norway than in many other countries. During the period from 2000-2006, 13469 urine or blood samples from employees in the offshore industry, shipping companies and aviation industry were submitted to the Norwegian Institute of Public Health for drug testing. The samples were analysed for benzodiazepines, illicit drugs, muscle relaxants with sedating properties, opioids and z-hypnotics. In total, 2.9% of the samples were positive for one or more substances. During the study period the prevalence decreased for morphine (from 1.9% to 1.1% and increased for amphetamine (from 0.04% to 0.6%, clonazepam (from 0% to 0.1%, methamphetamine (from 0.04% to 0.6%, nitrazepam (from 0% to 0.4% and oxazepam (from 0.5% to 1.3% (p<0.05. There was no significant change in prevalence for the other substances included in the analytical programme. Illicit drugs were significantly associated with lower age (OR: 0.93, p<0.05. This study found low prevalence of drugs among employees in companies with workplace drug testing programmes in Norway.

  13. Self-Reported Drug and Alcohol Use and Attitudes toward Drug Testing in High Schools with Random Student Drug Testing

    Science.gov (United States)

    DuPont, Robert L.; Campbell, Michael D.; Campbell, Teresa G.; Shea, Corinne L.; DuPont, Helen S.

    2013-01-01

    Many schools implement random student drug testing (RSDT) programs as a drug prevention strategy. This study analyzes self-report surveys of students in eight secondary schools with well-established RSDT programs, comparing students who understood they were subject to testing and students who understood they were not subject to testing. Students…

  14. Drug sensitivity testing platforms for gastric cancer diagnostics.

    Science.gov (United States)

    Lau, Vianne; Wong, Andrea Li-Ann; Ng, Christopher; Mok, Yingting; Lakshmanan, Manikandan; Yan, Benedict

    2016-02-01

    Gastric cancer diagnostics has traditionally been histomorphological and primarily the domain of surgical pathologists. Although there is an increasing usage of molecular and genomic techniques for clinical diagnostics, there is an emerging field of personalised drug sensitivity testing. In this review, we describe the various personalised drug sensitivity testing platforms and discuss the challenges facing clinical adoption of these assays for gastric cancer. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  15. APT drug R&D: the right active ingredient in the right presentation for the right therapeutic use.

    Science.gov (United States)

    Cavalla, David

    2009-11-01

    Drug repurposing, in which an established active pharmaceutical ingredient is applied in a new way - for example, for a new indication, and often combined with an alternative method of presentation, such as a novel delivery route - is an evolving strategy for pharmaceutical R&D. This article discusses examples of the success of this strategy, and presents an analysis of sales of US pharmaceutical products that suggests that this low-risk approach to new product development retains substantial commercial value.

  16. Human basophil degranulation test in drug allergy.

    Science.gov (United States)

    Sastre Domínguez, J; Sastre Castillo, A

    1986-01-01

    We have evaluated the usefulness of HBDT as an in vitro method for the diagnosis of drug allergy. Two hundred and thirty six patients with suspected drug sensitization to penicillin, streptomycin, sulfamides, pyrazolones and A.S.A. were analyzed. Seventy-nine of them were allergic; in 43 cases it was confirmed by in vivo methods. Other patients were diagnosed by clinical history only if they had more than two reactions to the same drug. In order to be included in this group patients with reactions to pyrazolones and A.S.A. had to have tolerated other NSAI, therefore these patients were allergic to one compound only. All patients were considered non-allergic were determined by a negative provocation test. In the group of allergic patients we obtained 63 (79%) positive degranulations and 16 (21%) negative. One hundred and thirty two (84%) negative degranulations and 25 (16%) positive were obtained in the group of non-allergic patients. Once having analyzed 10 statistical parameters with each drug, the HBOT appears to be a useful method for these drugs except for streptomycin. In 16 (80%) out of 20 aspirin sensitive asthmatic patients we found that their basophils were degranulated. In 7 patients with urticaria and/or angioedema by A.S.A. and other NSAI the degranulation was negative, confirming the absence of the involvement of basophils in this reactions.

  17. 'Allowing the right' and its currency in managing drug stigma in Greece.

    Science.gov (United States)

    Fotopoulou, Maria; Munro, Alison; Taylor, Avril

    2015-08-01

    Evidence suggests that problem drug users are still subject to high levels of stigmatization. In countries, like Greece, where families occupy a central position and honour is collectively attained, secondary drug stigma is also highly prevalent. However, little is known about how drug users and their families manage drug stigma in the specific cultural milieu that makes up Greece. This article presents findings from a qualitative study exploring how drug stigma both manifests itself and is managed by drug users and parents in the context of Greek familial culture. The study was conducted in two state drug agencies in Thessaloniki - Greece and involved the participation of 40 problem drug users (PDU) (23 male/17 female) and 8 parents of PDU. Qualitative, in-depth, interviews were used to collect narrative accounts about experiences of managing addiction, drug stigma and secondary stigma in the Greek parental home. 'Allowing the right' - broadly understood as referring to passing to others information which might devalue a person and consequently that person's family - is discussed in terms of drug stigma management in Greece. We highlight how this culturally specific notion can be viewed as an active strategy adopted by both individual drug users and parents of PDU to manage stigmatization by illustrating the various way in which not 'allowing the right' was described by participants, including drug problem discovery or disclosure and subsequent management of drug using careers and drug stigma within the Greek family context. Given the significance of the cultural notion of 'allowing the right' in the trajectory of drug use amongst PDU and more particularly in stigma management and secondary stigma management, the paper highlights the need for further research into the field in Greece. The need for targeted culturally specific and culturally relevant interventions aimed at reducing drug stigma is also highlighted in relation to both policy and practice. Copyright

  18. Analytical challenges in sports drug testing.

    Science.gov (United States)

    Thevis, Mario; Krug, Oliver; Geyer, Hans; Walpurgis, Katja; Baume, Norbert; Thomas, Andreas

    2018-03-01

    Analytical chemistry represents a central aspect of doping controls. Routine sports drug testing approaches are primarily designed to address the question whether a prohibited substance is present in a doping control sample and whether prohibited methods (for example, blood transfusion or sample manipulation) have been conducted by an athlete. As some athletes have availed themselves of the substantial breadth of research and development in the pharmaceutical arena, proactive and preventive measures are required such as the early implementation of new drug candidates and corresponding metabolites into routine doping control assays, even though these drug candidates are to date not approved for human use. Beyond this, analytical data are also cornerstones of investigations into atypical or adverse analytical findings, where the overall picture provides ample reason for follow-up studies. Such studies have been of most diverse nature, and tailored approaches have been required to probe hypotheses and scenarios reported by the involved parties concerning the plausibility and consistency of statements and (analytical) facts. In order to outline the variety of challenges that doping control laboratories are facing besides providing optimal detection capabilities and analytical comprehensiveness, selected case vignettes involving the follow-up of unconventional adverse analytical findings, urine sample manipulation, drug/food contamination issues, and unexpected biotransformation reactions are thematized.

  19. Human rights of drug users according to public health professionals in Brazil.

    Science.gov (United States)

    Ventura, Carla A A; Mendes, Isabel A C; Trevizan, Maria A; Rodrigues, Driéli P

    2013-03-01

    Health is a basic human right, and drug use represents a severe influence on people's health. This qualitative study aimed to understand how health professionals in a public health-care team working with drug users in a city of the state of São Paulo, Brazil, perceive the human rights of these users and how these rights are being respected in health care. Data were collected through semistructured interviews with 10 health professionals at the service under analysis. A thematic analysis of the interviews reveals the professionals' difficulty to define the concept of human right and contextualize these rights in their work environment. A deeper understanding of the right to health, however, represents an important premise for a more humanized care practice in health services to drug users.

  20. Medication monitoring and drug testing ethics project.

    Science.gov (United States)

    Payne, Richard; Moe, Jeffrey L; Sevier, Catherine Harvey; Sevier, David; Waitzkin, Michael

    2015-01-01

    In 2012, Duke University initiated a research project, funded by an unrestricted research grant from Millennium Laboratories, a drug testing company. The project focused on assessing the frequency and nature of questionable, unethical, and illegal business practices in the clinical drug testing industry and assessing the potential for establishing a business code of ethics. Laboratory leaders, clinicians, industry attorneys, ethicists, and consultants participated in the survey, were interviewed, and attended two face-to-face meetings to discuss a way forward. The study demonstrated broad acknowledgment of variations in the legal and regulatory environment, resulting in inconsistent enforcement of industry practices. Study participants expressed agreement that overtly illegal practices sometimes exist, particularly when laboratory representatives and clinicians discuss reimbursement, extent of testing, and potential business incentives with medical practitioners. Most respondents reported directly observing probable violations involving marketing materials, contracts, or, in the case of some individuals, directly soliciting people with offers of clinical supplies and other "freebies." While many study respondents were skeptical that voluntary standards alone would eliminate questionable business practices, most viewed ethics codes and credentialing as an important first step that could potentially mitigate uneven enforcement, while improving quality of care and facilitating preferred payment options for credentialed parties. Many were willing to participate in future discussions and industry-wide initiatives to improve the environment.

  1. Psychedelics and cognitive liberty: Reimagining drug policy through the prism of human rights.

    Science.gov (United States)

    Walsh, Charlotte

    2016-03-01

    This paper reimagines drug policy--specifically psychedelic drug policy--through the prism of human rights. Challenges to the incumbent prohibitionist paradigm that have been brought from this perspective to date--namely by calling for exemptions from criminalisation on therapeutic or religious grounds--are considered, before the assertion is made that there is a need to go beyond such reified constructs, calling for an end to psychedelic drug prohibitions on the basis of the more fundamental right to cognitive liberty. This central concept is explicated, asserted as being a crucial component of freedom of thought, as enshrined within Article 9 of the European Convention on Human Rights (ECHR). It is argued that the right to cognitive liberty is routinely breached by the existence of the system of drug prohibition in the United Kingdom (UK), as encoded within the Misuse of Drugs Act 1971 (MDA). On this basis, it is proposed that Article 9 could be wielded to challenge the prohibitive system in the courts. This legal argument is supported by a parallel and entwined argument grounded in the political philosophy of classical liberalism: namely, that the state should only deploy the criminal law where an individual's actions demonstrably run a high risk of causing harm to others. Beyond the courts, it is recommended that this liberal, rights-based approach also inform psychedelic drug policy activism, moving past the current predominant focus on harm reduction, towards a prioritization of benefit maximization. How this might translate in to a different regulatory model for psychedelic drugs, a third way, distinct from the traditional criminal and medical systems of control, is tentatively considered. However, given the dominant political climate in the UK--with its move away from rights and towards a more authoritarian drug policy--the possibility that it is only through underground movements that cognitive liberty will be assured in the foreseeable future is

  2. Security, development and human rights: normative, legal and policy challenges for the international drug control system.

    Science.gov (United States)

    Barrett, Damon

    2010-03-01

    This commentary addresses some of the challenges posed by the broader normative, legal and policy framework of the United Nations for the international drug control system. The 'purposes and principles' of the United Nations are presented and set against the threat based rhetoric of the drug control system and the negative consequences of that system. Some of the challenges posed by human rights law and norms to the international drug control system are also described, and the need for an impact assessment of the current system alongside alternative policy options is highlighted as a necessary consequence of these analyses. Copyright (c) 2010 Elsevier B.V. All rights reserved.

  3. Direct to consumer genetic testing and the libertarian right to test.

    Science.gov (United States)

    Loi, Michele

    2016-09-01

    I sketch a libertarian argument for the right to test in the context of 'direct to consumer' (DTC) genetic testing. A libertarian right to genetic tests, as defined here, relies on the idea of a moral right to self-ownership. I show how a libertarian right to test can be inferred from this general libertarian premise, at least as a prima facie right, shifting the burden of justification on regulators. I distinguish this distinctively libertarian position from some arguments based on considerations of utility or autonomy, which are sometimes labelled 'libertarian' because they oppose a tight regulation of the direct to consumer genetic testing sector. If one takes the libertarian right to test as a starting point, the whole discussion concerning autonomy and personal utility may be sidestepped. Finally, I briefly consider some considerations that justify the regulation of the DTC genetic testing market, compatible with the recognition of a prima facie right to test. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  4. When the Right (Drug) Should Be Left : Prenatal Drug Exposure and Heterotaxy Syndrome

    NARCIS (Netherlands)

    van Veenendaal, Nicole R.; Kusters, Cynthia D. J.; Oostra, Roelof-Jan; Bergman, Jorieke E. H.; Cobben, Jan-Maarten

    Background: Recent studies reported an association between prenatal propylthiouracil exposure and birth defects, including abnormal arrangement across the left-right body axis, suggesting an association with heterotaxy syndrome. Methods: This case-control and case-finding study used data from 1981

  5. 14 CFR 120.35 - Testing for prohibited drugs.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Testing for prohibited drugs. 120.35... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND... for prohibited drugs. (a) Each certificate holder or operator shall test each of its employees who...

  6. 10 CFR 26.31 - Drug and alcohol testing.

    Science.gov (United States)

    2010-01-01

    ... Transportation Workplace Drug and Alcohol Testing Programs” (65 FR 41944; August 9, 2001) to collect specimens... could be construed as a potential conflict of interest. The forensic toxicologist may not be an employee... or drug metabolites in Federal workplace drug testing programs and the licensee or other entity...

  7. 75 FR 3153 - Drug and Alcohol Testing Program; Correction

    Science.gov (United States)

    2010-01-20

    ... definition of prohibited drugs. In Sec. Sec. 120.103 and 120.211, we omitted the reference to Sec. 135.1 from.... FAA-2008-0937; Amendment No. 120-0A, 135-117A] RIN 2120-AJ37 Drug and Alcohol Testing Program... Aviation Administration (FAA) is correcting its drug and alcohol testing regulations published on May 14...

  8. Experiences with drug testing at a nuclear power plant

    International Nuclear Information System (INIS)

    Ray, H.B.

    1987-01-01

    After more than 2 yr of operation of a drug testing program at the San Onofre nuclear power plant site, the Southern California Edison Co. has had a number of experiences and lessons considered valuable. The drug testing program at San Onofre, implemented in September of 1984, continues in essentially the same form today. Prior to describing the program, the paper reviews several underlying issues that believed to be simultaneously satisfied by the program: trustworthiness, fitness and safety, public trust, and privacy and search. The overall drug testing program, periodic drug monitoring program, and unannounced drug testing program are described. In addition to the obvious features of a good drug testing program, which are described in the EEI guide, it is essential to consider such issues as the stated program rationale, employee relations, and disciplinary action measures when contemplating or engaging in drug testing at nuclear power plants

  9. Chemical dependency and drug testing in the workplace.

    OpenAIRE

    Osterloh, J D; Becker, C E

    1990-01-01

    Urine testing for drug use in the workplace is now widespread, with the prevalence of positive drug tests in the work force being 0% to 15%. The prevalence of marijuana use is highest, and this can be reliably tested. Though it is prudent to rid the workplace of drug use, there is little scientific study on the relationship of drug use and workplace outcomes, such as productivity and safety. Probable-cause testing and preemployment testing are the most common applications. Random testing has ...

  10. Why are generic drugs being held up in transit? Intellectual property rights, international trade, and the right to health in Brazil and beyond.

    Science.gov (United States)

    Rosina, Mônica Steffen Guise; Shaver, Lea

    2012-01-01

    Access to medicines faces a new legal threat: "border enforcement" of drug patents. Using Brazil as an example, this article shows how the right to health depends on international trade. Border seizures of generic drugs present human rights and trade institutions with a unique challenge. Can public health advocates rise to meet it? © 2012 American Society of Law, Medicine & Ethics, Inc.

  11. Are drug companies living up to their human rights responsibilities? The Merck perspective.

    Directory of Open Access Journals (Sweden)

    Geralyn S Ritter

    2010-09-01

    Full Text Available BACKGROUND TO THE DEBATE: The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The "Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines" include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.

  12. Are drug companies living up to their human rights responsibilities? Moving toward assessment.

    Science.gov (United States)

    Gruskin, Sofia; Raad, Zyde

    2010-09-28

    The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The "Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines" include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.

  13. Are drug companies living up to their human rights responsibilities? The Merck perspective.

    Science.gov (United States)

    Ritter, Geralyn S

    2010-09-28

    The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The "Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines" include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.

  14. Drug and alcohol testing results 2009 annual report

    Science.gov (United States)

    2013-11-01

    This is the 15th annual report of the results of the Federal Transit Administrations (FTA) Drug and Alcohol Testing Program. This report summarizes the reporting requirements for calendar year 2009, the requirements of the overall drug and alcohol...

  15. Drug and alcohol testing results 2007 annual report

    Science.gov (United States)

    2009-05-01

    This is the 13th annual report of the results of the Federal Transit Administrations (FTA) Drug and Alcohol Testing Program. This report summarizes the reporting requirements for calendar year 2007, the requirements of the overall drug and alcohol...

  16. Drug and Alcohol Testing Results 2008 Annual Report

    Science.gov (United States)

    2010-09-01

    This is the 14th annual report of the results of the Federal Transit Administration's (FTA) Drug and Alcohol Testing : Program. This report summarizes the reporting requirements for calendar year 2008, the requirements of the overall : drug and alcoh...

  17. Drug and alcohol testing results 2006 annual report.

    Science.gov (United States)

    2008-08-01

    This is the 12th annual report of the results of the Federal Transit Administration's (FTA) Drug and Alcohol Testing Program. This report summarizes the reporting requirements for calendar year 2006, the requirements of the overall drug and alcohol t...

  18. Scientific issues in drug testing: council on scientific affairs

    International Nuclear Information System (INIS)

    Anon.

    1987-01-01

    Testing for drugs in biologic fluids, especially urine, is a practice that has become widespread. The technology of testing for drugs in urine has greatly improved in recent years. Inexpensive screening techniques are not sufficiently accurate for forensic testing standards, which must be met wihen a person's employment or reputation may be affected by results. This is particularly a concern during screening of a population in which the prevalence of drug use is very low, in which the predictive value of a positive result would be quite low. Physicians should be aware that results from drug testing can yield accurate evidence of prior exposure to drugs, but they do not provide information about patterns of drug use, about abuse of or dependence on drugs, or about mental or physical impairments that may result from drug use

  19. Direct to consumer genetic testing and the libertarian right to test.

    Science.gov (United States)

    Bonython, Wendy Elizabeth; Arnold, Bruce Baer

    2017-08-20

    Loi recently proposed a libertarian right to direct to consumer genetic testing (DTCGT)- independent of autonomy or utility-reflecting Cohen's work on self-ownership and Hohfeld's model of jural relations. Cohen's model of libertarianism dealt principally with self-ownership of the physical body. Although Loi adequately accounts for the physical properties of DNA, DNA is also an informational substrate, highly conserved within families. Information about the genome of relatives of the person undergoing testing may be extrapolated without requiring direct engagement with their personal physical copy of the genome, triggering rights and interests of relatives that may differ from the rights and interests of others, that is, individual consumers, testing providers and regulators. Loi argued that regulatory interference with exercise of the right required justification, whereas prima facie exercise of the right did not. Justification of regulatory interference could include 'conflict with other people's rights', 'aggressive' use of the genome and 'harming others'. Harms potentially experienced by relatives as a result of the individual's exercise of a right to test include breach of genetic privacy, violation of their right to determine when, and if, they undertake genetic testing and discrimination. Such harms may justify regulatory intervention, in the event they are recognised; motives driving 'aggressive' use of the genome may also be relevant. Each of the above criteria requires clarification, as potential redundancies and tensions exist between them, with different implications affecting different groups of rights holders. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. Right lateralized white matter abnormalities in first-episode, drug-naive paranoid schizophrenia.

    Science.gov (United States)

    Guo, Wenbin; Liu, Feng; Liu, Zhening; Gao, Keming; Xiao, Changqing; Chen, Huafu; Zhao, Jingping

    2012-11-30

    Numerous studies in first-episode schizophrenia suggest the involvement of white matter (WM) abnormalities in multiple regions underlying the pathogenesis of this condition. However, there has never been a neuroimaging study in patients with first-episode, drug-naive paranoid schizophrenia by using tract-based spatial statistics (TBSS) method. Here, we used diffusion tensor imaging (DTI) with TBSS method to investigate the brain WM integrity in patients with first-episode, drug-naive paranoid schizophrenia. Twenty patients with first-episode, drug-naive paranoid schizophrenia and 26 healthy subjects matched with age, gender, and education level were scanned with DTI. An automated TBSS approach was employed to analyze the data. Voxel-wise statistics revealed that patients with paranoid schizophrenia had decreased fractional anisotropy (FA) values in the right superior longitudinal fasciculus (SLF) II, the right fornix, the right internal capsule, and the right external capsule compared to healthy subjects. Patients did not have increased FA values in any brain regions compared to healthy subjects. There was no correlation between the FA values in any brain regions and patient demographics and the severity of illness. Our findings suggest right-sided alterations of WM integrity in the WM tracts of cortical and subcortical regions may play an important role in the pathogenesis of paranoid schizophrenia. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  1. An Issue of Conflicting Rights: Nursing Student Charged with Drug Trafficking.

    Science.gov (United States)

    Cullen, Phyllis; And Others

    1997-01-01

    Outlines a case of a nursing student charged with drug trafficking who was not suspended due to concern over student rights. Reviews case law that would have supported suspension. Advocates clearly defined policies and procedures that ensure due process while allowing for disciplinary action. (SK)

  2. "Right to Try" Legislation Moving Through Congress: But Drug Companies and Some Patient Groups Want Changes.

    Science.gov (United States)

    Barlas, Stephen

    2017-12-01

    State "Right to Try" laws, which allow terminally ill patients to seek investigational treatments under certain circumstances, have created pressure for Congress to follow up with a federal law. Though facing opposition from patient advocates and the drug industry, a bill passed by the Senate is now making its way to the House.

  3. An assessment of drug testing within the construction industry.

    Science.gov (United States)

    Gerber, Jonathan K; Yacoubian, George S

    2002-01-01

    Drug testing in the workplace has gone from virtual nonexistence to widespread employer acceptance during the past two decades. This growth is particularly significant for the construction industry. High rates of alcohol and other drug use, coupled with the high-risk, safety-sensitive nature of the industry, have prompted the development of a variety of drug surveillance and prevention strategies. Despite this growing vigilance, no scholarly works have examined the impact of drug-related policies in the construction industry. To address this limitation, we investigate the efficacy of workplace drug-testing programs in reducing injury incident rates and workers' compensation experience-rating modification factors (MODs) within the construction industry. Analyses indicate that companies with drug-testing programs experienced a 51 percent reduction in incident rates within two years of implementation. Moreover, companies that drug test their employees experienced a significant reduction in their MODs. Policy implications are discussed in light of the current findings.

  4. 21 CFR 864.3260 - OTC test sample collection systems for drugs of abuse testing.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false OTC test sample collection systems for drugs of abuse testing. 864.3260 Section 864.3260 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology...

  5. Examining human rights and mental health among women in drug abuse treatment centers in Afghanistan.

    Science.gov (United States)

    Abadi, Melissa Harris; Shamblen, Stephen R; Johnson, Knowlton; Thompson, Kirsten; Young, Linda; Courser, Matthew; Vanderhoff, Jude; Browne, Thom

    2012-01-01

    Denial of human rights, gender disparities, and living in a war zone can be associated with severe depression and poor social functioning, especially for female drug abusers. This study of Afghan women in drug abuse treatment (DAT) centers assesses (a) the extent to which these women have experienced human rights violations and mental health problems prior to entering the DAT centers, and (b) whether there are specific risk factors for human rights violations among this population. A total of 176 in-person interviews were conducted with female patients admitted to three drug abuse treatment centers in Afghanistan in 2010. Nearly all women (91%) reported limitations with social functioning. Further, 41% of the women indicated they had suicide ideation and 27% of the women had attempted suicide at least once 30 days prior to entering the DAT centers due to feelings of sadness or hopelessness. Half of the women (50%) experienced at least one human rights violation in the past year prior to entering the DAT centers. Risk factors for human rights violations among this population include marital status, ethnicity, literacy, employment status, entering treatment based on one's own desire, limited social functioning, and suicide attempts. Conclusions stemming from the results are discussed.

  6. Testing for drugs of abuse in children and adolescents.

    Science.gov (United States)

    Levy, Sharon; Siqueira, Lorena M; Ammerman, Seth D; Gonzalez, Pamela K; Ryan, Sheryl A; Siqueira, Lorena M; Smith, Vincent C

    2014-06-01

    Drug testing is often used as part of an assessment for substance use in children and adolescents. However, the indications for drug testing and guidance on how to use this procedure effectively are not clear. The complexity and invasiveness of the procedure and limitations to the information derived from drug testing all affect its utility. The objective of this clinical report is to provide guidance to pediatricians and other clinicians on the efficacy and efficient use of drug testing on the basis of a review of the nascent scientific literature, policy guidelines, and published clinical recommendations.

  7. Examining human rights and mental health among women in drug abuse treatment centers in Afghanistan

    Directory of Open Access Journals (Sweden)

    Abadi MH

    2012-04-01

    Full Text Available Melissa Harris Abadi1, Stephen R Shamblen1, Knowlton Johnson1, Kirsten Thompson1, Linda Young1, Matthew Courser1, Jude Vanderhoff1, Thom Browne21Pacific Institute for Research and Evaluation – Louisville Center, Louisville, KY, USA; 2United States Department of State, Bureau of International Narcotics and Law Enforcement, Washington, DC, USAAbstract: Denial of human rights, gender disparities, and living in a war zone can be associated with severe depression and poor social functioning, especially for female drug abusers. This study of Afghan women in drug abuse treatment (DAT centers assesses (a the extent to which these women have experienced human rights violations and mental health problems prior to entering the DAT centers, and (b whether there are specific risk factors for human rights violations among this population. A total of 176 in-person interviews were conducted with female patients admitted to three drug abuse treatment centers in Afghanistan in 2010. Nearly all women (91% reported limitations with social functioning. Further, 41% of the women indicated they had suicide ideation and 27% of the women had attempted suicide at least once 30 days prior to entering the DAT centers due to feelings of sadness or hopelessness. Half of the women (50% experienced at least one human rights violation in the past year prior to entering the DAT centers. Risk factors for human rights violations among this population include marital status, ethnicity, literacy, employment status, entering treatment based on one’s own desire, limited social functioning, and suicide attempts. Conclusions stemming from the results are discussed.Keywords: Afghanistan, women, human rights, mental health, drug abuse treatment

  8. Test of right-handed currents in baryon semileptonic decays

    International Nuclear Information System (INIS)

    Garcia, A.; Huerta, R.; Maya, M.; Perez Marcial, R.

    1985-01-01

    The effect of a right-handed boson on baryon semileptonic decay is considered. The analysis of polarized and unpolarized decays is carried out and it is shown that the best place to look for a right-handed current (RHC) signature is in polarized baryon decay. However, our results are useful for high statistics experiments. In order to see the contribution of the right-handed currents in the case of unpolarized hyperon decay, the Cabibbo theory should be assumed. (orig.)

  9. [Pathogenic Mechanism and Diagnostic Testing for Drug Allergies].

    Science.gov (United States)

    Uno, Katsuji

    2018-01-01

     Three stages of the pathogenic mechanism of drug allergies can be considered: antigen formation, immune reaction and inflammation/disorder reaction. Drugs are thought to form 4 types of antigens: drug only, polymers, drug-carrier conjugates, and metabolite-carrier complexes. Antigens are recognized by B cell receptors and T cell receptors. Helper T cells (Th) are differentiated into four subsets, namely, Th1, Th2, Th17 and regulatory T cells (Treg). Th1 produces interleukin (IL)-2 and interferon (IFN)-γ, and activates macrophages and cytotoxic T cells (Tc). Macrophages induce type IV allergies, and Tc lead to serious type IV allergies. On the other hand, Th2 produces IL-4, IL-5, and IL-6, etc., and activates B cells. B cells produce IgE antibodies, and the IgE antibody affects mast cells and induces type I allergies. Activated eosinophil leads to the chronic state of type I allergy. Diagnostic testing for allergenic drugs is necessary for patients with drug allergies. Because in vivo diagnostic tests for allergenic drugs are associated with a risk and burden to the patient, in vitro allergy tests are recommended to identify allergenic drugs. In allergy tests performed in vitro, cytological tests are more effective than serological tests, and the leukocyte migration test (LMT) presently has the highest efficacy. An LMT-chamber is better than LMT-agarose in terms of usability and sensitivity, and it can detect about 80% of allergenic drugs.

  10. 75 FR 79308 - Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2011

    Science.gov (United States)

    2010-12-20

    ...-11213, Notice No. 14] Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2011... random testing positive rates were .037 percent for drugs and .014 percent for alcohol. Because the... effective December 20, 2010. FOR FURTHER INFORMATION CONTACT: Lamar Allen, Alcohol and Drug Program Manager...

  11. 77 FR 75896 - Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2013

    Science.gov (United States)

    2012-12-26

    ...-11213, Notice No. 16] Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2013...., Washington, DC 20590, (telephone 202-493- 1342); or Kathy Schnakenberg, FRA Alcohol/Drug Program Specialist... from FRA's Management Information System, the rail industry's random drug testing positive rate has...

  12. 75 FR 1547 - Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2010

    Science.gov (United States)

    2010-01-12

    ...-11213, Notice No. 13] RIN 2130-AA81 Alcohol and Drug Testing: Determination of Minimum Random Testing... percent for alcohol. Because the industry-wide random drug testing positive rate has remained below 1.0... effective upon publication. FOR FURTHER INFORMATION CONTACT: Lamar Allen, Alcohol and Drug Program Manager...

  13. Results from the 2013 drug and alcohol testing survey.

    Science.gov (United States)

    2015-12-01

    This report summarizes the results of the 2013 Federal Motor Carrier Safety Administration (FMCSA) Drug and Alcohol Testing Survey. This annual survey measures the percentage of drivers with commercial drivers licenses (CDLs) that test positive fo...

  14. Results from the 2008 Drug and Alcohol Testing Survey

    Science.gov (United States)

    2010-01-01

    This report summarizes the results of the 2008 Federal Motor Carrier Safety Administration Drug and Alcohol Testing Survey. This annual survey measures the percentage of drivers with commercial drivers licenses who test positive for controlled sub...

  15. Drug Testing in the Schools. Implications for Policy.

    Science.gov (United States)

    Bozeman, William C.; And Others

    Drug testing of district employees and students is examined from several perspectives: implications for school policy, legality, administration and protocol, and test reliability and accuracy. Substance abuse has become a major concern for educators, parents, and citizens as illegal drugs are more readily available. It is also pointed out that the…

  16. Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

    Science.gov (United States)

    Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E

    2015-10-01

    The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.

  17. Do pharmacists have a right to refuse to fill prescriptions for abortifacient drugs?

    Science.gov (United States)

    Weinstein, B D

    1992-01-01

    Some pharmacists opposed to abortion on moral ground are concerned by having to fill prescriptions for abortifacient drugs like mifepristone (RU-486). The issue of the right of pharmacists to refuse to fill such prescriptions depends on the model of the physician-pharmacist-patient relationship. The libertarian model of pharmacy practice holds that physicians, pharmacists, and patients are bound only by the contract that they freely negotiate with one another, thus the pharmacist has no moral obligation to fill a prescription for mifepristone unless he or she has expressly contracted to do so. The American Pharmaceutical Association's 1981 Code of Ethics does not specify what a pharmacist ought to do in particular circumstances. The right to refuse is strongly supported by the principles of nonmaleficence and respect for autonomy. These are principles of the libertarian model of the pharmacist-patient relationship but are also present in the guild or societal models stressing the duty to avoid harming others. Justification for pharmacists right of refusal appeals to their autonomy rights as members of the moral community rather than the profession of pharmacy. Since the professional right to autonomy is not absolute, moral consideration circumscribe it: it is difficult to argue that a pharmacist who believes that homosexuality is immoral has the right to refuse to fill a prescription for AZT. Even if a person who presents such a prescription is homosexual there is no causal relationship between filling a prescription for AZT and participating in a homosexual act. At the opposite end the libertarians reject the notion of even a basic right to health care. A woman in the above situation would not have a right to the abortifacient drug, so a pharmacist has no duty to dispense it. According to the technician model of professionalism, the pharmacist's personal values do not matter, so a pharmacist has a duty to provide the service.

  18. Guidelines for European workplace drug testing in oral fluid.

    Science.gov (United States)

    Cooper, Gail; Moore, Christine; George, Claire; Pichini, Simona

    2011-05-01

    Over the past decade, oral fluid has established itself as a robust testing matrix for monitoring drug use or misuse. Commercially available collection devices provide opportunities to collect and test oral fluid by the roadside and near-patient testing with both clinical and criminal justice applications. One of the main advantages of oral fluid relates to the collection of the matrix which is non-invasive, simple, and can be carried out under direct observation making it ideal for workplace drug testing. Laboratories offering legally defensible oral fluid workplace drug testing must adhere to national and international quality standards (ISO/IEC 17025); however, these standards do not address issues specific to oral fluid testing. The European Workplace Drug Testing Society (EWDTS) recognizes the importance of providing best practice guidelines to organizations offering testing and those choosing to use oral fluid drug testing to test their employees. The aim of this paper is to present the EWDTS guidelines for oral fluid workplace drug testing. Copyright © 2011 John Wiley & Sons, Ltd.

  19. 78 FR 78275 - Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2014

    Science.gov (United States)

    2013-12-26

    ...-11213, Notice No. 17] Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2014... December 26, 2013. FOR FURTHER INFORMATION CONTACT: Jerry Powers, FRA Drug and Alcohol Program Manager, W38...-493-6313); or Sam Noe, FRA Drug and Alcohol Program Specialist, (telephone 615-719- 2951). Issued in...

  20. 76 FR 80781 - Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2012

    Science.gov (United States)

    2011-12-27

    ...-11213, Notice No. 15] RIN 2130-AA81 Alcohol and Drug Testing: Determination of Minimum Random Testing...: Lamar Allen, Alcohol and Drug Program Manager, Office of Safety Enforcement, Mail Stop 25, Federal... Kathy Schnakenberg, FRA Alcohol/Drug Program Specialist, (telephone (719) 633-8955). Issued in...

  1. Communicating and Collaborating for the Right Lab Test and Diagnosis

    Centers for Disease Control (CDC) Podcasts

    This podcast is a scenario-based skit between a clinical pathologist and primary care physician around the challenges in ordering clinical laboratory tests and offers solutions to optimizing the use of laboratory services for quality patient care.

  2. 10 CFR 707.8 - Applicant drug testing.

    Science.gov (United States)

    2010-01-01

    ... DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.8 Applicant drug... final selection for employment or assignment to such a position. Provisions of this part do not prohibit contractors from conducting drug testing on applicants for employment in any position. ...

  3. Communicating and Collaborating for the Right Lab Test and Diagnosis

    Centers for Disease Control (CDC) Podcasts

    2016-10-13

    This podcast is a scenario-based skit between a clinical pathologist and primary care physician around the challenges in ordering clinical laboratory tests and offers solutions to optimizing the use of laboratory services for quality patient care.  Created: 10/13/2016 by Center for Surveillance, Epidemiology, and Laboratory Services (CSELS).   Date Released: 10/13/2016.

  4. Admissions of injection drug users to drug abuse treatment following HIV counseling and testing.

    Science.gov (United States)

    McCusker, J; Willis, G; McDonald, M; Lewis, B F; Sereti, S M; Feldman, Z T

    1994-01-01

    The outcomes of counseling and testing programs related to human immunodeficiency virus (HIV) infection and risk of infection among injection drug users (IDUs) are not well known or understood. A counseling and testing outcome of potential public health importance is attaining admission to drug abuse treatment by those IDUs who are either infected or who are at high risk of becoming infected. The authors investigated factors related to admission to drug abuse treatment among 519 IDUs who received HIV counseling and testing from September 1987 through December 1990 at a men's prison and at community-based testing sites in Worcester, MA. By June 1991, 123 of the 519 IDUs (24 percent) had been admitted to treatment. Variables associated with their admission included a long history of drug injection, frequent recent drug injection, cleaning injection equipment using bleach, prior drug treatment, and a positive HIV test result. Logistic regression analyses, controlling for effects of recruitment site, year, sex, and area of residence, generally confirmed the associations. IDUs in the study population who were HIV-infected sought treatment or were admitted to treatment more frequently than those who were not infected. The results indicate that access to drug abuse treatment should be facilitated for high-risk IDUs and for those who have begun to inject drugs recently.

  5. European guidelines for workplace drug testing in urine.

    Science.gov (United States)

    Taskinen, Sanna; Beck, Olof; Bosch, Tessa; Brcak, Michaela; Carmichael, Duncan; Fucci, Nadia; George, Claire; Piper, Mark; Salomone, Alberto; Schielen, Wim; Steinmeyer, Stefan; Weinmann, Wolfgang

    2017-06-01

    These European Guidelines for Workplace Drug Testing in Urine have been prepared and updated by the European Workplace Drug Testing Society (EWDTS). The first version of these urine guidelines was published in 2002. Since then, the guidelines have been followed by many laboratories in different European countries and their role has been essential particularly in countries lacking legislation for workplace drug testing. In 2014, the EWDTS started a guidelines updating project and published a new version of the urine guidelines in 2015. Here we represent this updated version of the urine guidelines. The European Guidelines are designed to establish best practice procedures whilst allowing individual countries to operate within the requirements of national customs and legislation. The EWDTS recommends that all European laboratories that undertake legally defensible workplace drug testing should use these guidelines as a template for accreditation. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  6. Do we have the training? The ethics of workplace drug testing and the GP.

    Science.gov (United States)

    Evans, Alan; Thornett, Andrew

    2003-08-01

    Workplace drug testing has been in place in Australia since the early 1990s. In some industries it is required by legislation, while in others, employers have introduced it as an apparent cost effective way of improving productivity, safety and the health of its workforce while reducing absenteeism, accident rates and even deaths. There are national standards in place for workplace drug testing regarding specimen collection and testing, and well documented processes to follow in establishing a drug screening program within a workforce. This article explores the ethics of workplace drug testing and questions the assumed rights and obligations of employer, employee and the clinician involved in occupational medicine. It is questionable whether most general practitioners have the appropriate training to deal with these ethical issues comprehensively.

  7. Toward a generic approach for : Stress testing of drug substances and drug products

    NARCIS (Netherlands)

    Klick, Silke; Muijselaar, Pim G.; Waterval, Joop; Eichinger, Thomas; Korn, Christian; Gerding, Thijs K.; Debets, Alexander J.; Sänger-Van De Griend, Cari; Van Den Beld, Cas; Somsen, Govert W.; De Jong, Gerhardus J.

    The Impurity Profiling Group has developed a generic approach for conducting stress testing on drug substances and drug products. The proposed strategy is evaluated and verified with historical data and new experiments. Results demonstrate that the proposed approach is reasonable and generates

  8. Investigating the correlation between wastewater analysis and roadside drug testing in South Australia.

    Science.gov (United States)

    Bade, Richard; Tscharke, Benjamin J; Longo, Marie; Cooke, Richard; White, Jason M; Gerber, Cobus

    2018-04-10

    The societal impact of drug use is well known. An example is when drug-intoxicated drivers increase the burden on policing and healthcare services. This work presents the correlation of wastewater analysis (using UHPLC-MS/MS) and positive roadside drug testing results for methamphetamine, 3,4-methylenedioxymethamphetamine (MDMA) and cannabis from December 2011-December 2016 in South Australia. Methamphetamine and MDMA showed similar trends between the data sources with matching increases and decreases, respectively. Cannabis was relatively steady based on wastewater analysis, but the roadside drug testing data started to diverge in the final part of the measurement period. The ability to triangulate data as shown here validates both wastewater analysis and roadside drug testing. This suggests that changes in overall population drug use revealed by WWA is consistent and proportional with changes in drug-driving behaviours. The results show that, at higher levels of drug use as measured by wastewater analysis, there is an increase in drug driving in the community and therefore more strain on health services and police. Copyright © 2018 Elsevier B.V. All rights reserved.

  9. In vitro pyrogen test for toxic or immunomodulatory drugs

    OpenAIRE

    Daneshian, Mardas; Guenther, Armin; Wendel, Albrecht; Hartung, Thomas; Aulock, Sonja von

    2006-01-01

    Pyrogenic contaminations of some classes of injectable drugs, e.g. toxic or immunomodulatory as well as false-positive drugs, represent a major risk which cannot yet be excluded due to the limitations of current tests. Here we describe a modification of the In vitro Pyrogen Test termed AWIPT (Adsorb, Wash, In vitro Pyrogen Test), which addresses this problem by introducing a pre-incubation step in which pyrogenic contaminations in the test sample are adsorbed to albumin-coated beads. After ri...

  10. Role of Urine Drug Testing in the Current Opioid Epidemic.

    Science.gov (United States)

    Mahajan, Gagan

    2017-12-01

    While the evidence for urine drug testing for patients on chronic opioid therapy is weak, the guidelines created by numerous medical societies and state and federal regulatory agencies recommend that it be included as one of the tools used to monitor patients for compliance with chronic opioid therapy. To get the most comprehensive results, clinicians should order both an immunoassay screen and confirmatory urine drug test. The immunoassay screen, which can be performed as an in-office point-of-care test or as a laboratory-based test, is a cheap and convenient study to order. Limitations of an immunoassay screen, however, include having a high threshold of detectability and only providing qualitative information about a select number of drug classes. Because of these restrictions, clinicians should understand that immunoassay screens have high false-positive and false-negative rates. Despite these limitations, though, the results can assist the clinician with making preliminary treatment decisions. In comparison, a confirmatory urine drug test, which can only be performed as a laboratory-based test, has a lower threshold of detectability and provides both qualitative and quantitative information. A urine drug test's greater degree of specificity allows for a relatively low false-negative and false-positive rate in contrast to an immunoassay screen. Like any other diagnostic test, an immunoassay screen and a confirmatory urine drug test both possess limitations. Clinicians must keep this in mind when interpreting an unexpected test result and consult with their laboratory when in doubt about the meaning of the test result to avoid making erroneous decisions that negatively impact both the patient and clinician.

  11. Pharmacogenetics and Predictive Testing of Drug Hypersensitivity Reactions.

    Science.gov (United States)

    Böhm, Ruwen; Cascorbi, Ingolf

    2016-01-01

    Adverse drug reactions adverse drug reaction (ADR) occur in approximately 17% of patients. Avoiding ADR is thus mandatory from both an ethical and an economic point of view. Whereas, pharmacogenetics changes of the pharmacokinetics may contribute to the explanation of some type A reactions, strong relationships of genetic markers has also been shown for drug hypersensitivity belonging to type B reactions. We present the classifications of ADR, discuss genetic influences and focus on delayed-onset hypersensitivity reactions, i.e., drug-induced liver injury, drug-induced agranulocytosis, and severe cutaneous ADR. A guidance how to read and interpret the contingency table is provided as well as an algorithm whether and how a test for a pharmacogenetic biomarker should be conducted.

  12. Swift and Certain, Proportionate and Consistent: Key Values of Urine Drug Test Consequences for Probationers.

    Science.gov (United States)

    Cadwallader, Amy B

    2017-09-01

    Traditionally, urine drug testing (UDT) in the correctional population (both prison and community corrections) has been infrequent, is scheduled, and has a high possibility of delayed results. Of practical relevance is that scheduled testing is ineffective for identifying drug misuse. Of ethical relevance is that consequences of positive scheduled tests can be unpredictable-in the form of overly severe punishment or a lack of treatment options-and that the scheduled testing paradigm is a poor way to change behaviors. More innovative programs now use a UDT paradigm with more frequent, random testing providing rapid results and certain, swift consequences and addiction treatment when warranted or requested. Studies have shown these new programs-the foundation of which is frequent, random UDTs-to significantly reduce drug use, criminal recidivism, and incarceration. © 2017 American Medical Association. All Rights Reserved.

  13. 77 FR 2606 - Pipeline Safety: Random Drug Testing Rate

    Science.gov (United States)

    2012-01-18

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID PHMSA-2012-0004] Pipeline Safety: Random Drug Testing Rate AGENCY: Pipeline and Hazardous Materials... pipelines and operators of liquefied natural gas facilities must select and test a percentage of covered...

  14. 75 FR 9018 - Pipeline Safety: Random Drug Testing Rate

    Science.gov (United States)

    2010-02-26

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID PHMSA-2010-0034] Pipeline Safety: Random Drug Testing Rate AGENCY: Pipeline and Hazardous Materials... pipelines and operators of liquefied natural gas facilities must select and test a percentage of covered...

  15. Sports drug testing using complementary matrices: Advantages and limitations.

    Science.gov (United States)

    Thevis, Mario; Geyer, Hans; Tretzel, Laura; Schänzer, Wilhelm

    2016-10-25

    Today, routine doping controls largely rely on testing whole blood, serum, and urine samples. These matrices allow comprehensively covering inorganic as well as low and high molecular mass organic analytes relevant to doping controls and are collecting and transferring from sampling sites to accredited anti-doping laboratories under standardized conditions. Various aspects including time and cost-effectiveness as well as intrusiveness and invasiveness of the sampling procedure but also analyte stability and breadth of the contained information have been motivation to consider and assess values potentially provided and added to modern sports drug testing programs by alternative matrices. Such alternatives could be dried blood spots (DBS), dried plasma spots (DPS), oral fluid (OF), exhaled breath (EB), and hair. In this review, recent developments and test methods concerning these alternative matrices and expected or proven contributions as well as limitations of these specimens in the context of the international anti-doping fight are presented and discussed, guided by current regulations for prohibited substances and methods of doping as established by the World Anti-Doping Agency (WADA). Focusing on literature published between 2011 and 2015, examples for doping control analytical assays concerning non-approved substances, anabolic agents, peptide hormones/growth factors/related substances and mimetics, β 2 -agonists, hormone and metabolic modulators, diuretics and masking agents, stimulants, narcotics, cannabinoids, glucocorticoids, and beta-blockers were selected to outline the advantages and limitations of the aforementioned alternative matrices as compared to conventional doping control samples (i.e. urine and blood/serum). Copyright © 2016 Elsevier B.V. All rights reserved.

  16. Reliability, Validity and Factor Structure of Drug Abuse Screening Test

    OpenAIRE

    Sayed Hadi Sayed Alitabar; Mojtaba Habibi; Maryam Falahatpisheh; Musa Arvin

    2016-01-01

    Background and Objective: According to the increasing of substance use in the country, more researches about this phenomenon are necessary. This Study Investigates the Validity, Reliability and Confirmatory Factor Structure of the Drug Abuse Screening test (DAST). Materials and Methods: The Sample Consisted of 381 Patients (143 Women and 238 Men) with a Multi-Stage Cluster Sampling of Areas 2, 6 and 12 of Tehran Were Selected from Each Region, 6 Randomly Selected Drug Rehabilitation Center. T...

  17. 'Worth the test?' Pragmatism, pill testing and drug policy in Australia.

    Science.gov (United States)

    Groves, Andrew

    2018-04-10

    Recent deaths of young Australian music festival attendees from 'party-drug' overdoses have sparked debate about the effectiveness of drug policies. Australia is widely lauded for its harm minimisation approach to drugs, and yet, over the last 30 years, it can be argued its policies have been fragmented, sometimes inconsistent and contradictory. The present article examines the root of this inconsistency, using it as a foundation to advocate for drug policy reform. In keeping with the goals of the National Drug Strategy to promote policy innovation, there is an opportunity to learn from international studies which have shown promising findings in the reduction of party-drug use and its harms through application of pill testing. This paper evaluates Australia's National Drug Strategy and pill testing through a lens of pragmatism, to determine whether there is space for testing practices in contemporary policy. Specifically, the paper analyses current drug policy literature and research studies, examining a range of key drug use indicators, social and political debate and research evidence. The need for policy reform, attitudinal and cultural shifts and development of stronger cross-sectoral partnerships is highlighted, to ensure a rational and logical approach that genuinely tackles drug policy-making and strategy from a broad public health perspective. Using a theoretical frame of pragmatism and drawing from national and international research evidence, this paper recommends the integration of pill testing into Australia's harm minimisation strategy.

  18. Oral fluid drug tests: effects of adulterants and foodstuffs.

    Science.gov (United States)

    Wong, Raphael C; Tran, Minhchau; Tung, James K

    2005-06-10

    An on-site oral fluid drug screen, Oratect, was used to investigate the effects of adulterants and foodstuffs on oral fluid test results. Common foods, beverages, food ingredients, cosmetics and hygienic products were demonstrated not to cause false positive results when tested 30 min after their consumption. Evaluations of two commercial oral fluid adulterants, "Clear Choice Fizzy Flush" and "Test'in Spit n Kleen Mouthwash" suggest their mechanism of action is the clearing of residual drugs of abuse compounds through rinsing of the oral cavity. They do not directly destroy the drug compounds or change the pH of the oral fluid. It is also suggested that a common mouthwash would perform similar action.

  19. 49 CFR 219.701 - Standards for drug and alcohol testing.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Standards for drug and alcohol testing. 219.701... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Drug and Alcohol Testing Procedures § 219.701 Standards for drug and alcohol testing. (a) Drug testing required or authorized by subparts B...

  20. Microbial sensor for drug susceptibility testing of Mycobacterium tuberculosis.

    Science.gov (United States)

    Zhang, Z-T; Wang, D-B; Li, C-Y; Deng, J-Y; Zhang, J-B; Bi, L-J; Zhang, X-E

    2018-01-01

    Drug susceptibility testing (DST) of clinical isolates of Mycobacterium tuberculosis is critical in treating tuberculosis. We demonstrate the possibility of using a microbial sensor to perform DST of M. tuberculosis and shorten the time required for DST. The sensor is made of an oxygen electrode with M. tuberculosis cells attached to its surface. This sensor monitors the residual oxygen consumption of M. tuberculosis cells after treatment with anti-TB drugs with glycerine as a carbon source. In principle, after drug pretreatment for 4-5 days, the response differences between the sensors made of drug-sensitive isolates are distinguishable from the sensors made of drug-resistant isolates. The susceptibility of the M. tuberculosis H37Ra strain, its mutants and 35 clinical isolates to six common anti-TB drugs: rifampicin, isoniazid, streptomycin, ethambutol, levofloxacin and para-aminosalicylic acid were tested using the proposed method. The results agreed well with the gold standard method (LJ) and were determined in significantly less time. The whole procedure takes approximately 11 days and therefore has the potential to inform clinical decisions. To our knowledge, this is the first study that demonstrates the possible application of a dissolved oxygen electrode-based microbial sensor in M. tuberculosis drug resistance testing. This study used the microbial sensor to perform DST of M. tuberculosis and shorten the time required for DST. The overall detection result of the microbial sensor agreed well with that of the conventional LJ proportion method and takes less time than the existing phenotypic methods. In future studies, we will build an O 2 electrode array microbial sensor reactor to enable a high-throughput drug resistance analysis. © 2017 The Authors. Journal of Applied Microbiology published by John Wiley & Sons Ltd on behalf of The Society for Applied Microbiology.

  1. Growing pains : how drug testing keeps workers and assets safe in a booming oil patch

    Energy Technology Data Exchange (ETDEWEB)

    Paulgaard, T S

    2006-06-15

    Drug abuse has become a subject of concern to the oil and gas industry, where mistakes in the operation of large machines can result in injury, death and the loss of millions of dollars. Pre-employment urine tests are becoming standard procedure in the oil field. Many supervisors refuse to let employees start work without a clear test. Urine samples are tested for the presence of cannabis, cocaine, opiates, amphetamines and phencyclidine. When a worker is injured or killed on the job, or after an uncommon error that causes significant damage, all parties involved are tested as soon as possible and a receipt of the results are expedited. The Alberta Human Rights and Citizenship Commission is now addressing the issue of drug testing, and has ascertained that drug and alcohol testing are only allowable in certain circumstances, and that it is discriminatory to test potential or existing employees for drug and alcohol use if the testing is not reasonable or justifiable. They have also suggested that there is a duty to accommodate persons with disabilities in the workplace. Drug and alcohol dependency fall within the meaning of disabled. Under the Construction Owner's Association of Alberta's Canadian Model for a Safe Workplace, testing must work in concert with treatment. Current employees are directed to seek help via an employee assistant plan. Workers and supervisors report that drug use is rampant in work camps. Industry-wide, fail rates for those who take part in drug testing are quoted by experts as ranging from between 2 to 14 per cent. 2 figs.

  2. Growing pains : how drug testing keeps workers and assets safe in a booming oil patch

    Energy Technology Data Exchange (ETDEWEB)

    Paulgaard, T.S.

    2006-06-15

    Drug abuse has become a subject of concern to the oil and gas industry, where mistakes in the operation of large machines can result in injury, death and the loss of millions of dollars. Pre-employment urine tests are becoming standard procedure in the oil field. Many supervisors refuse to let employees start work without a clear test. Urine samples are tested for the presence of cannabis, cocaine, opiates, amphetamines and phencyclidine. When a worker is injured or killed on the job, or after an uncommon error that causes significant damage, all parties involved are tested as soon as possible and a receipt of the results are expedited. The Alberta Human Rights and Citizenship Commission is now addressing the issue of drug testing, and has ascertained that drug and alcohol testing are only allowable in certain circumstances, and that it is discriminatory to test potential or existing employees for drug and alcohol use if the testing is not reasonable or justifiable. They have also suggested that there is a duty to accommodate persons with disabilities in the workplace. Drug and alcohol dependency fall within the meaning of disabled. Under the Construction Owner's Association of Alberta's Canadian Model for a Safe Workplace, testing must work in concert with treatment. Current employees are directed to seek help via an employee assistant plan. Workers and supervisors report that drug use is rampant in work camps. Industry-wide, fail rates for those who take part in drug testing are quoted by experts as ranging from between 2 to 14 per cent. 2 figs.

  3. In vitro pyrogen test for toxic or immunomodulatory drugs.

    Science.gov (United States)

    Daneshian, Mardas; Guenther, Armin; Wendel, Albrecht; Hartung, Thomas; von Aulock, Sonja

    2006-06-30

    Pyrogenic contaminations of some classes of injectable drugs, e.g. toxic or immunomodulatory as well as false-positive drugs, represent a major risk which cannot yet be excluded due to the limitations of current tests. Here we describe a modification of the In vitro Pyrogen Test termed AWIPT (Adsorb, Wash, In vitro Pyrogen Test), which addresses this problem by introducing a pre-incubation step in which pyrogenic contaminations in the test sample are adsorbed to albumin-coated beads. After rinsing, the beads are incubated with human whole blood and the release of the endogenous pyrogen interleukin-1beta is measured as a marker of pyrogenic activity. Intentional contaminations with lipopolysaccharide were retrieved from the chemotherapeutic agents paclitaxel, cisplatin and liposomal daunorubicin, the antibiotic gentamicin, the antifungal agent liposomal amphotericin B, and the corticosteroid prednisolone at lower dilutions than in the standard in vitro pyrogen test. This represents a promising new approach for the detection of pyrogenic contamination in drugs or in drugs containing interfering additives and should lead to improved safety levels.

  4. Patch testing in non-immediate cutaneous adverse drug reactions: value of extemporaneous patch tests.

    Science.gov (United States)

    Assier, Haudrey; Valeyrie-Allanore, Laurence; Gener, Gwendeline; Verlinde Carvalh, Muriel; Chosidow, Olivier; Wolkenstein, Pierre

    2017-11-01

    Patch testing following a standardized protocol is reliable for identifying the culprit drug in cutaneous adverse drug reactions (CADRs). However, these patch tests (PTs) require pharmaceutical material and staff, which are not always easily available. To evaluate an extemporaneous PT method in CADRs. We retrospectively analysed data for all patients referred to our department between March 2009 and June 2013 for patch testing after a non-immediate CADR. The patients who supplied their own suspected drugs were tested both with extemporaneous PTs and with conventional PTs. Extemporaneous PTs involved a nurse crushing and diluting the drug in pet. in a ratio of approximately one-third to two-thirds. Standardized PTs were performed according to guidelines, with commercial drugs diluted to 30% or with active ingredients diluted to 10%. We analysed the data for the two PT methods in terms of the number of positive test reactions, drugs tested, and type of CADR for patients in whom the two PT methods were used. In total, 75 of 156 patients underwent the two PT procedures, including 91 double tests. Overall, 21 tests gave positive reactions with the two methods, and 69 other tests gave negative results with the two methods. Our series yielded results similar to those of published series concerning the types of CADR and the drugs responsible. Our results suggest that, for CADRs, if a patient supplies a suspected drug but if the pharmaceutical material and staff are not available for conventional PTs, extemporaneous PTs performed by the nurse with the commercial drug used by the patient can be useful and reliable. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  5. 3D printed drug delivery and testing systems - a passing fad or the future?

    Science.gov (United States)

    Lim, Seng Han; Kathuria, Himanshu; Tan, Justin Jia Yao; Kang, Lifeng

    2018-05-18

    The US Food and Drug Administration approval of the first 3D printed tablet in 2015 has ignited growing interest in 3D printing, or additive manufacturing (AM), for drug delivery and testing systems. Beyond just a novel method for rapid prototyping, AM provides key advantages over traditional manufacturing of drug delivery and testing systems. These includes the ability to fabricate complex geometries to achieve variable drug release kinetics; ease of personalising pharmacotherapy for patient and lowering the cost for fabricating personalised dosages. Furthermore, AM allows fabrication of complex and micron-sized tissue scaffolds and models for drug testing systems that closely resemble in vivo conditions. However, there are several limitations such as regulatory concerns that may impede the progression to market. Here, we provide an overview of the advantages of AM drug delivery and testing, as compared to traditional manufacturing techniques. Also, we discuss the key challenges and future directions for AM enabled pharmaceutical applications. Copyright © 2018 Elsevier B.V. All rights reserved.

  6. Skin test concentrations for systemically administered drugs -- an ENDA/EAACI Drug Allergy Interest Group position paper

    NARCIS (Netherlands)

    Brockow, K.; Garvey, L. H.; Aberer, W.; Atanaskovic-Markovic, M.; Barbaud, A.; Bilo, M. B.; Bircher, A.; Blanca, M.; Bonadonna, B.; Campi, P.; Castro, E.; Cernadas, J. R.; Chiriac, A. M.; Demoly, P.; Grosber, M.; Gooi, J.; Lombardo, C.; Mertes, P. M.; Mosbech, H.; Nasser, S.; Pagani, M.; Ring, J.; Romano, A.; Scherer, K.; Schnyder, B.; Testi, S.; Torres, M.; Trautmann, A.; Terreehorst, I.

    2013-01-01

    Skin tests are of paramount importance for the evaluation of drug hypersensitivity reactions. Drug skin tests are often not carried out because of lack of concise information on specific test concentrations. The diagnosis of drug allergy is often based on history alone, which is an unreliable

  7. In Vitro Drug Sensitivity Tests to Predict Molecular Target Drug Responses in Surgically Resected Lung Cancer.

    Directory of Open Access Journals (Sweden)

    Ryohei Miyazaki

    Full Text Available Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs and anaplastic lymphoma kinase (ALK inhibitors have dramatically changed the strategy of medical treatment of lung cancer. Patients should be screened for the presence of the EGFR mutation or echinoderm microtubule-associated protein-like 4 (EML4-ALK fusion gene prior to chemotherapy to predict their clinical response. The succinate dehydrogenase inhibition (SDI test and collagen gel droplet embedded culture drug sensitivity test (CD-DST are established in vitro drug sensitivity tests, which may predict the sensitivity of patients to cytotoxic anticancer drugs. We applied in vitro drug sensitivity tests for cyclopedic prediction of clinical responses to different molecular targeting drugs.The growth inhibitory effects of erlotinib and crizotinib were confirmed for lung cancer cell lines using SDI and CD-DST. The sensitivity of 35 cases of surgically resected lung cancer to erlotinib was examined using SDI or CD-DST, and compared with EGFR mutation status.HCC827 (Exon19: E746-A750 del and H3122 (EML4-ALK cells were inhibited by lower concentrations of erlotinib and crizotinib, respectively than A549, H460, and H1975 (L858R+T790M cells were. The viability of the surgically resected lung cancer was 60.0 ± 9.8 and 86.8 ± 13.9% in EGFR-mutants vs. wild types in the SDI (p = 0.0003. The cell viability was 33.5 ± 21.2 and 79.0 ± 18.6% in EGFR mutants vs. wild-type cases (p = 0.026 in CD-DST.In vitro drug sensitivity evaluated by either SDI or CD-DST correlated with EGFR gene status. Therefore, SDI and CD-DST may be useful predictors of potential clinical responses to the molecular anticancer drugs, cyclopedically.

  8. 10 CFR 26.405 - Drug and alcohol testing.

    Science.gov (United States)

    2010-01-01

    ... NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS FFD Program for Construction § 26.405 Drug and..., as defined in § 26.5; (3) Post-accident. As soon as practical after an event involving a human error... contributed to the accident. The licensee or other entity shall test the individual(s) who committed the error...

  9. Effect of drugs on the thyroid function tests

    International Nuclear Information System (INIS)

    Cardoso, G.P.; Faria, A.C.S. de; Carvalho, M.C. de; Guimaraes, M.M.; Cordeiro, J.G.H.; Santa Casa do Rio de Janeiro

    1984-01-01

    The effects of drugs in the results of thyroid function tests, which could lead to misinterpretation of the real clinical state of the patients, are reviewed. The aspects of the metabolism of the thyreoidean hormones which could be related to these alterations are presented. (Author) [pt

  10. NCAA Drug-Testing Program 2010-11

    Science.gov (United States)

    National Collegiate Athletic Association (NJ1), 2010

    2010-01-01

    The National Collegiate Athletic Association (NCAA) Drug-Testing Program was created to protect the health and safety of student-athletes and to ensure that no one participant might have an artificially induced advantage or be pressured to use chemical substances. This publication describes this program in the following chapters: (1) NCAA…

  11. Development and evaluation of accelerated drug release testing methods for a matrix-type intravaginal ring.

    Science.gov (United States)

    Externbrink, Anna; Eggenreich, Karin; Eder, Simone; Mohr, Stefan; Nickisch, Klaus; Klein, Sandra

    2017-01-01

    Accelerated drug release testing is a valuable quality control tool for long-acting non-oral extended release formulations. Currently, several intravaginal ring candidates designed for the long-term delivery of steroids or anti-infective drugs are being in the developing pipeline. The present article addresses the demand for accelerated drug release methods for these formulations. We describe the development and evaluation of accelerated release methods for a steroid releasing matrix-type intravaginal ring. The drug release properties of the formulation were evaluated under real-time and accelerated test conditions. Under real-time test conditions drug release from the intravaginal ring was strongly affected by the steroid solubility in the release medium. Under sufficient sink conditions that were provided in release media containing surfactants drug release was Fickian diffusion driven. Both temperature and hydro-organic dissolution media were successfully employed to accelerate drug release from the formulation. Drug release could be further increased by combining the temperature effect with the application of a hydro-organic release medium. The formulation continued to exhibit a diffusion controlled release kinetic under the investigated accelerated conditions. Moreover, the accelerated methods were able to differentiate between different prototypes of the intravaginal ring that exhibited different release profiles under real-time test conditions. Overall, the results of the present study indicate that both temperature and hydro-organic release media are valid parameters for accelerating drug release from the intravaginal ring. Variation of either a single or both parameters yielded release profiles that correlated well with real-time release. Copyright © 2016 Elsevier B.V. All rights reserved.

  12. Development of immunotoxicity testing strategies for immunomodulatory drugs.

    Science.gov (United States)

    Kawabata, Thomas T; Evans, Ellen W

    2012-01-01

    The ICH S8 immunotoxicity testing guideline for human pharmaceuticals was published in 2006 and was intended to provide guidance for assessing the immunotoxicity potential of low-molecular-weight drugs that are not intended to alter the immune system. For drugs intended to modulate the immune system, immunotoxicity testing strategies are generally developed on a case-by-case approach since the targets, intended patient population, and mechanisms of action of the test compound will determine the type of testing needed. Some of the general principles of ICH S8, however, may be applied to immunotoxicity testing strategies for immunomodulatory drugs. A weight-of-evidence approach using factors discussed in ICH S8 in concert with an assessment of the potential value of additional immunotoxicity testing should be considered. For most situations, immunotoxicity studies with immunomodulatory compounds evaluate off-target effects on the immune system and exaggerated pharmacology. The potential use of data from these studies and considerations such as translatability to humans are discussed.

  13. Urine specimen validity test for drug abuse testing in workplace and court settings.

    Science.gov (United States)

    Lin, Shin-Yu; Lee, Hei-Hwa; Lee, Jong-Feng; Chen, Bai-Hsiun

    2018-01-01

    In recent decades, urine drug testing in the workplace has become common in many countries in the world. There have been several studies concerning the use of the urine specimen validity test (SVT) for drug abuse testing administered in the workplace. However, very little data exists concerning the urine SVT on drug abuse tests from court specimens, including dilute, substituted, adulterated, and invalid tests. We investigated 21,696 submitted urine drug test samples for SVT from workplace and court settings in southern Taiwan over 5 years. All immunoassay screen-positive urine specimen drug tests were confirmed by gas chromatography/mass spectrometry. We found that the mean 5-year prevalence of tampering (dilute, substituted, or invalid tests) in urine specimens from the workplace and court settings were 1.09% and 3.81%, respectively. The mean 5-year percentage of dilute, substituted, and invalid urine specimens from the workplace were 89.2%, 6.8%, and 4.1%, respectively. The mean 5-year percentage of dilute, substituted, and invalid urine specimens from the court were 94.8%, 1.4%, and 3.8%, respectively. No adulterated cases were found among the workplace or court samples. The most common drug identified from the workplace specimens was amphetamine, followed by opiates. The most common drug identified from the court specimens was ketamine, followed by amphetamine. We suggest that all urine specimens taken for drug testing from both the workplace and court settings need to be tested for validity. Copyright © 2017. Published by Elsevier B.V.

  14. 'False-positive' and 'false-negative' test results in clinical urine drug testing.

    Science.gov (United States)

    Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L

    2009-08-01

    The terms 'false-positive' and 'false-negative' are widely used in discussions of urine drug test (UDT) results. These terms are inadequate because they are used in different ways by physicians and laboratory professionals and they are too narrow to encompass the larger universe of potentially misleading, inappropriate and unexpected drug test results. This larger universe, while not solely comprised of technically 'true' or 'false' positive or negative test results, presents comparable interpretive challenges with corresponding clinical implications. In this review, we propose the terms 'potentially inappropriate' positive or negative test results in reference to UDT results that are ambiguous or unexpected and subject to misinterpretation. Causes of potentially inappropriate positive UDT results include in vivo metabolic conversions of a drug, exposure to nonillicit sources of a drug and laboratory error. Causes of potentially inappropriate negative UDT results include limited assay specificity, absence of drug in the urine, presence of drug in the urine, but below established assay cutoff, specimen manipulation and laboratory error. Clinical UDT interpretation is a complicated task requiring knowledge of recent prescription, over-the-counter and herbal drug administration, drug metabolism and analytical sensitivities and specificities.

  15. 49 CFR 40.13 - How do DOT drug and alcohol tests relate to non-DOT tests?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false How do DOT drug and alcohol tests relate to non... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Employer Responsibilities § 40.13 How do DOT drug and... non-DOT drug and alcohol testing programs. This prohibition includes the use of the DOT forms with...

  16. Comparison of Urine and Oral Fluid for Workplace Drug Testing.

    Science.gov (United States)

    Casolin, Armand

    2016-09-01

    To determine the relative detection rates of urine versus oral fluid testing in a safety sensitive industry and the correlation with diagnosed substance use disorders and possible impairment at work. The trial involved 1,500 paired urine and oral fluid tests performed in accordance with Australian Standard/New Zealand Standard (AS/NZS) 4308:2008 and AS 4760:2006. Workers who returned a positive test were screened for substance use disorders, as defined by DSM-5, and for possible impairment at work following that particular episode of substance use. Substances were detected in 3.7% (n = 56) of urine samples and 0.5% (n = 8) of oral fluid samples (p < 0.0001). One worker (0.07%) had a substance detected on oral fluid alone versus 49 workers (3.3%) who had substances detected on urine alone. Twelve workers returned a positive result, defined as being consistent with the use of an illicit drug or a controlled substance without a clinical indication and prescription. Nine workers tested positive on urine alone, one on oral fluid alone and two on both (p = 0.0114). Of note, 6/11 workers who tested positive on urine had possible impairment at work and 2/11 had a substance use disorder versus 2/3 and 0/3, respectively, who tested positive on oral fluid. Urine drug testing performed in accordance with AS/NZS 4308:2008 is more likely to detect overall substance use and illicit drug use than oral fluid testing conducted in accordance with AS 4760:2006. Urine testing performed in accordance with AS/NZS 4308:2008 may also be more likely to detect workers with possible impairment at work and substance use disorders than oral fluid testing performed in accordance with AS 4760:2006. © The Author 2016. Published by Oxford University Press.

  17. Current status of accreditation for drug testing in hair.

    Science.gov (United States)

    Cooper, Gail; Moeller, Manfred; Kronstrand, Robert

    2008-03-21

    At the annual meeting of the Society of Hair Testing in Vadstena, Sweden in 2006, a committee was appointed to address the issue of guidelines for hair testing and to assess the current status of accreditation amongst laboratories offering drug testing in hair. A short questionnaire was circulated amongst the membership and interested parties. Fifty-two responses were received from hair testing laboratories providing details on the amount and type of hair tests they offered and the status of accreditation within their facilities. Although the vast majority of laboratories follow current guidelines (83%), only nine laboratories were accredited to ISO/IEC 17025 for hair testing. A significant number of laboratories reporting that they were in the process of developing quality systems with a view to accrediting their methods within 2-3 years. This study provides an insight into the status of accreditation in hair testing laboratories and supports the need for guidelines to encourage best practice.

  18. Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives.

    Science.gov (United States)

    Bansal, Gulshan; Suthar, Nancy; Kaur, Jasmeen; Jain, Astha

    2016-07-01

    Stability testing is an important component of herbal drugs and products (HDPs) development process. Drugs regulatory agencies across the globe have recommended guidelines for the conduct of stability studies on HDPs, which require that stability data should be included in the product registration dossier. From the scientific viewpoint, numerous chemical constituents in an herbal drug are liable to varied chemical reactions under the influence of different conditions during its shelf life. These reactions can lead to altered chemical composition of HDP and consequently altered therapeutic profile. Many reports on stability testing of HDPs have appeared in literature since the last 10 years. A review of these reports reveals that there is wide variability in temperature (-80 to 100 °C), humidity (0-100%) and duration (a few hours-36 months) for stability assessment of HDPs. Of these, only 1% studies are conducted in compliance with the regulatory guidelines for stability testing. The present review is aimed at compiling all stability testing reports, understanding key challenges in stability testing of HDPs and suggesting possible solutions for these. The key challenges are classified as chemical complexity and biochemical composition variability in raw material, selection of marker(s) and influences of enzymes. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  19. HIV resistance testing and detected drug resistance in Europe

    DEFF Research Database (Denmark)

    Schultze, Anna; Phillips, Andrew N; Paredes, Roger

    2015-01-01

    to Southern Europe. CONCLUSIONS: Despite a concurrent decline in virological failure and testing, drug resistance was commonly detected. This suggests a selective approach to resistance testing. The regional differences identified indicate that policy aiming to minimize the emergence of resistance......OBJECTIVES: To describe regional differences and trends in resistance testing among individuals experiencing virological failure and the prevalence of detected resistance among those individuals who had a genotypic resistance test done following virological failure. DESIGN: Multinational cohort...... study. METHODS: Individuals in EuroSIDA with virological failure (>1 RNA measurement >500 on ART after >6 months on ART) after 1997 were included. Adjusted odds ratios (aORs) for resistance testing following virological failure and aORs for the detection of resistance among those who had a test were...

  20. 49 CFR 40.205 - How are drug test problems corrected?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false How are drug test problems corrected? 40.205 Section 40.205 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests § 40.205 How are drug test problems...

  1. Establishing a compulsory drug treatment prison: Therapeutic policy, principles, and practices in addressing offender rights and rehabilitation.

    Science.gov (United States)

    Birgden, Astrid; Grant, Luke

    2010-01-01

    A Compulsory Drug Treatment Correctional Center (CDTCC) was established in Australia in 2006 for repeat drug-related male offenders. Compulsory treatment law is inconsistent with a therapeutic jurisprudence approach. Despite the compulsory law, a normative offender rehabilitation framework has been established based on offender moral rights. Within moral rights, the offender rehabilitation framework addresses the core values of freedom (supporting autonomous decision-making) and well-being (supporting support physical, social, and psychological needs). Moral rights are underpinned by a theory or principle which, in this instance, is a humane approach to offender rehabilitation. While a law that permits offenders to choose drug treatment and rehabilitation is preferable, the article discusses the establishment of a prison based on therapeutic policy, principles, and practices that respond to participants as both rights-violators and rights-holders. The opportunity for accelerated community access and a therapeutic alliance with staff has resulted in offenders actively seeking to be ordered into compulsory drug treatment and rehabilitation. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

  2. Rapid drug susceptibility test of mycobacterium tuberculosis by bioluminescence sensor

    Science.gov (United States)

    Lu, Bin; Xu, Shunqing; Chen, Zifei; Zhou, Yikai

    2001-09-01

    With the persisting increase of drug-resistant stains of M. Tuberculosis around the world, rapid and sensitive detection of antibiotic of M. Tuberculosis is becoming more and more important. In the present study, drug susceptibility of M. tuberculosis were detected by recombination mycobacteriophage combined with bioluminescence sensor. It is based on the use of recombination mycobacteriophage which can express firefly luciferase when it infects viable mycobacteria, and can effectively produce quantifiable photon. Meanwhile, in mycobacterium cells treated with active antibiotic, no light is observed. The emitted light is recorded by a bioluminscence sensor, so the result of drug-resistant test can be determined by the naked eye. 159 stains of M. tuberculosis were applied to this test on their resistant to rifampin, streptomycin and isoniazid. It is found that the agreement of this assay with Liewenstein- Jensen slat is: rifampin 95.60 percent, isoniazid 91.82 percent, streptomycin 88.68 percent, which showed that it is a fast and practical method to scene and detect drug resistant of mycobacterium stains.

  3. Not to catch but to deter : simple, less intrusive drug and alcohol tests can improve workplace safety

    Energy Technology Data Exchange (ETDEWEB)

    Stastny, P.

    2009-04-15

    Canadian employees who test positive for drug use have access to a wide range of substance counselling and rehabilitation options. As a result of Canadian human right legislation, drug dependence is considered a disability, and Canadian employers are required to accommodate the employee and retain their position when they are deemed fit for work. While Alberta is considered an employee-friendly province, the oil and gas industry has significant hazards that require a lucid and attentive workforce. As a result, Alberta courts approved pre-employment drug testing in a recent court case. The decision involved an employee who tested positive for traces of marijuana. After being fired, the employee filed a complaint. Although the Queen's Bench decided in favour of the employee, the Alberta Court of Appeal stated that the company's pre-employment drug testing policy did not discriminate against the employee on the basis of a disability. Drug use amongst construction workers and employees in the energy industry has now reached upwards of 24 per cent. While urine testing is a commonly used drug testing method, oral fluid testing is now being more widely adopted in industry. Oral fluids can be used to detect recent drug and alcohol use rather than historical use and can be conducted in the presence of a test administrator. It was concluded that the aim of drug and alcohol testing is to deter substance abuse on the job. 3 figs.

  4. 76 FR 18072 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

    Science.gov (United States)

    2011-04-01

    ... Workplace Drug and Alcohol Testing Programs CFR Correction In Title 49 of the Code of Federal Regulations...) * * * (2) * * * (i) Positive, with drug(s)/metabolite(s) noted, with numerical values for the drug(s) or drug metabolite(s). (ii) Positive-dilute, with drug(s)/metabolite(s) noted, with numerical values for...

  5. Hair Testing for Drugs of Abuse and New Psychoactive Substances in a High-Risk Population.

    Science.gov (United States)

    Salomone, Alberto; Palamar, Joseph J; Gerace, Enrico; Di Corcia, Daniele; Vincenti, Marco

    2017-06-01

    Hundreds of new psychoactive substances (NPS) have emerged in the drug market over the last decade. Few drug surveys in the USA, however, ask about use of NPS, so prevalence and correlates of use are largely unknown. A large portion of NPS use is unintentional or unknown as NPS are common adulterants in drugs like ecstasy/Molly, and most NPS are rapidly eliminated from the body, limiting efficacy of urine, blood and saliva testing. We utilized a novel method of examining prevalence of NPS use in a high-risk population utilizing hair-testing. Hair samples from high-risk nightclub and dance music attendees were tested for 82 drugs and metabolites (including NPS) using ultra-high performance liquid chromatography-tandem mass spectrometry. Eighty samples collected from different parts of the body were analyzed, 57 of which detected positive for at least one substance-either a traditional or new drug. Among these, 26 samples tested positive for at least one NPS-the most common being butylone (25 samples). Other new drugs detected include methylone, methoxetamine, 5/6-APB, α-PVP and 4-FA. Hair analysis proved a powerful tool to gain objective biological drug-prevalence information, free from possible biases of unintentional or unknown intake and untruthful reporting of use. Such testing can be used actively or retrospectively to validate survey responses and inform research on consumption patterns, including intentional and unknown use, polydrug-use, occasional NPS intake and frequent or heavy use. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  6. Olodaterol and vilanterol detection in sport drug testing.

    Science.gov (United States)

    Chundela, Zdenek; Große, Joachim

    2015-01-01

    The possibility of the detection of olodaterol and vilanterol, two novel β2 -agonists, in human urine for the purpose of sport drug testing was investigated. Compounds of interest were analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) employing methods commonly used in the World Anti-Doping Agency (WADA) accredited laboratories. For both substances, the respective parent compound was found to be a suitable target analyte for monitoring therapeutic dose administration. Copyright © 2015 John Wiley & Sons, Ltd.

  7. The Rights and Responsibility of Test Takers When Large-Scale Testing Is Used for Classroom Assessment

    Science.gov (United States)

    van Barneveld, Christina; Brinson, Karieann

    2017-01-01

    The purpose of this research was to identify conflicts in the rights and responsibility of Grade 9 test takers when some parts of a large-scale test are marked by teachers and used in the calculation of students' class marks. Data from teachers' questionnaires and students' questionnaires from a 2009-10 administration of a large-scale test of…

  8. Reliability, Validity and Factor Structure of Drug Abuse Screening Test

    Directory of Open Access Journals (Sweden)

    Sayed Hadi Sayed Alitabar

    2016-05-01

    Full Text Available Background and Objective: According to the increasing of substance use in the country, more researches about this phenomenon are necessary. This Study Investigates the Validity, Reliability and Confirmatory Factor Structure of the Drug Abuse Screening test (DAST. Materials and Methods: The Sample Consisted of 381 Patients (143 Women and 238 Men with a Multi-Stage Cluster Sampling of Areas 2, 6 and 12 of Tehran Were Selected from Each Region, 6 Randomly Selected Drug Rehabilitation Center. The DAST Was Used as Instrument. Divergent & Convergent Validity of this Scale Was Assessed with Problems Assessment for Substance Using Psychiatric Patients (PASUPP and Relapse Prediction Scale (RPS.Results: The DAST after the First Time Factor Structure of Using Confirmatory Factor Analysis Was Confirmed. The DAST Had a Good Internal Consistency (Cranach’s Alpha, and the Reliability of the Test Within a Week, 0.9, 0.8. Also this Scale Had a Positive Correlation with Problems Assessment for Substance Using Psychiatric Patients and Relapse Prediction Scale (P<0.01.Conclusion: The Overall Results Showed that the Drug Abuse Screening Test in Iranian Society Is Valid. It Can Be Said that Self-Report Scale Tool Is Useful for Research Purposes and Addiction.

  9. Monoclonal antibody form and function: manufacturing the right antibodies for treating drug abuse.

    Science.gov (United States)

    Peterson, Eric; Owens, S Michael; Henry, Ralph L

    2006-05-26

    Drug abuse continues to be a major national and worldwide problem, and effective treatment strategies are badly needed. Antibodies are promising therapies for the treatment of medical problems caused by drug abuse, with several candidates in preclinical and early clinical trials. Monoclonal antibodies can be designed that have customized affinity and specificity against drugs of abuse, and because antibodies can be designed in various forms, in vivo pharmacokinetic characteristics can be tailored to suit specific clinical applications (eg, long-acting for relapse prevention, or short-acting for overdose). Passive immunization with antibodies against drugs of abuse has several advantages over active immunization, but because large doses of monoclonal antibodies may be needed for each patient, efficient antibody production technology is essential. In this minireview we discuss some of the antibody forms that may be effective clinical treatments for drug abuse, as well as several current and emerging production systems that could bridge the gap from discovery to patient use.

  10. Diagnosis of drug hypersensitivity: lymphocyte transformation test and cytokines

    International Nuclear Information System (INIS)

    Merk, Hans F.

    2005-01-01

    For all types of allergic reactions including immediate type of reactions, types II and III reactions as well as delayed-type reactions the recognition of the antigen by specifically sensitized T-lymphocytes is a prerequisite. Evidences for the key role of T-lymphocytes in the pathophysiology of allergic drug reactions are positive patch test reactions and the LTT. The proliferative response that can be measured by means of the incorporation of 3H-thymidine during DNA synthesis can be expressed as stimulation index (SI) which is the relation between the cell proliferation with antigen compared without antigen. In addition drug-specific activation of PBMC consistently resulted in IL-5 expression and secretion. The sensitivity of the LTT for the detection of drug sensitization could be improved up to 92% by the measurement of released interleukin-5. The expression and secretion of other cytokines such as IFN-γ and IL-10 was less consistently and had a diagnostic sensitivity of 36 and 50%, respectively. Microarrays are a promising new technical platform to look for better markers which can be used as a read out in the LTT and other similar assays and to study pharmacological interactions between drugs including cytokines such as interferons and the immune system

  11. Segmental hair testing to disclose chronic exposure to psychoactive drugs.

    Science.gov (United States)

    Marchei, Emilia; Palmi, Ilaria; Pichini, Simona; Pacifici, Roberta; Anton Airaldi, Ileana-Rita; Costa Orvay, Juan Antonio; García Serra, Joan; Bonet Serra, Bartolomé; García-Algar, Óscar

    2016-06-15

    This study presents the case of a 4-year-old healthy child admitted to the paediatric ward for suspected accidental intoxication due to ingestion of narcoleptic drugs (methylphenidate, sertraline and quetiapine), taken on a regular basis by his 8-year-old brother affected by Asperger syndrome.Intoxication can be objectively assessed by measurements of drugs and metabolites in biological matrices with short-term (blood and urine) or long-term (hair) detection windows. At the hospital, the child's blood and urine were analysed by immunoassay (confirmed by liquid chromatography-mass spectrometry), and sertraline and quetiapine and their metabolites were identified. The suspicion that the mother administered drugs chronically prompted the analysis of six, consecutive 2-cm segments of the child's hair, using ultra-high performance liquid chromatography-tandem mass spectrometry, thereby accounting for ingestion over the previous 12 months. Quetiapine was found in the first four segments with a mean concentration of 1.00 ng/mg ± 0.94 ng/mg hair while sertraline and its metabolite, desmethyl-sertraline, were found in all segments with a mean concentration of 2.65 ± 0.94 ng/mg and 1.50 ± 0.94 ng/mg hair, respectively. Hair analyses were negative for methylphenidate and its metabolite (ritalinic acid). Biological matrices testing for psychoactive drugs disclosed both acute and chronic intoxication with quetiapine and sertraline administered by the mother.

  12. 10 CFR 707.7 - Random drug testing requirements and identification of testing designated positions.

    Science.gov (United States)

    2010-01-01

    ... contractor, to have the potential to significantly affect the environment, public health and safety, or... evidence of the use of illegal drugs of employees in testing designated positions identified in this... section shall provide for random tests at a rate equal to 30 percent of the total number of employees in...

  13. Prosecution's Power, Procedural Rights, and Pleading Guilty: The Problem of Coercion in Plea Bargaining Drug Cases.

    Science.gov (United States)

    Cloyd, Jerald W.

    1979-01-01

    The forms of psychological pressure placed on the defendant's pleading in drug cases are examined, with emphasis on the interplay between rational and emotional aspects of such situations. Three stages in plea bargaining negotiations are outlined. (Author/MC)

  14. The price may not be right: the value of comparison shopping for prescription drugs.

    Science.gov (United States)

    Arora, Sanjay; Sood, Neeraj; Terp, Sophie; Joyce, Geoffrey

    2017-07-01

    To measure variations in drug prices across and within zip codes that may reveal simple strategies to improve patients' access to prescribed medications. We compared drug prices at different types of pharmacies across and within local markets. In-store prices were compared with a Web-based service providing discount coupons for prescription medications. Prices were collected for 2 generic antibiotics because most patients have limited experience with them and are less likely to know the price ranges for them. Drug prices were obtained via telephone from 528 pharmacies in Los Angeles (LA) County, California, from July to August 2014. Online prices were collected from GoodRx, a popular Web-based service that aggregates available discounts and directly negotiates with retail outlets. Drug prices found at independent pharmacies and by using discount coupons available online were lower on average than at grocery, big-box, or chain drug stores for 2 widely prescribed antibiotics. The lowest-price prescription was offered at a grocery, big-box, or chain drug store in 6% of zip codes within the LA County area. Drug prices varied dramatically within a zip code, however, and were less expensive in lower-income areas. The average price difference within a zip code was $52 for levofloxacin and $17 for azithromycin. Price shopping for medications within a small geographic area can yield considerable cost savings for the uninsured and consumers in high-deductible health plans with high negotiated prices. Clinicians and patient advocates have an incentive to convey this information to patients to improve adherence to prescribed medicines and lower the financial burden of purchasing prescription drugs.

  15. Animal models for testing anti-prion drugs.

    Science.gov (United States)

    Fernández-Borges, Natalia; Elezgarai, Saioa R; Eraña, Hasier; Castilla, Joaquín

    2013-01-01

    Prion diseases belong to a group of fatal infectious diseases with no effective therapies available. Throughout the last 35 years, less than 50 different drugs have been tested in different experimental animal models without hopeful results. An important limitation when searching for new drugs is the existence of appropriate models of the disease. The three different possible origins of prion diseases require the existence of different animal models for testing anti-prion compounds. Wild type, over-expressing transgenic mice and other more sophisticated animal models have been used to evaluate a diversity of compounds which some of them were previously tested in different in vitro experimental models. The complexity of prion diseases will require more pre-screening studies, reliable sporadic (or spontaneous) animal models and accurate chemical modifications of the selected compounds before having an effective therapy against human prion diseases. This review is intended to put on display the more relevant animal models that have been used in the search of new antiprion therapies and describe some possible procedures when handling chemical compounds presumed to have anti-prion activity prior to testing them in animal models.

  16. Can neuropsychological testing produce unequivocal evidence of brain damage? II. Testing for right vs. left differences.

    Science.gov (United States)

    Reitan, Ralph M; Wolfson, Deborah

    2008-01-01

    Sensation and perception, as well as motor functions, have played an important role in the history of psychology. Although tests of these abilities are sometimes included in neuropsychological assessments, comparisons of intraindividual performances on the two sides of the body (as a basis for drawing conclusions and comparisons about the functional status of the two cerebral hemispheres) are in many instances neglected or considered only casually. This study, utilizing several motor and sensory-perceptual tests, compared intraindividual differences on the two sides of the body in a group of controls and a group of persons with brain damage. The results indicated that the sensory-perceptual tests were particularly effective in differentiating the groups. More than 60% of the group with brain damage had greater differences on the two sides of the body than did any of the controls. These findings suggest that a substantial proportion of persons with cerebral disease or damage may be subject to unequivocal identification using sensory-perceptual tests that take only about 20 minutes to administer. These tests may serve a valuable role as an adjunct to comprehensive neuropsychological evaluation and should be further evaluated in this respect.

  17. Skin test concentrations for systemically administered drugs -- an ENDA/EAACI Drug Allergy Interest Group position paper

    DEFF Research Database (Denmark)

    Brockow, K; Garvey, L H; Aberer, W

    2013-01-01

    Skin tests are of paramount importance for the evaluation of drug hypersensitivity reactions. Drug skin tests are often not carried out because of lack of concise information on specific test concentrations. The diagnosis of drug allergy is often based on history alone, which is an unreliable...... indicator of true hypersensitivity.To promote and standardize reproducible skin testing with safe and nonirritant drug concentrations in the clinical practice, the European Network and European Academy of Allergy and Clinical Immunology (EAACI) Interest Group on Drug Allergy has performed a literature...... search on skin test drug concentration in MEDLINE and EMBASE, reviewed and evaluated the literature in five languages using the GRADE system for quality of evidence and strength of recommendation. Where the literature is poor, we have taken into consideration the collective experience of the group...

  18. Towards a pragmatic human migraine model for drug testing

    DEFF Research Database (Denmark)

    Hansen, Emma Katrine; Olesen, Jes

    2017-01-01

    Background A model for the testing of novel anti-migraine drugs should preferably use healthy volunteers for ease of recruiting. Isosorbide-5-mononitrate (5-ISMN) provokes headache in healthy volunteers with some migraine features such as pulsating pain quality and aggravation by physical activity.......003). Difference in area under the headache score curve (AUC) 0-4 hours between sumatriptan and placebo was not significant ( p = 0.30). Conclusion 5-ISMN is a very powerful inducer of migraine-like headache in healthy individuals but the headache does not respond to sumatriptan. The model is not useful for future...

  19. 10 CFR 26.65 - Pre-access drug and alcohol testing.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Pre-access drug and alcohol testing. 26.65 Section 26.65... § 26.65 Pre-access drug and alcohol testing. (a) Purpose. This section contains pre-access testing... days. If an individual has negative results from drug and alcohol tests that were conducted under the...

  20. Is Chronic Dialysis the Right Hard Renal End Point To Evaluate Renoprotective Drug Effects?

    NARCIS (Netherlands)

    Weldegiorgis, Misghina; de Zeeuw, Dick; Dwyer, Jamie P.; Mol, Peter; Heerspink, Hiddo J. L.

    2017-01-01

    Background and objectives: RRT and doubling of serum creatinine are considered the objective hard end points in nephrology intervention trials. Because both are assumed to reflect changes in the filtration capacity of the kidney, drug effects, if present, are attributed to kidney protection.

  1. Formation of the diuretic chlorazanil from the antimalarial drug proguanil--implications for sports drug testing.

    Science.gov (United States)

    Thevis, Mario; Geyer, Hans; Thomas, Andreas; Tretzel, Laura; Bailloux, Isabelle; Buisson, Corinne; Lasne, Francoise; Schaefer, Maximilian S; Kienbaum, Peter; Mueller-Stoever, Irmela; Schänzer, Wilhelm

    2015-11-10

    Chlorazanil (Ordipan, N-(4-chlorophenyl)-1,3,5-triazine-2,4-diamine) is a diuretic agent and as such prohibited in sport according to the regulations of the World Anti-Doping Agency (WADA). Despite its introduction into clinical practice in the late 1950s, the worldwide very first two adverse analytical findings were registered only in 2014, being motive for an in-depth investigation of these cases. Both individuals denied the intake of the drug; however, the athletes did declare the use of the antimalarial prophylactic agent proguanil due to temporary residences in African countries. A structural similarity between chlorazanil and proguanil is given but no direct metabolic relation has been reported in the scientific literature. Moreover, chlorazanil has not been confirmed as a drug impurity of proguanil. Proguanil however is metabolized in humans to N-(4-chlorophenyl)-biguanide, which represents a chemical precursor in the synthesis of chlorazanil. In the presence of formic acid, formaldehyde, or formic acid esters, N-(4-chlorophenyl)-biguanide converts to chlorazanil. In order to probe for potential sources of the chlorazanil detected in the doping control samples, drug formulations containing proguanil and urine samples of individuals using proguanil as antimalarial drug were subjected to liquid chromatography-high resolution/high accuracy mass spectrometry. In addition, in vitro simulations with 4-chlorophenyl-biguanide and respective reactants were conducted in urine and resulting specimens analyzed for the presence of chlorazanil. While no chlorazanil was found in drug formulations, the urine samples of 2 out of 4 proguanil users returned findings for chlorazanil at low ng/mL levels, similar to the adverse analytical findings in the doping control samples. Further, in the presence of formaldehyde, formic acid and related esters, 4-chlorophenyl-biguanide was found to produce chlorazanil in human urine, suggesting that the detection of the obsolete diuretic

  2. 77 FR 10666 - Pipeline Safety: Post Accident Drug and Alcohol Testing

    Science.gov (United States)

    2012-02-23

    ... 199 [Docket No. PHMSA-2011-0335] Pipeline Safety: Post Accident Drug and Alcohol Testing AGENCY... operators of Liquefied Natural Gas (LNG) facilities to conduct post- accident drug and alcohol tests of..., operators must drug and alcohol test each covered employee whose performance either contributed to the...

  3. 36 CFR 3.11 - When is testing for alcohol or drugs required?

    Science.gov (United States)

    2010-07-01

    ..., DEPARTMENT OF THE INTERIOR BOATING AND WATER USE ACTIVITIES § 3.11 When is testing for alcohol or drugs... procedures of the blood, breath, saliva or urine for the purpose of determining blood alcohol and/or drug... admissible in any related judicial proceeding. (2) Any test or tests for the presence of alcohol and drugs...

  4. 49 CFR 655.49 - Refusal to submit to a drug or alcohol test.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Refusal to submit to a drug or alcohol test. 655... TRANSIT ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PREVENTION OF ALCOHOL MISUSE AND PROHIBITED DRUG USE IN TRANSIT OPERATIONS Types of Testing § 655.49 Refusal to submit to a drug or alcohol test. (a) Each...

  5. 49 CFR 40.341 - Must service agents comply with DOT drug and alcohol testing requirements?

    Science.gov (United States)

    2010-10-01

    ... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Roles and Responsibilities of Service Agents § 40.341 Must service agents comply with DOT drug and alcohol testing... requirements of this part and the DOT agency drug and alcohol testing regulations. (b) If you do not comply...

  6. 49 CFR 40.207 - What is the effect of a cancelled drug test?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false What is the effect of a cancelled drug test? 40.207 Section 40.207 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests § 40.207 What is the effect of...

  7. 75 FR 22809 - Mandatory Guidelines for Federal Workplace Drug Testing Programs

    Science.gov (United States)

    2010-04-30

    ... time for related training in Federal and federally-regulated workplace drug testing programs and will... related training in Federal and federally-regulated workplace drug testing programs, including HHS... DEPARTMENT OF HEALTH AND HUMAN SERVICES Mandatory Guidelines for Federal Workplace Drug Testing...

  8. 76 FR 34086 - Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information...

    Science.gov (United States)

    2011-06-10

    ... Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information Regarding Specific Issues Related to the Use of the Oral Fluid Specimen for Drug Testing AGENCY: Substance Abuse and Mental... may be applied to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (oral fluid...

  9. Employee assistance programs, drug testing, and workplace injury.

    Science.gov (United States)

    Waehrer, Geetha M; Miller, Ted R; Hendrie, Delia; Galvin, Deborah M

    2016-06-01

    Little is known about the effects of employee assistance programs (EAPs) on occupational injuries. Multivariate regressions probed a unique data set that linked establishment information about workplace anti-drug programs in 1988 with occupational injury rates for 1405 establishments. EAPs were associated with a significant reduction in both no-lost-work and lost-work injuries, especially in the manufacturing and transportation, communication and public utilities industries (TCPU). Lost-work injuries were more responsive to specific EAP characteristics, with lower rates associated with EAPs staffed by company employees (most likely onsite). Telephone hotline services were associated with reduced rates of lost-work injuries in manufacturing and TCPU. Drug testing was associated with reductions in the rate of minor injuries with no lost work, but had no significant relationship with lost-work injuries. This associational study suggests that EAPs, especially ones that are company-staffed and ones that include telephone hotlines, may prevent workplace injuries. Copyright © 2016. Published by Elsevier Ltd.

  10. Evaluation of the pentylenetetrazole seizure threshold test in epileptic mice as surrogate model for drug testing against pharmacoresistant seizures.

    Science.gov (United States)

    Töllner, Kathrin; Twele, Friederike; Löscher, Wolfgang

    2016-04-01

    Resistance to antiepileptic drugs (AEDs) is a major problem in epilepsy therapy, so that development of more effective AEDs is an unmet clinical need. Several rat and mouse models of epilepsy with spontaneous difficult-to-treat seizures exist, but because testing of antiseizure drug efficacy is extremely laborious in such models, they are only rarely used in the development of novel AEDs. Recently, the use of acute seizure tests in epileptic rats or mice has been proposed as a novel strategy for evaluating novel AEDs for increased antiseizure efficacy. In the present study, we compared the effects of five AEDs (valproate, phenobarbital, diazepam, lamotrigine, levetiracetam) on the pentylenetetrazole (PTZ) seizure threshold in mice that were made epileptic by pilocarpine. Experiments were started 6 weeks after a pilocarpine-induced status epilepticus. At this time, control seizure threshold was significantly lower in epileptic than in nonepileptic animals. Unexpectedly, only one AED (valproate) was less effective to increase seizure threshold in epileptic vs. nonepileptic mice, and this difference was restricted to doses of 200 and 300 mg/kg, whereas the difference disappeared at 400mg/kg. All other AEDs exerted similar seizure threshold increases in epileptic and nonepileptic mice. Thus, induction of acute seizures with PTZ in mice pretreated with pilocarpine does not provide an effective and valuable surrogate method to screen drugs for antiseizure efficacy in a model of difficult-to-treat chronic epilepsy as previously suggested from experiments with this approach in rats. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. people who inject drugs, HIV risk, and HIV testing uptake in sub-Saharan Africa.

    Science.gov (United States)

    Asher, Alice K; Hahn, Judith A; Couture, Marie-Claude; Maher, Kelsey; Page, Kimberly

    2013-01-01

    Dramatic rises in injection drug use (IDU) in sub-Saharan Africa account for increasingly more infections in a region already overwhelmed by the HIV epidemic. There is no known estimate of the number of people who inject drugs (PWID) in the region, or the associated HIV prevalence in PWID. We reviewed literature with the goal of describing high-risk practices and exposures in PWID in sub-Saharan Africa, as well as current HIV prevention activities aimed at drug use. The literature search looked for articles related to HIV risk, injection drug users, stigma, and HIV testing in sub-Saharan Africa. This review found evidence demonstrating high rates of HIV in IDU populations in sub-Saharan Africa, high-risk behaviors of the populations, lack of knowledge regarding HIV, and low HIV testing uptake. There is an urgent need for action to address IDU in order to maintain recent decreases in the spread of HIV in sub-Saharan Africa. Copyright © 2013 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

  12. Human engineered heart tissue as a model system for drug testing.

    Science.gov (United States)

    Eder, Alexandra; Vollert, Ingra; Hansen, Arne; Eschenhagen, Thomas

    2016-01-15

    Drug development is time- and cost-intensive and, despite extensive efforts, still hampered by the limited value of current preclinical test systems to predict side effects, including proarrhythmic and cardiotoxic effects in clinical practice. Part of the problem may be related to species-dependent differences in cardiomyocyte biology. Therefore, the event of readily available human induced pluripotent stem cell (hiPSC)-derived cardiomyocytes (CM) has raised hopes that this human test bed could improve preclinical safety pharmacology as well as drug discovery approaches. However, hiPSC-CM are immature and exhibit peculiarities in terms of ion channel function, gene expression, structural organization and functional responses to drugs that limit their present usefulness. Current efforts are thus directed towards improving hiPSC-CM maturity and high-content readouts. Culturing hiPSC-CM as 3-dimensional engineered heart tissue (EHT) improves CM maturity and anisotropy and, in a 24-well format using silicone racks, enables automated, multiplexed high content readout of contractile function. This review summarizes the principal technology and focuses on advantages and disadvantages of this technology and its potential for preclinical drug screening. Copyright © 2015 Elsevier B.V. All rights reserved.

  13. Test systems in drug discovery for hazard identification and risk assessment of human drug-induced liver injury.

    Science.gov (United States)

    Weaver, Richard J; Betts, Catherine; Blomme, Eric A G; Gerets, Helga H J; Gjervig Jensen, Klaus; Hewitt, Philip G; Juhila, Satu; Labbe, Gilles; Liguori, Michael J; Mesens, Natalie; Ogese, Monday O; Persson, Mikael; Snoeys, Jan; Stevens, James L; Walker, Tracy; Park, B Kevin

    2017-07-01

    The liver is an important target for drug-induced toxicities. Early detection of hepatotoxic drugs requires use of well-characterized test systems, yet current knowledge, gaps and limitations of tests employed remains an important issue for drug development. Areas Covered: The current state of the science, understanding and application of test systems in use for the detection of drug-induced cytotoxicity, mitochondrial toxicity, cholestasis and inflammation is summarized. The test systems highlighted herein cover mostly in vitro and some in vivo models and endpoint measurements used in the assessment of small molecule toxic liabilities. Opportunities for research efforts in areas necessitating the development of specific tests and improved mechanistic understanding are highlighted. Expert Opinion: Use of in vitro test systems for safety optimization will remain a core activity in drug discovery. Substantial inroads have been made with a number of assays established for human Drug-induced Liver Injury. There nevertheless remain significant gaps with a need for improved in vitro tools and novel tests to address specific mechanisms of human Drug-Induced Liver Injury. Progress in these areas will necessitate not only models fit for application, but also mechanistic understanding of how chemical insult on the liver occurs in order to identify translational and quantifiable readouts for decision-making.

  14. "It's our DNA, we deserve the right to test!" A content analysis of a petition for the right to access direct-to-consumer genetic testing.

    Science.gov (United States)

    Su, Yeyang; Borry, Pascal; Otte, Ina C; Howard, Heidi C

    2013-09-01

    Various companies are currently advertising or selling genetic tests over the internet using a model of provision referred to as 'direct-to-consumer' (DTC). This commercial offer of DTC genetic testing (GT) has fueled a number of scientific, ethical and policy debates. To date there have been few studies published regarding the users' perspective. This study aimed to obtain information regarding the issues raised by individuals who signed a petition in support of DTC GT and the 'unrestricted' access to their genetic information. We conducted qualitative content analysis of comments written by individuals who signed a public online petition initiated by DIYgenomics (CA, USA) to support "personal access to genetic information". Of the 523 individuals who signed the petition sponsored by DIYgenomics, 247 individuals also wrote individual comments. A content analysis of these comments reveals that petitioners raised six main issues in support of unrestricted access to DTC GT: that their ownership of their DNA should allow them to have unrestricted access to their genomic information; that they should have the right to their genomic information; that the government has no place in (further) regulating DTC GT; that healthcare professionals should not be placed as intermediaries when purchasing DTC GT services; that many petioners who had already obtained DTC GT had positive experiences with this model of provision; and that genealogy or ancestry DNA testing is one of the main activities petitioners wish to have 'unrestricted' or 'direct' access. These results give insight into why individuals may support unrestricted access to their genomic information and confirm some of the motivations of users for purchasing DTC GT. Our analysis also brings to the forefront themes that have been raised less often in empirical studies involving motivations to purchase DTC GT services; these include the strongly held beliefs of some petitioners that, since they own their DNA, they

  15. Illicit drugs, testing, prevention and work in France: ethical and legal issues.

    Science.gov (United States)

    Fantoni-Quinton, Sophie; Bossu, Bernard; Morgenroth, Thomas; Frimat, Paul

    2010-09-01

    The use of illicit drugs in the workplace raises issues pertaining to prevention and safety and the responsibility of the various members of staff. It also brings into question the interface between work and private life. If employees are in theory responsible for their own safety and risk heavy penalties in the event of the consumption of illicit drugs in the workplace, such behaviour has to be proved. In reality, the worker can only be partially and marginally held liable, given the fact that the employer is prohibited from infringing on their rights and liberties (restrictions on the searching of their personal belongings and lockers as well as on the carrying out of breath testing and saliva testing under restrictive conditions). Employers have for their part a broader range of responsibilities and, above all, an absolute obligation to achieve specific goals in terms of health and safety resulting in the need to take action. In accordance with the International Labour Organization recommendations, European and national legislation, the employer has to implement a suitable preventive policy. However, where is the balance between prevention and repression? Very few studies have raised these issues and our aim is to precisely situate the place of drug testing in the employer's repressive arsenal in France and to try to answer the legal and ethical issues raised. Thus, for example, repression can only be acceptable when it deals with moderate and non-addicted users, or it could be tantamount to discrimination.

  16. [Isoproterenol stress test for the evaluation of the residual stenosis of the right ventricular outflow tract].

    Science.gov (United States)

    Suzuki, T; Fukuda, T; Kashima, I; Sato, M; Miura, M; Ueda, H; Yoshiba, S

    2001-07-01

    Hemodynamic changes of the right side of the heart during isoproterenol stress test were assessed and analyzed in 36 patients who underwent definitive repair of tetralogy of Fallot or double outlet right ventricle with pulmonary stenosis. Patients having atresia of the pulmonary artery were excluded from the study. 24 of the patients had previously undergone reconstruction of the right ventricular outflow tract (RVOT) with preserving the pulmonary valvar annulus (group N), whilst the remaining 12 patients had undergone transannular enlargement of RVOT with a patch (group T). Preservation of the pulmonary valvar annulus was determined when the intra-operative measurement of diameter of the pulmonary valvar annulus showed values greater than 90% of normal. In both groups, the isoproterenol infusion increased the right to left ventricular peak pressure (RVP/LVP) ratio, pressure gradient between the right ventricle and main pulmonary artery (RV-mPAP), and pressure gradient between the main pulmonary artery and peripheral pulmonary artery (m-pPAP). These values were significantly higher than those measured at rest. When comparisons were made between groups, RV-mPAP of group N was significantly higher than that of group T, both at rest and during stress test. By contrast, m-pPAP of group T was significantly higher than that of group N, both at rest and during stress test. Although no significant difference was found between the groups in RVP/LVP at rest and during stress test, RVP/LVP of both groups increased to the level of more than 0.6 after the isoproterenol infusion. These results led us to conclude that preservation of the pulmonary valvar annulus was better to be applied only to the patients who fulfilled our criterions. Additionally, in the setting of patch reconstruction of the pulmonary artery, every effort should be made so as not to leave the residual stenosis of the peripheral pulmonary artery.

  17. 46 CFR 4.06-3 - Requirements for alcohol and drug testing following a serious marine incident.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Requirements for alcohol and drug testing following a... drug testing is conducted: (a) Alcohol testing. (1) Alcohol testing must be conducted on each... only if the alcohol testing meets all of the requirements of this part. (b) Drug testing. (1) Drug...

  18. 21 CFR 809.40 - Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs...

    Science.gov (United States)

    2010-04-01

    ... OTC test sample collection systems for drugs of abuse testing. 809.40 Section 809.40 Food and Drugs... Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing. (a) Over-the-counter (OTC) test sample collection systems for drugs of abuse testing (§ 864.3260...

  19. 10 CFR 707.13 - Medical review of results of tests for illegal drug use.

    Science.gov (United States)

    2010-01-01

    ... another test, performed by the gas chromatography/mass spectrometry method (GC/MS). This procedure is... 10 Energy 4 2010-01-01 2010-01-01 false Medical review of results of tests for illegal drug use... Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be...

  20. Full-course drug challenge test in the diagnosis of delayed allergic reactions to penicillin

    DEFF Research Database (Denmark)

    Borch, Jakob E; Bindslev-Jensen, Carsten

    2011-01-01

    Drug challenge test (DCT) has long been the most sensitive test in the allergological work-up when investigating for penicillin allergy.......Drug challenge test (DCT) has long been the most sensitive test in the allergological work-up when investigating for penicillin allergy....

  1. Hypothesis driven drug design: improving quality and effectiveness of the design-make-test-analyse cycle.

    Science.gov (United States)

    Plowright, Alleyn T; Johnstone, Craig; Kihlberg, Jan; Pettersson, Jonas; Robb, Graeme; Thompson, Richard A

    2012-01-01

    In drug discovery, the central process of constructing and testing hypotheses, carefully conducting experiments and analysing the associated data for new findings and information is known as the design-make-test-analyse cycle. Each step relies heavily on the inputs and outputs of the other three components. In this article we report our efforts to improve and integrate all parts to enable smooth and rapid flow of high quality ideas. Key improvements include enhancing multi-disciplinary input into 'Design', increasing the use of knowledge and reducing cycle times in 'Make', providing parallel sets of relevant data within ten working days in 'Test' and maximising the learning in 'Analyse'. Copyright © 2011 Elsevier Ltd. All rights reserved.

  2. College Athletes and Drug Testing: Attitudes and Behaviors by Gender and Sport

    OpenAIRE

    Schneider, Dona; Morris, Joyce

    1993-01-01

    We surveyed varsity athletes at a Big East university to assess attitudes toward a mandatory drug education and testing program and examined whether there were differences in drug-related attitudes and behaviors based on gender or varsity sport. We found no statistically significant differences in personal drug use behaviors based on gender or team affiliation. Attitudes about drug use and knowledge of a teammate using drugs did show significant differences based on varsity sport. Tennis play...

  3. Five year results of an international proficiency testing programme for measurement of antifungal drug concentrations

    NARCIS (Netherlands)

    Lempers, V.J.C.; Alffenaar, J.W.C.; Touw, D.J.; Burger, D.M.; Uges, D.R.A.; Aarnoutse, R.E.; Brüggemann, R.J.M.

    2014-01-01

    OBJECTIVES: Since 2007 the Dutch Association for Quality Assessment in Therapeutic Drug Monitoring (KKGT) has organized an international interlaboratory proficiency testing (PT) programme for measurement of antifungal drugs in plasma. We describe the 5 year results of the laboratories' performance.

  4. 75 FR 26183 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

    Science.gov (United States)

    2010-05-11

    ... 2105-AE01 Procedures for Transportation Workplace Drug and Alcohol Testing Programs AGENCY: Office of...: For program issues, Bohdan Baczara, Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey... of Federal Regulations, as follows: [[Page 26184

  5. Method used to test the imaging consistency of binocular camera's left-right optical system

    Science.gov (United States)

    Liu, Meiying; Wang, Hu; Liu, Jie; Xue, Yaoke; Yang, Shaodong; Zhao, Hui

    2016-09-01

    To binocular camera, the consistency of optical parameters of the left and the right optical system is an important factor that will influence the overall imaging consistency. In conventional testing procedure of optical system, there lacks specifications suitable for evaluating imaging consistency. In this paper, considering the special requirements of binocular optical imaging system, a method used to measure the imaging consistency of binocular camera is presented. Based on this method, a measurement system which is composed of an integrating sphere, a rotary table and a CMOS camera has been established. First, let the left and the right optical system capture images in normal exposure time under the same condition. Second, a contour image is obtained based on the multiple threshold segmentation result and the boundary is determined using the slope of contour lines near the pseudo-contour line. Third, the constraint of gray level based on the corresponding coordinates of left-right images is established and the imaging consistency could be evaluated through standard deviation σ of the imaging grayscale difference D (x, y) between the left and right optical system. The experiments demonstrate that the method is suitable for carrying out the imaging consistency testing for binocular camera. When the standard deviation 3σ distribution of imaging gray difference D (x, y) between the left and right optical system of the binocular camera does not exceed 5%, it is believed that the design requirements have been achieved. This method could be used effectively and paves the way for the imaging consistency testing of the binocular camera.

  6. Women's opinions of legal requirements for drug testing in prenatal care.

    Science.gov (United States)

    Tucker Edmonds, Brownsyne; Mckenzie, Fatima; Austgen, MacKenzie B; Carroll, Aaron E; Meslin, Eric M

    2017-07-01

    To explore women's attitudes and perceptions regarding legal requirements for prenatal drug testing. Web-based survey of 500 US women (age 18-45) recruited from a market research survey panel. A 24-item questionnaire assessed their opinion of laws requiring doctors to routinely verbal screen and urine drug test patients during pregnancy; recommendations for consequences for positive drug tests during pregnancy; and opinion of laws requiring routine drug testing of newborns. Additional questions asked participants about the influence of such laws on their own care-seeking behaviors. Data were analyzed for associations between participant characteristics and survey responses using Pearson's chi-squared test. The majority of respondents (86%) stated they would support a law requiring verbal screening of all pregnant patients and 73% would support a law requiring universal urine drug testing in pregnancy. Fewer respondents were willing to support laws that required verbal screening or urine drug testing (68% and 61%, respectively) targeting only Medicaid recipients. Twenty-one percent of respondents indicated they would be offended if their doctors asked them about drug use and 14% indicated that mandatory drug testing would discourage prenatal care attendance. Women would be more supportive of policies requiring universal rather than targeted screening and testing for prenatal drug use. However, a noteworthy proportion of women would be discouraged from attending prenatal care - a reminder that drug testing policies may have detrimental effects on maternal child health.

  7. Mutagenicity in drug development: interpretation and significance of test results.

    Science.gov (United States)

    Clive, D

    1985-03-01

    , methapyrilene). In vivo mutagenicity assays are more physiological but appear to be relatively insensitive due to the inability to achieve sufficiently high acute plasma levels to mimic cumulative long-term effects. Examination of the mutagenicity of naturally occurring analogs may indicate the irrelevance of a test compound's mutagenicity (e.g., deoxyguanosine and the structurally related antiviral drug, acyclovir, have identical mutagenicity patterns). Life-threatening or severe debilitating diseases (e.g., cancer, severe psychoses, severe crippling arthritis, sight-threatening diseases) may justify treatment with mutagenic or even carcinogenic therapeutic agents (benefit/risk considerations).(ABSTRACT TRUNCATED AT 400 WORDS)

  8. Everybody needs sphingolipids, right! Mining for new drug targets in protozoan sphingolipid biosynthesis.

    Science.gov (United States)

    Mina, John G M; Denny, P W

    2018-02-01

    Sphingolipids (SLs) are an integral part of all eukaryotic cellular membranes. In addition, they have indispensable functions as signalling molecules controlling a myriad of cellular events. Disruption of either the de novo synthesis or the degradation pathways has been shown to have detrimental effects. The earlier identification of selective inhibitors of fungal SL biosynthesis promised potent broad-spectrum anti-fungal agents, which later encouraged testing some of those agents against protozoan parasites. In this review we focus on the key enzymes of the SL de novo biosynthetic pathway in protozoan parasites of the Apicomplexa and Kinetoplastidae, outlining the divergence and interconnection between host and pathogen metabolism. The druggability of the SL biosynthesis is considered, alongside recent technology advances that will enable the dissection and analyses of this pathway in the parasitic protozoa. The future impact of these advances for the development of new therapeutics for both globally threatening and neglected infectious diseases is potentially profound.

  9. Investigating the feasibility of temperature-controlled accelerated drug release testing for an intravaginal ring.

    Science.gov (United States)

    Externbrink, Anna; Clark, Meredith R; Friend, David R; Klein, Sandra

    2013-11-01

    The objective of the present study was to investigate if temperature can be utilized to accelerate drug release from Nuvaring®, a reservoir type intravaginal ring based on polyethylene vinyl acetate copolymer that releases a constant dose of contraceptive steroids over a duration of 3 weeks. The reciprocating holder apparatus (USP 7) was utilized to determine real-time and accelerated etonogestrel release from ring segments. It was demonstrated that drug release increased with increasing temperature which can be attributed to enhanced drug diffusion. An Arrhenius relationship of the zero-order release constants was established, indicating that temperature is a valid parameter to accelerate drug release from this dosage form and that the release mechanism is maintained under these accelerated test conditions. Accelerated release tests are particularly useful for routine quality control to assist during batch release of extended release formulations that typically release the active over several weeks, months or even years, since they can increase the product shelf life. The accelerated method should therefore be able to discriminate between formulations with different release characteristics that can result from normal manufacturing variance. In the case of Nuvaring®, it is well known that the process parameters during the extrusion process strongly influence the polymeric structure. These changes in the polymeric structure can affect the permeability which, in turn, is reflected in the release properties. Results from this study indicate that changes in the polymeric structure can lead to a different temperature dependence of the release rate, and as a consequence, the accelerated method can become less sensitive to detect changes in the release properties. When the accelerated method is utilized during batch release, it is therefore important to take this possible restriction into account and to evaluate the accelerated method with samples from non

  10. The current status of community drug testing via the analysis of drugs and drug metabolites in sewage

    Directory of Open Access Journals (Sweden)

    Malcolm J. Reid

    2011-12-01

    Full Text Available Over the past few years the analysis of drug residues in sewage has been promoted as a means of estimating the level of drug use in communities. Measured drug residue concentrations in the sewage are used to determine the load (total mass of the drug being used by the entire community. Knowledge of the size or population of the community then allows for the calculation of drug-use relative to population (typically drug-mass/day/1000 inhabitants which facilitates comparisons between differing communities or populations. Studies have been performed in many European countries, including Norway, as well as in the US and Australia. The approach has successfully estimated the use of cocaine, amphetamine, methamphetamine, MDMA, cannabis, nicotine and alcohol. The analysis of biomarkers of drug use in sewage has great potential to support and complement existing techniques for estimating levels of drug use, and as such has been identified as a promising development by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA; www.emcdda.europa.eu/wastewater-analysis. The approach is not without its challenges, and ongoing collaboration across Europe aims at agreeing upon best-practice and harmonising the methods being used. In Norway development is being performed through the NFR RUSMIDDEL funded DrugMon (www.niva.no/drugmon project that has led to the development of many new techniques, significantly improved our understanding of the uncertainties associated with the approach and allowed the coordination of Europe wide collaboration which has included all important intercalibration exercises. Application of the technique can provide evidence-based and real-time estimates of collective drug use with the resulting data used to improve the much needed estimates of drug use and dependency.

  11. Testing antidepressant compounds in a neuropsychological model of drug action

    NARCIS (Netherlands)

    Cerit, Hilal

    2015-01-01

    Although much research effort has been put into the development of new antidepressant drugs, the process of developing a drug often fails at the stage of large randomized controlled trials (RCTs) in which an initially promising compound appears to lack efficacy after all. Several experimental

  12. Hair testing to assess both known and unknown use of drugs amongst ecstasy users in the electronic dance music scene.

    Science.gov (United States)

    Palamar, Joseph J; Salomone, Alberto; Gerace, Enrico; Di Corcia, Daniele; Vincenti, Marco; Cleland, Charles M

    2017-10-01

    Data on both known and unknown drug use in the electronic dance music (EDM) scene is important to inform prevention and harm reduction. While surveys are the most common method of querying drug use, additional biological data can help validate use and detect unknown/unintentional use of drugs such as new psychoactive substances (NPS). We sought to determine the extent of both known and unknown use of various substances in this high-risk scene. We hair-tested 90 self-reported past-year ecstasy/MDMA/Molly users attending EDM parties in New York City during the summer of 2016 using UHPLC-MS/MS. Results were compared to self-reported past-year use. Three quarters (74.4%) tested positive for MDMA, a third (33.3%) tested positive for an NPS, and 27.8% tested positive specifically for one or more synthetic cathinones (e.g., butylone, ethylone, pentylone, methylone, alpha-PVP). Half (51.1%) of participants tested positive for a drug not self-reported, with most testing positive for synthetic cathinones (72.0%), methamphetamine (69.0%), other NPS stimulants (e.g., 4-FA, 5/6-APB; 66.7%), or new dissociatives (e.g., methoxetamine, diphenidine; 60.0%). Attending parties every other week or more often, reporting higher-frequency ecstasy pill use, having tested one's ecstasy, and having found out one's ecstasy was adulterated, were risk factors for testing positive for synthetic cathinones and NPS in general. Hair testing appears to be a valuable addition to drug epidemiology studies. Many EDM party attendees-even those who test their ecstasy-are unknowingly using NPS and/or other drugs. Prevention information and harm reduction may help reduce unknown/unintentional use. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Contrast media: interactions with other drugs and clinical tests

    International Nuclear Information System (INIS)

    Morcos, Sameh K.; Exley, C.M.; Thomsen, Henrik S.

    2005-01-01

    Many patients with multiple medical problems who are receiving a variety of drugs are investigated with imaging techniques which require intravascular contrast media. The Contrast Media Safety Committee of the European Society of Urogenital Radiology therefore decided to review the literature and to draw up simple guidelines on interactions between contrast media and other drugs. An extensive literature search was carried out and summarized in a report. Based on the available information, simple guidelines have been drawn up. The report and guidelines were discussed at the 11th European Symposium on Urogenital Radiology in Santiago de Compostela. Contrast media may interact with other drugs, and may interfere with isotope studies and biochemical measurements. Awareness of the patient drug history is important to avoid potential hazards. Simple guidelines are presented. (orig.)

  14. A single-question screening test for drug use in primary care.

    Science.gov (United States)

    Smith, Peter C; Schmidt, Susan M; Allensworth-Davies, Donald; Saitz, Richard

    2010-07-12

    Drug use (illicit drug use and nonmedical use of prescription drugs) is common but underrecognized in primary care settings. We validated a single-question screening test for drug use and drug use disorders in primary care. Adult patients recruited from primary care waiting rooms were asked the single screening question, "How many times in the past year have you used an illegal drug or used a prescription medication for nonmedical reasons?" A response of at least 1 time was considered positive for drug use. They were also asked the 10-item Drug Abuse Screening Test (DAST-10). The reference standard was the presence or absence of current (past year) drug use or a drug use disorder (abuse or dependence) as determined by a standardized diagnostic interview. Drug use was also determined by oral fluid testing for common drugs of abuse. Of 394 eligible primary care patients, 286 (73%) completed the interview. The single screening question was 100% sensitive (95% confidence interval [CI], 90.6%-100%) and 73.5% specific (95% CI, 67.7%-78.6%) for the detection of a drug use disorder. It was less sensitive for the detection of self-reported current drug use (92.9%; 95% CI, 86.1%-96.5%) and drug use detected by oral fluid testing or self-report (81.8%; 95% CI, 72.5%-88.5%). Test characteristics were similar to those of the DAST-10 and were affected very little by participant demographic characteristics. The single screening question accurately identified drug use in this sample of primary care patients, supporting the usefulness of this brief screen in primary care.

  15. Urine Testing for Drugs of Abuse. NIDA Research Monograph Series 73.

    Science.gov (United States)

    Hawks, Richard L., Ed.; Chiang, C. Nora, Ed.

    In the past 5 years, a growing concern over the use of illicit drugs in the workplace has led to an interest in urinalysis as a way to detect and deter drug use. This monograph provides information that will assist those involved in the planning or implementation of drug testing programs in making informed choices. Articles include: (1)…

  16. 77 FR 26471 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs: 6-acetylmorphine (6-AM...

    Science.gov (United States)

    2012-05-04

    ... scientific methodologies the laboratories must use for testing. Because of these requirements and to create... of Forensic Toxicologists (SOFT) & The International Association of Forensic Toxicologists (TIAFT... drug or drug metabolite in his or her system, as in the case of other drugs (see Sec. 40.137...

  17. European recommendations for the clinical use of HIV drug resistance testing: 2011 update

    DEFF Research Database (Denmark)

    Vandamme, Anne-Mieke; Camacho, Ricardo J; Ceccherini-Silberstein, Francesca

    2011-01-01

    , and other drug targets (integrase and envelope) if such drugs were part of the failing regimen; (iii) consider testing for CCR5 tropism at virologic failure or when a change of therapy has to be made in absence of detectable viral load, and in the latter case test DNA or last detectable plasma RNA; (iv...... the following recommendations concerning the indications for resistance testing: for HIV-1 (i) test earliest sample for protease and reverse transcriptase drug resistance in drug-naive patients with acute or chronic infection; (ii) test protease and reverse transcriptase drug resistance at virologic failure...... is needed after treatment failure. The Panel recommends genotyping in most situations, using updated and clinically evaluated interpretation systems. It is mandatory that laboratories performing HIV resistance tests take part regularly in external quality assurance programs, and that they consider storing...

  18. 78 FR 37231 - Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2013-06-20

    .... 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in... comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane...

  19. Evaluation of three rapid oral fluid test devices on the screening of multiple drugs of abuse including ketamine.

    Science.gov (United States)

    Tang, Magdalene H Y; Ching, C K; Poon, Simon; Chan, Suzanne S S; Ng, W Y; Lam, M; Wong, C K; Pao, Ronnie; Lau, Angus; Mak, Tony W L

    2018-05-01

    Rapid oral fluid testing (ROFT) devices have been extensively evaluated for their ability to detect common drugs of abuse; however, the performance of such devices on simultaneous screening for ketamine has been scarcely investigated. The present study evaluated three ROFT devices (DrugWipe ® 6S, Ora-Check ® and SalivaScreen ® ) on the detection of ketamine, opiates, methamphetamine, cannabis, cocaine and MDMA. A liquid chromatography tandem mass spectrometry (LCMS) assay was firstly established and validated for confirmation analysis of the six types of drugs and/or their metabolites. In the field test, the three ROFT devices were tested on subjects recruited from substance abuse clinics/rehabilitation centre. Oral fluid was also collected using Quantisal ® for confirmation analysis. A total of 549 samples were collected in the study. LCMS analysis on 491 samples revealed the following drugs: codeine (55%), morphine (49%), heroin (40%), methamphetamine (35%), THC (8%), ketamine (4%) and cocaine (2%). No MDMA-positive cases were observed. Results showed that the overall specificity and accuracy were satisfactory and met the DRUID standard of >80% for all 3 devices. Ora-Check ® had poor sensitivities (ketamine 36%, methamphetamine 63%, opiates 53%, cocaine 60%, THC 0%). DrugWipe ® 6S showed good sensitivities in the methamphetamine (83%) and opiates (93%) tests but performed relatively poorly for ketamine (41%), cocaine (43%) and THC (22%). SalivaScreen ® also demonstrated good sensitivities in the methamphetamine (83%) and opiates (100%) tests, and had the highest sensitivity for ketamine (76%) and cocaine (71%); however, it failed to detect any of the 28 THC-positive cases. The test completion rate (proportion of tests completed with quality control passed) were: 52% (Ora-Check ® ), 78% (SalivaScreen ® ) and 99% (DrugWipe ® 6S). Copyright © 2018 Elsevier B.V. All rights reserved.

  20. Results from the 2012 drug and alcohol testing survey : [analysis brief].

    Science.gov (United States)

    2014-12-01

    This report summarizes the results of the 2012 Federal Motor Carrier Safety Administration (FMCSA) Drug and Alcohol Testing Survey. This annual survey measures the percentage of drivers with commercial drivers licenses (CDLs) who test positive for...

  1. Results from the 2015 Drug and Alcohol Testing Survey : analysis brief.

    Science.gov (United States)

    2017-06-01

    This report summarizes the results of the 2015 Federal Motor Carrier Safety Administration (FMCSA) Drug and Alcohol Testing Survey. This annual survey measures the percentage of commercial drivers license (CDL) drivers who test positive for contro...

  2. Results from the 2014 drug and alcohol testing survey : analysis brief.

    Science.gov (United States)

    2016-10-01

    This report summarizes the results of the 2014 Federal Motor Carrier Safety Administration (FMCSA) Drug and Alcohol Testing Survey. This annual survey measures the percentage of commercial drivers license (CDL) drivers who test positive for contro...

  3. Results from the 2016 Drug and Alcohol Testing Survey : Analysis Brief

    Science.gov (United States)

    2018-01-01

    This report summarizes the results of the 2016 Federal Motor Carrier Safety Administration (FMCSA) Drug and Alcohol Testing Survey. This annual survey measures the percentage of commercial drivers license (CDL) drivers who test positive for contro...

  4. Testing quark mixing in minimal left–right symmetric models with b-tags at the LHC

    International Nuclear Information System (INIS)

    Fowlie, Andrew; Marzola, Luca

    2014-01-01

    Motivated by a hint in a CMS search for right-handed W-bosons in eejj final states, we propose an experimental test of quark-mixing matrices in a general left–right symmetric model, based on counting the numbers of b-tags from right-handed W-boson hadronic decays. We find that, with our test, differences between left- and right-handed quark-mixing matrices could be detected at the LHC with √(s)=14 TeV. With an integrated luminosity of about 20/fb, our test is sensitive to right-handed quark-mixing angles as small as about 30° and with 3000/fb, our test's sensitivity improves to right-handed mixing angles as small as about 7.5°. Our test's sensitivity might be further enhanced by tuning b-tagging efficiency against purity

  5. Resistance mechanisms and drug susceptibility testing of nontuberculous mycobacteria.

    NARCIS (Netherlands)

    Ingen, J. van; Boeree, M.J.; Soolingen, D. van; Mouton, J.W.

    2012-01-01

    Nontuberculous mycobacteria (NTM) are increasingly recognized as causative agents of opportunistic infections in humans. For most NTM infections the therapy of choice is drug treatment, but treatment regimens differ by species, in particular between slow (e.g. Mycobacterium avium complex,

  6. Frequently Asked Questions about Drug Testing in Schools

    Science.gov (United States)

    ... of 8th, 10th, and 12th graders showed that past-year use of illicit drugs other than marijuana is ... use of the prescription stimulant Adderall® in the past year. 1 Read more about the MTF survey results ...

  7. Take with Food: Study Tests Lowering Dose of Prostate Cancer Drug

    Science.gov (United States)

    ... Cancer Currents Blog Cancer Currents Blog Take with Food: Study Tests Lowering Dose of Prostate Cancer Drug Subscribe April ... to this page included, e.g., “Take with Food: Study Tests Lowering Dose of Prostate Cancer Drug was originally ...

  8. 75 FR 38422 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

    Science.gov (United States)

    2010-07-02

    ... 2105-AD84 Procedures for Transportation Workplace Drug and Alcohol Testing Programs AGENCY: Office of..., 2011. DATES: This rule is effective July 2, 2010. FOR FURTHER INFORMATION CONTACT: For program issues... Federal Regulations, as follows: PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING...

  9. Urine and oral fluid drug testing in support of pain management.

    Science.gov (United States)

    Kwong, Tai C; Magnani, Barbarajean; Moore, Christine

    2017-09-01

    In recent years, the abuse of opioid drugs has resulted in greater prevalence of addiction, overdose, and deaths attributable to opioid abuse. The epidemic of opioid abuse has prompted professional and government agencies to issue practice guidelines for prescribing opioids to manage chronic pain. An important tool available to providers is the drug test for use in the initial assessment of patients for possible opioid therapy, subsequent monitoring of compliance, and documentation of suspected aberrant drug behaviors. This review discusses the issues that most affect the clinical utility of drug testing in chronic pain management with opioid therapy. It focuses on the two most commonly used specimen matrices in drug testing: urine and oral fluid. The advantages and disadvantages of urine and oral fluid in the entire testing process, from specimen collection and analytical methodologies to result interpretation are reviewed. The analytical sensitivity and specificity limitations of immunoassays used for testing are examined in detail to draw attention to how these shortcomings can affect result interpretation and influence clinical decision-making in pain management. The need for specific identification and quantitative measurement of the drugs and metabolites present to investigate suspected aberrant drug behavior or unexpected positive results is analyzed. Also presented are recent developments in optimization of test menus and testing strategies, such as the modification of the standard screen and reflexed-confirmation testing model by eliminating some of the initial immunoassay-based tests and proceeding directly to definitive testing by mass spectrometry assays.

  10. Affordable HIV drug-resistance testing for monitoring of antiretroviral therapy in sub-Saharan Africa.

    Science.gov (United States)

    Inzaule, Seth C; Ondoa, Pascale; Peter, Trevor; Mugyenyi, Peter N; Stevens, Wendy S; de Wit, Tobias F Rinke; Hamers, Raph L

    2016-11-01

    Increased provision of antiretroviral therapy in sub-Saharan Africa has led to a growing number of patients with therapy failure and acquired drug-resistant HIV, driving the demand for more costly further lines of antiretroviral therapy. In conjunction with accelerated access to viral load monitoring, feasible and affordable technologies to detect drug-resistant HIV could help maximise the durability and rational use of available drug regimens. Potential low-cost technologies include in-house Sanger and next-generation sequencing in centralised laboratories, and point mutation assays and genotype-free systems that predict response to antiretroviral therapy at point-of-care. Strengthening of centralised high-throughput laboratories, including efficient systems for sample referral and results delivery, will increase economies-of-scale while reducing costs. Access barriers can be mitigated by standardisation of in-house assays into commercial kits, use of polyvalent instruments, and adopting price-reducing strategies. A stepwise rollout approach should improve feasibility, prioritising WHO-recommended population-based surveillance and management of complex patient categories, such as patients failing protease inhibitor-based antiretroviral therapy. Implementation research, adaptations of existing WHO guidance, and political commitment, will be key to support the appropriate investments and policy changes. In this Personal View, we discuss the potential role of HIV drug resistance testing for population-based surveillance and individual patient management in sub-Saharan Africa. We review the strengths and challenges of promising low-cost technologies and how they can be implemented. Copyright © 2016 Elsevier Ltd. All rights reserved.

  11. 49 CFR 655.61 - Action when an employee has a verified positive drug test result or has a confirmed alcohol test...

    Science.gov (United States)

    2010-10-01

    ... drug test result or has a confirmed alcohol test result of 0.04 or greater, or refuses to submit to a... drug test result or has a confirmed alcohol test result of 0.04 or greater, or refuses to submit to a... performing a safety-sensitive function. (3) If an employee refuses to submit to a drug or alcohol test...

  12. Risk mitigation for children exposed to drugs during gestation: A critical role for animal preclinical behavioral testing.

    Science.gov (United States)

    Zucker, Irving

    2017-06-01

    Many drugs with unknown safety profiles are administered to pregnant women, placing their offspring at risk. I assessed whether behavioral outcomes for children exposed during gestation to antidepressants, anxiolytics, anti-seizure, analgesic, anti-nausea and sedative medications can be predicted by more extensive animal studies than are part of the FDA approval process. Human plus rodent data were available for only 8 of 33 CNS-active drugs examined. Similar behavioral and cognitive deficits, including autism and ADHD emerged in human offspring and in animal models of these disorders after exposure to fluoxetine, valproic acid, carbamazepine, phenytoin, phenobarbital and acetaminophen. Rodent data helpful in identifying and predicting adverse effects of prenatal drug exposure in children were first generated many years after drugs were FDA-approved and administered to pregnant women. I recommend that enhanced behavioral testing of rodent offspring exposed to drugs prenatally should begin during preclinical drug evaluation and continue during Phase I clinical trials, with findings communicated to physicians and patients in drug labels. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Flow cytometry susceptibility testing for conventional antifungal drugs and Comparison with the NCCLS Broth Macrodilution Test

    Directory of Open Access Journals (Sweden)

    M.J. Najafzadeh

    2009-08-01

    Full Text Available Introduction: During the last decade, the incidence of fungal infection has been increased in many countries. Because of the advent of resistant to antifungal agents, determination of an efficient strategic plan for treatment of fungal disease is an important issue in clinical mycology. Many methods have been introduced and developed for determination of invitro susceptibility tests. During the recent years, flow cytometry has developed to solving the problem and many papers have documented the usefulness of this technique. Materials and methods: As the first step, the invitro susceptibility of standard PTCC (Persian Type of Culture Collection strain and some clinical isolates of Candida consisting of Candida albicans, C. dubliniensis, C. glabrata, C. kefyer and C. parapsilosis were evaluated by macrodilution broth method according to NCCLS (National Committee for Clinical Laboratory Standards guidelines and flow cytometry susceptibility test. Results:  The data indicated that macro dilution broth methods and flow cytometry have the same results in determination of MIC (Minimum Inhibitory Concentration for amphotericin B, clotrimazole, fluconazole, ketoconazole and miconazole in C. albicans PTCC 5027 as well as clinical Candida isolates, such as C.albicans, C.dubliniensis, C.glabrata C.kefyr, and C.parapsilosis. Discussion: Comparing the results obtained by macrodilution broth and flow cytometry methods revealed that flow cytometry was faster. It is suggested that flow cytometry susceptibility test can be used as a powerful tool for determination of MIC and administration of the best antifungal drug in treatment of patients with Candida infections.

  14. 21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

    Science.gov (United States)

    2010-04-01

    ... research animals or in vitro tests. 312.160 Section 312.160 Food and Drugs FOOD AND DRUG ADMINISTRATION... Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests. (a) Authorization to ship. (1)(i) A person...

  15. Bioengineered Liver Models for Drug Testing and Cell Differentiation Studies

    Directory of Open Access Journals (Sweden)

    Gregory H. Underhill

    2018-01-01

    Full Text Available In vitro models of the human liver are important for the following: (1 mitigating the risk of drug-induced liver injury to human beings, (2 modeling human liver diseases, (3 elucidating the role of single and combinatorial microenvironmental cues on liver cell function, and (4 enabling cell-based therapies in the clinic. Methods to isolate and culture primary human hepatocytes (PHHs, the gold standard for building human liver models, were developed several decades ago; however, PHHs show a precipitous decline in phenotypic functions in 2-dimensional extracellular matrix–coated conventional culture formats, which does not allow chronic treatment with drugs and other stimuli. The development of several engineering tools, such as cellular microarrays, protein micropatterning, microfluidics, biomaterial scaffolds, and bioprinting, now allow precise control over the cellular microenvironment for enhancing the function of both PHHs and induced pluripotent stem cell–derived human hepatocyte-like cells; long-term (4+ weeks stabilization of hepatocellular function typically requires co-cultivation with liver-derived or non–liver-derived nonparenchymal cell types. In addition, the recent development of liver organoid culture systems can provide a strategy for the enhanced expansion of therapeutically relevant cell types. Here, we discuss advances in engineering approaches for constructing in vitro human liver models that have utility in drug screening and for determining microenvironmental determinants of liver cell differentiation/function. Design features and validation data of representative models are presented to highlight major trends followed by the discussion of pending issues that need to be addressed. Overall, bioengineered liver models have significantly advanced our understanding of liver function and injury, which will prove useful for drug development and ultimately cell-based therapies.

  16. Miracle drug: Brazil approves never-tested cancer medicine.

    Science.gov (United States)

    Kuchenbecker, Ricardo S; Mota, Daniel M

    2017-07-01

    Background Brazil recently approved synthetic phosphoetanolamine, a popularly dubbed 'cancer pill', a substance that has been shown to kill cancer cells in lab animal models but was not yet formally accessed in humans, and thus despite the existence of any evidence of its efficacy and safety. Methods The authors describe the recent decision of Brazil to aprove phosphoetanolamine in the context of growing 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty. Results The approval of phosphoetanolamine despite the existence of any evidence of its efficacy and safety represents to the authors one of the saddest and surrealistic episodes in Brazil's recent public health history. Brazil's current economic crisis is fueling the 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty in the context of rising economic constrains and a progressive failing state. The authors state that the Phosphoetanolamine's approval bill violates current legal prohibition of commercialisation of drugs without the Brazilian national drug regulatory agency's approval and thus may represent a potential menace to Brazil's pharmacogovernance and the country's governance to health technology assessment at the Brazilian national health systems. Conclusion Phosphoetanolamine's approval illustrates that the combination of flawed decision making, economic crisis and political interference may threaten weak governance mechanisms for drug regulation and health technology assessment and thus representing an extra burden in the sustainability of universal access-based national health systems.

  17. 49 CFR Appendix B to Part 40 - DOT Drug Testing Semi-Annual Laboratory Report to Employers

    Science.gov (United States)

    2010-10-01

    ... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Pt. 40, App. B Appendix B to Part 40—DOT Drug Testing.... Specimen Results Reported (total number) By Test Reason (a) Pre-employment (number) (b) Post-Accident...

  18. Challenges with gonorrhea in the era of multi-drug and extensively drug resistance – are we on the right track?

    Science.gov (United States)

    Unemo, Magnus; Golparian, Daniel; Shafer, William M

    2015-01-01

    Neisseria gonorrhoeae has retained antimicrobial resistance to drugs previously recommended for first-line empiric treatment of gonorrhea, and resistance to ceftriaxone, the last option for monotherapy, is evolving. Crucial actions to combat this developing situation include implementing response plans; considering use of dual antimicrobial regimens; enhancing surveillance of gonorrhea, gonococcal antimicrobial resistance, treatment failures and antimicrobial use/misuse and improving prevention, early diagnosis, contact tracing and treatment. The ways forward also include an intensified research to identify novel antimicrobial resistance determinants and develop and evaluate appropriate use of molecular antimicrobial resistance testing, ideally point-of-care and with simultaneous detection of gonococci, to supplement culture-based methods and ideally guide tailored treatment. It is crucial with an enhanced understanding of the dynamics of the national and international emergence, transmission and evolution of antimicrobial-resistant gonococcal strains. Genome sequencing combined with epidemiological metadata will detail these issues and might also revolutionize the molecular antimicrobial resistance testing. Ultimately, novel antimicrobials are essential and some antimicrobials in development have shown potent in vitro activity against gonococci. Several of these antimicrobials deserve further attention for potential future treatment of gonorrhea. PMID:24702589

  19. Development, implementation and management of a drug testing program in the workplace

    Energy Technology Data Exchange (ETDEWEB)

    Burtis, C.A.

    1990-01-01

    To combat the rising use of drugs in the workplace many American companies have implemented drug testing programs and are testing employees and job applicants for use of illegal drugs. In addition, on September 15, 1986, Executive Order No.12564 was issued by President Reagan, which requires all federal agencies to develop programs and policies, one of the goals of which is to achieve a drug-free federal workplace. Included in this Executive Order is the requirement that federal agencies implement drug testing has become a prevalent practice as a means to detect and deter drug use in the workplace. Before a drug testing program is implemented, it is imperative that policies and procedures are developed that (1) ensure the accuracy of test results, (2) protect the validity and integrity of the specimen, (3) guarantee due process, and (4) maintain confidentiality. To make certain that these prerequisites were met in the government drug testing programs, the US Department of Health and Human Services (HHS) was directed to develop technical and scientific guidelines for conducting such programs. 15 refs., 1 fig., 2 tabs.

  20. Prediction of clinical response to drugs in ovarian cancer using the chemotherapy resistance test (CTR-test).

    Science.gov (United States)

    Kischkel, Frank Christian; Meyer, Carina; Eich, Julia; Nassir, Mani; Mentze, Monika; Braicu, Ioana; Kopp-Schneider, Annette; Sehouli, Jalid

    2017-10-27

    In order to validate if the test result of the Chemotherapy Resistance Test (CTR-Test) is able to predict the resistances or sensitivities of tumors in ovarian cancer patients to drugs, the CTR-Test result and the corresponding clinical response of individual patients were correlated retrospectively. Results were compared to previous recorded correlations. The CTR-Test was performed on tumor samples from 52 ovarian cancer patients for specific chemotherapeutic drugs. Patients were treated with monotherapies or drug combinations. Resistances were classified as extreme (ER), medium (MR) or slight (SR) resistance in the CTR-Test. Combination treatment resistances were transformed by a scoring system into these classifications. Accurate sensitivity prediction was accomplished in 79% of the cases and accurate prediction of resistance in 100% of the cases in the total data set. The data set of single agent treatment and drug combination treatment were analyzed individually. Single agent treatment lead to an accurate sensitivity in 44% of the cases and the drug combination to 95% accuracy. The detection of resistances was in both cases to 100% correct. ROC curve analysis indicates that the CTR-Test result correlates with the clinical response, at least for the combination chemotherapy. Those values are similar or better than the values from a publication from 1990. Chemotherapy resistance testing in vitro via the CTR-Test is able to accurately detect resistances in ovarian cancer patients. These numbers confirm and even exceed results published in 1990. Better sensitivity detection might be caused by a higher percentage of drug combinations tested in 2012 compared to 1990. Our study confirms the functionality of the CTR-Test to plan an efficient chemotherapeutic treatment for ovarian cancer patients.

  1. Transporters affecting biochemical test results: Creatinine-drug interactions.

    Science.gov (United States)

    Chu, X; Bleasby, K; Chan, G H; Nunes, I; Evers, R

    2016-11-01

    Creatinine is eliminated by the kidneys through a combination of glomerular filtration and active transport. Drug-induced increases in serum creatinine (SCr) and/or reduced creatinine renal clearance are used as a marker for acute kidney injury. However, inhibition of active transport of creatinine can result in reversible and, therefore, benign increases in SCr levels. Herein, the transporters involved in creatinine clearance are discussed, in addition to limitations of using creatinine as a biomarker for kidney damage. © 2016 American Society for Clinical Pharmacology and Therapeutics.

  2. Psychometric properties of the Turkish versions of the Drug Use Disorders Identification Test (DUDIT) and the Drug Abuse Screening Test (DAST-10) in the prison setting.

    Science.gov (United States)

    Evren, Cuneyt; Ogel, Kultegin; Evren, Bilge; Bozkurt, Muge

    2014-01-01

    The aim of this study was to evaluate psychometric properties of the Drug Use Disorders Identification Test (DUDIT) and the Drug Abuse Screening Test (DAST-10) in prisoners with (n = 124) or without (n = 78) drug use disorder. Participants were evaluated with the DUDIT, the DAST-10, and the Addiction Profile Index-Short (API-S). The DUDIT and the DAST-10 were found to be psychometrically sound drug abuse screening measures with high convergent validity when compared with each other (r = 0.86), and API-S (r = 0.88 and r = 0.84, respectively), and to have a Cronbach's α of 0.93 and 0.87, respectively. In addition, a single component accounted for 58.28% of total variance for DUDIT, whereas this was 47.10% for DAST-10. The DUDIT had sensitivity and specificity scores of 0.95 and 0.79, respectively, when using the optimal cut-off score of 10, whereas these scores were 0.88 and 0.74 for the DAST-10 when using the optimal cut-off score of 4. Additionally, both the DUDIT and the DAST-10 showed good discriminant validity as they differentiated prisoners with drug use disorder from those without. Findings support the Turkish versions of both the DUDIT and the DAST-10 as reliable and valid drug abuse screening instruments that measure unidimensional constructs.

  3. Optimizing Oral Bioavailability in Drug Discovery: An Overview of Design and Testing Strategies and Formulation Options.

    Science.gov (United States)

    Aungst, Bruce J

    2017-04-01

    For discovery teams working toward new, orally administered therapeutic agents, one requirement is to attain adequate systemic exposure after oral dosing, which is best accomplished when oral bioavailability is optimized. This report summarizes the bioavailability challenges currently faced in drug discovery, and the design and testing methods and strategies currently utilized to address the challenges. Profiling of discovery compounds usually includes separate assessments of solubility, permeability, and susceptibility to first-pass metabolism, which are the 3 most likely contributors to incomplete oral bioavailability. An initial assessment of absorption potential may be made computationally, and high throughput in vitro assays are typically performed to prioritize compounds for in vivo studies. The initial pharmacokinetic study is a critical decision point in compound evaluation, and the importance of the effect the dosing vehicle or formulation can have on oral bioavailability, especially for poorly water soluble compounds, is emphasized. Dosing vehicles and bioavailability-enabling formulations that can be used for discovery and preclinical studies are described. Optimizing oral bioavailability within a chemical series or for a lead compound requires identification of the barrier limiting bioavailability, and methods used for this purpose are outlined. Finally, a few key guidelines are offered for consideration when facing the challenges of optimizing oral bioavailability in drug discovery. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  4. Designing, testing, and implementing a sustainable nurse home visiting program: right@home.

    Science.gov (United States)

    Goldfeld, Sharon; Price, Anna; Kemp, Lynn

    2018-05-01

    Nurse home visiting (NHV) offers a potential platform to both address the factors that limit access to services for families experiencing adversity and provide effective interventions. Currently, the ability to examine program implementation is hampered by a lack of detailed description of actual, rather than expected, program development and delivery in published studies. Home visiting implementation remains a black box in relation to quality and sustainability. However, previous literature would suggest that efforts to both report and improve program implementation are vital for NHV to have population impact and policy sustainability. In this paper, we provide a case study of the design, testing, and implementation of the right@home program, an Australian NHV program and randomized controlled trial. We address existing gaps related to implementation of NHV programs by describing the processes used to develop the program to be trialed, summarizing its effectiveness, and detailing the quality processes and implementation evaluation. The weight of our evidence suggests that NHV can be a powerful and sustainable platform for addressing inequitable outcomes, particularly when the program focuses on parent engagement and partnership, delivers evidence-based strategies shown to improve outcomes, includes fidelity monitoring, and is adapted to and embedded within existing service delivery systems. © 2018 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals, Inc. on behalf of The New York Academy of Sciences.

  5. Drug susceptibility testing of Mycobacterium tuberculosis to fluoroquinolones

    DEFF Research Database (Denmark)

    Johansen, I S; Larsen, A R; Sandven, P

    2003-01-01

    In the first attempt to establish a quality assurance programme for susceptibility testing of Mycobacterium tuberculosis to fluoroquinolones, 20 strains with different fluoroquinolone susceptibility patterns were distributed by the Supranational Reference Laboratory in Stockholm to the other...

  6. The lymphocyte transformation test for the diagnosis of drug allergy: sensitivity and specificity.

    Science.gov (United States)

    Nyfeler, B; Pichler, W J

    1997-02-01

    The diagnosis of a drug allergy is mainly based upon a very detailed history and the clinical findings. In addition, several in vitro or in vivo tests can be performed to demonstrate a sensitization to a certain drug. One of the in vitro tests is the lymphocyte transformation test (LTT), which can reveal a sensitization of T-cells by an enhanced proliferative response of peripheral blood mononuclear cells to a certain drug. To evaluate the sensitivity and specificity of the LTT, 923 case histories of patients with suspected drug allergy in whom a LTT was performed were retrospectively analysed. Based on the history and provocation tests, the probability (P) of a drug allergy was estimated to be > 0.9, 0.5-0.9, 0.1-0.5 or 0.9) had a positive LTT, which indicates a sensitivity of 78%. If allergies to betalactam-antibiotics were analysed separately, the sensitivity was 74.4%. Fifteen of 102 patients where a classical drug allergy could be excluded (P sensitization could be demonstrated as well (i.e. hen's egg lysozyme, 7/7). In 632 of the 923 cases, skin tests were also performed (scratch and/or epicutaneous), for which we found a lower sensitivity than for the LTT (64%), while the specificity was the same (85%). Although our data are somewhat biased by the high number of penicillin allergies and cannot be generalized to drug allergies caused by other compounds, we conclude that the LTT is a useful diagnostic test in drug allergies, able to support the diagnosis of a drug allergy and to pinpoint the relevant drug.

  7. 75 FR 76069 - Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of...

    Science.gov (United States)

    2010-12-07

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Random Drug and Alcohol Testing... minimum random drug and alcohol testing percentage rates for the period January 1, 2011, through December... Regulations Title 14, section 120.109(b) (for drug testing), and 120.217(c) (for alcohol testing). Issued in...

  8. 77 FR 71669 - Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of...

    Science.gov (United States)

    2012-12-03

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Random Drug and Alcohol Testing... the minimum random drug and alcohol testing percentage rates for the period January 1, 2013, through... Regulations Title 14, Sec. Sec. 120.109(b) (for drug testing), and 120.217(c) (for alcohol testing). Issued in...

  9. 76 FR 74843 - Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of...

    Science.gov (United States)

    2011-12-01

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Random Drug and Alcohol Testing... the minimum random drug and alcohol testing percentage rates for the period January 1, 2012, through... Regulations Title 14, Sec. 120.109(b) (for drug testing), and 120.217(c) (for alcohol testing). Issued in...

  10. 78 FR 77196 - Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of...

    Science.gov (United States)

    2013-12-20

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Random Drug and Alcohol Testing... the minimum random drug and alcohol testing percentage rates for the period January 1, 2014, through... Federal Regulations Title 14, section 120.109(b) (for drug testing), and 120.217(c) (for alcohol testing...

  11. 49 CFR 40.321 - What is the general confidentiality rule for drug and alcohol test information?

    Science.gov (United States)

    2010-10-01

    ... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Confidentiality and Release of Information § 40.321 What is the general confidentiality rule for drug and alcohol test... DOT drug or alcohol testing process, you are prohibited from releasing individual test results or...

  12. Black/White Differences in Adolescent Drug Use: A Test of Six Hypotheses

    Science.gov (United States)

    Rote, Sunshine M.; Taylor, John

    2014-01-01

    Six specific hypotheses have been developed to account for why Caucasians have higher rates of drug use compared to African-Americans. This article utilizes data from a South Florida-based community study of 893 young adults (1998-2002) to test these hypotheses. Specifically, Caucasians (1) initiate drug use at younger ages than African-Americans…

  13. 78 FR 71036 - Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting...

    Science.gov (United States)

    2013-11-27

    ... PHMSA-2013-0248] Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In Information AGENCY: Pipeline... Management Information System (MIS) Data; and New Method for Operators to Obtain User Name and Password for...

  14. FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR

    Science.gov (United States)

    An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing.  Br

  15. FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR Staging

    Science.gov (United States)

    An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing.  Br

  16. Current status and burning issues in immunotoxicity testing of drugs

    International Nuclear Information System (INIS)

    Laan, Jan Willem van der; Loveren, Henk van

    2005-01-01

    Besides pathology endpoints, additional immune function endpoints have been included in the Note for Guidance on Repeated Dose Toxicity by the European Union (July 2001), which concern the analysis of antibody responses to a T-cell-dependent antigen. Guidance papers of other regulatory authorities are published as well. The main issue is the need for functional immunotoxicity testing to detect unintended immunosuppression. The International Conference on Harmonization (ICH) has surveyed studies from the files of the pharmaceutical industry to find the proportion of compounds that can be detected by additional immunotoxicity testing. Preliminary analysis shows that 10-15% of the compounds in the survey only react positively to the additional tests. More data are requested from the pharmaceutical industry. The Expert Working Group of the ICH has decided to choose a cause-for-concern approach to immmunotoxicity rather than a routine-screening approach. The causes for concern are to be defined during ICH negotiations

  17. An investigation of classification algorithms for predicting HIV drug resistance without genotype resistance testing

    CSIR Research Space (South Africa)

    Brandt, P

    2014-01-01

    Full Text Available is limited in low-resource settings. In this paper we investigate machine learning techniques for drug resistance prediction from routine treatment and laboratory data to help clinicians select patients for confirmatory genotype testing. The techniques...

  18. 49 CFR 40.163 - How does the MRO report drug test results?

    Science.gov (United States)

    2010-10-01

    ... How does the MRO report drug test results? (a) As the MRO, it is your responsibility to report all... copy of that report in a format suitable for inspection and auditing by a DOT representative. (f) You...

  19. 14 CFR 120.109 - Types of drug testing required.

    Science.gov (United States)

    2010-01-01

    ... that employee's performance either contributed to an accident or can not be completely discounted as a... determination, using the best information available at the time of the determination, that the employee's performance could not have contributed to the accident. The employee shall submit to post-accident testing...

  20. [Reduction of animal experiments in experimental drug testing].

    Science.gov (United States)

    Behrensdorf-Nicol, H; Krämer, B

    2014-10-01

    In order to ensure the quality of biomedical products, an experimental test for every single manufactured batch is required for many products. Especially in vaccine testing, animal experiments are traditionally used for this purpose. For example, efficacy is often determined via challenge experiments in laboratory animals. Safety tests of vaccine batches are also mostly performed using laboratory animals. However, many animal experiments have clear inherent disadvantages (low accuracy, questionable transferability to humans, unclear significance). Furthermore, for ethical reasons and animal welfare aspects animal experiments are also seen very critical by the public. Therefore, there is a strong trend towards replacing animal experiments with methods in which no animals are used ("replacement"). If a replacement is not possible, the required animal experiments should be improved in order to minimize the number of animals necessary ("reduction") and to reduce pain and suffering caused by the experiment to a minimum ("refinement"). This "3R concept" is meanwhile firmly established in legislature. In recent years many mandatory animal experiments have been replaced by alternative in vitro methods or improved according to the 3R principles; numerous alternative methods are currently under development. Nevertheless, the process from the development of a new method to its legal implementation takes a long time. Therefore, supplementary regulatory measures to facilitate validation and acceptance of new alternative methods could contribute to a faster and more consequent implementation of the 3R concept in the testing of biomedical products.

  1. Optimization and validation of CEDIA drugs of abuse immunoassay tests in serum on Hitachi 912.

    Science.gov (United States)

    Kirschbaum, Katrin M; Musshoff, Frank; Schmithausen, Ricarda; Stockhausen, Sarah; Madea, Burkhard

    2011-10-10

    Due to sensitive limits of detection of chromatographic methods and low limit values regarding the screening of drugs under the terms of impairment in safe driving (§ 24a StVG, Street Traffic Law in Germany), preliminary immunoassay (IA) tests should be able to detect also low concentrations of legal and illegal drugs in serum in forensic cases. False-negatives should be avoided, the rate of false-positive samples should be low due to cost and time. An optimization of IA cutoff values and a validation of the assay is required for each laboratory. In a retrospective study results for serum samples containing amphetamine, methylenedioxy derivatives, cannabinoids, benzodiazepines, cocaine (metabolites), methadone and opiates obtained with CEDIA drugs of abuse reagents on a Hitachi 912 autoanalyzer were compared with quantitative results of chromatographic methods (gas or liquid chromatography coupled with mass spectrometry (GC/MS or LC/MS)). Firstly sensitivity, specificity, positive and negative predictive values and overall misclassification rates were evaluated by contingency tables and compared to ROC-analyses and Youden-Indices. Secondly ideal cutoffs were statistically calculated on the basis of sensitivity and specificity as decisive statistical criteria with focus on a high sensitivity (low rates of false-negatives), i.e. using the Youden-Index. Immunoassay (IA) and confirmatory results were available for 3014 blood samples. Sensitivity was 90% or more for nearly all analytes: amphetamines (IA cutoff 9.5 ng/ml), methylenedioxy derivatives (IA cutoff 5.5 ng/ml), cannabinoids (IA cutoff 14.5 ng/ml), benzodiazepines (IA cutoff >0 ng/ml). Test of opiates showed a sensitivity of 86% for a IA cutoff value of >0 ng/ml. Values for specificity ranged between 33% (methadone, IA cutoff 10 ng/ml) and 90% (cocaine, IA cutoff 20 ng/ml). Lower cutoff values as recommended by ROC analyses were chosen for most tests to decrease the rate of false-negatives. Analyses enabled

  2. Drug target mining and analysis of the Chinese tree shrew for pharmacological testing.

    Directory of Open Access Journals (Sweden)

    Feng Zhao

    Full Text Available The discovery of new drugs requires the development of improved animal models for drug testing. The Chinese tree shrew is considered to be a realistic candidate model. To assess the potential of the Chinese tree shrew for pharmacological testing, we performed drug target prediction and analysis on genomic and transcriptomic scales. Using our pipeline, 3,482 proteins were predicted to be drug targets. Of these predicted targets, 446 and 1,049 proteins with the highest rank and total scores, respectively, included homologs of targets for cancer chemotherapy, depression, age-related decline and cardiovascular disease. Based on comparative analyses, more than half of drug target proteins identified from the tree shrew genome were shown to be higher similarity to human targets than in the mouse. Target validation also demonstrated that the constitutive expression of the proteinase-activated receptors of tree shrew platelets is similar to that of human platelets but differs from that of mouse platelets. We developed an effective pipeline and search strategy for drug target prediction and the evaluation of model-based target identification for drug testing. This work provides useful information for future studies of the Chinese tree shrew as a source of novel targets for drug discovery research.

  3. Is Genetic Testing Right for You? | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... Testing CLINSEQ®: A Large-Scale Medical Sequencing Clinical Research Pilot Study Prenatal Screening - Prenatal testing information, including ultrasound, amniocentesis, and chorionic villus sampling ( ...

  4. Are drug companies living up to their human rights responsibilities? The perspective of the former United Nations Special Rapporteur (2002-2008.

    Directory of Open Access Journals (Sweden)

    Paul Hunt

    2010-09-01

    Full Text Available BACKGROUND TO THE DEBATE: The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The "Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines" include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.

  5. Are drug companies living up to their human rights responsibilities? The perspective of the former United Nations Special Rapporteur (2002-2008).

    Science.gov (United States)

    Hunt, Paul; Khosla, Rajat

    2010-09-28

    The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The "Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines" include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.

  6. Cost-effectiveness analysis of introducing malaria diagnostic testing in drug shops

    DEFF Research Database (Denmark)

    Hansen, Kristian Schultz; Clarke, Siân E.; Lal, Sham

    2017-01-01

    Background Private sector drug shops are an important source of malaria treatment in Africa, yet diagnosis without parasitological testing is common among these providers. Accurate rapid diagnostic tests for malaria (mRDTs) require limited training and present an opportunity to increase access...... to correct diagnosis. The present study was a cost-effectiveness analysis of the introduction of mRDTs in Ugandan drug shops. Methods Drug shop vendors were trained to perform and sell subsidised mRDTs and artemisinin-based combination therapies (ACTs) in the intervention arm while vendors offered ACTs...... following presumptive diagnosis of malaria in the control arm. The effect on the proportion of customers with fever ‘appropriately treated of malaria with ACT’ was captured during a randomised trial in drug shops in Mukono District, Uganda. Health sector costs included: training of drug shop vendors...

  7. Transfer of drug dissolution testing by statistical approaches: Case study

    Science.gov (United States)

    AL-Kamarany, Mohammed Amood; EL Karbane, Miloud; Ridouan, Khadija; Alanazi, Fars K.; Hubert, Philippe; Cherrah, Yahia; Bouklouze, Abdelaziz

    2011-01-01

    The analytical transfer is a complete process that consists in transferring an analytical procedure from a sending laboratory to a receiving laboratory. After having experimentally demonstrated that also masters the procedure in order to avoid problems in the future. Method of transfers is now commonplace during the life cycle of analytical method in the pharmaceutical industry. No official guideline exists for a transfer methodology in pharmaceutical analysis and the regulatory word of transfer is more ambiguous than for validation. Therefore, in this study, Gauge repeatability and reproducibility (R&R) studies associated with other multivariate statistics appropriates were successfully applied for the transfer of the dissolution test of diclofenac sodium as a case study from a sending laboratory A (accredited laboratory) to a receiving laboratory B. The HPLC method for the determination of the percent release of diclofenac sodium in solid pharmaceutical forms (one is the discovered product and another generic) was validated using accuracy profile (total error) in the sender laboratory A. The results showed that the receiver laboratory B masters the test dissolution process, using the same HPLC analytical procedure developed in laboratory A. In conclusion, if the sender used the total error to validate its analytical method, dissolution test can be successfully transferred without mastering the analytical method validation by receiving laboratory B and the pharmaceutical analysis method state should be maintained to ensure the same reliable results in the receiving laboratory. PMID:24109204

  8. Rational use and interpretation of urine drug testing in chronic opioid therapy.

    Science.gov (United States)

    Reisfield, Gary M; Salazar, Elaine; Bertholf, Roger L

    2007-01-01

    Urine drug testing (UDT) has become an essential feature of pain management, as physicians seek to verify adherence to prescribed opioid regimens and to detect the use of illicit or unauthorized licit drugs. Results of urine drug tests have important consequences in regard to therapeutic decisions and the trust between physician and patient. However, reliance on UDT to confirm adherence can be problematic if the results are not interpreted correctly, and evidence suggests that many physicians lack an adequate understanding of the complexities of UDT and the factors that can affect test results. These factors include metabolic conversion between drugs, genetic variations in drug metabolism, the sensitivity and specificity of the analytical method for a particular drug or metabolite, and the effects of intentional and unintentional interferants. In this review, we focus on the technical features and limitations of analytical methods used for detecting drugs or their metabolites in urine, the statistical constructs that are pertinent to ordering UDT and interpreting test results, and the application of these concepts to the clinical monitoring of patients maintained on chronic opioid therapy.

  9. 49 CFR Appendix F to Part 40 - Drug and Alcohol Testing Information that C/TPAs May Transmit to Employers

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Drug and Alcohol Testing Information that C/TPAs... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Pt. 40, App. F Appendix F to Part 40—Drug and Alcohol Testing Information that C/TPAs May Transmit to Employers 1. If you...

  10. 14 CFR 120.11 - Refusal to submit to a drug or alcohol test by a Part 61 certificate holder.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Refusal to submit to a drug or alcohol test...: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Individuals Certificated Under Parts 61, 63, and 65 § 120.11 Refusal to submit to a drug or alcohol test by a Part 61 certificate holder. (a) This...

  11. 10 CFR 26.67 - Random drug and alcohol testing of individuals who have applied for authorization.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Random drug and alcohol testing of individuals who have... PROGRAMS Granting and Maintaining Authorization § 26.67 Random drug and alcohol testing of individuals who... other entity relies on drug and alcohol tests that were conducted before the individual applied for...

  12. 14 CFR 120.15 - Refusal to submit to a drug or alcohol test by a Part 65 certificate holder.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Refusal to submit to a drug or alcohol test...: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Individuals Certificated Under Parts 61, 63, and 65 § 120.15 Refusal to submit to a drug or alcohol test by a Part 65 certificate holder. (a) This...

  13. 14 CFR 120.13 - Refusal to submit to a drug or alcohol test by a Part 63 certificate holder.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Refusal to submit to a drug or alcohol test...: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Individuals Certificated Under Parts 61, 63, and 65 § 120.13 Refusal to submit to a drug or alcohol test by a Part 63 certificate holder. (a) This...

  14. 49 CFR 40.15 - May an employer use a service agent to meet DOT drug and alcohol testing requirements?

    Science.gov (United States)

    2010-10-01

    ... drug and alcohol testing requirements? 40.15 Section 40.15 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Employer Responsibilities § 40.15 May an employer use a service agent to meet DOT drug and alcohol testing requirements? (a...

  15. 49 CFR 40.203 - What problems cause a drug test to be cancelled unless they are corrected?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false What problems cause a drug test to be cancelled unless they are corrected? 40.203 Section 40.203 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests § 40.203...

  16. 21 CFR 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Testing and research conducted by or with funds... Categories of Records § 20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration. (a) Any list that may be prepared by the Food and Drug Administration of testing and research...

  17. Annual banned-substance review: analytical approaches in human sports drug testing.

    Science.gov (United States)

    Thevis, Mario; Kuuranne, Tiia; Geyer, Hans; Schänzer, Wilhelm

    2017-01-01

    There has been an immense amount of visibility of doping issues on the international stage over the past 12 months with the complexity of doping controls reiterated on various occasions. Hence, analytical test methods continuously being updated, expanded, and improved to provide specific, sensitive, and comprehensive test results in line with the World Anti-Doping Agency's (WADA) 2016 Prohibited List represent one of several critical cornerstones of doping controls. This enterprise necessitates expediting the (combined) exploitation of newly generated information on novel and/or superior target analytes for sports drug testing assays, drug elimination profiles, alternative test matrices, and recent advances in instrumental developments. This paper is a continuation of the series of annual banned-substance reviews appraising the literature published between October 2015 and September 2016 concerning human sports drug testing in the context of WADA's 2016 Prohibited List. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  18. Evaluation of rapid radiometric method for drug susceptibility testing of Mycobacterium tuberculosis

    International Nuclear Information System (INIS)

    Siddiqi, S.H.; Libonati, J.P.; Middlebrook, G.

    1981-01-01

    A total of 106 isolates of Mycobacterium tuberculosis were tested for drug susceptibility by the conventional 7H11 plate method and by a new rapid radiometric method using special 7H12 liquid medium with 14 C-labeled substrate. Results obtained by the two methods were compared for rapidity, sensitivity, and specificity of the new test method. There was 98% overall agreement between the results obtained by the two methods. Of a total of 424 drug tests, only 8 drug results did not agree, mostly in the case of streptomycin. This new procedure was found to be rapid, with 87% of the tests results reportable within 4 days and 98% reportable within 5 days as compared to the usual 3 weeks required with the conventional indirect susceptibility test method. The results of this preliminary study indicate that the rapid radiometric method seems to have the potential for routine laboratory use and merits further investigations

  19. Zero-inflated Poisson model based likelihood ratio test for drug safety signal detection.

    Science.gov (United States)

    Huang, Lan; Zheng, Dan; Zalkikar, Jyoti; Tiwari, Ram

    2017-02-01

    In recent decades, numerous methods have been developed for data mining of large drug safety databases, such as Food and Drug Administration's (FDA's) Adverse Event Reporting System, where data matrices are formed by drugs such as columns and adverse events as rows. Often, a large number of cells in these data matrices have zero cell counts and some of them are "true zeros" indicating that the drug-adverse event pairs cannot occur, and these zero counts are distinguished from the other zero counts that are modeled zero counts and simply indicate that the drug-adverse event pairs have not occurred yet or have not been reported yet. In this paper, a zero-inflated Poisson model based likelihood ratio test method is proposed to identify drug-adverse event pairs that have disproportionately high reporting rates, which are also called signals. The maximum likelihood estimates of the model parameters of zero-inflated Poisson model based likelihood ratio test are obtained using the expectation and maximization algorithm. The zero-inflated Poisson model based likelihood ratio test is also modified to handle the stratified analyses for binary and categorical covariates (e.g. gender and age) in the data. The proposed zero-inflated Poisson model based likelihood ratio test method is shown to asymptotically control the type I error and false discovery rate, and its finite sample performance for signal detection is evaluated through a simulation study. The simulation results show that the zero-inflated Poisson model based likelihood ratio test method performs similar to Poisson model based likelihood ratio test method when the estimated percentage of true zeros in the database is small. Both the zero-inflated Poisson model based likelihood ratio test and likelihood ratio test methods are applied to six selected drugs, from the 2006 to 2011 Adverse Event Reporting System database, with varying percentages of observed zero-count cells.

  20. Development of paper-based color test-strip for drug detection in aquatic environment: Application to oxytetracycline.

    Science.gov (United States)

    Gomes, Helena I A S; Sales, M Goreti F

    2015-03-15

    The wide use of antibiotics in aquaculture has led to the emergence of resistant microbial species. It should be avoided/minimized by controlling the amount of drug employed in fish farming. For this purpose, the present work proposes test-strip papers aiming at the detection/semi-quantitative determination of organic drugs by visual comparison of color changes, in a similar analytical procedure to that of pH monitoring by universal pH paper. This is done by establishing suitable chemical changes upon cellulose, attributing the paper the ability to react with the organic drug and to produce a color change. Quantitative data is also enabled by taking a picture and applying a suitable mathematical treatment to the color coordinates given by the HSL system used by windows. As proof of concept, this approach was applied to oxytetracycline (OXY), one of the antibiotics frequently used in aquaculture. A bottom-up modification of paper was established, starting by the reaction of the glucose moieties on the paper with 3-triethoxysilylpropylamine (APTES). The so-formed amine layer allowed binding to a metal ion by coordination chemistry, while the metal ion reacted after with the drug to produce a colored compound. The most suitable metals to carry out such modification were selected by bulk studies, and the several stages of the paper modification were optimized to produce an intense color change against the concentration of the drug. The paper strips were applied to the analysis of spiked environmental water, allowing a quantitative determination for OXY concentrations as low as 30ng/mL. In general, this work provided a simple, method to screen and discriminate tetracycline drugs, in aquaculture, being a promising tool for local, quick and cheap monitoring of drugs. Copyright © 2014 Elsevier B.V. All rights reserved.

  1. Testing for drug and alcohol аbuse at the workplace

    Directory of Open Access Journals (Sweden)

    Zoran Kavrakovski

    2009-12-01

    Full Text Available Drug and alcohol abuse in the workplace represents a great risk to employee’s health and safety. More than 50% of the employees worldwide are related to easily accessible drug abuse, while 70% of the employees are related to alcohol abuse in the workplace. Tests for detecting drug and alcohol abuse in the workplace should be part of a new regulation, compulsory for all employees in the Republic of Macedonia. Implementing this sort of testing program should at the same time be a step towards devising particular solutions that shall bring about greater safety in the working environment. A key element in the implementation is to devise and establish an adequate policy that shall determine the risk factors within a working establishment which shall clearly express its position regarding drug and alcohol abuse during working hours. Along with the risk factors, the policy may also include the program for testing both, employees and the ones who are about to be employed, for drug and alcohol abuse. In order to implement this sort of test, it must be in accordance with the Occupational Safety and Health Act (Official gazette of the Republic of Macedonia, No 92/07, 2007 and a legal framework has to be defined, that shall regulate and solve numerous aspects of this issue, in order to fully implement the program for drug free working environment pursuant to the Declaration and the decrees of the United Nations General Assembly in 1998.

  2. Juvenile Animal Testing: Assessing Need and Use in the Drug Product Label.

    Science.gov (United States)

    Baldrick, Paul

    2018-01-01

    Juvenile animal testing has become an established part of drug development to support safe clinical use in the human pediatric population and for eventual drug product label use. A review of European Paediatric Investigation Plan decisions showed that from 2007 to mid-2017, 229 drugs had juvenile animal work requested, almost exclusively incorporating general toxicology study designs, in rat (57.5%), dog (8%), mouse (4.5%), monkey (4%), pig (2%), sheep (1%), rabbit (1%), hamster (0.5%), and species not specified (21.5%). A range of therapeutic areas were found, but the most common areas were infectious diseases (15%), endocrinology (13.5%), oncology (13%), neurology (11%), and cardiovascular diseases (10%). Examination of major clinical indications within these therapeutic areas showed some level of consistency in the species of choice for testing and the pediatric age that required support. Examination of juvenile animal study findings presented in product labels raises questions around how useful the data are to allow prescribing the drug to a child. It is hopeful that the new ICH S11 guideline "Nonclinical Safety Testing in Support of Development of Pediatric Medicines" currently in preparation will aid drug developers in clarifying the need for juvenile animal studies as well as in promoting a move away from toxicology studies with a conventional design. This would permit more focused testing to examine identified areas of toxicity or safety concerns and clarify the presentation/interpretation of juvenile animal study findings for proper risk assessment by a drug prescriber.

  3. Selecting participants when testing new drugs: the implications of age and gender discrimination.

    Science.gov (United States)

    Ferguson, Pamela R

    2002-01-01

    Pharmaceutical products are rigorously tested for safety and efficacy prior to being licensed for use. During this testing process the archetypal research subject is a young male; women and older people are less frequently invited to participate. This is especially true at the early stages, but can also occur in the later phases of drug testing. This paper considers the reasons for the relative under-representation of these groups, and the legal implications of failing to include as research subjects the very types of people who will ultimately consume these drugs.

  4. 49 CFR 40.199 - What problems always cause a drug test to be cancelled?

    Science.gov (United States)

    2010-10-01

    ... cancelled? 40.199 Section 40.199 Transportation Office of the Secretary of Transportation PROCEDURES FOR... cause a drug test to be cancelled? (a) As the MRO, when the laboratory discovers a “fatal flaw” during... specimen has been “Rejected for Testing” (with the reason stated). You must always cancel such a test. (b...

  5. 75 FR 8526 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

    Science.gov (United States)

    2010-02-25

    ... 2105-AD64 Procedures for Transportation Workplace Drug and Alcohol Testing Programs AGENCY: Office of... required method. However, in response to comments requesting additional flexibility in testing methods, the... may increase flexibility and lower costs for employers who choose to use them over more expensive...

  6. Implementation of in vitro replacement technologies in regulatory drug testing - An innovation systems perspective

    NARCIS (Netherlands)

    Kooijman, M.; Van Meer, P.J.K.; Moors, E.H.M.; Hekkert, M.P.; Schellekens, H.

    2011-01-01

    The replacement of in vivo methods by in vitro methods in regulatory drug testing is rare. The aim of this research is to identify barriers and drivers of the replacement of in vivo methods by in vitro methods in Europe. We studied two cases. The first case is the Draize eye test. Since 2009, the in

  7. Withdrawal of fall-risk-increasing drugs in older persons: Effect on mobility test outcomes

    NARCIS (Netherlands)

    N. van der Velde (Nathalie); B.H.Ch. Stricker (Bruno); H.A.P. Pols (Huib); T.J.M. van der Cammen (Tischa)

    2007-01-01

    textabstractBackground: Previously, we have shown that withdrawal of fall-risk-increasing drugs (FRIDs) as a single intervention reduces falls incidence. Improvement of mobility may be an important factor in this finding and we therefore tested whether mobility tests improved after FRID withdrawal.

  8. Withdrawal of fall-risk-increasing drugs in older persons: effect on mobility test outcomes

    NARCIS (Netherlands)

    van der Velde, Nathalie; Stricker, Bruno H. Ch; Pols, Huibert A. P.; van der Cammen, Tischa J. M.

    2007-01-01

    BACKGROUND: Previously, we have shown that withdrawal of fall-risk-increasing drugs (FRIDs) as a single intervention reduces falls incidence. Improvement of mobility may be an important factor in this finding and we therefore tested whether mobility tests improved after FRID withdrawal. METHODS: In

  9. Schools as Good Parent: Symbolism versus Substance in Drug and Alcohol Testing of School Children.

    Science.gov (United States)

    Hutton, Chris

    1992-01-01

    Discusses the decision to implement a drug and alcohol testing program, analyzing how such programs fit within the traditional functions of criminal and administrative law, pinpoints some messages conveyed by testing programs, and discusses factual premises that should underlay such programs. Reviews recent U.S. Supreme Court rulings and gauges…

  10. 75 FR 5722 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

    Science.gov (United States)

    2010-02-04

    ... personal identifying information about an employee (other than a social security number (SSN) or other... testing required under this part. (c) As a drug testing laboratory located in Canada or Mexico which is... procedures. (d) As an IITF located in Canada or Mexico which is not certified by HHS under the NLCP, you are...

  11. Aspects of analysis of small-sample right censored data using generalized Wilcoxon rank tests

    OpenAIRE

    Öhman, Marie-Louise

    1994-01-01

    The estimated bias and variance of commonly applied and jackknife variance estimators and observed significance level and power of standardised generalized Wilcoxon linear rank sum test statistics and tests, respectively, of Gehan and Prentice are compared in a Monte Carlo simulation study. The variance estimators are the permutational-, the conditional permutational- and the jackknife variance estimators of the test statistic of Gehan, and the asymptotic- and the jackknife variance estimator...

  12. Inaccuracy of transthoracic echocardiography for the identification of right-sided vegetation in patients with no history of intravenous drug abuse or cardiac device insertion.

    Science.gov (United States)

    Xie, Jiang; Liu, Shuang; Yang, Jinghua; Xu, Jie; Zhu, Guangfa

    2014-06-01

    The use of transthoracic echocardiography (TTE) to identify right-sided infective endocarditis (RSIE) vegetation is controversial. Data are scarce for patients with no history of intravenous drug abuse (IVDA) or cardiac device insertion. This study analysed the consistency of presurgical echocardiographic results with surgical findings for vegetation identification, and the factors that influence accuracy of echocardiography. This retrospective trial divided infective endocarditis (IE) patients into three subgroups according to the results of their presurgical TTE: left-sided native IE (LSNIE), left-sided prosthetic valve IE (LSPIE) and RSIE. The accuracy of TTE was tested by comparing vegetation (number and location), detected presurgery by TTE, with actual findings during surgery. In total, 416 patients were analysed, 322 with LSNIE, 31 with LSPIE and 63 with RSIE. Consistency between TTE findings and surgical results was lower in the RSIE group compared with the LSPIE and LSNIE groups. Consistency was lowered by the presence of vegetation in multiple locations and atypical distribution--both of which were increased in the RSIE group. The chance of vegetation in both sides of the heart rose with increased numbers of vegetation locations in RSIE patients. A high proportion of RSIE patients had congenital heart defects, mostly ventricular septal defects. TTE may be unsuitable for RSIE patients with no history of IVDA or cardiac device insertion, because multifocal and atypically distributed vegetation may influence detection accuracy. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  13. Alteration of basal ganglia and right frontoparietal network in early drug-naïve Parkinson’s disease during heat pain stimuli and resting state

    Directory of Open Access Journals (Sweden)

    Ying eTan

    2015-08-01

    Full Text Available Background: The symptoms and pathogenesis of Parkinson’s disease (PD are complicated and accurate diagnosis is difficult, particularly in early-stage. Functional magnetic resonance imaging is noninvasive and characterized by the integration of different brain areas at functional connectivity (FC. Considering pain process in PD, we hypothesized that pain is one of the earliest symptoms and investigated whether FC of the pain network was disrupted in PD without pain.Methods: Fourteen early drug-naïve PD without pain and 17 age- and sex-matched healthy controls (HC participated in our test. We investigate abnormalities in FC and in functional network connectivity in PD compared with HC during the task (51 °C heat pain stimuli and at rest.Results: Compared with HC, PD showed decreased FC in basal ganglia network (BGN, salience network (SN and sensorimotor network in two states respectively. FNC between the BGN and the SN are reduced during both states in PD compared with HC. In addition, the FNC associated with right frontoparietal network (RFPN was also significantly disturbed during the task.Conclusion: These findings suggest that BGN plays a role in the pathological mechanisms of pain underlying PD, and RFPN likely contributes greatly to harmonization between intrinsic brain activity and external stimuli.

  14. Ethical and human rights dimensions in prenatal HIV/AIDS testing ...

    African Journals Online (AJOL)

    Objectives: To evaluate the conflicts between the rights of society and those of mothers-to-be and the unborn, which raise difficult ethical and legal questions ... even though their consideration is essential if the country is to align its practices with existing national laws, as well as international conventions to which it is a ...

  15. Policing, massive street drug testing and poly-substance use chaos in Georgia - a policy case study.

    Science.gov (United States)

    Otiashvili, David; Tabatadze, Mzia; Balanchivadze, Nino; Kirtadze, Irma

    2016-01-16

    Since early 2000, intensive policing, wide scale street drug testing, and actions aimed at limiting the availability of specific drugs have been implemented in Georgia. Supporters of this approach argue that fear of drug testing and resulting punishment compels drug users to stop using and prevents youth from initiating drug use. It has been also stated that reduction in the availability of specific drugs should be seen as an indication of the overall success of counter-drug efforts. The aim of the current review is to describe the drug-related law enforcement response in Georgia and its impact on illicit drug consumption and drug-related harm. We reviewed relevant literature that included peer-reviewed scientific articles, stand-alone research reports, annual drug situation reports, technical reports and program data. This was also supplemented by the review of relevant legislation and judicial practices for the twelve year period between 2002 and 2014. Every episode of reduced availability of any "traditional" injection drug was followed by the discovery/introduction of a new injection preparation. The pattern of drug consumption was normally driven by users' attempts to substitute their drug of choice through mixing together available alternative substances. Chaotic poly-substance use and extensive utilization of home-made injection drugs, prepared from toxic precursors, became common. Massive random street drug testing had little or no effect on the prevalence of problem drug use. Intensive harassment of drug users and exclusive focus on reducing the availability of specific drugs did not result in reduction of the prevalence of injecting drug use. Repressive response of Georgian anti-drug authorities relied heavily on consumer sanctions, which led to shifts in drug users' behavior. In most cases, these shifts were associated with the introduction and use of new toxic preparations and subsequent harm to the physical and mental health of drug consumers.

  16. Measuring right-hemisphere dysfunction in children: validity of two new computer tests

    NARCIS (Netherlands)

    Sips, H.J.W.A.; C.E. Catsman-Berrevoets (Coriene); H.R. van Dongen (Huug); van der Werff, P.J.J.; Brooke, L.J.

    1994-01-01

    textabstractThe validity of two new computer‐mediated tests for the detection of right‐cerebral hemisphere lesions in children–the Right‐hemisphere Dysfunction Test and the Visual Perception Test–was evaluated. Normative data were drawn from a group of 91 children (aged five to 14 years) and 14

  17. Introduction to Special Issue: The Human, Human Rights and DNA Identity Tests

    DEFF Research Database (Denmark)

    Vaisman, Noa

    2018-01-01

    might these new ways of imagining the subject shape present and future human rights law and practice? The papers examine a variety of scientific technologies—personalized medicine and organ transplant, mitochondrial DNA replacement, and scaffolds and regenerative medicine—and their implications for our......This special issue examines the diverse realities created by the intersection of emerging technologies, new scientific knowledge, and the human being. It engages with two key questions: how is the human being shaped and constructed in new ways through advances in science and technology? and how...... conceptualization of the human subject. Each is then followed by a commentary that both brings to light new dimensions of the original paper and presents a new theoretical take on the topic. Together these papers offer a serious challenge to the vision of the human subject at the root of human rights law. Instead...

  18. 49 CFR 40.323 - May program participants release drug or alcohol test information in connection with legal...

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false May program participants release drug or alcohol... the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING... information pertaining to an employee's drug or alcohol test without the employee's consent in certain legal...

  19. Willingness to Provide a Hair Sample for Drug Testing among Electronic Dance Music Party Attendees.

    Science.gov (United States)

    Palamar, Joseph J; Salomone, Alberto; Cleland, Charles M; Sherman, Scott

    2018-04-25

    Non-disclosure of drug use on surveys is common and many drug users unknowingly ingest adulterant or replacement drugs, which leads to underreporting of use of these drugs. Biological testing can complement survey research, and hair-testing is an appealing method as many drugs are detectable for months post-use. We examined willingness to donate a hair sample to be tested among those surveyed in a population at high risk for consuming adulterated drugs-electronic dance music (EDM) party attendees. We surveyed 933 adults entering EDM parties in New York City in 2017. Hair donation response rates and reasons for refusal were examined from this cross-sectional study. A third (n = 312; 33.4%) provided a hair sample. Lack of interest (21.0%), lack of time (19.8%), not wanting a lock of hair cut (17.7%), and disinterest in having hair cut in public (13.8%) were the main reported reasons for refusal. 4.7% refused because they could not receive results. Past-year drug users were more likely to fear identification than non-users (p<.001). Asian participants were at lower odds of providing a hair sample (aOR = 0.53, 95% CI = 0.32-0.87), and those reporting past-year use of LSD (aOR = 1.62, 95% CI = 1.11-2.35), opioids (nonmedical; aOR = 1.93, 95% CI = 1.25-2.99), and/or methamphetamine (aOR = 3.43, 95% CI = 1.36-8.62) were at higher odds of providing a sample than non-users of these drugs. Only a third of participants provided a hair sample and we found individual-level differences regarding willingness to provide a sample. Factors contributing to refusal should be considered to increase response rates and generalizability of results.

  20. Pill testing or drug checking in Australia: Acceptability of service design features.

    Science.gov (United States)

    Barratt, Monica J; Bruno, Raimondo; Ezard, Nadine; Ritter, Alison

    2018-02-01

    This study aimed to determine design features of a drug-checking service that would be feasible, attractive and likely to be used by Australian festival and nightlife attendees. Web survey of 851 Australians reporting use of psychostimulants and/or hallucinogens and attendance at licensed venues past midnight and/or festivals in the past year (70% male; median age 23 years). A drug-checking service located at festivals or clubs would be used by 94%; a fixed-site service external to such events by 85%. Most (80%) were willing to wait an hour for their result. Almost all (94%) would not use a service if there was a possibility of arrest, and a majority (64%) would not use a service that did not provide individual feedback of results. Drug-checking results were only slightly more attractive if they provided comprehensive quantitative results compared with qualitative results of key ingredients. Most (93%) were willing to pay up to $5, and 68% up to $10, per test. One-third (33%) reported willingness to donate a whole dose for testing: they were more likely to be male, younger, less experienced, use drugs more frequently and attend venues/festivals less frequently. In this sample, festival- or club-based drug-checking services with low wait times and low cost appear broadly attractive under conditions of legal amnesty and individualised feedback. Quantitative analysis of ecstasy pills requiring surrender of a whole pill may appeal to a minority in Australia where pills are more expensive than elsewhere. [Barratt MJ, Bruno R, Ezard N, Ritter A. Pill testing or drug checking in Australia: Acceptability of service design features. Drug Alcohol Rev 2017;00:000-000]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  1. Engineering Macaca fascicularis cytochrome P450 2C20 to reduce animal testing for new drugs.

    Science.gov (United States)

    Rua, Francesco; Sadeghi, Sheila J; Castrignanò, Silvia; Di Nardo, Giovanna; Gilardi, Gianfranco

    2012-12-01

    In order to develop in vitro methods as an alternative to P450 animal testing in the drug discovery process, two main requisites are necessary: 1) gathering of data on animal homologues of the human P450 enzymes, currently very limited, and 2) bypassing the requirement for both the P450 reductase and the expensive cofactor NADPH. In this work, P450 2C20 from Macaca fascicularis, homologue of the human P450 2C8 has been taken as a model system to develop such an alternative in vitro method by two different approaches. In the first approach called "molecular Lego", a soluble self-sufficient chimera was generated by fusing the P450 2C20 domain with the reductase domain of cytochrome P450 BM3 from Bacillus megaterium (P450 2C20/BMR). In the second approach, the need for the redox partner and also NADPH were both obviated by the direct immobilization of the P450 2C20 on glassy carbon and gold electrodes. Both systems were then compared to those obtained from the reconstituted P450 2C20 monooxygenase in presence of the human P450 reductase and NADPH using paclitaxel and amodiaquine, two typical drug substrates of the human P450 2C8. The K(M) values calculated for the 2C20 and 2C20/BMR in solution and for 2C20 immobilized on electrodes modified with gold nanoparticles were 1.9 ± 0.2, 5.9 ± 2.3, 3.0 ± 0.5 μM for paclitaxel and 1.2 ± 0.2, 1.6±0.2 and 1.4 ± 0.2 μM for amodiaquine, respectively. The data obtained not only show that the engineering of M. fascicularis did not affect its catalytic properties but also are consistent with K(M) values measured for the microsomal human P450 2C8 and therefore show the feasibility of developing alternative in vitro animal tests. Copyright © 2012 Elsevier Inc. All rights reserved.

  2. Drug susceptibility testing of Mycobacterium Avium subsp. Avium isolates from naturally infected domestic pigeons to avian tuberculosis

    Directory of Open Access Journals (Sweden)

    Kaveh Parvandar

    2016-01-01

    Conclusion: We suggest drug susceptibility testing for more nontuberculous mycobateria, particularly M. avium complex isolated from infected birds and humans, as well as molecular basics of drug sensitivity in order to detect resistance genes of pathogenic M. avium subsp. avium.

  3. Evaluation of MGIT 960 System for the Second-Line Drugs Susceptibility Testing of Mycobacterium tuberculosis

    Directory of Open Access Journals (Sweden)

    Hyejin Kim

    2013-01-01

    Full Text Available Many laboratories validate DST of the second-line drugs by BACTEC MGIT 960 system. The objective of this study is to evaluate the critical concentration and perform DST for the 2nd line drugs. We evaluated 193 clinical strains of M. tuberculosis isolated from patients in South Korea. Testing the critical concentration of six second-line drugs was performed by MGIT 960 and compared with L-J proportion method. The critical concentration was determined to establish the most one that gave the difference between drug resistance and susceptibility in MGIT960 system. Good agreement of the following concentrations was found: Concordance was 95% for 0.5 μg/mL of moxifloxacin; 93.6%, 1.0 μg/mL of levofloxacin; 97.5%, 2.5 μg/mL of kanamycin; 90.6%, 2.5 μg/mL of capreomycin; 86.2%, 5.0 μg/mL of ethionamide; and 90.8%, 2.0 μg/mL of ρ-aminosalicylic acid. The critical concentrations of the four drugs, moxifloxacin, levofloxacin, kanamycin, and capreomycin, were concordant and reliable for testing 2nd line drug resistance. Further study of ethionamide and ρ-aminosalicylic acid is required.

  4. The Potential Impact of Up-Front Drug Sensitivity Testing on India's Epidemic of Multi-Drug Resistant Tuberculosis.

    Directory of Open Access Journals (Sweden)

    Kuldeep Singh Sachdeva

    Full Text Available In India as elsewhere, multi-drug resistance (MDR poses a serious challenge in the control of tuberculosis (TB. The End TB strategy, recently approved by the world health assembly, aims to reduce TB deaths by 95% and new cases by 90% between 2015 and 2035. A key pillar of this approach is early diagnosis of tuberculosis, including use of higher-sensitivity diagnostic testing and universal rapid drug susceptibility testing (DST. Despite limitations of current laboratory assays, universal access to rapid DST could become more feasible with the advent of new and emerging technologies. Here we use a mathematical model of TB transmission, calibrated to the TB epidemic in India, to explore the potential impact of a major national scale-up of rapid DST. To inform key parameters in a clinical setting, we take GeneXpert as an example of a technology that could enable such scale-up. We draw from a recent multi-centric demonstration study conducted in India that involved upfront Xpert MTB/RIF testing of all TB suspects.We find that widespread, public-sector deployment of high-sensitivity diagnostic testing and universal DST appropriately linked with treatment could substantially impact MDR-TB in India. Achieving 75% access over 3 years amongst all cases being diagnosed for TB in the public sector alone could avert over 180,000 cases of MDR-TB (95% CI 44187 - 317077 cases between 2015 and 2025. Sufficiently wide deployment of Xpert could, moreover, turn an increasing MDR epidemic into a diminishing one. Synergistic effects were observed with assumptions of simultaneously improving MDR-TB treatment outcomes. Our results illustrate the potential impact of new and emerging technologies that enable widespread, timely DST, and the important effect that universal rapid DST in the public sector can have on the MDR-TB epidemic in India.

  5. The Quest for Standard Tests in Prioritizing Water Use Rights in ...

    African Journals Online (AJOL)

    Moreover, there are problems of depletion, pollution, water grabbing, wastage of water, and water crisis that are attributable to lack of comprehensive regulations, or confusions in putting policy options. The regulatory tools lack clarity and sufficiency with regard to the incorporation of standard tests. There is thus the need for ...

  6. Introducing rapid diagnostic tests for malaria into registered drug shops in Uganda

    DEFF Research Database (Denmark)

    Mbonye, Anthony K; Clarke, Sîan E; Lal, Sham

    2015-01-01

    BACKGROUND: Malaria is a major public health problem in Uganda and the current policy recommends introduction of rapid diagnostic tests for malaria (RDTs) to facilitate effective case management. However, provision of RDTs in drug shops potentially raises a new set of issues, such as adherence...... to RDTs results, management of severe illnesses, referral of patients, and relationship with caretakers. The main objective of the study was to examine the impact of introducing RDTs in registered drug shops in Uganda and document lessons and policy implications for future scale-up of malaria control...... in the private health sector. METHODS: A cluster-randomized trial introducing RDTs into registered drug shops was implemented in central Uganda from October 2010 to July 2012. An evaluation was undertaken to assess the impact and the processes involved with the introduction of RDTs into drug shops, the lessons...

  7. Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs.

    Science.gov (United States)

    van Gelder, Teun; Gabardi, Steven

    2013-08-01

    Within the field of solid organ transplantation, the patents for a number of immunosuppressive drugs have expired in the last few years. Tacrolimus, cyclosporine, and mycophenolate mofetil are now available as generic drugs. In some countries, the market penetration of these generic formulations is as high as 70%, whereas in some other countries, this figure is below 10%. Several professional societies have published position papers on the risks and benefits of generic substitution of immunosuppressive drugs. It often appears that transplant professionals are not fully aware of the requirements for registration of generic drugs. This article describes the registration requirements with a focus on bioequivalence testing, the strengths and weaknesses in this process, and the differences between Europe and the US. © 2013 The Authors Transplant International © 2013 European Society for Organ Transplantation. Published by Blackwell Publishing Ltd.

  8. A cost-effective smartphone-based antimicrobial susceptibility test reader for drug resistance testing (Conference Presentation)

    Science.gov (United States)

    Feng, Steve W.; Tseng, Derek; Di Carlo, Dino; Garner, Omai B.; Ozcan, Aydogan

    2017-03-01

    Antimicrobial susceptibility testing (AST) is commonly used for determining microbial drug resistance, but routine testing, which can significantly reduce the spread of multi-drug resistant organisms, is not regularly performed in resource-limited and field-settings due to technological challenges and lack of trained diagnosticians. We developed a portable cost-effective smartphone-based colorimetric 96-well microtiter plate (MTP) reader capable of automated AST without the need for a trained diagnostician. This system is composed of a smartphone used in conjunction with a 3D-printed opto-mechanical attachment, which holds a set of inexpensive light-emitting-diodes and fiber-optic cables coupled to the 96-well MTP for enabling the capture of the transmitted light through each well by the smartphone camera. Images of the MTP plate are captured at multiple exposures and uploaded to a local or remote server (e.g., a laptop) for automated processing/analysis of the results using a custom-designed smartphone application. Each set of images are combined to generate a high dynamic-range image and analyzed for well turbidity (indicative of bacterial growth), followed by interpretative analysis per plate to determine minimum inhibitory concentration (MIC) and drug susceptibility for the specific bacterium. Results are returned to the originating device within 1 minute and shown to the user in tabular form. We demonstrated the capability of this platform using MTPs prepared with 17 antibiotic drugs targeting Gram-negative bacteria and tested 82 patient isolate MTPs of Klebsiella pneumoniae, achieving well turbidity accuracy of 98.19%, MIC accuracy of 95.15%, and drug susceptibility interpretation accuracy of 99.06%, meeting the FDA defined criteria for AST.

  9. Setting accelerated dissolution test for PLGA microspheres containing peptide, investigation of critical parameters affecting drug release rate and mechanism.

    Science.gov (United States)

    Tomic, I; Vidis-Millward, A; Mueller-Zsigmondy, M; Cardot, J-M

    2016-05-30

    The objective of this study was development of accelerated in vitro release method for peptide loaded PLGA microspheres using flow-through apparatus and assessment of the effect of dissolution parameters (pH, temperature, medium composition) on drug release rate and mechanism. Accelerated release conditions were set as pH 2 and 45°C, in phosphate buffer saline (PBS) 0.02M. When the pH was changed from 2 to 4, diffusion controlled phases (burst and lag) were not affected, while release rate during erosion phase decreased two-fold due to slower ester bonds hydrolyses. Decreasing temperature from 45°C to 40°C, release rate showed three-fold deceleration without significant change in release mechanism. Effect of medium composition on drug release was tested in PBS 0.01M (200 mOsm/kg) and PBS 0.01M with glucose (380 mOsm/kg). Buffer concentration significantly affected drug release rate and mechanism due to the change in osmotic pressure, while ionic strength did not have any effect on peptide release. Furthermore, dialysis sac and sample-and-separate techniques were used, in order to evaluate significance of dissolution technique choice on the release process. After fitting obtained data to different mathematical models, flow-through method was confirmed as the most appropriate for accelerated in vitro dissolution testing for a given formulation. Copyright © 2016 Elsevier B.V. All rights reserved.

  10. Diagnostic accuracy of a two-item Drug Abuse Screening Test (DAST-2).

    Science.gov (United States)

    Tiet, Quyen Q; Leyva, Yani E; Moos, Rudolf H; Smith, Brandy

    2017-11-01

    Drug use is prevalent and costly to society, but individuals with drug use disorders (DUDs) are under-diagnosed and under-treated, particularly in primary care (PC) settings. Drug screening instruments have been developed to identify patients with DUDs and facilitate treatment. The Drug Abuse Screening Test (DAST) is one of the most well-known drug screening instruments. However, similar to many such instruments, it is too long for routine use in busy PC settings. This study developed and validated a briefer and more practical DAST for busy PC settings. We recruited 1300 PC patients in two Department of Veterans Affairs (VA) clinics. Participants responded to a structured diagnostic interview. We randomly selected half of the sample to develop and the other half to validate the new instrument. We employed signal detection techniques to select the best DAST items to identify DUDs (based on the MINI) and negative consequences of drug use (measured by the Inventory of Drug Use Consequences). Performance indicators were calculated. The two-item DAST (DAST-2) was 97% sensitive and 91% specific for DUDs in the development sample and 95% sensitive and 89% specific in the validation sample. It was highly sensitive and specific for DUD and negative consequences of drug use in subgroups of patients, including gender, age, race/ethnicity, marital status, educational level, and posttraumatic stress disorder status. The DAST-2 is an appropriate drug screening instrument for routine use in PC settings in the VA and may be applicable in broader range of PC clinics. Published by Elsevier Ltd.

  11. Annular phased array transducer for preclinical testing of anti-cancer drug efficacy on small animals.

    Science.gov (United States)

    Kujawska, Tamara; Secomski, Wojciech; Byra, Michał; Postema, Michiel; Nowicki, Andrzej

    2017-04-01

    A technique using pulsed High Intensity Focused Ultrasound (HIFU) to destroy deep-seated solid tumors is a promising noninvasive therapeutic approach. A main purpose of this study was to design and test a HIFU transducer suitable for preclinical studies of efficacy of tested, anti-cancer drugs, activated by HIFU beams, in the treatment of a variety of solid tumors implanted to various organs of small animals at the depth of the order of 1-2cm under the skin. To allow focusing of the beam, generated by such transducer, within treated tissue at different depths, a spherical, 2-MHz, 29-mm diameter annular phased array transducer was designed and built. To prove its potential for preclinical studies on small animals, multiple thermal lesions were induced in a pork loin ex vivo by heating beams of the same: 6W, or 12W, or 18W acoustic power and 25mm, 30mm, and 35mm focal lengths. Time delay for each annulus was controlled electronically to provide beam focusing within tissue at the depths of 10mm, 15mm, and 20mm. The exposure time required to induce local necrosis was determined at different depths using thermocouples. Location and extent of thermal lesions determined from numerical simulations were compared with those measured using ultrasound and magnetic resonance imaging techniques and verified by a digital caliper after cutting the tested tissue samples. Quantitative analysis of the results showed that the location and extent of necrotic lesions on the magnetic resonance images are consistent with those predicted numerically and measured by caliper. The edges of lesions were clearly outlined although on ultrasound images they were fuzzy. This allows to conclude that the use of the transducer designed offers an effective noninvasive tool not only to induce local necrotic lesions within treated tissue without damaging the surrounding tissue structures but also to test various chemotherapeutics activated by the HIFU beams in preclinical studies on small animals

  12. Planck-scale induced left–right gauge theory at LHC and experimental tests

    Directory of Open Access Journals (Sweden)

    M.K. Parida

    2016-05-01

    Full Text Available Recent measurements at LHC have inspired searches for TeV scale left–right gauge theory originating from grand unified theories. We show that inclusion of Planck-scale induced effects due to dim.5 operator not only does away with all the additional intermediate symmetries, but also it predicts the minimal set of light Higgs scalars tailored after neutrino masses and dilepton, or trilepton signals. The heavy-light neutrino mixings are predicted from charged fermion mass fits in SO(10 and LFV constraints which lead to new predictions for dilepton or trilepton production signals. Including fine-structure constant matching and two-loop, and threshold effects predict MWR=g2R104.3±1.5±0.2 GeV and proton lifetime τp=1036.15±5.8±0.2 yrs with WR gauge boson coupling g2R=0.56–0.57. Predictions on lepton flavour and lepton number violations are accessible to ongoing experiments. Current CMS data on di-electron excess at s=8 TeV are found to be consistent with WR gauge boson mass MWR≥1.9–2.2 TeV which also agrees with the values obtained from dijet resonance production data. We also discuss plausible explanations for diboson production excesses observed at LHC and make predictions expected at s=14 TeV.

  13. 75 FR 13009 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

    Science.gov (United States)

    2010-03-18

    ... DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Part 40 [Docket DOT-OST-2008-0088] RIN OST 2105-AD84 Procedures for Transportation Workplace Drug and Alcohol Testing Programs Correction In rule document 2010-3731 beginning on page 8528 in the issue of Thursday, February 25, 2010, make the...

  14. 21 CFR 211.110 - Sampling and testing of in-process materials and drug products.

    Science.gov (United States)

    2010-04-01

    ... PHARMACEUTICALS Production and Process Controls § 211.110 Sampling and testing of in-process materials and drug... capsule weight variation; (2) Disintegration time; (3) Adequacy of mixing to assure uniformity and... production process, e.g., at commencement or completion of significant phases or after storage for long...

  15. 75 FR 8524 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

    Science.gov (United States)

    2010-02-25

    ... 2105-AD67 Procedures for Transportation Workplace Drug and Alcohol Testing Programs AGENCY: Office of... IFR to mitigate this conflict between the DOT rules and what we view as beneficial State laws by.... It merely eliminated a conflict that would have precluded parties from complying with certain State...

  16. Screening for Drug Abuse Among College Students: Modification of the Michigan Alcoholism Screening Test

    Science.gov (United States)

    Cannell, M. Barry; Favazza, Armando R.

    1978-01-01

    Modified version of the Michigan Alcoholism Screening Test was anonymously given to 245 college students on two Midwestern university campuses. Cutoff score for suspected drug abuse was set at five points. The percent of students scoring five or more points was 25 and 22 from campuses A and B respectively. (Author)

  17. 77 FR 60318 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs: 6-acetylmorphine (6-AM...

    Science.gov (United States)

    2012-10-03

    ... 2105-AE14 Procedures for Transportation Workplace Drug and Alcohol Testing Programs: 6-acetylmorphine... 12866 and Regulatory Flexibility Act This Final Rule is not significant for purposes of Executive Order... certify, under the Regulatory Flexibility Act, that this rule does not have a significant economic impact...

  18. 75 FR 8528 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

    Science.gov (United States)

    2010-02-25

    ... OST 2105-AD84 Procedures for Transportation Workplace Drug and Alcohol Testing Programs AGENCY: Office... of small entities, for purposes of the Regulatory Flexibility Act. The Department makes these... necessary for the Department to conduct a regulatory evaluation or Regulatory Flexibility Analysis for this...

  19. Test Sample for the Spatially Resolved Quantification of Illicit Drugs on Fingerprints Using Imaging Mass Spectrometry

    NARCIS (Netherlands)

    Muramoto, S.; Forbes, T.P.; van Asten, A.C.; Gillen, G.

    2015-01-01

    A novel test sample for the spatially resolved quantification of illicit drugs on the surface of a fingerprint using time-of-flight secondary ion mass spectrometry (ToF-SIMS) and desorption electrospray ionization mass spectrometry (DESI-MS) was demonstrated. Calibration curves relating the signal

  20. Receipt and timing of HIV drug resistance testing in six U.S. jurisdictions.

    Science.gov (United States)

    Dasgupta, Sharoda; Hall, H Irene; Hernandez, Angela L; Ocfemia, M Cheryl Bañez; Saduvala, Neeraja; Oster, Alexandra M

    2017-12-01

    The Department of Health and Human Services recommends drug resistance testing at linkage to HIV care. Because receipt and timing of testing are not well characterized, we examined testing patterns among persons with diagnosed HIV who are linked to care. Using surveillance data in six jurisdictions for persons aged ≥13 years with HIV infection diagnosed in 2013, we assessed the proportion receiving testing, and among these, the proportion receiving testing at linkage. Multivariable log-binomial regression modeling estimated associations between selected characteristics and receipt of testing (1) overall, and (2) at linkage among those tested. Of 9,408 persons linked to care, 66% received resistance testing, among whom 68% received testing at linkage. Less testing was observed among male persons who inject drugs (PWID), compared with men who have sex with men (adjusted prevalence ratio [aPR]: 0.88; 95% confidence interval [CI]: 0.81-0.97) and persons living in areas with population testing was lower for persons with initial CD4 counts ≥500 cells/mm 3 , compared with those with CD4 counts tested, testing at linkage was lower among male PWID (aPR: 0.85; CI: 0.75-0.95) and, in some jurisdictions, persons with CD4 counts ≥500 cells/mm 3 (aPR range: 0.63-0.73). Two-thirds of persons with diagnosed HIV who were linked to care received resistance testing, and most received testing at linkage as recommended. Improving receipt and timing of testing among male PWID, persons in less populous settings, and in all jurisdictions, regardless of CD4 count, may improve care outcomes.

  1. Routine HIV testing in Botswana: a population-based study on attitudes, practices, and human rights concerns.

    Directory of Open Access Journals (Sweden)

    Sheri D Weiser

    2006-07-01

    adopted elsewhere, measures should be implemented to assure true informed consent and human rights safeguards, including protection from HIV-related discrimination and protection of women against partner violence related to testing.

  2. Simple, direct drug susceptibility testing technique for diagnosis of drug-resistant tuberculosis in resource-poor settings.

    Science.gov (United States)

    Kim, C-K; Joo, Y-T; Lee, E P; Park, Y K; Kim, H-J; Kim, S J

    2013-09-01

    The Korean Institute of Tuberculosis, Seoul, Republic of Korea. To develop a simple, direct drug susceptibility testing (DST) technique using Kudoh-modified Ogawa (KMO) medium. The critical concentrations of isoniazid (INH), rifampicin (RMP), kanamycin (KM) and ofloxacin (OFX) for KMO medium were calibrated by comparing the minimal inhibitory concentrations (MICs) against clinical isolates of Mycobacterium tuberculosis on KMO with those on Löwenstein-Jensen (LJ). The performance of the direct KMO DST technique was evaluated on 186 smear-positive sputum specimens and compared with indirect LJ DST. Agreement of MICs on direct vs. indirect DST was high for INH, RMP and OFX. KM MICs on KMO were ∼10 g/ml higher than those on LJ. The critical concentrations of INH, RMP, OFX and KM for KMO were therefore set at 0.2, 40.0, 2.0, and 40.0 g/ml. The evaluation of direct DST of smear-positive sputum specimens showed 100% agreement with indirect LJ DST for INH and RMP. However, the respective susceptible and resistant predictive values were 98.8% and 100% for OFX, and 100% and 80% for KM. Direct DST using KMO is useful, with clear advantages of a shorter turnaround time, procedural simplicity and low cost compared to indirect DST. It may be most indicated in resource-poor settings for programmatic management of drug-resistant tuberculosis.

  3. In vitro anticancer drug test: A new method emerges from the model of glioma stem cells

    Directory of Open Access Journals (Sweden)

    Gabriele Riva

    2014-01-01

    Full Text Available Glioblastoma multiforme (GBM is a grade IV astrocytoma and the most common malignant brain tumor. Current therapies provide a median survival of 12–15 months after diagnosis, due to the high recurrence rate. The failure of current therapies may be due to the presence, within the tumor, of cells characterized by enhanced self-renewal capacity, multilineage differentiation potential and elevated invasive behavior, called glioma stem cells (GSCs. To evaluate the pharmacological efficacy of selected drugs on six GSC lines, we set up a multiple drug responsivity assay based on the combined evaluation of cytomorphological and functional parameters, including the analysis of polymorphic nuclei, mitotic index and cell viability. In order to understand the real pharmacological efficacy of the tested drugs, we assigned a specific drug responsivity score to each GSC line, integrating the data produced by multiple assays. In this work we explored the antineoplastic effects of paclitaxel (PTX, an inhibitor of microtubule depolymerization, utilized as standard treatment in several cancers, and of valproic acid (VPA, an inhibitor of histone deacetylases (HDACs with multiple anticancer properties. We classified the six GSC lines as responsive or resistant to these drugs, on the basis of their responsivity scores. This method can also be useful to identify the best way to combine two or more drugs. In particular, we utilized the pro-differentiating effect of VPA to improve the PTX effectiveness and we observed a significant reduction of cell viability compared to single treatments.

  4. The synergistic use of computation, chemistry and biology to discover novel peptide-based drugs: the time is right.

    Science.gov (United States)

    Audie, J; Boyd, C

    2010-01-01

    The case for peptide-based drugs is compelling. Due to their chemical, physical and conformational diversity, and relatively unproblematic toxicity and immunogenicity, peptides represent excellent starting material for drug discovery. Nature has solved many physiological and pharmacological problems through the use of peptides, polypeptides and proteins. If nature could solve such a diversity of challenging biological problems through the use of peptides, it seems reasonable to infer that human ingenuity will prove even more successful. And this, indeed, appears to be the case, as a number of scientific and methodological advances are making peptides and peptide-based compounds ever more promising pharmacological agents. Chief among these advances are powerful chemical and biological screening technologies for lead identification and optimization, methods for enhancing peptide in vivo stability, bioavailability and cell-permeability, and new delivery technologies. Other advances include the development and experimental validation of robust computational methods for peptide lead identification and optimization. Finally, scientific analysis, biology and chemistry indicate the prospect of designing relatively small peptides to therapeutically modulate so-called 'undruggable' protein-protein interactions. Taken together a clear picture is emerging: through the synergistic use of the scientific imagination and the computational, chemical and biological methods that are currently available, effective peptide therapeutics for novel targets can be designed that surpass even the proven peptidic designs of nature.

  5. Right upper-quadrant pain in a patient with drug abuse, secondary syphilis and occult hepatitis B virus.

    Science.gov (United States)

    Fielding, Cory M; Angulo, Paul

    2014-01-01

    To describe the etiology of hepatitis and identify occult hepatitis B virus (HBV) infection. A 40-year-old man presented with severe abdominal pain and jaundice, a history of acute HBV infection that had cleared as well as the use of acetaminophen, methamphetamine, buprenorphine and marijuana. He admitted to having had unprotected sex with multiple partners of both genders. A thorough skin examination revealed papulosquamous lesions on his penis, scrotum, upper and lower extremities and feet. Transaminases and bilirubin were elevated. His rapid plasma reagin was reactive, and hepatitis serologies showed occult HBV. Liver biopsy showed severe hepatitis, but the stains for hepatitis B surface antigen and hepatitis B core antigen were negative. The pathological findings were highly indicative of drug-induced hepatitis without evidence of chronic hepatitis, reactivation of HBV or syphilitic hepatitis. With supportive management and abstinence from drugs, his condition improved. This case describes a patient with multiple potential causes for hepatitis and highlights the importance of obtaining a detailed social history. Further, one should consider the presence of occult HBV and recognize the serologic pattern. © 2014 S. Karger AG, Basel.

  6. In-vitro antimycobacterial drug susceptibility testing of non-tubercular mycobacteria by tetrazolium microplate assay.

    Science.gov (United States)

    Sankar, Manimuthu Mani; Gopinath, Krishnamoorthy; Singla, Roopak; Singh, Sarman

    2008-07-11

    Non-tubercular mycobacteria (NTM) has not been given due attention till the recent epidemic of HIV. This has led to increasing interest of health care workers in their biology, epidemiology and drug resistance. However, timely detection and drug susceptibility profiling of NTM isolates are always difficult in resource poor settings like India. Furthermore, no standardized methodology or guidelines are available to reproduce the results with clinical concordance. To find an alternative and rapid method for performing the drug susceptibility assay in a resource limited settings like India, we intended to evaluate the utility of Tetrazolium microplate assay (TEMA) in comparison with proportion method for reporting the drug resistance in clinical isolates of NTM. A total of fifty-five NTM isolates were tested for susceptibility against Streptomycin, Rifampicin, Ethambutol, Ciprofloxacin, Ofloxacin, Azithromycin, and Clarithromycin by TEMA and the results were compared with agar proportion method (APM). Of the 55 isolates, 23 (41.8%) were sensitive to all the drugs and the remaining 32 (58.2%) were resistant to at least one drug. TEMA had very good concordance with APM except with minor discrepancies. Susceptibility results were obtained in the median of 5 to 9 days by TEMA. The NTM isolates were highly sensitive against Ofloxacin (98.18% sensitive) and Ciprofloxacin (90.09% sensitive). M. mucogenicum was sensitive only to Clarithromycin and resistant to all the other drugs tested. The concordance between TEMA and APM ranged between 96.4 - 100%. Tetrazolium Microplate Assay is a rapid and highly reproducible method. However, it must be performed only in tertiary level Mycobacteriology laboratories with proper bio-safety conditions.

  7. A Microfluidic Channel Method for Rapid Drug-Susceptibility Testing of Pseudomonas aeruginosa.

    Directory of Open Access Journals (Sweden)

    Yoshimi Matsumoto

    Full Text Available The recent global increase in the prevalence of antibiotic-resistant bacteria and lack of development of new therapeutic agents emphasize the importance of selecting appropriate antimicrobials for the treatment of infections. However, to date, the development of completely accelerated drug susceptibility testing methods has not been achieved despite the availability of a rapid identification method. We proposed an innovative rapid method for drug susceptibility testing for Pseudomonas aeruginosa that provides results within 3 h. The drug susceptibility testing microfluidic (DSTM device was prepared using soft lithography. It consisted of five sets of four microfluidic channels sharing one inlet slot, and the four channels are gathered in a small area, permitting simultaneous microscopic observation. Antimicrobials were pre-introduced into each channel and dried before use. Bacterial suspensions in cation-adjusted Mueller-Hinton broth were introduced from the inlet slot and incubated for 3 h. Susceptibilities were microscopically evaluated on the basis of differences in cell numbers and shapes between drug-treated and control cells, using dedicated software. The results of 101 clinically isolated strains of P. aeruginosa obtained using the DSTM method strongly correlated with results obtained using the ordinary microbroth dilution method. Ciprofloxacin, meropenem, ceftazidime, and piperacillin caused elongation in susceptible cells, while meropenem also induced spheroplast and bulge formation. Morphological observation could alternatively be used to determine the susceptibility of P. aeruginosa to these drugs, although amikacin had little effect on cell shape. The rapid determination of bacterial drug susceptibility using the DSTM method could also be applicable to other pathogenic species, and it could easily be introduced into clinical laboratories without the need for expensive instrumentation.

  8. Cognitive tests predict real-world errors: the relationship between drug name confusion rates in laboratory-based memory and perception tests and corresponding error rates in large pharmacy chains.

    Science.gov (United States)

    Schroeder, Scott R; Salomon, Meghan M; Galanter, William L; Schiff, Gordon D; Vaida, Allen J; Gaunt, Michael J; Bryson, Michelle L; Rash, Christine; Falck, Suzanne; Lambert, Bruce L

    2017-05-01

    Drug name confusion is a common type of medication error and a persistent threat to patient safety. In the USA, roughly one per thousand prescriptions results in the wrong drug being filled, and most of these errors involve drug names that look or sound alike. Prior to approval, drug names undergo a variety of tests to assess their potential for confusability, but none of these preapproval tests has been shown to predict real-world error rates. We conducted a study to assess the association between error rates in laboratory-based tests of drug name memory and perception and real-world drug name confusion error rates. Eighty participants, comprising doctors, nurses, pharmacists, technicians and lay people, completed a battery of laboratory tests assessing visual perception, auditory perception and short-term memory of look-alike and sound-alike drug name pairs (eg, hydroxyzine/hydralazine). Laboratory test error rates (and other metrics) significantly predicted real-world error rates obtained from a large, outpatient pharmacy chain, with the best-fitting model accounting for 37% of the variance in real-world error rates. Cross-validation analyses confirmed these results, showing that the laboratory tests also predicted errors from a second pharmacy chain, with 45% of the variance being explained by the laboratory test data. Across two distinct pharmacy chains, there is a strong and significant association between drug name confusion error rates observed in the real world and those observed in laboratory-based tests of memory and perception. Regulators and drug companies seeking a validated preapproval method for identifying confusing drug names ought to consider using these simple tests. By using a standard battery of memory and perception tests, it should be possible to reduce the number of confusing look-alike and sound-alike drug name pairs that reach the market, which will help protect patients from potentially harmful medication errors. Published by the BMJ

  9. High-throughput 3D spheroid culture and drug testing using a 384 hanging drop array.

    Science.gov (United States)

    Tung, Yi-Chung; Hsiao, Amy Y; Allen, Steven G; Torisawa, Yu-suke; Ho, Mitchell; Takayama, Shuichi

    2011-02-07

    Culture of cells as three-dimensional (3D) aggregates can enhance in vitro tests for basic biological research as well as for therapeutics development. Such 3D culture models, however, are often more complicated, cumbersome, and expensive than two-dimensional (2D) cultures. This paper describes a 384-well format hanging drop culture plate that makes spheroid formation, culture, and subsequent drug testing on the obtained 3D cellular constructs as straightforward to perform and adapt to existing high-throughput screening (HTS) instruments as conventional 2D cultures. Using this platform, we show that drugs with different modes of action produce distinct responses in the physiological 3D cell spheroids compared to conventional 2D cell monolayers. Specifically, the anticancer drug 5-fluorouracil (5-FU) has higher anti-proliferative effects on 2D cultures whereas the hypoxia activated drug commonly referred to as tirapazamine (TPZ) are more effective against 3D cultures. The multiplexed 3D hanging drop culture and testing plate provides an efficient way to obtain biological insights that are often lost in 2D platforms.

  10. The Effect of Race on Provider Decisions to Test for Illicit Drug Use in the Peripartum Setting

    Science.gov (United States)

    KUNINS, HILLARY VEDA; BELLIN, ERAN; CHAZOTTE, CYNTHIA; DU, EVELYN; ARNSTEN, JULIA HOPE

    2010-01-01

    Background Testing for illicit drugs may expose women who test positive to severe legal and social consequences. It is unknown whether racial disparities in drug testing practices underlie observed disparities in legal and social consequences of positive tests. Methods Using administrative hospital and birth certificate data, we analyzed factors associated with both receipt and results of illicit drug testing among women with live births during 2002–2003. We assessed the independent association of race and other sociodemographic factors with both receipt of a drug test by the mother or her newborn infant and positive maternal or neonatal toxicology results, after controlling for obstetrical conditions and birth outcomes associated with maternal substance abuse. Results Of the 8487 women with live births, 244 mother-newborn pairs (3%) were tested for illicit drug use. Black women and their newborns were 1.5 times more likely to be tested for illicit drugs as nonblack women in multivariable analysis. However, race was not independently associated with a positive result. Conclusions We identified racial differences in rates of testing for illicit drug use between black and nonblack women. We found equivalent positivity rates among tested black and nonblack women. The prevalence of drug use among untested women is unknown, however, so although tested women had equivalent rates of substance use detected, whether black and nonblack substance users are equally likely to be identified in the course of peripartum care remains uncertain. PMID:17388741

  11. Increased functional connectivity strength of right inferior temporal gyrus in first-episode, drug-naive somatization disorder.

    Science.gov (United States)

    Su, Qinji; Yao, Dapeng; Jiang, Muliang; Liu, Feng; Jiang, Jiajing; Xu, Chunxing; Dai, Yi; Yu, Miaoyu; Long, Liling; Li, Hongzheng; Liu, Jianrong; Zhang, Zhikun; Zhang, Jian; Xiao, Changqing; Guo, Wenbin

    2015-01-01

    Evidence of brain structural and functional alterations have been implicated in patients with somatization disorder (SD). However, little is known about brain functional connectivity in SD. In the present study, resting-state functional magnetic resonance imaging (fMRI) and graph theory were used to obtain a comprehensive view of whole-brain functional connectivity and to investigate the changes of voxel-wise functional networks in patients with SD. Twenty-five first-episode, medication-naive patients with SD and 28 age-, sex- and education-matched healthy controls (HCs) underwent resting-state fMRI. The graph theory approach was employed to analyze the data. Compared to the HCs, patients with SD showed significantly increased functional connectivity strength in the right inferior temporal gyrus (ITG). There is a significant positive correlation between the z-values of the cluster in the right ITG and Hamilton Anxiety Scale scores. Our findings indicate that there is a disruption of the functional connectivity pattern in the right ITG in first-episode, treatment-naive patients with SD, which bears clinical significance. © The Royal Australian and New Zealand College of Psychiatrists 2014.

  12. Task demands modulate decision and eye movement responses in the chimeric face test: examining the right hemisphere processing account

    Directory of Open Access Journals (Sweden)

    Jason eCoronel

    2014-03-01

    Full Text Available A large and growing body of work, conducted in both brain-intact and brain-damaged populations, has used the free viewing chimeric face test as a measure of hemispheric dominance for the extraction of emotional information from faces. These studies generally show that normal right-handed individuals tend to perceive chimeric faces as more emotional if the emotional expression is presented on the half of the face to the viewer’s left (left hemiface. However, the mechanisms underlying this lateralized bias remain unclear. Here, we examine the extent to which this bias is driven by right hemisphere processing advantages versus default scanning biases in a unique way -- by changing task demands. In particular, we compare the original task with one in which right-hemisphere-biased processing cannot provide a decision advantage. Our behavioral and eye-movement data are inconsistent with the predictions of a default scanning bias account and support the idea that the left hemiface bias found in the chimeric face test is largely due to strategic use of right hemisphere processing mechanisms.

  13. Optimizing urine drug testing for monitoring medication compliance in pain management.

    Science.gov (United States)

    Melanson, Stacy E F; Ptolemy, Adam S; Wasan, Ajay D

    2013-12-01

    It can be challenging to successfully monitor medication compliance in pain management. Clinicians and laboratorians need to collaborate to optimize patient care and maximize operational efficiency. The test menu, assay cutoffs, and testing algorithms utilized in the urine drug testing panels should be periodically reviewed and tailored to the patient population to effectively assess compliance and avoid unnecessary testing and cost to the patient. Pain management and pathology collaborated on an important quality improvement initiative to optimize urine drug testing for monitoring medication compliance in pain management. We retrospectively reviewed 18 months of data from our pain management center. We gathered data on test volumes, positivity rates, and the frequency of false positive results. We also reviewed the clinical utility of our testing algorithms, assay cutoffs, and adulterant panel. In addition, the cost of each component was calculated. The positivity rate for ethanol and 3,4-methylenedioxymethamphetamine were us to optimize our testing panel for monitoring medication compliance in pain management and reduce cost. Wiley Periodicals, Inc.

  14. HIV drug resistance testing among patients failing second line antiretroviral therapy. Comparison of in-house and commercial sequencing.

    Science.gov (United States)

    Chimukangara, Benjamin; Varyani, Bhavini; Shamu, Tinei; Mutsvangwa, Junior; Manasa, Justen; White, Elizabeth; Chimbetete, Cleophas; Luethy, Ruedi; Katzenstein, David

    2017-05-01

    HIV genotyping is often unavailable in low and middle-income countries due to infrastructure requirements and cost. We compared genotype resistance testing in patients with virologic failure, by amplification of HIV pol gene, followed by "in-house" sequencing and commercial sequencing. Remnant plasma samples from adults and children failing second-line ART were amplified and sequenced using in-house and commercial di-deoxysequencing, and analyzed in Harare, Zimbabwe and at Stanford, U.S.A, respectively. HIV drug resistance mutations were determined using the Stanford HIV drug resistance database. Twenty-six of 28 samples were amplified and 25 were successfully genotyped. Comparison of average percent nucleotide and amino acid identities between 23 pairs sequenced in both laboratories were 99.51 (±0.56) and 99.11 (±0.95), respectively. All pairs clustered together in phylogenetic analysis. Sequencing analysis identified 6/23 pairs with mutation discordances resulting in differences in phenotype, but these did not impact future regimens. The results demonstrate our ability to produce good quality drug resistance data in-house. Despite discordant mutations in some sequence pairs, the phenotypic predictions were not clinically significant. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. On the Relationship between Right- brain and Left- brain Dominance and Reading Comprehension Test Performance of Iranian EFL Learners

    Directory of Open Access Journals (Sweden)

    Hassan Soleimani

    2012-05-01

    Full Text Available A tremendous amount of works have been conducted by psycholinguistics to identify hemisphere processing during second/ foreign language learning, or in other words to investigate the role of the brain hemisphere dominance in language performance of learners. Most of these researches have focused on single words and word pairs (e.g., Anaki et al., 1998; Arzouan et. al., 2007; Faust & Mahal, 2007 or simple sentences (Rapp et al., 2007; Kacinik & Chiarello, 2007, and it has been discovered that there is an advantage of right hemisphere for metaphors and an
    advantage of left hemisphere for literal text. But the present research was designed to study Iranian EFL learners' performance in different reading tasks, so there could be differences between the consequences of the former research and the results of the present study due to the context. Here left-brain and right-brain dominance was investigated in 60 individuals (20 right-handed and 10 left-handed male, 20 right-handed and 10 left-handed female via the Edinburg Handedness Questionnaire (EHQ. The research results suggested that the right-handed learners who are supposed to be left-brain outperformed the left-handed ones; and regarding participant's gender, male learners outperformed female learners on reading comprehension test tasks.

  16. [Clinical evaluation of triage as drug-of-abuse test kit].

    Science.gov (United States)

    Yoshioka, Toshiharu; Kohriyama, Kazuaki; Kondo, Rumiko; Goto, Kyoko; Yashiki, Mikio

    2003-01-01

    There are about 60,000 chemical substances which may cause poisoning. Identifying the cause substances is, therefore, very important for patient at emergency department. Triage is an immunoassay kit for the qualitative test for the metabolites of 8 major abuse drugs in urine. We assessed the usefullness of Triage on two patient groups. The first Group consists of the patients considered having not taken substances at initial diagnosis; the second Group consists of the patients considered having taken substances. The result are as follows. 1) The rate of Triage positive patients in the first Group were: attempt-suicide 23%, coma 24%, shock 10%, trauma 7%, respectively. Except for the habitually used medicine, narcotic and stimulant drugs were detected. In the first Group, negative result of Triage was effective in diagnosing the patients as not poisoned, excluding the possitivity of 8 major drugs usage. 2) The rate of Triage positive patients in the second Group were very high: attempt-suicide 77%, coma 51%, shock 57%, trauma 30%, respectively, showing mostly any of 8 major drugs were the cause of poisoning. In the second Group, positive result of Triage was effective in diagnosing the patient as poisoning or as coexisting poisoning with other diseases. 3) The specificity of Triage diagnosis in the first Group was 80% (113/142). The specificity and the sensitivity in the second Group were 64% (50/78) and 97% (74/76), respectively. These results means that Triage is very useful for diagnosis on 8 major drugs poisoning. 4) Triage is efficient for identifying the cause substances in drug poisoning and, therefore, can save medical expense. Triage is a very useful test kit at emergency department.

  17. Sensitivity test of tumor cell to anticancer drug using diffusion chamber

    Energy Technology Data Exchange (ETDEWEB)

    Soejima, S [Hirosaki Univ., Aomori (Japan). School of Medicine

    1978-11-01

    The diffusion chamber method and xenogeneic transplantation of human cancer cells in rats were studied clinically to test the sensitivity of these cells to anticancer drugs. The growth of Hirosaki sarcoma in a diffusion chamber inserted in to Wistar rats was influenced by the difference in tumor cell counts in the chamber. The growth rate in the chamber inserted in to the subcutaneous tissue was more constant than in the abdominal cavity, but the degree of proliferation of tumor cells in the abdominal cavity was more than in the subcutaneous tissue. Sarcoma and solid type sarcoma were affected by mitomycin C (MMC). The effect was greater in dd-mice than in Donryu rats. Solid type Yoshida sarcoma inserted in to the subcutaneous tissue of Donryu rat was not affected by MMC. The degree of sensitivity of methylcholanthrene induced tumor cells, inserted in to the subcutaneous tissue of Donryu rats, to MMC differed according to various conditions of the hosts. Clinically, the influences of anticancer drugs on human cancer cells inserted in to the subcutaneous tissue of /sup 60/Co-irradiated Donryu rats were observed. There were various grades of sensitivity of gastric cancer cells to anticancer drugs. MMC was effective in 53% of the cases, Cyclophosphamide in 40%, 5-FU in 54%, cytosine arabinoside in 32%, and FT-207 in 57%. Twenty-seven percent were not affected by anticancer drugs. On histological examination, tubular adenocarcinoma cells had a high sensitivity to anticancer drugs, while poorly differentiated adenocarcinoma cells had a low sensitive. Anticancer drugs selected according to the sensitivity of human cancer cells had a marked effective on advanced cancer cells. The diffusion chamber method was useful in determining the degree of bone marrow toxicity of anticancer drugs.

  18. A computerized stroop test for the evaluation of psychotropic drugs in healthy participants.

    Science.gov (United States)

    Pilli, Raveendranadh; Naidu, Mur; Pingali, Usha Rani; Shobha, J C; Reddy, A Praveen

    2013-04-01

    The Stroop paradigm evaluates susceptibility to interference and is sensitive to dysfunction in frontal lobes and drug effects. The aim of the present study was to establish a simple and reliable computerized version of Stroop color-word test, which can be used for screening of various psychotropic drugs. The standardized method was followed in all cases, by recording the reaction time (RT) in msec in 24 healthy participants using computerized version of Stroop color-word test. Reproducibility of the test procedure was evaluated by recording the RTs by a single experimenter on two sessions (interday reproducibility). Validity of the model was further tested by evaluating the psychotropic effect of Zolpidem 5 mg, Caffeine 500 mg, or Placebo on 24 healthy subjects in a randomized, double blind three-way crossover design. The method was found to produce low variability with coefficient of variation less than 10%. Interday reproducibility was very good as shown by Bland-Altman plot with most of the values within ±2SD. There was a significant increase in RTs in Stroop performance with Zolpidem at 1 hr and 2 hrs; in contrast, caffeine significantly decreased RTs in Stroop performance at 1 hr only compared to placebo. The Stroop color-word recording and analysis system is simple, sensitive to centrally acting drug effects, and has potential for future experimental psychomotor assessment studies.

  19. Users and abusers : does your company have a drug problem? Putting the right programs in place to maintain a healthy workforce

    Energy Technology Data Exchange (ETDEWEB)

    Kostiuk, D. [Precision Drilling Corp., Calgary, AB (Canada)

    2006-07-01

    The manager of human resources at Canada's leading drilling company described the workforce challenges facing the industry, with particular reference to providing a safe work environment. With operations primarily in western Canada, Precision Drilling has a field employee base of over 7000 employees. In order to ensure a safe workplace for the thousands of people working and living in isolated communities in a safety-sensitive industry, Precision has taken a proactive approach to address substance abuse. The company discontinued its pre-employment drug testing policy, and has instead opted for post-incident and reasonable cause testing. The company has introduced a formal referral process and provides general awareness sessions to all employees, including management training sessions on the impacts of drugs and alcohol on the workplace. tabs., figs.

  20. Usefulness of hair analysis and psychological tests for identification of alcohol and drugs of abuse consumption in driving license regranting.

    Science.gov (United States)

    Lendoiro, Elena; de Castro, Ana; Jiménez-Morigosa, Cristian; Gomez-Fraguela, Xosé A; López-Rivadulla, Manuel; Cruz, Angelines

    2018-05-01

    with declaration of alcohol consumption ≥4 times/month and with previous fine for DUI of alcohol. In addition, AUDIT scores and EtG concentration in hair had a moderate but significant Spearman correlation (r=0.331, p<0.05). The combination of psychological tests and hair analysis seems to be a promising tool to identify individuals with chronic and problematic consumption of alcohol and drugs of abuse. Moreover, their application during driving license regranting procedures could increase the effectiveness of DARE courses, reduce recidivism and improve road safety. Copyright © 2018 Elsevier B.V. All rights reserved.

  1. [Effect of psychotropic drugs on activity of anticonvulsants in maximal electroshock test].

    Science.gov (United States)

    Alikina, N A; Tregubov, A L; Kotegov, V P

    2010-08-01

    The effect ofpsychotropic drugs on the pharmacological properties of anticonvulsants was studied on white mice under maximal electroshock (ME) test conditions. Changes in the anticonvulsant effect of phenobarbital, diphenin, carbamazepine, hexamidine were traced upon their joint administration with psychotropic drugs, including piracetam, aminalon, amitriptyline, imizine, levomepromazine, and lithium oxybutyrate. An important result of research is the fact, that in no one of combinations the basic pharmacological effect of anticonvulsants was decreased. Based on the results of experiments, the most rational combinations of anticonvulsants with psychotropic preparations were revealed as manifested in the ME test. As criterion of rational combination was the increase in the activity of anticonvulsants and reduction of their toxicity in combination or at least invariance of this parameter. Rational combinations include (i) phenobarbital with piracetam, amitriptyline, levomepromazine, and lithium oxybutyrate; (ii) carbamazepine with piracetam; and (iii) hexamidine with amitriptyline, levomepromazine and imizine.

  2. 49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

    Science.gov (United States)

    2010-10-01

    ..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS) Data... 49 Transportation 1 2010-10-01 2010-10-01 false DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the Secretary...

  3. Errors on the Trail Making Test Are Associated with Right Hemispheric Frontal Lobe Damage in Stroke Patients

    Directory of Open Access Journals (Sweden)

    Bruno Kopp

    2015-01-01

    Full Text Available Measures of performance on the Trail Making Test (TMT are among the most popular neuropsychological assessment techniques. Completion time on TMT-A is considered to provide a measure of processing speed, whereas completion time on TMT-B is considered to constitute a behavioral measure of the ability to shift between cognitive sets (cognitive flexibility, commonly attributed to the frontal lobes. However, empirical evidence linking performance on the TMT-B to localized frontal lesions is mostly lacking. Here, we examined the association of frontal lesions following stroke with TMT-B performance measures (i.e., completion time and completion accuracy measures using voxel-based lesion-behavior mapping, with a focus on right hemispheric frontal lobe lesions. Our results suggest that the number of errors, but not completion time on the TMT-B, is associated with right hemispheric frontal lesions. This finding contradicts common clinical practice—the use of completion time on the TMT-B to measure cognitive flexibility, and it underscores the need for additional research on the association between cognitive flexibility and the frontal lobes. Further work in a larger sample, including left frontal lobe damage and with more power to detect effects of right posterior brain injury, is necessary to determine whether our observation is specific for right frontal lesions.

  4. Perceptions of Iranian Female Drug Users Toward HIV Testing: A Qualitative Content Analysis.

    Science.gov (United States)

    Jamshidimanesh, Mansoureh; Khoie, Effat Merghati; Mousavi, Seyed Abbas; Keramat, Afsaneh; Emamian, Mohammad Hassan

    Drug-dependent women are the vulnerable population deprived of access to health services and also have particular relevance to public health perspective because they are important bridge population for driving HIV/AIDS epidemic. This qualitative study aimed to explore the perception of drug-dependent women regarding HIV testing. In this qualitative study, we approached 23 women with substance use disorders in 2 of the selected drop-in centers in the south Tehran. Focus group discussion, face-to-face semistructured interviews, and field notes were used to collect the data. Qualitative content analysis was used to extract the explanatory model of women's perceptions about HIV testing. Four main themes emerged from the data: forgotten health during use, having misconception, and sharing of sexual partner in secrecy and concerns. Seven subthemes were extracted, including not being sex worker, point of ruin, voluntary selection and concerns about fear of abandonment and fear of loss and death, double concern, and future of children. Beliefs and values of drug-dependent women can be positive points leading them to do an HIV test, and misconceptions of these women would be corrected by using safe behavioral skills training.

  5. Ethnic hair care products may increase false positives in hair drug testing.

    Science.gov (United States)

    Kidwell, David A; Smith, Frederick P; Shepherd, Arica R

    2015-12-01

    The question of why different races appear more susceptible to hair contamination by external drugs remains controversial. This research studied susceptibility of head hair to external cocaine and methamphetamine when hair products have been applied. Three different chemical classes of ethnic hair products were applied to Caucasian, Asian, and African hair. Some products increased the methamphetamine and cocaine concentrations in all hair types. A unique finding of this research is that certain ethnic hair products can replace moisture as a diffusion medium, thereby increasing the susceptibility to contamination over 100-fold compared to petroleum-based products. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  6. Drugs potentially affecting the extent of airways reversibility on pulmonary function testing are frequently consumed despite guidelines

    Directory of Open Access Journals (Sweden)

    Southcott A

    2013-08-01

    Full Text Available Terry E Jones,1 AnneMarie Southcott,2 Sean Homan3 1Pharmacy Department, The Queen Elizabeth Hospital, Woodville South, SA, 2Respiratory and Sleep Medicine, Western Health, Footscray, VIC, 3Respiratory Unit, The Queen Elizabeth Hospital, Woodville South, SA, Australia Background: The increase in forced expiratory volume in one second (FEV1 effected by a bronchodilator is routinely assessed when patients undertake pulmonary function testing (PFT. Several drug classes can theoretically affect the magnitude of the increase in FEV1. Withholding periods are advised for many but not all such drugs. Anecdotally, many subjects presenting for PFT are found to have taken drugs that might affect the test. We did an audit of patients presenting for PFT to assess the frequency with which FEV1 reversibility might be affected by drugs. Methods: One hundred subjects presenting to the laboratory for PFT were questioned about recent drug consumption by an independent pharmacy intern. Reversibility of FEV1 was assumed to have been affected if drugs of interest were consumed within defined withholding periods or two half-lives for drugs without such data. Results: Sixty-three subjects were prescribed drugs likely to affect FEV1 reversibility. Thirty-six subjects consumed at least one such drug within the withholding period. Half (18 of these patients consumed β-blockers with or without β-agonists. Sixty-five subjects did not recall receiving any advice about withholding drugs prior to the test and only 10 recalled receiving advice from their clinician or pulmonary function technician. Conclusion: Subjects presenting for PFT are infrequently advised to withhold drugs that may affect FEV1 reversibility, and consequently, often take such drugs close to the time of the test. Therefore, it is likely that the increase in FEV1 is frequently affected by interference from drugs and this might impact on diagnosis and/or treatment options. Keywords: lung function tests, beta

  7. Mycobacterium abscessus subsp. abscessus Lung Disease: Drug Susceptibility Testing in Sputum Culture Negative Conversion

    Directory of Open Access Journals (Sweden)

    Takehiko Kobayashi

    2018-01-01

    Full Text Available Background: Among Mycobacterium abscessus complex infections, patients with M. abscessus subsp. abscessus (MAA lung disease are difficult to treat and no standard therapy has been established. Few reports have investigated the drug susceptibility of these strains. We retrospectively investigated how in vitro drug susceptibility testing (DST of MAA affects the induction of sputum conversion using pharmacotherapy. Methods: Patients with MAA lung disease diagnosed and treated between 2010 and 2014 at our hospital were enrolled and divided into Group A (sputum conversion without relapse within 1 year and Group B (persistent positive cultured or negative conversion with relapse. MAA was identified in M. abscessus using sequence with genotyping, and DST of MAA was performed. Results: We assessed 23 patients (9 males and 14 females. There were 8 patients in Group A and 15 in Group B. Higher prevalence of susceptible isolates for clarithromycin (CAM susceptibility on day 14 was noted in Group A than in Group B (P = 0.03 and no significant difference observed in the two groups for other drugs. Conclusions: In vitro DST of MAA, especially CAM susceptibility on day 14, affected the results of negative conversion. No other drugs were found to affect sputum culture negative conversion.

  8. A Modified Murine Embryonic Stem Cell Test for Evaluating the Teratogenic Effects of Drugs on Early Embryogenesis.

    Directory of Open Access Journals (Sweden)

    Ruoxing Yu

    Full Text Available Mammalian fetal development is easily disrupted by exogenous agents, making it essential to test new drug candidates for embryotoxicity and teratogenicity. To standardize the testing of drugs that might be used to treat pregnant women, the U.S. Food and Drug Administration (FDA formulated special grade categories, labeled A, B, C, D and X, that define the level of risk associated with the use of a specific drug during pregnancy. Drugs in categories (Cat. D and X are those with embryotoxic and/or teratogenic effects on humans and animals. However, which stages of pregnancy are affected by these agents and their molecular mechanisms are unknown. We describe here an embryonic stem cell test (EST that classifies FDA pregnancy Cat.D and Cat.X drugs into 4 classes based on their differing effects on primitive streak formation. We show that ~84% of Cat.D and Cat.X drugs target this period of embryogenesis. Our results demonstrate that our modified EST can identify how a drug affects early embryogenesis, when it acts, and its molecular mechanism. Our test may thus be a useful addition to the drug safety testing armamentarium.

  9. Protecting the unprotected: mixed-method research on drug use, sex work and rights in Pakistan's fight against HIV/AIDS.

    Science.gov (United States)

    Mayhew, S; Collumbien, M; Qureshi, A; Platt, L; Rafiq, N; Faisel, A; Lalji, N; Hawkes, S

    2009-04-01

    To investigate the nature and extent of human rights abuses against three vulnerable groups (injecting drug users (IDUs) and male and female sex workers), to understand the social and sexual linkages between them and to examine how protecting their rights could enhance the impact of HIV prevention policies. In-depth interviews were carried out with 38 high-risk respondents (IDUs and female, male and transgender sex workers) and a bio-behavioural survey was performed of 813 IDU/sex worker respondents in Rawalpindi. People in all vulnerable groups interacted both sexually and socially. All groups experienced human rights abuses by state and non-state actors which increased their HIV risk. Non-state actors, including relations and sex worker clients, are responsible for verbal, physical and sexual violence. State actors (particularly police) perpetrate harassment, exploitation and abuse of all vulnerable groups with impunity. Health service providers fail to provide adequate services for vulnerable groups. High levels of discrimination and abuse of human dignity of all groups studied were revealed. This violates their physical and mental integrity and also leads to an increased risk of HIV. The sexual and social interactions between groups mean that human rights abuses experienced by one high-risk group can increase the risk of HIV both for them and other groups. The protection of human rights needs to become an integral part of a multisector response to the risk of HIV/AIDS by state and non-state agencies. The Government of Pakistan should work at both legal and programme levels to protect the rights of, and minimise discrimination against, groups vulnerable to HIV in order to reduce the potential for the spread of HIV before the epidemic takes hold.

  10. Racial/ethnic differences in report of drug testing practices at the workplace level in the U.S.

    Science.gov (United States)

    Becker, William C; Meghani, Salimah; Tetrault, Jeanette M; Fiellin, David A

    2014-01-01

    It is unknown whether racial/ethnic differences in report of workplace drug testing persist when analyzed within and across various occupations. We sought to examine the association between worker demographics, workplace characteristics, and report of employment in a workplace that performs drug testing. We performed a cross-sectional study of the 2008-2010 National Survey on Drug Use and Health examining the relationship between race/ethnicity and report of workplace drug testing among employed, white, black, or Hispanic respondents ≥18 years old. In logistic regression analysis, we adjusted for demographic, occupational, and other relevant variables and performed stratified analyses among three specific occupations. Among 69,163 respondents, 48.2% reported employment in a workplace that performs drug testing. On multivariable analysis, younger age, male sex, black race, income greater than $20,000, completion of high school and non-urban residence were associated with report of drug testing at one's workplace among the full sample as were non-white collar occupation, work in medium or large workplace, and absence of other substance abuse/dependence. In stratified analyses, black race was associated with report of workplace level drug testing among executive/administrative/managerial/financial workers and technicians/related support occupations; Hispanic ethnicity was associated with the outcome among technicians/related support occupations. Racial/ethnic differences in report of workplace drug testing exist within and across various occupations. These differences have important public health implications deserving further study. Increased report of drug testing where racial/ethnic minorities work highlights the potential bias that can be introduced when drug testing policies are not implemented in a universal fashion. © American Academy of Addiction Psychiatry.

  11. [Hydroxyurea (hydroxycarbamide)-induced hepatic dysfunction confirmed by drug-induced lymphocyte stimulation test].

    Science.gov (United States)

    Shimizu, Takayuki; Mori, Takehiko; Karigane, Daiki; Kikuchi, Taku; Koda, Yuya; Toyama, Takaaki; Nakajima, Hideaki; Okamoto, Shinichiro

    2014-01-01

    A 62-year-old man with refractory leukemia transformed from myelodysplastic syndrome was placed on hydroxyurea (hydroxycarbamide) at a daily dose of 500 mg. Because of insufficient cytoreductive efficacy, the dose was increased to 1,500 mg five days later. Eight days after the initiation of hydroxyurea, the patient started complaining of chills, fever, and vomiting. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were markedly elevated to 5,098 and 3,880 IU/l from 44 and 59 IU/l in one day, respectively. Tests for hepatitis viruses were all negative. With the discontinuation of hydroxyurea, AST and ALT returned to their former levels within two weeks. A drug-induced lymphocyte stimulation test for hydroxyurea was positive with a stimulating index of 2.0. Hepatic dysfunction has been recognized as one of the side effects of hydroxyurea. However, there have been only a limited number of reports demonstrating drug allergy to have a role in hepatic dysfunction accompanied by fever and gastrointestinal symptoms. The findings of our case strongly suggest that all presentations could be explained by drug allergy. Physicians should be mindful of the potential for acute and severe hepatic dysfunction due to allergic reaction against hydroxyurea.

  12. Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites

    International Nuclear Information System (INIS)

    Prueksaritanont, Thomayant; Lin, Jiunn H.; Baillie, Thomas A.

    2006-01-01

    This paper aims to provide a scientifically based perspective on issues surrounding the proposed toxicology testing of synthetic drug metabolites as a means of ensuring adequate nonclinical safety evaluation of drug candidates that generate metabolites considered either to be unique to humans or are present at much higher levels in humans than in preclinical species. We put forward a number of theoretical considerations and present several specific examples where the kinetic behavior of a preformed metabolite given to animals or humans differs from that of the corresponding metabolite generated endogenously from its parent. The potential ramifications of this phenomenon are that the results of toxicity testing of the preformed metabolite may be misleading and fail to characterize the true toxicological contribution of the metabolite when formed from the parent. It is anticipated that such complications would be evident in situations where (a) differences exist in the accumulation of the preformed versus generated metabolites in specific tissues, and (b) the metabolite undergoes sequential metabolism to a downstream product that is toxic, leading to differences in tissue-specific toxicity. Owing to the complex nature of this subject, there is a need to treat drug metabolite issues in safety assessment on a case-by-case basis, in which a knowledge of metabolite kinetics is employed to validate experimental paradigms that entail administration of preformed metabolites to animal models

  13. Annual banned-substance review: analytical approaches in human sports drug testing.

    Science.gov (United States)

    Thevis, Mario; Kuuranne, Tiia; Walpurgis, Katja; Geyer, Hans; Schänzer, Wilhelm

    2016-01-01

    The aim of improving anti-doping efforts is predicated on several different pillars, including, amongst others, optimized analytical methods. These commonly result from exploiting most recent developments in analytical instrumentation as well as research data on elite athletes' physiology in general, and pharmacology, metabolism, elimination, and downstream effects of prohibited substances and methods of doping, in particular. The need for frequent and adequate adaptations of sports drug testing procedures has been incessant, largely due to the uninterrupted emergence of new chemical entities but also due to the apparent use of established or even obsolete drugs for reasons other than therapeutic means, such as assumed beneficial effects on endurance, strength, and regeneration capacities. Continuing the series of annual banned-substance reviews, literature concerning human sports drug testing published between October 2014 and September 2015 is summarized and reviewed in reference to the content of the 2015 Prohibited List as issued by the World Anti-Doping Agency (WADA), with particular emphasis on analytical approaches and their contribution to enhanced doping controls. Copyright © 2016 John Wiley & Sons, Ltd.

  14. Full-course drug challenge test in the diagnosis of delayed allergic reactions to penicillin.

    Science.gov (United States)

    Borch, Jakob E; Bindslev-Jensen, Carsten

    2011-01-01

    Drug challenge test (DCT) has long been the most sensitive test in the allergological work-up when investigating for penicillin allergy. To improve sensitivity of the diagnostic work-up in diagnosing penicillin allergics with histories of allergic reactions on day 2 or later in the course of penicillin treatment. A full-course DCT was added to the current protocol if specific IgE, skin tests and DCT were all negative in patients who had a nonimmediate reaction to penicillin treatment. Sixteen patients with a history of an immediate reaction to penicillin treatment underwent testing with negative outcomes. Fifty percent of patients undergoing full-course DCT experienced a cutaneous adverse drug reaction. None of the controls reacted (p = 0.001). The mean time of reaction was 6 days. Penicillin V accounted for most reactions. Urticaria was the most frequent clinical reaction observed. Full-course DCT offers an improvement of sensitivity and predictive values of the diagnostic work-up of allergic reactions to penicillin occurring on day 2 of penicillin treatment or later. Copyright © 2011 S. Karger AG, Basel.

  15. Structured evaluation of rodent behavioral tests used in drug discovery research

    Directory of Open Access Journals (Sweden)

    Anders eHånell

    2014-07-01

    Full Text Available A large variety of rodent behavioral tests are currently being used to evaluate traits such as sensory-motor function, social interactions, anxiety-like and depressive-like behavior, substance dependence and various forms of cognitive function. Most behavioral tests have an inherent complexity, and their use requires consideration of several aspects such as the source of motivation in the test, the interaction between experimenter and animal, sources of variability, the sensory modality required by the animal to solve the task as well as costs and required work effort. Of particular importance is a test’s validity because of its influence on the chance of successful translation of preclinical results to clinical settings. High validity may, however, have to be balanced against practical constraints and there are no behavioral tests with optimal characteristics. The design and development of new behavioral tests is therefore an ongoing effort and there are now well over one hundred tests described in the contemporary literature. Some of them are well established following extensive use, while others are novel and still unproven. The task of choosing a behavioral test for a particular project may therefore be daunting and the aim of the present review is to provide a structured way to evaluate rodent behavioral tests aimed at drug discovery research.

  16. Teacher Narratives and Student Engagement: Testing Narrative Engagement Theory in Drug Prevention Education

    Science.gov (United States)

    Miller-Day, Michelle; Hecht, Michael L.; Krieger, Janice L.; Pettigrew, Jonathan; Shin, YoungJu; Graham, John

    2015-01-01

    Testing narrative engagement theory, this study examines student engagement and teachers’ spontaneous narratives told in a narrative-based drug prevention curriculum. The study describes the extent to which teachers share their own narratives in a narrative-based curriculum, identifies dominant narrative elements, forms and functions, and assesses the relationships among teacher narratives, overall lesson narrative quality, and student engagement. One hundred videotaped lessons of the keepin’ it REAL drug prevention curriculum were coded and the results supported the claim that increased narrative quality of a prevention lesson would be associated with increased student engagement. The quality of narrativity, however, varied widely. Implications of these results for narrative-based prevention interventions and narrative pedagogy are discussed. PMID:26690668

  17. The effects of ifenprodil on the activity of antidepressant drugs in the forced swim test in mice.

    Science.gov (United States)

    Poleszak, Ewa; Wośko, Sylwia; Serefko, Anna; Wlaź, Aleksandra; Kasperek, Regina; Dudka, Jarosław; Wróbel, Andrzej; Nowak, Gabriel; Wlaź, Piotr

    2014-12-01

    According to reports in the literature, more than 30% of depressive patients fail to achieve remission. Therapy with the conventional antidepressant drugs may induce the serious adverse reactions. Moreover, its benefits may be seen at least 2-4 weeks after the first dose. Therefore, the alternative strategies for prevention and treatment of depression are sought. The main aim of our study was to assess the effects of ifenprodil given at a non-active dose (10mg/kg) on the activity of antidepressant agents from diverse pharmacological groups. The antidepressant-like effect was assessed by the forced swim test in mice. Ifenprodil potentiated the antidepressant-like effect of imipramine (15mg/kg) and fluoxetine (5mg/kg) while did not reduce the immobility time of animals which simultaneously received reboxetine (2.5mg/kg) or tianeptine (15mg/kg). The concomitant administration of certain commonly prescribed antidepressant drugs that affect the serotonergic neurotransmission (i.e., typical tricyclic antidepressants and selective serotonin reuptake inhibitors) with a negative modulator selectively binding to the GluN1/N2B subunits of the NMDA receptor complex (i.e., ifenprodil) may induce a more pronounced antidepressant-like effect than monotherapy. However, these findings still need to be confirmed in further experiments. Copyright © 2014 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

  18. Staff training makes a difference: improvements in neonatal illicit drug testing and intervention at a tertiary hospital.

    Science.gov (United States)

    Oral, Resmiye; Koc, Feyza; Jogerst, Kristen; Bayman, Levent; Austin, Andrea; Sullivan, Shannon; Bayman, Emine Ozgur

    2014-07-01

    This project explored the impact of staff training on the rates of perinatal maternal and neonatal illicit drug testing. Controlled, retrospective chart review on 1186 newborn and mother dyads from 2006 (pre-training control group) and on 1861 dyads from 2009 (post-training study group) was completed. Differences between rates of infant and mother drug testing were compared. Increased drug testing rates for the mothers and infants led to increased case finding that tripled both for the mothers (13-3.7%, p importance of and encourages other hospitals to analyze the efficacy of their current protocol and staff training practices in place to ensure the best child protection services.

  19. Utility of humanized BLT mice for analysis of dengue virus infection and antiviral drug testing.

    Science.gov (United States)

    Frias-Staheli, Natalia; Dorner, Marcus; Marukian, Svetlana; Billerbeck, Eva; Labitt, Rachael N; Rice, Charles M; Ploss, Alexander

    2014-02-01

    Dengue virus (DENV) is the cause of a potentially life-threatening disease that affects millions of people worldwide. The lack of a small animal model that mimics the symptoms of DENV infection in humans has slowed the understanding of viral pathogenesis and the development of therapies and vaccines. Here, we investigated the use of humanized "bone marrow liver thymus" (BLT) mice as a model for immunological studies and assayed their applicability for preclinical testing of antiviral compounds. Human immune system (HIS) BLT-NOD/SCID mice were inoculated intravenously with a low-passage, clinical isolate of DENV-2, and this resulted in sustained viremia and infection of leukocytes in lymphoid and nonlymphoid organs. In addition, DENV infection increased serum cytokine levels and elicited DENV-2-neutralizing human IgM antibodies. Following restimulation with DENV-infected dendritic cells, in vivo-primed T cells became activated and acquired effector function. An adenosine nucleoside inhibitor of DENV decreased the circulating viral RNA when administered simultaneously or 2 days postinfection, simulating a potential treatment protocol for DENV infection in humans. In summary, we demonstrate that BLT mice are susceptible to infection with clinical DENV isolates, mount virus-specific adaptive immune responses, and respond to antiviral drug treatment. Although additional refinements to the model are required, BLT mice are a suitable platform to study aspects of DENV infection and pathogenesis and for preclinical testing of drug and vaccine candidates. IMPORTANCE Infection with dengue virus remains a major medical problem. Progress in our understanding of the disease and development of therapeutics has been hampered by the scarcity of small animal models. Here, we show that humanized mice, i.e., animals engrafted with components of a human immune system, that were infected with a patient-derived dengue virus strain developed clinical symptoms of the disease and mounted

  20. A novel dissolution media for testing drug release from a nanostructured polysaccharide-based colon specific drug delivery system: an approach to alternative colon media.

    Science.gov (United States)

    Kotla, Niranjan G; Singh, Sima; Maddiboyina, Balaji; Sunnapu, Omprakash; Webster, Thomas J

    2016-01-01

    The aim of this study was to develop a novel microbially triggered and animal-sparing dissolution method for testing of nanorough polysaccharide-based micron granules for colonic drug delivery. In this method, probiotic cultures of bacteria present in the colonic region were prepared and added to the dissolution media and compared with the performance of conventional dissolution methodologies (such as media with rat cecal and human fecal media). In this study, the predominant species (such as Bacteroides, Bifidobacterium, Lactobacillus species, Eubacterium and Streptococcus) were cultured in 12% w/v skimmed milk powder and 5% w/v grade "A" honey. Approximately 10(10)-10(11) colony forming units m/L of probiotic culture was added to the dissolution media to test the drug release of polysaccharide-based formulations. A USP dissolution apparatus I/II using a gradient pH dissolution method was used to evaluate drug release from formulations meant for colonic drug delivery. Drug release of guar gum/Eudragit FS30D coated 5-fluorouracil granules was assessed under gastric and small intestine conditions within a simulated colonic environment involving fermentation testing with the probiotic culture. The results with the probiotic system were comparable to those obtained from the rat cecal and human fecal-based fermentation model, thereby suggesting that a probiotic dissolution method can be successfully applied for drug release testing of any polysaccharide-based oral formulation meant for colonic delivery. As such, this study significantly adds to the nanostructured biomaterials' community by elucidating an easier assay for colonic drug delivery.

  1. Drug Susceptibility Testing of 31 Antimicrobial Agents on Rapidly Growing Mycobacteria Isolates from China.

    Science.gov (United States)

    Pang, Hui; Li, Guilian; Zhao, Xiuqin; Liu, Haican; Wan, Kanglin; Yu, Ping

    2015-01-01

    Several species of rapidly growing mycobacteria (RGM) are now recognized as human pathogens. However, limited data on effective drug treatments against these organisms exists. Here, we describe the species distribution and drug susceptibility profiles of RGM clinical isolates collected from four southern Chinese provinces from January 2005 to December 2012. Clinical isolates (73) were subjected to in vitro testing with 31 antimicrobial agents using the cation-adjusted Mueller-Hinton broth microdilution method. The isolates included 55 M. abscessus, 11 M. fortuitum, 3 M. chelonae, 2 M. neoaurum, and 2 M. septicum isolates. M. abscessus (75.34%) and M. fortuitum (15.07%), the most common species, exhibited greater antibiotic resistance than the other three species. The isolates had low resistance to amikacin, linezolid, and tigecycline, and high resistance to first-line antituberculous agents, amoxicillin-clavulanic acid, rifapentine, dapsone, thioacetazone, and pasiniazid. M. abscessus and M. fortuitum were highly resistant to ofloxacin and rifabutin, respectively. The isolates showed moderate resistance to the other antimicrobial agents. Our results suggest that tigecycline, linezolid, clofazimine, and cefmetazole are appropriate choices for M. abscessus infections. Capreomycin, sulfamethoxazole, tigecycline, clofazimine, and cefmetazole are potentially good choices for M. fortuitum infections. Our drug susceptibility data should be useful to clinicians.

  2. Drug Susceptibility Testing of 31 Antimicrobial Agents on Rapidly Growing Mycobacteria Isolates from China

    Directory of Open Access Journals (Sweden)

    Hui Pang

    2015-01-01

    Full Text Available Objectives. Several species of rapidly growing mycobacteria (RGM are now recognized as human pathogens. However, limited data on effective drug treatments against these organisms exists. Here, we describe the species distribution and drug susceptibility profiles of RGM clinical isolates collected from four southern Chinese provinces from January 2005 to December 2012. Methods. Clinical isolates (73 were subjected to in vitro testing with 31 antimicrobial agents using the cation-adjusted Mueller-Hinton broth microdilution method. The isolates included 55 M. abscessus, 11 M. fortuitum, 3 M. chelonae, 2 M. neoaurum, and 2 M. septicum isolates. Results. M. abscessus (75.34% and M. fortuitum (15.07%, the most common species, exhibited greater antibiotic resistance than the other three species. The isolates had low resistance to amikacin, linezolid, and tigecycline, and high resistance to first-line antituberculous agents, amoxicillin-clavulanic acid, rifapentine, dapsone, thioacetazone, and pasiniazid. M. abscessus and M. fortuitum were highly resistant to ofloxacin and rifabutin, respectively. The isolates showed moderate resistance to the other antimicrobial agents. Conclusions. Our results suggest that tigecycline, linezolid, clofazimine, and cefmetazole are appropriate choices for M. abscessus infections. Capreomycin, sulfamethoxazole, tigecycline, clofazimine, and cefmetazole are potentially good choices for M. fortuitum infections. Our drug susceptibility data should be useful to clinicians.

  3. Can patients with asthma feel inhaler therapy working right away? Two clinical trials testing the effect of timing of assessment on patient perception.

    Science.gov (United States)

    Leidy, Nancy Kline; Gutierrez, Benjamin; Lampl, Kathy; Uryniak, Tom; O'Brien, Christopher D

    2009-12-01

    Feeling a maintenance therapy work right away may provide positive reinforcement and may offer one way to improve adherence in patients with asthma. Precise measurement is required to accurately compare the presence of this effect across clinical trial treatment groups. Two randomized, controlled studies tested whether timing of assessment (daily vs weekly, study 1; and predose vs postdose, study 2) influenced patients' reports of whether they can feel a medication working right away (perception), and their satisfaction with this perception (satisfaction). These 2-week US-based multicenter double-blind, parallel-group studies included patients > or = 18 years of age with mild to moderate persistent asthma. In each, patients were randomized to one of two drugs with different onset profiles: budesonide/formoterol pressurized metered-dose inhaler (pMDI) 80/4.5 microg x 2 inhalations (160/9 microg) twice daily or budesonide pMDI 80 microg x 2 inhalations (160 microg) twice daily. Patients were further randomized to complete previously validated perception and satisfaction questions in a cross-over fashion, either daily and weekly (N = 123) or predose and postdose (N = 134). Patient surveys also assessed perceptions of the onset of effect of medication and their value of these perceptions. No significant differences were observed in patients' reports of perception, either daily versus weekly or predose versus postdose. A statistically significant difference in satisfaction was found in study 1 only, favoring weekly recall (p away (136 of 157 patients) identified positive airway sensations. Most patients reported that feeling their medication work right away is reassuring and would help them manage their asthma. Assessment timing has no effect on patient response to the perception of feeling a medication working right away. Differences found in satisfaction levels reported with weekly versus daily recall were consistent across treatment groups, indicating that no bias

  4. Clinical implications of molecular drug resistance testing for Mycobacterium tuberculosis: a TBNET/RESIST-TB consensus statement

    NARCIS (Netherlands)

    Domínguez, J.; Boettger, E. C.; Cirillo, D.; Cobelens, F.; Eisenach, K. D.; Gagneux, S.; Hillemann, D.; Horsburgh, R.; Molina-Moya, B.; Niemann, S.; Tortoli, E.; Whitelaw, A.; Lange, C.

    2016-01-01

    The emergence of drug-resistant strains of Mycobacterium tuberculosis is a challenge to global tuberculosis (TB) control. Although culture-based methods have been regarded as the gold standard for drug susceptibility testing (DST), molecular methods provide rapid information on mutations in the M.

  5. Beta-Test Data On An Assessment Of Textbook Problem Solving Ability: An Argument For Right/Wrong Grading?

    Science.gov (United States)

    Cummings, Karen; Marx, Jeffrey D.

    2010-10-01

    We have developed an assessment of students' ability to solve standard textbook style problems and are currently engaged in the validation and revision process. The assessment covers the topics of force and motion, conservation of momentum and conservation of energy at a level consistent with most calculus-based, introductory physics courses. This tool is discussed in more detail in an accompanying paper by Marx and Cummings. [1] Here we present preliminary beta-test data collected at four schools during the 2009/2010 academic year. Data include both pre- and post-instruction results for introductory physics courses as well as results for physics majors in later years. In addition, we present evidence that right/wrong grading may well be a perfectly acceptable grading procedure for a course-level assessment of this type.

  6. Right patient, Right blood

    DEFF Research Database (Denmark)

    Selberg, Hanne; Madsen, Trine Stougaard

    2014-01-01

    Right patient, Right Blood Simulation based training in blood transfusion practice in nursing education Background: In spite of strict checking procedures to handling transfusion of blood severe adverse reactions are likely to happen and the major cause of morbidity occurs to be liable to human...

  7. Ethics, genetic testing, and athletic talent: children's best interests, and the right to an open (athletic) future.

    Science.gov (United States)

    Camporesi, Silvia; McNamee, Mike J

    2016-03-01

    In this paper we discuss the ethics of genetics-based talent identification programs in sports. We discuss the validity and reliability of the tests and the claims made by direct to consumer companies, before presenting a range of ethical issues concerning child-parent/guardian relations raised by these tests, which we frame in terms of parental/guardian duties, children's rights, and best interests. We argue that greater ethical emphasis needs to be put on the parental decision on the wellbeing on the child going forward, not on ex post justifications on the basis of good and bad consequences. Best interests decisions made by a third party seem to comprise both subjective and objective elements, but only a holistic approach can do justice to these questions by addressing the wellbeing of the child in a temporal manner and taking into account the child's perspective on its wellbeing. Such decisions must address wider questions of what a good (sports)parent ought do to help the child flourish and how to balance the future-adult focus necessary to nurture talent with the wellbeing of the child in the present. We conclude that current genetic tests for "talent" do not predict aptitude or success to any significant degree and are therefore only marginally pertinent for talent identification. Claims that go beyond current science are culpable and attempt to exploit widespread but naïve perceptions of the efficacy of genetics information to predict athletic futures. Sports physicians and health care professionals involved in sport medicine should therefore discourage the use of these tests. Copyright © 2016 the American Physiological Society.

  8. Drug-addiction and boundaries of the Self A psychoanalytical reading through the Rorschach test

    Directory of Open Access Journals (Sweden)

    Silvia Marfisi

    2016-05-01

    Full Text Available The present research intends to analyse the phenomenon of drug addiction through the Rorschach test. The protocols, analysed according to the French School Method, have been administered to a sample of 10 subjects. The data have been evaluated integrating quantitative and qualitative aspects, which have revealed the main dimensions of the drug addicted personality, mainly regarding the functioning modes of the narcissistic personality based on the over-investment of limits. The results show an impoverished cognitive set where the capacity of the investment in the imaginary activity is absent and a certain rigidity of thinking is revealed. The investment in the formal aspects of the table provides justification of the emotional isolation where the attention to the external reality acts as a defence from an internal reality whose impoverishment is perceived as threatening and distressing. Interesting outcomes are evident in relation to the emotional sphere and the attempt of social adaptation from some indexes such as the quantity of human responses which result to be in the normative range. The Rorschach test provided an important contribution in this evaluation/understanding of the drug addicted personality: if on the one hand it confirmed some basic traits of the functioning of these subjects, on the other hand it provided the possibility to research new and unexpected frontiers that,  from the closure and the over investment of the boundaries of the Self (predominance of formal responses, of “reponses peau”, reaches an attempt of psychic stimulation addressing a “primitive” emotional sphere, in the form of specular relations (reflection responses or partial (Hd.

  9. Withdrawal of fall-risk-increasing drugs in older persons: effect on tilt-table test outcomes

    NARCIS (Netherlands)

    van der Velde, Nathalie; van den Meiracker, Anton H.; Pols, Huibert A. P.; Stricker, Bruno H. Ch; van der Cammen, Tischa J. M.

    2007-01-01

    OBJECTIVES: To determine whether outcomes of tilt-table tests improved after withdrawal of fall-risk-increasing drugs (FRIDs). DESIGN: Prospective cohort study. SETTING: Geriatric outpatient clinic. PARTICIPANTS: Two hundred eleven new, consecutive outpatients, recruited from April 2003 until

  10. A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the "Metabolites in Safety Testing" Regulatory Guidance.

    Science.gov (United States)

    Schadt, Simone; Bister, Bojan; Chowdhury, Swapan K; Funk, Christoph; Hop, Cornelis E C A; Humphreys, W Griffith; Igarashi, Fumihiko; James, Alexander D; Kagan, Mark; Khojasteh, S Cyrus; Nedderman, Angus N R; Prakash, Chandra; Runge, Frank; Scheible, Holger; Spracklin, Douglas K; Swart, Piet; Tse, Susanna; Yuan, Josh; Obach, R Scott

    2018-06-01

    Since the introduction of metabolites in safety testing (MIST) guidance by the Food and Drug Administration in 2008, major changes have occurred in the experimental methods for the identification and quantification of metabolites, ways to evaluate coverage of metabolites, and the timing of critical clinical and nonclinical studies to generate this information. In this cross-industry review, we discuss how the increased focus on human drug metabolites and their potential contribution to safety and drug-drug interactions has influenced the approaches taken by industry for the identification and quantitation of human drug metabolites. Before the MIST guidance was issued, the method of choice for generating comprehensive metabolite profile was radio chromatography. The MIST guidance increased the focus on human drug metabolites and their potential contribution to safety and drug-drug interactions and led to changes in the practices of drug metabolism scientists. In addition, the guidance suggested that human metabolism studies should also be accelerated, which has led to more frequent determination of human metabolite profiles from multiple ascending-dose clinical studies. Generating a comprehensive and quantitative profile of human metabolites has become a more urgent task. Together with technological advances, these events have led to a general shift of focus toward earlier human metabolism studies using high-resolution mass spectrometry and to a reduction in animal radiolabel absorption/distribution/metabolism/excretion studies. The changes induced by the MIST guidance are highlighted by six case studies included herein, reflecting different stages of implementation of the MIST guidance within the pharmaceutical industry. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

  11. Field-test of a date-rape drug detection device.

    Science.gov (United States)

    Quest, Dale W; Horsley, Joanne

    2007-01-01

    Drink Safe Technology Version 1.2 is an inexpensive color-change reagent test marketed internationally for use by consumers in settings such as a night club to detect potentially incapacitating concentrations of gamma-hydroxybutyric acid (GHB) and ketamine in beverages. The objective of this study was to compare product performance in the laboratory and performance in the hands of consumers in the field. Product performance in the laboratory adhered to the protocol defined by the manufacturer. Product performance in the hands of consumers in field settings allowed browsing participants to pipette an aliquot of their own drinks into randomly coded vials containing authentic drugs, or pure water, so as to yield the same concentrations of GHB or ketamine specified in the manufacturer-defined protocol, or blanks. Consumers were to proceed according to the directions printed on the product, and to record their results on a card with a code corresponding with the vial to which they had added an aliquot of their beverage. Diagnostic performance was calculated using two-way analysis. In the laboratory, Drink Safe Technology Version 1.2 reliably detected GHB and ketamine at concentrations specified by the manufacturer's protocol. The reactive color change denoting a positive test for GHB was rapid, but a positive test for ketamine required substantially more time to resolve. Nonetheless, test accuracy following the manufacturer's protocol in the laboratory was 100%. In the field, based on 101 paired-test results recorded by consumers, the test efficiency was 65.1%, sensitivity 50%, and specificity 91.6%. The product performed much better in the laboratory than it did in the hand of consumers in the field. There seems to be considerable potential for consumers to misinterpret a test result. The potential for consumers to record a false-negative test result for a spiked drink is cause for concern.

  12. The Trump Hypothesis: Testing Immigrant Populations as a Determinant of Violent and Drug-Related Crime in the United States

    OpenAIRE

    Green, David

    2016-01-01

    Objectives: To test the “Trump Hypothesis”: whether immigrants are responsible for higher levels of violent and drug-related crime in the United States, as asserted by Donald Trump in his 2015 presidential campaign announcement. This is achieved using recent crime and immigration data, thus testing the common public perception linking immigrants to crime, and providing an updated assessment of the immigrant-crime nexus. Methods: Rates of violent crime and drug arrests by state are pooled for ...

  13. In vitro testing of chemotherapeutic drug combinations in acute myelocytic leukaemia using the fluorometric microculture cytotoxicity assay (FMCA).

    Science.gov (United States)

    Larsson, R; Fridborg, H; Kristensen, J; Sundström, C; Nygren, P

    1993-05-01

    The fluorometric microculture cytotoxicity assay (FMCA) was employed for analysing the effect of different chemotherapeutic drug combinations and their single constituents in 44 cases of acute myelocytic leukaemia (AML). A large heterogeneity with respect to cell kill was observed for all combinations tested, the interactions ranging from antagonistic to synergistic in terms of the multiplicative concept for drug interactions. However, an 'additive' model provided a significantly better fit of the data compared to the effect of the most active single agent of the combination (Dmax) for several common antileukaemic drug combinations. When the two interaction models were related to treatment outcome 38% of the non-responders showed preference for the additive model whereas the corresponding figure for responders was 80%. Overall, in 248 of 290 (85%) tests performed with drug combinations, there was an agreement between the effect of the combination and that of the most active single component. Direct comparison of Dmax and the combination for correlation with clinical outcome demonstrated only minor differences in the ability to predict drug resistance. The results show that FMCA appear to report drug interactions in samples from patients with AML in accordance with clinical experience. Furthermore, testing single agents as a substitute for drug combinations may be adequate for detection of clinical drug resistance to combination therapy in AML.

  14. Spillover effects of HIV testing policies: changes in HIV testing guidelines and HCV testing practices in drug treatment programs in the United States

    Directory of Open Access Journals (Sweden)

    Jemima A. Frimpong

    2016-07-01

    Full Text Available Abstract Background To examine the extent to which state adoption of the Centers for Disease Control and Prevention (CDC 2006 revisions to adult and adolescent HIV testing guidelines is associated with availability of other important prevention and medical services. We hypothesized that in states where the pretest counseling requirement for HIV testing was dropped from state legislation, substance use disorder treatment programs would have higher availability of HCV testing services than in states that had maintained this requirement. Methods We analyzed a nationally representative sample of 383 opioid treatment programs from the 2005 and 2011 National Drug Abuse Treatment System Survey (NDATSS. Data were collected from program directors and clinical supervisors through telephone surveys. Multivariate logistic regression models were used to measure associations between state adoption of CDC recommended guidelines for HIV pretest counseling and availability of HCV testing services. Results The effects of HIV testing legislative changes on HCV testing practices varied by type of opioid treatment program. In states that had removed the requirement for HIV pretest counseling, buprenorphine-only programs were more likely to offer HCV testing to their patients. The positive spillover effect of HIV pretest counseling policies, however, did not extend to methadone programs and did not translate into increased availability of on-site HCV testing in either program type. Conclusions Our findings highlight potential positive spillover effects of HIV testing policies on HCV testing practices. They also suggest that maximizing the benefits of HIV policies may require other initiatives, including resources and programmatic efforts that support systematic integration with other services and effective implementation.

  15. Patterns of HIV testing, drug use, and sexual behaviors in people who use drugs: findings from a community-based outreach program in Phnom Penh, Cambodia.

    Science.gov (United States)

    Mburu, Gitau; Ngin, Chanrith; Tuot, Sovannary; Chhoun, Pheak; Pal, Khuondyla; Yi, Siyan

    2017-12-05

    People who use drugs are an important priority for HIV programs. However, data related to their utilization of HIV services are limited. This paper reports patterns of HIV testing, drug use, and risk and service perception among people who use drugs. Study participants were receiving HIV and harm reduction services from a community-based program in Phnom Penh, comprised of itinerant peer-led outreach and static drop-in centers. This was a mixed-methods study conducted in 2014, comprising of a quantitative survey using a structured questionnaire, followed by two focus group discussions among a sub-sample of survey participants. Participants were recruited from hotspots in five HIV high-burden communes using a two-stage cluster sampling method. Quantitative descriptive analyses and qualitative thematic analyses were performed. This study included 151 people who use drugs with a mean age of 31.2 (SD = 6.5) years; 77.5% were male and 39.1% were married. The most common drugs used were methamphetamines (72.8%) and heroin (39.7%), and 38.0% injected drugs in the past 3 months. Overall, 83.3% had been tested for HIV in the past 6 months, of whom 62.5% had been tested by peers through community-based outreach. However, there were ongoing HIV risks: 37.3% were engaging in sex on drugs, only 35.6% used a condom at last sexual intercourse, and 10.8% had had a sexually transmitted infection in the last 6 months. Among people who reported injecting drugs in the past 3 months, 27.5% reported re-using needles/syringes. Almost half (46.5%) perceived themselves as being at lower risk of HIV compared to the general population. Qualitative results contextualized the findings of low perception of HIV risks and suggested that although services were often unavailable on weekends, at night, or during national holidays, peer-led community-based outreach was highly accepted. A peer-led community-based approach was effective in reaching people who use drugs with HIV and harm reduction

  16. A novel dissolution media for testing drug release from a nanostructured polysaccharide-based colon specific drug delivery system: an approach to alternative colon media

    Directory of Open Access Journals (Sweden)

    Kotla NG

    2016-03-01

    Full Text Available Niranjan G Kotla,1,2 Sima Singh,1,3 Balaji Maddiboyina,4 Omprakash Sunnapu,2 Thomas J Webster5,6 1School of Pharmaceutical Sciences, Lovely Professional University, Punjab, India; 2Technologies for the Advancement of Science, Institute for Stem Cell Biology and Regenerative Medicine, Bangalore, Karnataka, India; 3Department of Pharmaceutical Sciences, Birla Institute of Technology, Mesra, Ranchi, Jharkhand, India; 4Department of Pharmaceutics, Vishwabharathi College of Pharmaceutical Sciences, Guntur, Andhra Pradesh, India; 5Department of Chemical Engineering, Northeastern University, Boston, MA, USA; 6Center of Excellence for Advanced Materials Research, King Abdulaziz University, Jeddah, Saudi Arabia Abstract: The aim of this study was to develop a novel microbially triggered and animal-sparing dissolution method for testing of nanorough polysaccharide-based micron granules for colonic drug delivery. In this method, probiotic cultures of bacteria present in the colonic region were prepared and added to the dissolution media and compared with the performance of conventional dissolution methodologies (such as media with rat cecal and human fecal media. In this study, the predominant species (such as Bacteroides, Bifidobacterium, Lactobacillus species, Eubacterium and Streptococcus were cultured in 12% w/v skimmed milk powder and 5% w/v grade “A” honey. Approximately 1010–1011 colony forming units m/L of probiotic culture was added to the dissolution media to test the drug release of polysaccharide-based formulations. A USP dissolution apparatus I/II using a gradient pH dissolution method was used to evaluate drug release from formulations meant for colonic drug delivery. Drug release of guar gum/Eudragit FS30D coated 5-fluorouracil granules was assessed under gastric and small intestine conditions within a simulated colonic environment involving fermentation testing with the probiotic culture. The results with the probiotic system were

  17. Advancing the vesosome, a multifunctional drug delivery platform, toward applied in vivo testing

    Science.gov (United States)

    Wong, Benjamin J.

    An optimal drug delivery vehicle should circulate long enough to reach the site of illness or disease, possess a large drug loading capacity, retain its contents over the course of treatment, and be able deliver its contents at a rate appropriate for maximum therapeutic benefit at the site of interest. The vesosome, a large lipid bilayer enclosing multiple, smaller liposomes, is our solution to addressing these needs. The external lipid bilayer offers a second barrier of protection for interior components and can also serve as the anchor for active targeting components. Furthermore, internal compartmentalization permits customization of separate environments for multiple therapeutics and release triggers. Previous work established the ability of the vesosome to retain its contents in vitro an order of magnitude longer than liposomes. To be viable in vivo, the vesosome must be functionalized for biocompatibility and tracking, and its synthetic procedure must be repeatable, reliable and result in a purified product. The vesosome was functionalized by introducing biocompatible polymers, such as poly(ethylene glycol) (PEG), and fluorescent dyes in their lipid-bound forms into the external membrane of the vesosome. The external vesosomal membrane is formed from large, flat lipid sheets in the interdigitated (L betaI) phase which, when heated, are used to encapsulate smaller drug-containing vesicles. Through X-Ray diffraction (XRD) and freeze-fracture transmission electron microscopy (FF-TEM), we established that the molar amounts of functionalized lipid required to label the vesosome for tracking and biocompatibility (˜5--7mol% total) did not prevent the formation of the interdigitated phase. Thus, functionalization of the external vesosome membrane can be achieved through functionalization of interdigitated sheets. For in vivo testing, functionalized vesosomes must be separated from unencapsulated vesicles and purification was performed using size exclusion

  18. Behavioral effects of antiepileptic drugs in rats: Are the effects on mood and behavior detectable in open-field test?

    Science.gov (United States)

    Zimcikova, Eva; Simko, Julius; Karesova, Iva; Kremlacek, Jan; Malakova, Jana

    2017-11-01

    Behavioral side effects of antiepileptic drugs (AEDs) are common including both positive and negative effects on mood, anxiety, depression, and psychosis. We aimed to evaluate behavioral patterns in rats after administration of lamotrigine, levetiracetam, phenytoin, topiramate, carbamazepine, gabapentin, pregabalin, and zonisamide. The open-field test was performed and locomotion, rearing, grooming, central latency and defecation were recorded over a 5min interval for each rat (8 rats in each group receiving AED and 16 controls). Kruskal-Wallis nonparametric test or ANOVA were used to assess differences among the groups. The experimental groups did not differ in latency to enter the center compartment, neither in the decline of locomotor activity in the 1st and the 5th minute of the observation, nor in number of rears. Significant differences among groups were observed in the total number of lines crossed, grooming, as well in the number of fecal pellets. Locomotor activity was significantly increased in lamotrigine, if compared with gabapentin and pregabalin (ANOVA; p <0.05). Rats exposed to topiramate displayed a significantly increased number of grooming (when compared to pregabalin: p<0.01). Defecation (the number of fecal pellets) significantly increased in the gabapentin and carbamazepine group. There are significant differences between AEDs in terms of their behavioral profile. It is of great importance to evaluate these effects in clinical practice to bring more clear insight into these positive or negative side effects of AEDs. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  19. Local tolerance testing of parenteral drugs: how to put into practice.

    Science.gov (United States)

    Jochims, Karin; Kemkowski, Joerg; Nolte, Thomas; Bartels, Thomas; Heusener, Alexander

    2003-10-01

    Notwithstanding that there are national and international guidelines about local tolerance testing of parenteral drugs in animals, in particular to mention CPMP/SWP/2145/00 (Note for Guidance on Non-Clinical Local Tolerance Testing of Medicinal Products), very heterogeneous study designs have been established in the past. A working group including experts of the leading pharmaceutical industry from German-language countries, named "Arbeitskreis Lokale Verträglichkeit," has been intensively discussing the experimental procedures in detail for a period of six years and has been considering their pros and cons. This team of experts now feels confident to give some recommendations for study conduct besides describing different materials and methods for this type of toxicological study. Special knowledge from toxicologists as well as pathologists from our working group has been taken into account. This paper deals with choice of species, number of animals used, controls, administration sites, volumes, rate and frequency, length of observation period, termination, clinical, macroscopic and histopathological examinations and, finally, overall assessment criteria and conclusion. Our purpose is that this paper may be of value for: *The study director who is inexperienced in the conduction of local tolerance testing and who may need a standard design as his first step into this new field. *The well-versed study director who would like to know how others have done in the past, who may examine self-critically his own practice and who is open to our team's recommendations, tips and tricks from practice. *The specialist at a regulatory authority who, finally, reviews study reports, assesses their format and content and, above all, decides on the approval of a drug product.

  20. A patch test confirmed phenobarbital-induced fixed drug eruption in a child.

    Science.gov (United States)

    Chadly, Zohra; Aouam, Karim; Chaabane, Amel; Belhadjali, Hichem; Abderrazzak Boughattas, Naceur; Zili, Jamel Eddine

    2014-06-01

    A-10-year-old girl was referred to our department for multiple hyperpigmented plaques. One week previously, she had been given one suppository of acetylsalicylic acid - phenobarbital for fever. Twelve hours after the drug intake the child developed pruritic red plaques on the left thigh. Six weeks after resolution of the acute reaction, patch tests were performed separately, with phenobarbital and acetylsalicylic acid. On 48-hour reading, only the phenobarbital patch test on residual pigmented lesion was positive. Because of possible cross-reactions between aromatic anticonvulsants, subsequent patch tests using carbamazepine and phenytoin on residual pigmented lesions were performed. They were all negative at 48-hour reading. To our knowledge, only two isolated pediatric cases of Phenobarbital-induced FDE have been reported in the literature. In this case report, as it was difficult to determine whether phenobarbital or acetylsalicylic acid was responsible for this reaction, subsequent patch tests allowed the identification of the culprit component since it was positive to phenobarbital.

  1. HIV Testing, Care, and Treatment Among Women Who Use Drugs From a Global Perspective: Progress and Challenges.

    Science.gov (United States)

    Metsch, Lisa; Philbin, Morgan M; Parish, Carrigan; Shiu, Karen; Frimpong, Jemima A; Giang, Le Minh

    2015-06-01

    The article reviews data on HIV testing, treatment, and care outcomes for women who use drugs in 5 countries across 5 continents. We chose countries in which the HIV epidemic has, either currently or historically, been fueled by injection and non-injection drug use and that have considerable variation in social structural and drug policies: Argentina, Vietnam, Australia, Ukraine, and the United States. There is a dearth of available HIV care continuum outcome data [ie, testing, linkage, retention, antiretroviral therapy (ART) provision, viral suppression] among women drug users, particularly among noninjectors. Although some progress has been made in increasing HIV testing in this population, HIV-positive women drug users in 4 of the 5 countries have not fully benefitted from ART nor are they regularly engaged in HIV care. Issues such as the criminalization of drug users, HIV-specific criminal laws, and the lack of integration between substance use treatment and HIV primary care play a major role. Strategies that effectively address the pervasive factors that prevent women drug users from engaging in HIV care and benefitting from ART and other prevention services are critical. Future success in enhancing the HIV continuum for women drug users should consider structural and contextual level barriers and promote social, economic, and legal policies that overhaul the many years of discrimination and stigmatization faced by women drug users worldwide. Such efforts must emphasis the translation of policies into practice and approaches to implementation that can help HIV-infected women who use drugs engage at all points of the HIV care continuum.

  2. Evaluating motives: Two simple tests to identify and avoid entanglement in legally dubious urine drug testing schemes.

    Science.gov (United States)

    Barnes, Michael C; Worthy, Stacey L

    2015-01-01

    This article educates healthcare practitioners on the legal framework prohibiting abusive practices in urine drug testing (UDT) in medical settings, discusses several profit-driven UDT schemes that have resulted in enforcement actions, and provides recommendations for best practices in UDT to comply with state and federal fraud and anti-kickback statutes. The authors carefully reviewed and analyzed statutes, regulations, adivsory opinions, case law, court documents, articles from legal journals, and news articles. Certain facts-driven UDT arrangements tend to violate federal and state healthcare laws and regulations, including Stark law, the anti-kickback statute, the criminal health care fraud statute, and the False Claims Act. Healthcare practitioners who use UDT can help ensure that they are in compliance with applicable federal and state laws by evaluating whether their actions are motivated by providing proper care to their patients rather than by profits. They must avoid schemes that violate the spirit of the law while appearing to comply with the letter of the law. Such a simple self-evaluation of motive can reduce a practitioner's likelihood of civil fines and criminal liability.

  3. Simple PCR assays improve the sensitivity of HIV-1 subtype B drug resistance testing and allow linking of resistance mutations.

    Directory of Open Access Journals (Sweden)

    Jeffrey A Johnson

    Full Text Available BACKGROUND: The success of antiretroviral therapy is known to be compromised by drug-resistant HIV-1 at frequencies detectable by conventional bulk sequencing. Currently, there is a need to assess the clinical consequences of low-frequency drug resistant variants occurring below the detection limit of conventional genotyping. Sensitive detection of drug-resistant subpopulations, however, requires simple and practical methods for routine testing. METHODOLOGY: We developed highly-sensitive and simple real-time PCR assays for nine key drug resistance mutations and show that these tests overcome substantial sequence heterogeneity in HIV-1 clinical specimens. We specifically used early wildtype virus samples from the pre-antiretroviral drug era to measure background reactivity and were able to define highly-specific screening cut-offs that are up to 67-fold more sensitive than conventional genotyping. We also demonstrate that sequencing the mutation-specific PCR products provided a direct and novel strategy to further detect and link associated resistance mutations, allowing easy identification of multi-drug-resistant variants. Resistance mutation associations revealed in mutation-specific amplicon sequences were verified by clonal sequencing. SIGNIFICANCE: Combined, sensitive real-time PCR testing and mutation-specific amplicon sequencing provides a powerful and simple approach that allows for improved detection and evaluation of HIV-1 drug resistance mutations.

  4. Culture and drug susceptibility testing among previously treated tuberculosis patients in the Dominican Republic, 2014

    Directory of Open Access Journals (Sweden)

    Katia J. Romero Mercado

    Full Text Available ABSTRACT Multidrug-resistant tuberculosis (MDR-TB is a major public health concern that threatens global progress toward effective TB control. The risk of MDR-TB is increased in patients who have received previous TB treatment. This article describes the performance of culture and drug susceptibility testing (DST in patients registered as previously treated TB patients in the Dominican Republic in 2014, based on operational research that followed a retrospective cohort design and used routine program data. Under the current system of TB culturing and DST, the majority of patients with previously treated TB do not undergo DST, and those who do often experience considerable delay in obtaining their results. The lack of DST and delay in receiving DST results leads to underestimation of the number of MDR-TB cases and hinders the timely initiation of MDR-TB treatment.

  5. Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

    Energy Technology Data Exchange (ETDEWEB)

    Elliott, Kevin C., E-mail: ke@sc.edu [University of South Carolina, Department of Philosophy, USC NanoCenter (United States); Volz, David C. [University of South Carolina, Department of Environmental Health Sciences, Arnold School of Public Health (United States)

    2012-01-15

    Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345-1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

  6. Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

    International Nuclear Information System (INIS)

    Elliott, Kevin C.; Volz, David C.

    2012-01-01

    Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345–1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

  7. Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

    Science.gov (United States)

    Elliott, Kevin C.; Volz, David C.

    2012-01-01

    Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345-1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

  8. A spheroid-based 3-D culture model for pancreatic cancer drug testing, using the acid phosphatase assay

    International Nuclear Information System (INIS)

    Wen, Z.; Liao, Q.; Hu, Y.; You, L.; Zhou, L.; Zhao, Y.

    2013-01-01

    Current therapy for pancreatic cancer is multimodal, involving surgery and chemotherapy. However, development of pancreatic cancer therapies requires a thorough evaluation of drug efficacy in vitro before animal testing and subsequent clinical trials. Compared to two-dimensional culture of cell monolayer, three-dimensional (3-D) models more closely mimic native tissues, since the tumor microenvironment established in 3-D models often plays a significant role in cancer progression and cellular responses to the drugs. Accumulating evidence has highlighted the benefits of 3-D in vitro models of various cancers. In the present study, we have developed a spheroid-based, 3-D culture of pancreatic cancer cell lines MIAPaCa-2 and PANC-1 for pancreatic drug testing, using the acid phosphatase assay. Drug efficacy testing showed that spheroids had much higher drug resistance than monolayers. This model, which is characteristically reproducible and easy and offers rapid handling, is the preferred choice for filling the gap between monolayer cell cultures and in vivo models in the process of drug development and testing for pancreatic cancer

  9. A spheroid-based 3-D culture model for pancreatic cancer drug testing, using the acid phosphatase assay

    Directory of Open Access Journals (Sweden)

    Z. Wen

    2013-08-01

    Full Text Available Current therapy for pancreatic cancer is multimodal, involving surgery and chemotherapy. However, development of pancreatic cancer therapies requires a thorough evaluation of drug efficacy in vitro before animal testing and subsequent clinical trials. Compared to two-dimensional culture of cell monolayer, three-dimensional (3-D models more closely mimic native tissues, since the tumor microenvironment established in 3-D models often plays a significant role in cancer progression and cellular responses to the drugs. Accumulating evidence has highlighted the benefits of 3-D in vitro models of various cancers. In the present study, we have developed a spheroid-based, 3-D culture of pancreatic cancer cell lines MIAPaCa-2 and PANC-1 for pancreatic drug testing, using the acid phosphatase assay. Drug efficacy testing showed that spheroids had much higher drug resistance than monolayers. This model, which is characteristically reproducible and easy and offers rapid handling, is the preferred choice for filling the gap between monolayer cell cultures and in vivo models in the process of drug development and testing for pancreatic cancer.

  10. A Study on the Reliability of an On-Site Oral Fluid Drug Test in a Recreational Context

    Directory of Open Access Journals (Sweden)

    Stefano Gentili

    2016-01-01

    Full Text Available The reliability of DrugWipe 5A on site test for principal drugs of abuse (cannabis, amphetamines, cocaine, and opiates detection in oral fluid was assessed by comparing the on-site results with headspace solid-phase microextraction (HS-SPME gas chromatography-mass spectrometry (GC-MS analysis on samples extracted by the device collection pad. Oral fluid samples were collected at recreational settings (e.g., discos, pubs, and music bars of Rome metropolitan area. Eighty-three club goers underwent the on-site drug screening test with one device. Independently from the result obtained, a second device was used just to collect another oral fluid sample subsequently extracted and analyzed in the laboratory following HS-SPME procedure, gas chromatographic separation by a capillary column, and MS detection by electron impact ionization. DrugWipe 5A on-site test showed 54 samples (65.1% positive to one or more drugs of abuse, whereas 75 samples (90.4% tested positive for one or more substances following GC-MS assay. Comparing the obtained results, the device showed sensitivity, specificity, and accuracy around 80% for amphetamines class. Sensitivity (67 and 50% was obtained for cocaine and opiates, while both sensitivity and accuracy were unsuccessful (29 and 53%, resp. for cannabis, underlying the limitation of the device for this latter drug class.

  11. Right secondary somatosensory cortex-a promising novel target for the treatment of drug-resistant neuropathic orofacial pain with repetitive transcranial magnetic stimulation.

    Science.gov (United States)

    Lindholm, Pauliina; Lamusuo, Salla; Taiminen, Tero; Pesonen, Ullamari; Lahti, Ari; Virtanen, Arja; Forssell, Heli; Hietala, Jarmo; Hagelberg, Nora; Pertovaara, Antti; Parkkola, Riitta; Jääskeläinen, Satu

    2015-07-01

    High-frequency repetitive transcranial magnetic stimulation (rTMS) of the motor cortex has analgesic effect; however, the efficacy of other cortical targets and the mode of action remain unclear. We examined the effects of rTMS in neuropathic orofacial pain, and compared 2 cortical targets against placebo. Furthermore, as dopaminergic mechanisms modulate pain responses, we assessed the influence of the functional DRD2 gene polymorphism (957C>T) and the catechol-O-methyltransferase (COMT) Val158Met polymorphism on the analgesic effect of rTMS. Sixteen patients with chronic drug-resistant neuropathic orofacial pain participated in this randomized, placebo-controlled, crossover study. Navigated high-frequency rTMS was given to the sensorimotor (S1/M1) and the right secondary somatosensory (S2) cortices. All subjects were genotyped for the DRD2 957C>T and COMT Val158Met polymorphisms. Pain, mood, and quality of life were monitored throughout the study. The numerical rating scale pain scores were significantly lower after the S2 stimulation than after the S1/M1 (P = 0.0071) or the sham (P = 0.0187) stimulations. The Brief Pain Inventory scores were also lower 3 to 5 days after the S2 stimulation than those at pretreatment baseline (P = 0.0127 for the intensity of pain and P = 0.0074 for the interference of pain) or after the S1/M1 (P = 0.001 and P = 0.0001) and sham (P = 0.0491 and P = 0.0359) stimulations. No correlations were found between the genetic polymorphisms and the analgesic effect in the present small clinical sample. The right S2 cortex is a promising new target for the treatment of neuropathic orofacial pain with high-frequency rTMS.

  12. A Statistical Analysis of the Deterrence Effects of the Military Services' Drug Testing Policies

    National Research Council Canada - National Science Library

    Martinez, Antonio

    1998-01-01

    .... Using data from the 1995 Department of Defense Survey of Health Related Behaviors Among Military Personnel and the 1995 National Household Survey on Drug Abuse, illicit drug use rates are modeled...

  13. Drug susceptibility testing in microaerophilic parasites: Cysteine strongly affects the effectivities of metronidazole and auranofin, a novel and promising antimicrobial

    Directory of Open Access Journals (Sweden)

    David Leitsch

    2017-12-01

    Full Text Available The microaerophilic parasites Entamoeba histolytica, Trichomonas vaginalis, and Giardia lamblia annually cause hundreds of millions of human infections which are treated with antiparasitic drugs. Metronidazole is the most often prescribed drug but also other drugs are in use, and novel drugs with improved characteristics are constantly being developed. One of these novel drugs is auranofin, originally an antirheumatic which has been relabelled for the treatment of parasitic infections. Drug effectivity is arguably the most important criterion for its applicability and is commonly assessed in susceptibility assays using in vitro cultures of a given pathogen. However, drug susceptibility assays can be strongly affected by certain compounds in the growth media. In the case of microaerophilic parasites, cysteine which is added in large amounts as an antioxidant is an obvious candidate because it is highly reactive and known to modulate the toxicity of metronidazole in several microaerophilic parasites.In this study, it was attempted to reduce cysteine concentrations as far as possible without affecting parasite viability by performing drug susceptibility assays under strictly anaerobic conditions in an anaerobic cabinet. Indeed, T. vaginalis and E. histolytica could be grown without any cysteine added and the cysteine concentration necessary to maintain G. lamblia could be reduced to 20%. Susceptibilities to metronidazole were found to be clearly reduced in the presence of cysteine. With auranofin the protective effect of cysteine was extreme, providing protection to concentrations up to 100-fold higher as observed in the absence of cysteine. With three other drugs tested, albendazole, furazolidone and nitazoxanide, all in use against G. lamblia, the effect of cysteine was less pronounced. Oxygen was found to have a less marked impact on metronidazole and auranofin than cysteine but bovine bile which is standardly used in growth media for G

  14. 49 CFR 385.605 - New entrant registration driver's license and drug and alcohol testing requirements.

    Science.gov (United States)

    2010-10-01

    ... America-Domiciled Carriers § 385.605 New entrant registration driver's license and drug and alcohol... carrier must subject each of the drivers described in paragraph (a) of this section to drug and alcohol... 49 Transportation 5 2010-10-01 2010-10-01 false New entrant registration driver's license and drug...

  15. Organotypic cultures as tools for testing neuroactive drugs - link between in-vitro and in-vivo experiments.

    Science.gov (United States)

    Drexler, B; Hentschke, H; Antkowiak, B; Grasshoff, C

    2010-01-01

    The development of neuroactive drugs is a time consuming procedure. Candidate drugs must be run through a battery of tests, including receptor studies and behavioural tests on animals. As a rule, numerous substances with promising properties as assessed in receptor studies must be eliminated from the development pipeline in advanced test phases because of unforeseen problems like intolerable side-effects or unsatisfactory performance in the whole organism. Clearly, test systems of intermediate complexity would alleviate this inefficiency. In this review, we propose cultured organotypic brain slices as model systems that could bridge the 'interpolation gap' between receptors and the brain, with a focus on the development of new general anaesthetics with lesser side effects. General anaesthesia is based on the modulation of neurotransmitter receptors and other conductances located on neurons in diverse brain regions, including cerebral cortex and spinal cord. It is well known that different components of general anaesthesia, e.g. hypnosis and immobility, are produced by the depression of neuronal activity in distinct brain regions. The ventral horn of the spinal cord is an important structure for the induction of immobility. Thus, the potentially immobilizing effects of a newly designed drug can be estimated from its depressant effect on neuronal network activity in cultured spinal slices. A drug's sedative and hypnotic potential can be examined in cortical cultures. Combined with genetically engineered mice, this approach can point to receptor subtypes most relevant to the drug's intended net effect and in return can help in the design of more selective drugs. In conclusion, the use of organotypic cultures permits predictions of neuroactive properties of newly designed drugs on an intermediate level, and should therefore open up avenues for a more creative and economic drug development process.

  16. PHARMACOLOGICAL IN VITRO MODELS IN PRE-CLINICAL DRUG TESTING - EXAMPLE OF hSERT TRANSFECTED HUMAN EMBRYONIC KIDNEY CELLS

    Directory of Open Access Journals (Sweden)

    Mihajlo Jakovljević

    2012-06-01

    Full Text Available Preclinical drug testing should be considered an important stage during examinations of its efficiency and safety in any likely indication observed. Purpose of the process is acquisition of substantial amount of particular drug-related data before approaching clinical trials in humans. Historical preclinical testing relied on available testing in microbe cultures and animal models. During recent decades laboratory techniques of human cell lines cultivation have been developed and improved. These provide unique possibility of drug acting mechanism testing in a simplified environment lacking basic homeostatic mechanisms. Some examples of these are measuring drug impact to biochemical transport, signaling or anabolic processes. Humane cell lines of embrional kidney 293 are an example of easy-to-grow and disseminate and quite endurable cell line. This methodological article notices some of the details of HEK293 cells cultivation and breading. We took transfection as an example of in vitro model creation for drug testing. Transfection refers to gene introduction into HEK293 cellular genome in order to achieve membrane expression of coded protein. In our case it would be human serotonin transporter. Article contains description of one particular methodological approach in measuring human serotonin transporter expression. The role and importance of serotonin pump in affective disorders genesis was already widely recognized. Aim of the paper was to emphasize feasibility of cell cultivation and its advantages in comparison with alternative traditional methods.

  17. Antimalarial drug susceptibility testing of Plasmodium falciparum in Brazil using a radioisotope method

    Directory of Open Access Journals (Sweden)

    Cerutti Junior Crispim

    1999-01-01

    Full Text Available From March 1996 to August 1997, a study was carried out in a malaria endemic area of the Brazilian Amazon region. In vivo sensitivity evaluation to antimalarial drugs was performed in 129 patients. Blood samples (0.5 ml were drawn from each patient and cryopreserved to proceed to in vitro studies. In vitro sensitivity evaluation performed using a radioisotope method was carried out with the cryopreserved samples from September to December 1997. Thirty-one samples were tested for chloroquine, mefloquine, halofantrine, quinine, arteether and atovaquone. Resistance was evidenced in 96.6% (29/30 of the samples tested for chloroquine, 3.3% (1/30 for quinine, none (0/30 for mefloquine and none for halofantrine (0/30. Overall low sensitivity was evidenced in 10% of the samples tested for quinine, 22.5% tested for halofantrine and in 20% tested for mefloquine. Means of IC 50 values were 132.2 (SD: 46.5 ng/ml for chloroquine, 130.6 (SD: 49.6 ng/ml for quinine, 3.4 (SD: 1.3 ng/ml for mefloquine, 0.7 (SD: 0.3 ng/ml for halofantrine, 1 (SD: 0.6 ng/ml for arteether and 0.4 (SD: 0.2 ng/ml for atovaquone. Means of chloroquine IC 50 of the tested samples were comparable to that of the chloroquine-resistant strain W2 (137.57 ng/ml and nearly nine times higher than that of the chloroquine-sensitive strain D6 (15.09 ng/ml. Means of quinine IC 50 of the tested samples were 1.7 times higher than that of the low sensitivity strain W2 (74.84 ng/ml and nearly five times higher than that of the quinine-sensitive strain D6 (27.53 ng/ml. These results disclose in vitro high resistance levels to chloroquine, low sensitivity to quinine and evidence of decreasing sensitivity to mefloquine and halofantrine in the area under evaluation.

  18. The Impact of Animal Rights on the Use of Animals for Biomedical Research, Product Testing and Evaluation.

    Science.gov (United States)

    Baier, Stephen W.

    1993-01-01

    Clarifies the issues of animal rights as they effect animal use in research and education through an examination of the current use of animals, a historical look at animal use, and a consideration of the philosophical underpinnings of the animal rights and pro-use viewpoints. (PR)

  19. Random mandatory drugs testing of prisoners: a biassed means of gathering information.

    Science.gov (United States)

    Gore, S M; Bird, A G; Strang, J S

    1999-01-01

    Our objective was to develop and test a methodology for inferring the percentage of prisoners currently using opiates from the percentage of prisoners testing positive for opiates in random mandatory drugs testing (rMDT). The study used results from Willing Anonymous Salivary HIV (WASH) studies (1994-6) in six adult Scottish prisons, and surveys (1994-5 and 1997) in 14 prisons in England and Wales. For Scottish prisons, the percentage of prisoners currently using opiates was determined by assuming, with varying empirical support, that: current users of opiates in prison were 1.5 times as many as current inside-injectors; and current inside-injectors were 0.75 times as many as ever injectors in prison. We also assumed that current inside-users' frequency of use of opiates (by any route) was equal to the frequency of inside-injecting by current inside-injectors in Aberdeen and Lowmoss Prisons in 1996, namely six times in 4 weeks. We assumed that some scheduling of heroin-use prior to weekends takes place, so that only 50% of current inside-users of opiates would test positive for opiates in rMDT: these assumptions allow us to arrive at WASH-based expectations for the total percentage of prisoners testing positive for opiates in rMDT. For England and Wales, a multiplier of 118/68 was applied which was derived from prisoners' interviews, to convert the results from ever inside-injectors, as determined by WASH studies, to the percentage of current inside users of opiates. We made the same assumptions on frequency of inside-use of opiates as in dealing with the Scottish results. We expected 202.7 opiate positive results in April to September 1997 in rMDTs at six adult prisons in Scotland, 226 were observed. We expected 227.0 at a set of 13 adult prisons and one other in England and Wales; 211 were observed. Further testing of the methodology for prisons in England and Wales will be possible when 1997 WASH data are released. So far, the methodology has performed well

  20. Assessment of the stability of DNA in specimens collected under conditions for drug testing-A pilot study.

    Science.gov (United States)

    White, Robert M; Mitchell, John M; Hart, E Dale; Evans, Amy; Meaders, Meredith; Norsworthy, Sarah E; Hayes, Eugene D; Flegel, Ron; Maha, George C; Shaffer, Megan D; Hall, Erin M; Rogers, Kelley

    2018-02-01

    For forensic biological sample collections, the specimen donor is linked solidly to his or her specimen through a chain of custody (CoC) sometimes referenced as a chain of evidence. Rarely, a donor may deny that a urine or oral fluid (OF) specimen is his or her specimen even with a patent CoC. The goal of this pilot study was to determine the potential effects of short-term storage on the quality and quantity of DNA in both types of specimen under conditions that may be encountered with employment-related drug testing specimens. Fresh urine and freshly collected oral fluid all produced complete STR profiles. For the "pad" type OF collectors, acceptable DNA was extractable both from the buffer/preservative and the pad. Although fresh urine and OF produced complete STR profiles, partial profiles were obtained after storage for most samples. An exception was the DNA in the Quantisal OF collector, from which a complete profile was obtained for both freshly collected OF and stored OF. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. Influence of different test parameters on in vitro drug release from topical diclofenac formulations in a vertical diffusion cell setup.

    Science.gov (United States)

    Klein, S

    2013-07-01

    In the past decades, the vertical diffusion cell has emerged as a useful device for testing drug release of topical dosage forms. However, to date neither a general USP method nor formulation-related monographs have been published in international pharmacopoeia. The purpose of the present work was to examine the influence of different test parameters in a vertical diffusion cell setup on in vitro drug release from semi-solid preparations for cutaneous application. Diclofenac was selected as the model compound. Release experiments were performed in a 7 ml Microett vertical diffusion cell system. Various test parameters, including the media composition and pH, degassing, membrane material and pore size, stirring speed and stirrer type, were varied. Results obtained with different test parameter settings clearly indicate that both drug properties and instrumental details can have a huge impact on the outcome of in vitro diffusion/drug release studies with the vertical diffusion cell. Thus, the selection of adequate test parameters is crucial for the success of the release experiments and, as shown in the present study, optimal test parameters/conditions need to be established and validated on a case by case study.

  2. FDA-approved drugs that are spermatotoxic in animals and the utility of animal testing for human risk prediction.

    Science.gov (United States)

    Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo

    2018-02-01

    This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.

  3. Political Ideology and Precautionary Reasoning: Testing the Palliative Function of Right-Wing Ideology on Obsessive-Compulsive Symptoms

    DEFF Research Database (Denmark)

    Osmundsen, Mathias; Petersen, Michael Bang

    2017-01-01

    Precautionary models of political ideology suggest that people on the right are motivated by needs to neutralize threats in everyday life more than those on the left. This article examines whether this ideological difference extends to a psychological scale that directly captures the need to engage...... of threat in everyday life? Using a communication experiment, we find that exposure to real-world policy assurances from the Republican Party (i.e., the US conservative party) provides a small, most likely short-lived reduction in obsessive-compulsive symptoms among Americans. We discuss how these findings...... shed light on the key paradox about the psychology of right-wing ideology: how right-wing ideology can function to reduce insecurity while people on the right still have higher levels of insecurity....

  4. Drug testing with alternative matrices II. Mechanisms of cocaine and codeine deposition in hair.

    Science.gov (United States)

    Joseph, R E; Höld, K M; Wilkins, D G; Rollins, D E; Cone, E J

    1999-10-01

    A 10-week inpatient study was performed to evaluate cocaine, codeine, and metabolite disposition in biological matrices collected from volunteers. An initial report described drug disposition in plasma, sebum, and stratum corneum collected from five African-American males. This report focuses on drug disposition in hair and sweat collected from the same five subjects. Following a three-week washout period, three doses of cocaine HCl (75 mg/70 kg, subcutaneous) and three doses of codeine SO4 (60 mg/70 kg, oral) were administered on alternating days in week 4 (low-dose week). The same dosing sequence was repeated in week 8 with doubled doses (high-dose week). Hair was collected by shaving the entire scalp once each week. Hair from the anterior vertex was divided into two portions. One portion was washed with isopropanol and phosphate buffer; the other portion was not washed. Hair was enzymatically digested, samples were centrifuged, and the supernatant was collected. Sweat was collected periodically by placing PharmChek sweat patches on the torso. Drugs were extracted from sweat patches with methanol/0.2 M sodium acetate buffer (75:25, v/v). Supernatants from hair digests, hair washes, and sweat patch extracts were processed by solid-phase extraction followed by gas chromatography-mass spectrometry analysis for cocaine, codeine, 6-acetylmorphine, and metabolites. Cocaine and codeine were the primary analytes identified in sweat patches and hair. Drugs were detected in sweat within 8 h after dosing, and drug secretion primarily occurred within 24 h after dosing. No clear relationship was observed between dose and drug concentrations in sweat. Drug incorporation into hair appeared to be dose-dependent. Drugs were detected in hair within 1-3 days after the last drug administration; peak drug concentrations generally occurred in the following 1-2 weeks; thereafter, drug concentrations decreased. Solvent washes removed 50-55% of cocaine and codeine from hair collected 1

  5. Trafficking of drug candidates relevant for sports drug testing: detection of non-approved therapeutics categorized as anabolic and gene doping agents in products distributed via the Internet.

    Science.gov (United States)

    Thevis, Mario; Geyer, Hans; Thomas, Andreas; Schänzer, Wilhelm

    2011-05-01

    Identifying the use of non-approved drugs by cheating athletes has been a great challenge for doping control laboratories. This is due to the additional complexities associated with identifying relatively unknown and uncharacterized compounds and their metabolites as opposed to known and well-studied therapeutics. In 2010, the prohibited drug candidates and gene doping substances AICAR and GW1516, together with the selective androgen receptor modulator (SARM) MK-2866 were obtained by the Cologne Doping Control Laboratory from Internet suppliers and their structure, quantity, and formulation elucidated. All three compounds proved authentic as determined by liquid chromatography-high resolution/high accuracy (tandem) mass spectrometry and comparison to reference material. While AICAR was provided as a colourless powder in 100 mg aliquots, GW1516 was obtained as an orange/yellow suspension in water/glycerol (150 mg/ml), and MK-2866 (25 mg/ml) was shipped dissolved in polyethylene glycol (PEG) 300. In all cases, the quantified amounts were considerably lower than indicated on the label. The substances were delivered via courier, with packaging identifying them as containing 'amino acids' and 'green tea extract', arguably to circumvent customs control. Although all of the substances were declared 'for research only', their potential misuse in illicit performance-enhancement cannot be excluded; moreover sports drug testing authorities should be aware of the facile availability of black market copies of these drug candidates. Copyright © 2011 John Wiley & Sons, Ltd.

  6. Cytotoxic drug sensitivity testing of tumor cells from patients with ovarian carcinoma using the fluorometric microculture cytotoxicity assay (FMCA).

    Science.gov (United States)

    Csoka, K; Larsson, R; Tholander, B; Gerdin, E; de la Torre, M; Nygren, P

    1994-08-01

    The automated fluorometric microculture cytotoxicity assay (FMCA) is based on the measurement of fluorescence generated from cellular hydrolysis of fluorescein diacetate (FDA) to fluorescein by viable cells after a 72-hr culture period in microtiter plates. The FMCA was adopted for chemosensitivity testing of tumor cells from patients with ovarian carcinoma. Thirty-seven samples of solid tumors and malignant effusions were obtained from 35 patients at diagnosis or relapse. Tumor cells from solid samples and effusions were prepared by enzymatic digestion and centrifugation, respectively, followed by Percoll or Ficoll purification. The fluorescence was proportional to the number of cells/well and considerably higher in tumor cells than in contaminating normal cells. The effect of up to 19 cytotoxic drugs was successfully assessed in 70% of the samples and there was a good correlation between drug sensitivity data reported by the FMCA and the DiSC assay performed in parallel. The overall drug sensitivity pattern in vitro corresponded well to the clinical experience. The effect of cisplatin varied considerably between patients and resistance was found also in cases not previously exposed to cytotoxic drugs. The FMCA is a rapid and simple method that seems to report clinically relevant cytotoxic drug sensitivity data in ovarian carcinomas. In the future, this method may contribute to optimizing chemotherapy by assisting in individualized drug selection and new drug development.

  7. In vitro and in vivo models for testing arrhythmogenesis in drugs.

    Science.gov (United States)

    Carlsson, L

    2006-01-01

    The steadily increasing list of drugs associated with prolongation of the QT interval and torsades de pointes (TdP) constitute a medical problem of major concern. Hence, there is a need at an early stage to identify drug candidates with an inherent capacity to induce repolarization-related proarrhythmias, avoiding exposure of large populations to potentially harmful drugs. Furthermore, the availability of clinically relevant and predictive animal models should reduce the risk that effective and potentially life-saving drugs never reach the market. This review will discuss the pros and cons of some in vivo and in vitro animal models for assessing proarrhythmia liability.

  8. Drug-mediated toxicity: illuminating the 'bad' in the test tube by means of cellular assays?

    Science.gov (United States)

    Tralau, Tewes; Luch, Andreas

    2012-07-01

    Health problems are rising worldwide, be it as a consequence of lifestyle and longevity in increasingly affluent societies or due to a sharp rise in bacterial antibiotic resistance. The pharmaceutical industry is caught between high rates of attrition and the rather slow pace of a historically large regulatory system for pharmacological safety. Meanwhile, the past decade has seen a tremendous evolution of the biological toolbox, most notably of cellular assays, stem-cell differentiation and organ-mimicking systems. These systems were readily adapted for lead-compound identification. However, their use as toxicological test systems is lagging behind, not least because of a lack of regulatory acceptance. This review tries to elucidate the scale of the problem and discusses the applicability of the assays currently available, with particular regard to the use of stem cells. Copyright © 2012 Elsevier Ltd. All rights reserved.

  9. Assessment of Substances Abuse in Burn Patients by Using Drug Abuse Screening Test

    Directory of Open Access Journals (Sweden)

    Kobra Gaseminegad

    2012-04-01

    Full Text Available There has been an increase in the frequency of substance abuse among hospitalized burn injury patients. However, few studies have investigated substance abuse among burn patients. This study was aimed to identify the incidence of substance abuse in burn injury patients using the "Drug Abuse Screening Test" (DAST-20. We determined the validity of DAST-20 in spring 2010. Subsequently, this descriptive study was performed on 203 burn injury patients who fit the study's inclusion criteria. We chose a score of 6 as the cutoff and thus achieved a sensitivity of 89% and a specificity of 85% for the DAST-20. During the study, we gathered demographic data, burn features and DAST-20 results for all patients. Patients with scores of 6 or more were considered to be substances abusers. A statistical analysis was conducted using SPSS v16 software. According to the DAST-20 results, 33% of the patients were in the user group. The mean score of DAST-20 was significantly higher among users than it was among nonusers (P<0.05. The level of substance abuse was severe in 77% of users. No significant differences were found among the substances, with the exception of alcohol. Substance abuse is an important risk factor for burn patients. In addition, this study showed that DAST-20 is a valid screening measure for studies on burn patients.

  10. A Low Cost/Low Power Open Source Sensor System for Automated Tuberculosis Drug Susceptibility Testing

    Directory of Open Access Journals (Sweden)

    Kyukwang Kim

    2016-06-01

    Full Text Available In this research an open source, low power sensor node was developed to check the growth of mycobacteria in a culture bottle with a nitrate reductase assay method for a drug susceptibility test. The sensor system reports the temperature and color sensor output frequency change of the culture bottle when the device is triggered. After the culture process is finished, a nitrite ion detecting solution based on a commercial nitrite ion detection kit is injected into the culture bottle by a syringe pump to check bacterial growth by the formation of a pigment by the reaction between the solution and the color sensor. Sensor status and NRA results are broadcasted via a Bluetooth low energy beacon. An Android application was developed to collect the broadcasted data, classify the status of cultured samples from multiple devices, and visualize the data for the end users, circumventing the need to examine each culture bottle manually during a long culture period. The authors expect that usage of the developed sensor will decrease the cost and required labor for handling large amounts of patient samples in local health centers in developing countries. All 3D-printerable hardware parts, a circuit diagram, and software are available online.

  11. Deformable microparticles with multiple functions for drug delivery and device testing

    Science.gov (United States)

    Thula, Taili T.

    Since the HIV epidemic of the 1990s, researchers have attempted to develop a red blood cell analog. Even though some of these substitutes are now in Phase III of clinical trials, their use is limited by side effects and short half-life in the human body. As a result, there is still a need for an effective erythrocyte analog with minimum immunogenic and side effects, so that it can be used for multiple applications. Finding new approaches to develop more efficient blood substitutes will not only bring valuable advances in the clinical approach, but also in the area of in vitro testing of medical devices. We examined the feasibility of creating a deformable multi-functional, biodegradable, biocompatible particle for applications in drug delivery and device testing. As a preliminary evaluation, we synthesized different types of microcapsules using natural and synthetic polymers, various cross-linking agents, and diverse manufacturing techniques. After fully characterizing of each system, we determined the most promising red blood cell analog in terms of deformability, stability and toxicity. We also examined the encapsulation and release of bovine serum albumin (BSA) within these deformable particles. After removal of cross-linkers, zinc- and copper-alginate microparticles surrounded by multiple polyelectrolyte layers of chitosan oligosaccharide and alginate were deformable and remained stable under physiological pressures applied by the micropipette technique. In addition, multiple coatings decreased toxicity of heavy-metal crosslinked particles. BSA encapsulation and release from chitosan-alginate microspheres were contingent on the crosslinker and number of polyelectrolyte coatings, respectively. Further rheological studies are needed to determine how closely these particles simulate the behavior of erythrocytes. Also, studies on the encapsulation and release of different proteins, including hemoglobin, are needed to establish the desired controlled release of

  12. Political Ideology and Precautionary Reasoning: Testing the Palliative Function of Right-Wing Ideology on Obsessive-Compulsive Symptoms

    DEFF Research Database (Denmark)

    Osmundsen, Mathias; Petersen, Michael Bang

    2017-01-01

    Precautionary models of political ideology suggest that people on the right are motivated by needs to neutralize threats in everyday life more than those on the left. This article examines whether this ideological difference extends to a psychological scale that directly captures the need to engage...... in everyday precautionary actions to reduce feelings of threat: a scale of obsessive-compulsive symptoms. Across four samples (including a nationally representative sample), we find that stronger obsessive-compulsive symptoms are associated with more right-wing ideological preferences, particularly for social...... rather than economic issues. Most importantly, we use the scale of obsessive-compulsive symptoms to examine a crucial feature of the precautionary model of political ideology that has been left underexplored: does the promotion of right-wing policies serve a palliative function to reduce feelings...

  13. Development of postcompressional textural tests to evaluate the mechanical properties of medicated chewing gum tablets with high drug loadings.

    Science.gov (United States)

    Al Hagbani, Turki; Nazzal, Sami

    2018-02-01

    Medicated chewing gum tablets (CGTs) represent a unique platform for drug delivery. Loading directly compressible gums with high concentrations of powdered medication, however, results in compacts with hybrid properties between a chewable gum and a brittle tablet. The aim of the present study was to develop textural tests that can identify the point at which CGTs begin to behave like a solid tablet upon drug incorporation. Curcumin (CUR) CGTs made with Health in gum were prepared with increasing CUR load from 0 to 100% and were characterized for their mechanical properties by a single-bite (knife) and a two-bite tests. From each test several parameters were extracted and correlated with drug loading. In the single-bite test, the change in the resistance of the compacts to plastic deformation was found to give a definitive guide on whether they behave as gums or tablets. A more in depth analysis of the impact of CUR loading on the chewability of the CGTs was provided by the two-bite test where CUR loading was found to have a nonlinear impact on the mechanical properties of compacts. An upper limit of 10% was found to yield compacts with gum-like properties, which were abolished at higher CUR loads. The textural test procedure outlined in this study are expected to assist those involved in the formulation of medicated gums for pharmaceutical applications in making an informed decision on the impact of drug loading on gum behavior before proceeding with clinical testing. There is a growing interest in utilizing medicated chewing gums for drug delivery, especially those made using directly compressible gum bases, such as Health in gum. Directly compressing a gum base with high amounts of solid drug powder, however, poses a challenge as it may result in compressed compacts with hybrid properties between a chewing gum and a hard tablet. Currently, official Pharmacopeias do not specify a testing procedure for the estimation of the mechanical and textural properties of

  14. Implementation of the national tuberculosis guidelines on culture and drug sensitivity testing in Guatemala, 2013.

    Science.gov (United States)

    Samayoa-Peláez, Maritza; Ayala, Nancy; Yadon, Zaida E; Heldal, Einar

    2016-01-01

    Objective To assess whether the National Tuberculosis Program (NTP) guidelines for culture and drug sensitivity testing (DST) in Guatemala were successfully implemented, particularly in cases of smear-negative pulmonary tuberculosis (TB) or previously treated TB, by documenting notification rates by department (geographic area), disease type and category, and culture and DST results. Methods This was a cross-sectional, operational research study that merged and linked all patients registered by the NTP and the National Reference Laboratory in 2013, eliminating duplicates. The proportions with culture (for new smear negative pulmonary cases) and culture combined with DST (for previously treated patients) were estimated and analyzed by department. Data were analyzed using EpiData Analysis version 2.2. Results There were 3 074 patients registered with TB (all forms), for a case notification rate of 20/100 000 population. Of these, 2 842 had new TB, of which 2 167 (76%) were smear-positive pulmonary TB (PTB), 385 (14%) were smear-negative PTB, and 290 (10%) were extrapulmonary TB. There were 232 (8%) previously treated cases. Case notification rates (all forms) varied by department from 2-68 per 100 000 population, with the highest rates seen in the southwest and northeast part of Guatemala. Of new TB patients, 136 had a culture performed and 55 had DST of which the results were 33 fully sensitive, 9 monoresistant, 3 polyresistant, and 10 multidrug resistant TB (MDR-TB). Only 21 (5%) of new smear-negative PTB patients had cultures. Of 232 previously treated patients, 54 (23%) had a culture and 47 (20%) had DST, of which 29 were fully sensitive, 7 monoresistant, 2 polyresistant, and 9 MDR-TB. Of 22 departments (including the capital), culture and DST was performed in new smear-negative PTB in 7 departments (32%) and in previously treated TB in 13 departments (59%). Conclusions Despite national guidelines, only 5% of smear-negative PTB cases had a culture and only 20% of

  15. Implementation of the national tuberculosis guidelines on culture and drug sensitivity testing in Guatemala, 2013

    Directory of Open Access Journals (Sweden)

    Maritza Samayoa-Peláez

    Full Text Available ABSTRACT Objective To assess whether the National Tuberculosis Program (NTP guidelines for culture and drug sensitivity testing (DST in Guatemala were successfully implemented, particularly in cases of smear-negative pulmonary tuberculosis (TB or previously treated TB, by documenting notification rates by department (geographic area, disease type and category, and culture and DST results. Methods This was a cross-sectional, operational research study that merged and linked all patients registered by the NTP and the National Reference Laboratory in 2013, eliminating duplicates. The proportions with culture (for new smear negative pulmonary cases and culture combined with DST (for previously treated patients were estimated and analyzed by department. Data were analyzed using EpiData Analysis version 2.2. Results There were 3 074 patients registered with TB (all forms, for a case notification rate of 20/100 000 population. Of these, 2 842 had new TB, of which 2 167 (76% were smear-positive pulmonary TB (PTB, 385 (14% were smear-negative PTB, and 290 (10% were extrapulmonary TB. There were 232 (8% previously treated cases. Case notification rates (all forms varied by department from 2–68 per 100 000 population, with the highest rates seen in the southwest and northeast part of Guatemala. Of new TB patients, 136 had a culture performed and 55 had DST of which the results were 33 fully sensitive, 9 monoresistant, 3 polyresistant, and 10 multidrug resistant TB (MDR-TB. Only 21 (5% of new smear-negative PTB patients had cultures. Of 232 previously treated patients, 54 (23% had a culture and 47 (20% had DST, of which 29 were fully sensitive, 7 monoresistant, 2 polyresistant, and 9 MDR-TB. Of 22 departments (including the capital, culture and DST was performed in new smear-negative PTB in 7 departments (32% and in previously treated TB in 13 departments (59%. Conclusions Despite national guidelines, only 5% of smear-negative PTB cases had a culture and

  16. Validation of the cephalosporin intradermal skin test for predicting immediate hypersensitivity: a prospective study with drug challenge.

    Science.gov (United States)

    Yoon, S-Y; Park, S Y; Kim, S; Lee, T; Lee, Y S; Kwon, H-S; Cho, Y S; Moon, H-B; Kim, T-B

    2013-07-01

    Cephalosporin is a major offending agent in terms of drug hypersensitivity along with penicillin. Cephalosporin intradermal skin tests (IDTs) have been widely used; however, their validity for predicting immediate hypersensitivity has not been studied. This study aimed to determine the predictive value of cephalosporin intradermal skin testing before administration of the drug. We prospectively conducted IDTs with four cephalosporins, one each of selected first-, second-, third-, or fourth-generation cephalosporins: ceftezol; cefotetan or cefamandole; ceftriaxone or cefotaxime; and flomoxef, respectively, as well as with penicillin G. After the skin test, whatever the result, one of the tested cephalosporins was administered intravenously and the patient was carefully observed. We recruited 1421 patients who required preoperative cephalosporins. Seventy-four patients (74/1421, 5.2%) were positive to at least one cephalosporin. However, none of responders had immediate hypersensitivity reactions after a challenge dose of the same or different cephalosporin, which were positive in the skin test. Four patients who suffered generalized urticaria and itching after challenge gave negative skin tests for the corresponding drug. The IDT for cephalosporin had a sensitivity of 0%, a specificity of 97.5%, a negative predictive value of 99.7%, and a positive predictive value (PPV) of 0%, when challenged with the same drugs that were positive in the skin test. Routine skin testing with a cephalosporin before its administration is not useful for predicting immediate hypersensitivity because of the extremely low sensitivity and PPV of the skin test (CRIS registration no. KCT0000455). © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  17. The rod orientation test in patients with right-hemisphere infarction : a clinical study of spatial perception in 154 subjects

    NARCIS (Netherlands)

    J.D. Meerwaldt (Johannes David (Jan))

    1982-01-01

    textabstractThis thesis describes a clinical study of disturbances of spatial perception. Chapter I gives a short review of hemispheric asymmetry. For a long time the right hemisphere was regarded as the minor hemisphere, of which substantial regions were thought to have no specific function.

  18. Testing the Language of German Cerebral Palsy Patients with Right Hemispheric Language Organization after Early Left Hemispheric Damage

    Science.gov (United States)

    Schwilling, Eleonore; Krageloh-Mann, Ingeborg; Konietzko, Andreas; Winkler, Susanne; Lidzba, Karen

    2012-01-01

    Language functions are generally represented in the left cerebral hemisphere. After early (prenatally acquired or perinatally acquired) left hemispheric brain damage language functions may be salvaged by reorganization into the right hemisphere. This is different from brain lesions acquired in adulthood which normally lead to aphasia. Right…

  19. Correlates of Illicit Drug Use Among Indigenous Peoples in Canada: A Test of Social Support Theory.

    Science.gov (United States)

    Cao, Liqun; Burton, Velmer S; Liu, Liu

    2018-02-01

    Relying on a national stratified random sample of Indigenous peoples aged 19 years old and above in Canada, this study investigates the correlates of illicit drug use among Indigenous peoples, paying special attention to the association between social support measures and illegal drug use. Results from multivariate logistical regression show that measures of social support, such as residential mobility, strength of ties within communities, and lack of timely counseling, are statistically significant correlates of illicit drug use. Those identifying as Christian are significantly less likely to use illegal drugs. This is the first nationwide analysis of the illicit drug usage of Indigenous peoples in Canada. The results are robust because we have controlled for a range of comorbidity variables as well as a series of sociodemographic variables. Policy implications from these findings are discussed.

  20. 3D pancreatic carcinoma spheroids induce a matrix-rich, chemoresistant phenotype offering a better model for drug testing

    International Nuclear Information System (INIS)

    Longati, Paola; Heuchel, Rainer L; Jia, Xiaohui; Eimer, Johannes; Wagman, Annika; Witt, Michael-Robin; Rehnmark, Stefan; Verbeke, Caroline; Toftgård, Rune; Löhr, Matthias

    2013-01-01

    Pancreatic ductal adenocarcinoma (PDAC) is the fourth most common cause of cancer related death. It is lethal in nearly all patients, due to an almost complete chemoresistance. Most if not all drugs that pass preclinical tests successfully, fail miserably in the patient. This raises the question whether traditional 2D cell culture is the correct tool for drug screening. The objective of this study is to develop a simple, high-throughput 3D model of human PDAC cell lines, and to explore mechanisms underlying the transition from 2D to 3D that might be responsible for chemoresistance. Several established human PDAC and a KPC mouse cell lines were tested, whereby Panc-1 was studied in more detail. 3D spheroid formation was facilitated with methylcellulose. Spheroids were studied morphologically, electron microscopically and by qRT-PCR for selected matrix genes, related factors and miRNA. Metabolic studies were performed, and a panel of novel drugs was tested against gemcitabine. Comparing 3D to 2D cell culture, matrix proteins were significantly increased as were lumican, SNED1, DARP32, and miR-146a. Cell metabolism in 3D was shifted towards glycolysis. All drugs tested were less effective in 3D, except for allicin, MT100 and AX, which demonstrated effect. We developed a high-throughput 3D cell culture drug screening system for pancreatic cancer, which displays a strongly increased chemoresistance. Features associated to the 3D cell model are increased expression of matrix proteins and miRNA as well as stromal markers such as PPP1R1B and SNED1. This is supporting the concept of cell adhesion mediated drug resistance

  1. [Autopsy and blood testing for alcohol and drugs/medicine after traffic fatalities is not routinely conducted].

    Science.gov (United States)

    Uhrenholt, Lars; Schumacher, Bente; Freeman, Michael

    2010-09-27

    In some road traffic crashes with fatal outcome, the police investigations lead to charges against and prosecution of a person. The police can request a medico-legal autopsy as well as a toxicological examination, but the extent to which this is done, and the role here of in the legal setting is unknown. Information concerning traffic crashes with fatal outcome in the period 2000-2004 in Aarhus Police District was retrieved and compared. The information included comprised crash specific and legal information, as well as medical data concerning autopsy, examination for alcohol, drugs and/or medicine. In all, 81 traffic crashes had a fatal outcome for 92 persons, of whom 17 (18%) were autopsied, 55 (60%) were tested for alcohol, and five (5%) were examined for drugs/medicine. Twenty-six were charged with negligent homicide, of which 18 were convicted. Autopsy was performed in four of these cases, 19 were tested for alcohol and one was tested for drugs/medicine. This study shows that the police requests few medico-legal autopsies following road traffic fatalities, and that testing for alcohol as well as drugs/medicine is not conducted routinely. As a consequence, important information may not come to the knowledge of the police in cases of negligent homicide. We recommend that postmortem examination be conducted routinely in traffic-related homicide cases to secure the best possible conditions for a legal evaluation.

  2. Student Drug Testing and the Surveillance School Economy: An Analysis of Media Representation and Policy Transfer in Australian Schools

    Science.gov (United States)

    Taylor, Emmeline

    2018-01-01

    Anxieties relating to the health, safety and security of schoolchildren have been met with a variety of surveillance apparatus in schools internationally. Drawing on findings from a content analysis of newspaper reports relating to drug testing in Australian schools, this article seeks to excavate the ways in which the media shapes, informs,…

  3. Política de medicamentos: da universalidade de direitos aos limites da operacionalidade Drugs policy: from the universality of rights to the limits of operation

    Directory of Open Access Journals (Sweden)

    Patrícia Aparecida Baumgratz de Paula

    2009-01-01

    Full Text Available O presente artigo discute os motivos que levaram à adoção de uma política de medicamentos no Brasil. Para tanto busca, através de uma revisão bibliográfica, fazer um resgate histórico dos múltiplos fatores que interferiram na construção dessa política. Além de traçar a trajetória deste processo, o artigo procura assinalar algumas de suas características no Brasil contemporâneo. Enfatiza-se, aqui, a política de saúde como uma política universalista e igualitária, reclamando a responsabilidade do Estado na efetivação do direito à saúde preconizado na Constituição de 1988. Nesse contexto, apontam-se as razões para que a política de medicamentos seja parte integrante da política de saúde, com o objetivo de se obter um acesso mais próximo do integral, entendendo que o campo da saúde é também um espaço onde a cidadania deva ser buscada de modo pleno.This article discusses the reasons that led to the adoption of a drug policy in Brazil. For this, through a literature review, it aims to make a historic rescue of multiple factors that interfered in the construction of this policy. Besides showing the trajectory of this process, it aims to identify its characteristics in the contemporary Brazil. The article also emphasizes the health policy as universal and egalitarian, claiming the responsibility of the State in order to accomplish the right to health advocated in the 1988 Constitution. In this context, this paper outlines the reasons why the policy of medicines is an integral part of health policy, aiming to get a more full access for the whole population. Therefore, it is intended to assist the understanding that health care is also an area where citizenship should be sought fully.

  4. Testing Left-Right extensions of the standard model of electroweak interactions with double-beta decay and LHC measurements

    Science.gov (United States)

    Civitarese, O.; Suhonen, J.; Zuber, K.

    2015-07-01

    The minimal extension of the standard model of electroweak interactions allows for massive neutrinos, a massive right-handed boson WR, and a left-right mixing angle ζ. While an estimate of the light (electron) neutrino can be extracted from the non-observation of the neutrinoless double beta decay, the limits on the mixing angle and the mass of the righthanded (RH) boson may be extracted from a combined analysis of the double beta decay measurements (GERDA, EXO-200 and KamLAND-Zen collaborations) and ATLAS data on the two-jets two-leptons signals following the excitation of a virtual RH boson mediated by a heavy-mass neutrino. In this work we shall compare results of both types of experiments, and show that the estimates are not in tension.

  5. Compensation or inhibitory failure? Testing hypotheses of age-related right frontal lobe involvement in verbal memory ability using structural and diffusion MRI.

    Science.gov (United States)

    Cox, Simon R; Bastin, Mark E; Ferguson, Karen J; Allerhand, Mike; Royle, Natalie A; Maniega, Susanna Muñoz; Starr, John M; MacLullich, Alasdair M J; Wardlaw, Joanna M; Deary, Ian J; MacPherson, Sarah E

    2015-02-01

    Functional neuroimaging studies report increased right prefrontal cortex (PFC) involvement during verbal memory tasks amongst low-scoring older individuals, compared to younger controls and their higher-scoring contemporaries. Some propose that this reflects inefficient use of neural resources through failure of the left PFC to inhibit non-task-related right PFC activity, via the anterior corpus callosum (CC). For others, it indicates partial compensation - that is, the right PFC cannot completely supplement the failing neural network, but contributes positively to performance. We propose that combining structural and diffusion brain MRI can be used to test predictions from these theories which have arisen from fMRI studies. We test these hypotheses in immediate and delayed verbal memory ability amongst 90 healthy older adults of mean age 73 years. Right hippocampus and left dorsolateral prefrontal cortex (DLPFC) volumes, and fractional anisotropy (FA) in the splenium made unique contributions to verbal memory ability in the whole group. There was no significant effect of anterior callosal white matter integrity on performance. Rather, segmented linear regression indicated that right DLPFC volume was a significantly stronger positive predictor of verbal memory for lower-scorers than higher-scorers, supporting a compensatory explanation for the differential involvement of the right frontal lobe in verbal memory tasks in older age. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

  6. Drugs as instruments: Describing and testing a behavioral approach to the study of neuroenhancement

    Directory of Open Access Journals (Sweden)

    Ralf Brand

    2016-08-01

    Full Text Available Neuroenhancement (NE is the non-medical use of psychoactive substances to produce a subjective enhancement in psychological functioning and experience. So far empirical investigations of individuals’ motivation for NE however have been hampered by the lack of theoretical foundation. This study aimed to apply drug instrumentalization theory to user motivation for NE. We argue that NE should be defined and analyzed from a behavioral perspective rather than in terms of the characteristics of substances used for NE. In the empirical study we explored user behavior by analyzing relationships between drug options (use over-the-counter products, prescription drugs, illicit drugs and postulated drug instrumentalization goals (e.g. improved cognitive performance, counteracting fatigue, improved social interaction. Questionnaire data from 1,438 university students were subjected to exploratory and confirmatory factor analysis to address the question of whether analysis of drug instrumentalization should be based on the assumption that users are aiming to achieve a certain goal and choose their drug accordingly or whether NE behavior is more strongly rooted in a decision to try or use a certain drug option. We used factor mixture modeling to explore whether users could be separated into qualitatively different groups defined by a shared ‘goal × drug option’ configuration. Our results indicate, first, that individuals’ decisions about NE are eventually based on personal attitude to drug options (e.g. willingness to use an over-the-counter product but not to abuse prescription drugs rather than motivated by desire to achieve a specific goal (e.g. fighting tiredness for which different drug options might be tried. Second, data analyses suggested two qualitatively different classes of users. Both predominantly used over-the-counter products, but ‘neuroenhancers’ might be characterized by a higher propensity to instrumentalize over

  7. Maternal hair testing for the assessment of fetal exposure to drug of abuse during early pregnancy: Comparison with testing in placental and fetal remains.

    Science.gov (United States)

    Falcon, M; Pichini, S; Joya, J; Pujadas, M; Sanchez, A; Vall, O; García Algar, O; Luna, A; de la Torre, R; Rotolo, M C; Pellegrini, M

    2012-05-10

    Drug use by pregnant women in the first trimester of pregnancy and subsequent fetal exposure during early gestation can be assessed only by repetitive/systematic maternal blood/urine analysis or segmental hair analysis. No evidence of any relationship between maternal/fetal exposure during this specific period of gestation has been demonstrated to date in a human model. To clarify drugs toxicokinetics and transplacental passage during early pregnancy, the presence of the most widely used recreational drugs of abuse and metabolites was investigated in the proximal 4cm hair segments of women undergoing voluntary termination of pregnancy (n=280) during the 12th week of gestation and the results were compared to those from placenta and fetal tissue samples in order to verify whether maternal hair testing can reflect fetal exposure and, if so, to what extent. Hair, placenta and fetal remains were analyzed by validated gas chromatography mass spectrometry assays. Eighty one positive hair samples were identified: 60 were positive for cannabis (74.1%), 28 for cocaine (34.6%), 7 for opiates (8.6%), 3 for MDMA (3.7%) and 18.5% were positive for more than one drug. The positive hair test results were confirmed in placenta/fetal tissues in 10 cases out of 60 for cannabis (16. 7%); in 7 out of 28 for cocaine (25%); and none for the 6 opiates positive cases and 3 MDMA cases, respectively. Drugs/metabolites in hair of pregnant women can be used as biomarkers of past drug use (repetitive or sporadic), although the use is not always reflected in fetal/placental tissues. There are several possible hypotheses to explain the results: (1) the use occurred before the start of pregnancy, (2) past sporadic consumption which could be measured in hair but not in fetal and placental remains because of the narrow window of drug detection in placental/fetal tissues; (3) the sensitivity of the analytical methods was not high enough for the detection of the minute amount of drugs of abuse and

  8. Hygrine and cuscohygrine as possible markers to distinguish coca chewing from cocaine abuse in workplace drug testing.

    Science.gov (United States)

    Rubio, C; Strano-Rossi, S; Tabernero, M J; Anzillotti, L; Chiarotti, M; Bermejo, A M

    2013-04-10

    Cocaine abuse is widespread all over the world, and is performed generally by sniffing, injecting or smoking cocaine or crack. The distinction between the recreational use of cocaine from the practice of the so called "coqueo" is still an issue in those countries where this habit is diffused and where it is not considered an addiction, by this reason is necessary to develop a method for to distinguish the coca chewers and cocaine abusers. The use of an unique marker to distinguish between cocaine abuse and chewing of coca leaves is of fundamental importance in those countries where this habit is diffused. Certain alkaloids of the leaves of Erythroxylum coca are lost during the process of extraction/purification of cocaine and it is not possible to find them neither in seizures of chlorhidrate of cocaine nor urine samples of cocaine abusers. These markers are the hygrine and cuscohygrine that are present in the leaves of E. coca. A fast GC/MS method involving a liquid:liquid extraction procedure with tertbutylmethylether (TBME) is proposed for the determination of some alkaloids in cocaine leaves, cocaine seizures and biological samples. All specimens were alkalinized to pH 9 with a carbonate/bicarbonate buffer and then extracted with TBME. The analysis was carry out by GC/MS with electron impact at 70 eV and in full scan mode. The results demonstrate that hygrine and cuscohygrine are not found neither in the urine of cocaine abusers nor in cocaine seizures. For this reason this compounds could be considered as markers of coca chewing. This developed method permits to distinguish coca chewing from cocaine abuse in workplace drug testing through the analysis of urine samples. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  9. Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing.

    Science.gov (United States)

    Altomare, Christopher; Kinzler, Eric R; Buchhalter, August R; Cone, Edward J; Costantino, Anthony

    The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.

  10. Cost-effectiveness of HIV drug resistance testing to inform switching to second line antiretroviral therapy in low income settings

    DEFF Research Database (Denmark)

    Phillips, Andrew; Cambiano, Valentina; Nakagawa, Fumiyo

    2014-01-01

    BACKGROUND: To guide future need for cheap resistance tests for use in low income settings, we assessed cost-effectiveness of drug resistance testing as part of monitoring of people on first line ART - with switching from first to second line ART being conditional on NNRTI drug resistance mutations...... being identified. METHODS: An individual level simulation model of HIV transmission, progression and the effect of ART which accounts for adherence and resistance development was used to compare outcomes of various potential monitoring strategies in a typical low income setting in sub-Saharan Africa....... Underlying monitoring strategies considered were based on clinical disease, CD4 count or viral load. Within each we considered a strategy in which no further measures are performed, one with a viral load measure to confirm failure, and one with both a viral load measure and a resistance test. Predicted...

  11. Compensation or inhibitory failure? Testing hypotheses of age-related right frontal lobe involvement in verbal memory ability using structural and diffusion MRI

    Science.gov (United States)

    Cox, Simon R.; Bastin, Mark E.; Ferguson, Karen J.; Allerhand, Mike; Royle, Natalie A.; Maniega, Susanna Muñoz; Starr, John M.; MacLullich, Alasdair M.J.; Wardlaw, Joanna M.; Deary, Ian J.; MacPherson, Sarah E.

    2015-01-01

    Functional neuroimaging studies report increased right prefrontal cortex (PFC) involvement during verbal memory tasks amongst low-scoring older individuals, compared to younger controls and their higher-scoring contemporaries. Some propose that this reflects inefficient use of neural resources through failure of the left PFC to inhibit non-task-related right PFC activity, via the anterior corpus callosum (CC). For others, it indicates partial compensation – that is, the right PFC cannot completely supplement the failing neural network, but contributes positively to performance. We propose that combining structural and diffusion brain MRI can be used to test predictions from these theories which have arisen from fMRI studies. We test these hypotheses in immediate and delayed verbal memory ability amongst 90 healthy older adults of mean age 73 years. Right hippocampus and left dorsolateral prefrontal cortex (DLPFC) volumes, and fractional anisotropy (FA) in the splenium made unique contributions to verbal memory ability in the whole group. There was no significant effect of anterior callosal white matter integrity on performance. Rather, segmented linear regression indicated that right DLPFC volume was a significantly stronger positive predictor of verbal memory for lower-scorers than higher-scorers, supporting a compensatory explanation for the differential involvement of the right frontal lobe in verbal memory tasks in older age. PMID:25241394

  12. Advantages of analyzing postmortem brain samples in routine forensic drug screening-Case series of three non-natural deaths tested positive for lysergic acid diethylamide (LSD).

    Science.gov (United States)

    Mardal, Marie; Johansen, Sys Stybe; Thomsen, Ragnar; Linnet, Kristian

    2017-09-01

    Three case reports are presented, including autopsy findings and toxicological screening results, which were tested positive for the potent hallucinogenic drug lysergic acid diethylamide (LSD). LSD and its main metabolites were quantified in brain tissue and femoral blood, and furthermore hematoma and urine when available. LSD, its main metabolite 2-oxo-3-hydroxy-LSD (oxo-HO-LSD), and iso-LSD were quantified in biological samples according to a previously published procedure involving liquid-liquid extraction and ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS). LSD was measured in the brain tissue of all presented cases at a concentration level from 0.34-10.8μg/kg. The concentration level in the target organ was higher than in peripheral blood. Additional psychoactive compounds were quantified in blood and brain tissue, though all below toxic concentration levels. The cause of death in case 1 was collision-induced brain injury, while it was drowning in case 2 and 3 and thus not drug intoxication. However, the toxicological findings could help explain the decedent's inability to cope with brain injury or drowning incidents. The presented findings could help establish reference concentrations in brain samples and assist in interpretation of results from forensic drug screening in brain tissue. This is to the author's knowledge the first report of LSD, iso-LSD, and oxo-HO-LSD measured in brain tissue samples. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. An analytical method for assessing stage-specific drug activity in Plasmodium vivax malaria: implications for ex vivo drug susceptibility testing.

    Directory of Open Access Journals (Sweden)

    Douglas H Kerlin

    Full Text Available The emergence of highly chloroquine (CQ resistant P. vivax in Southeast Asia has created an urgent need for an improved understanding of the mechanisms of drug resistance in these parasites, the development of robust tools for defining the spread of resistance, and the discovery of new antimalarial agents. The ex vivo Schizont Maturation Test (SMT, originally developed for the study of P. falciparum, has been modified for P. vivax. We retrospectively analysed the results from 760 parasite isolates assessed by the modified SMT to investigate the relationship between parasite growth dynamics and parasite susceptibility to antimalarial drugs. Previous observations of the stage-specific activity of CQ against P. vivax were confirmed, and shown to have profound consequences for interpretation of the assay. Using a nonlinear model we show increased duration of the assay and a higher proportion of ring stages in the initial blood sample were associated with decreased effective concentration (EC(50 values of CQ, and identify a threshold where these associations no longer hold. Thus, starting composition of parasites in the SMT and duration of the assay can have a profound effect on the calculated EC(50 for CQ. Our findings indicate that EC(50 values from assays with a duration less than 34 hours do not truly reflect the sensitivity of the parasite to CQ, nor an assay where the proportion of ring stage parasites at the start of the assay does not exceed 66%. Application of this threshold modelling approach suggests that similar issues may occur for susceptibility testing of amodiaquine and mefloquine. The statistical methodology which has been developed also provides a novel means of detecting stage-specific drug activity for new antimalarials.

  14. Non-operative management of right side thoracoabdominal penetrating injuries--the value of testing chest tube effluent for bile.

    Science.gov (United States)

    De Rezende Neto, João Baptista; Guimarães, Tiago Nunes; Madureira, João Lopo; Drumond, Domingos André Fernandes; Leal, Juliana Campos; Rocha, Aroldo; Oliveira, Rodrigo Guimarães; Rizoli, Sandro B

    2009-05-01

    While mandatory surgery for all thoracoabdominal penetrating injuries is advocated by some, the high rate of unnecessary operations challenges this approach. However, the consequences of intrathoracic bile remains poorly investigated. We sought to evaluate the outcome of patients who underwent non-operative management of right side thoracoabdominal (RST) penetrating trauma, and the levels of bilirubin obtained from those patients' chest tube effluent. We managed non-operatively all stable patients with a single RST penetrating injury. Chest tube effluent samples were obtained six times within (4-8 h; 12-16 h; 20-24 h; 28-32 h; 36-40 h; 48 h and 72 h) of admission for bilirubin measurement and blood for complete blood count, bilirubin, alanine (ALT) and aspartate aminotransferases (AST) assays. For comparison we studied patients with single left thoracic penetrating injury. Forty-two patients with RST injuries were included. All had liver and lung injuries confirmed by CT scans. Only one patient failed non-operative management. Chest tube bilirubin peaked at 48 h post-trauma (mean 3.3+/-4.1 mg/dL) and was always higher than both serum bilirubin (pchest tube effluent from control group (27 patients with left side thoracic trauma). Serum ALT and AST were higher in RST injury patients (ptrauma appears to be safe. Bile originating from the liver injury reaches the right thoracic cavity but does not reflect the severity of that injury. The highest concentration was found in the patient failing non-operative management. The presence of intrathoracic bile in selected patients who sustain RST penetrating trauma, with liver injury, does not preclude non-operative management. Our study suggests that monitoring chest tube effluent bilirubin may provide helpful information when managing a patient non-operatively.

  15. Second line drug susceptibility testing to inform the treatment of rifampin-resistant tuberculosis: a quantitative perspective

    Directory of Open Access Journals (Sweden)

    Emily A. Kendall

    2017-03-01

    Full Text Available Treatment failure and resistance amplification are common among patients with rifampin-resistant tuberculosis (TB. Drug susceptibility testing (DST for second-line drugs is recommended for these patients, but logistical difficulties have impeded widespread implementation of second-line DST in many settings. To provide a quantitative perspective on the decision to scale up second-line DST, we synthesize literature on the prevalence of second-line drug resistance, the expected clinical and epidemiologic benefits of using second-line DST to ensure that patients with rifampin-resistant TB receive effective regimens, and the costs of implementing (or not implementing second-line DST for all individuals diagnosed with rifampin-resistant TB. We conclude that, in most settings, second-line DST could substantially improve treatment outcomes for patients with rifampin-resistant TB, reduce transmission of drug-resistant TB, prevent amplification of drug resistance, and be affordable or even cost-saving. Given the large investment made in each patient treated for rifampin-resistant TB, these payoffs would come at relatively small incremental cost. These anticipated benefits likely justify addressing the real challenges faced in implementing second-line DST in most high-burden settings.

  16. The banning of sportsmen and women who fail drug tests is unjustifiable.

    Science.gov (United States)

    Shuster, S; Devine, J W

    2013-01-01

    The use of performance enhancing drugs among elite athletes has been in the headlines recently, particularly with Lance Armstrong's fall from grace and his admission about widespread doping. Many argue that the use of drugs confers an unfair advantage and is ultimately dangerous to the health of the athletes. Others, like Professor Shuster, argue that the use of drugs is no different from other techniques employed by athletes to boost their performance: swimmers shaving their body hair; skiers wearing sleek body armour; archers and shooters having laser eye surgery to improve their accuracy. Professor Shuster puts forward the provocative argument that since 'there is no acceptable proof (that) drugs improve competitive performance and their use is no different from accepted sports practice, banning them is wrong and immoral.' JW Devine argues the other side, that the use of performance enhancing drugs poses a 'significant risk to the health of athletes' and perhaps more importantly, 'threatens to undermine the very purpose of sport' by disrupting the 'balance of excellences'.

  17. Development in Assay Methods for in Vitro Antimalarial Drug Efficacy Testing: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Shweta Sinha

    2017-10-01

    Full Text Available The emergence and spread of drug resistance are the major challenges in malaria eradication mission. Besides various strategies laid down by World Health Organization, such as vector management, source reduction, early case detection, prompt treatment, and development of new diagnostics and vaccines, nevertheless the need for new and efficacious drugs against malaria has become a critical priority on the global malaria research agenda. At several screening stages, millions of compounds are screened (1,000–2,000,000 compounds per screening campaign, before pre-clinical trials to select optimum lead. Carrying out in vitro screening of antimalarials is very difficult as different assay methods are subject to numerous sources of variability across different laboratories around the globe. Despite this, in vitro screening is an essential part of antimalarial drug development as it enables to resource various confounding factors such as host immune response and drug–drug interaction. Therefore, in this article, we try to illustrate the basic necessity behind in vitro study and how new methods are developed and subsequently adopted for high-throughput antimalarial drug screening and its application in achieving the next level of in vitro screening based on the current approaches (such as stem cells.

  18. De-labelling self-reported penicillin allergy within the emergency department through the use of skin tests and oral drug provocation testing.

    Science.gov (United States)

    Marwood, Joseph; Aguirrebarrena, Gonzalo; Kerr, Stephen; Welch, Susan A; Rimmer, Janet

    2017-10-01

    Self-reported penicillin allergy is common among patients attending the ED, but is a poor predictor of true immunoglobulin E-mediated hypersensitivity to penicillin. We hypothesise that with a combination of skin testing and drug provocation testing, selected patients can be safely de-labelled of their allergy. This prospective study enrolled a sample of patients presenting to an urban academic ED between 2011 and 2016 with a self-reported allergy to penicillin. Standardised skin prick and intradermal testing with amoxicillin and both major and minor determinants of penicillin was performed in the department. If negative, testing was followed by a graded oral challenge of amoxicillin over 9 days. The primary end point was the allergy status of participants at the end of the study. A total of 100 patients (mean age 42; standard deviation 14 years; 54% women) completed the testing. Of these, 81% (95% confidence interval 71.9-88.2) showed no hypersensitivity to penicillin and were labelled non-allergic. The majority (16/19) of allergies were confirmed by skin testing, with three suspected allergies detected by the oral challenge. Women were more likely than men to have a true penicillin allergy, with odds ratio of 4.0 (95% confidence interval 1.23-13.2). There were no serious adverse events. Selected patients in the ED who self-report an allergy to penicillin can be safely tested there for penicillin allergy, using skin tests and oral drug provocation testing. This testing allows a significant de-labelling of penicillin allergy, with the majority of these patients able to tolerate penicillin without incident. © 2017 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  19. [Identification and drug susceptibility testing of Mycobacterium thermoresistibile and Mycobacterium elephantis isolated from a cow with mastitis].

    Science.gov (United States)

    Li, W B; Ji, L Y; Xu, D L; Liu, H C; Zhao, X Q; Wu, Y M; Wan, K L

    2018-05-10

    Objective: To understand the etiological characteristics and drug susceptibility of Mycobacterium thermoresistibile and Mycobacterium elephantis isolated from a cow with mastitis and provide evidence for the prevention and control of infectious mastitis in cows. Methods: The milk sample was collected from a cow with mastitis, which was pretreated with 4 % NaOH and inoculated with L-J medium for Mycobacterium isolation. The positive cultures were initially identified by acid-fast staining and multi-loci PCR, then Mycobacterium species was identified by the multiple loci sequence analysis (MLSA) with 16S rRNA , hsp65 , ITS and SodA genes. The drug sensitivity of the isolates to 27 antibiotics was tested by alamar blue assay. Results: Two anti-acid stain positive strains were isolated from the milk of a cow with mastitis, which were identified as non- tuberculosis mycobacterium by multi-loci PCR, and multi-loci nucleic acid sequence analysis indicated that one strain was Mycobacterium thermoresistibile and another one was Mycobacterium elephantis . The results of the drug susceptibility test showed that the two strains were resistant to most antibiotics, including rifampicin and isoniazid, but they were sensitive to amikacin, moxifloxacin, levofloxacin, ethambutol, streptomycin, tobramycin, ciprofloxacin and linezolid. Conclusions: Mycobacterium thermoresistibile and Mycobacterium elephantis were isolated in a cow with mastitis and the drug susceptibility spectrum of the pathogens were unique. The results of the study can be used as reference for the prevention and control the infection in cows.

  20. An introduction to drug testing: the expanding role of mass spectrometry.

    Science.gov (United States)

    Hammett-Stabler, Catherine; Cotten, Steven W

    2012-01-01

    Measurement of drugs and their metabolites in biological fluids is the foundation of both therapeutic drug monitoring (TDM) and toxicology. Though different in their application, each discipline depends upon accurate identification and quantification if the measurements are to be useful. Thousands of methods are described for drug analysis but until recently most have relied upon analytical tools, such as spectrophotometry and immunoassay, that suffer from lack of specificity and sensitivity. The introduction of methods based on mass spectrometry (MS), coupled to gas or liquid chromatography, has revolutionized these areas. The methods are proving to be robust, versatile, and economical. This chapter introduces the reader to the application of MS to TDM and toxicology, the steps that should be considered during implementation, and the processes that should be implemented to assure continued quality.

  1. Generation of Multicellular Tumor Spheroids with Microwell-Based Agarose Scaffolds for Drug Testing.

    Directory of Open Access Journals (Sweden)

    Xue Gong

    Full Text Available Three dimensional multicellular aggregate, also referred to as cell spheroid or microtissue, is an indispensable tool for in vitro evaluating antitumor activity and drug efficacy. Compared with classical cellular monolayer, multicellular tumor spheroid (MCTS offers a more rational platform to predict in vivo drug efficacy and toxicity. Nevertheless, traditional processing methods such as plastic dish culture with nonadhesive surfaces are regularly time-consuming, laborious and difficult to provide uniform-sized spheroids, thus causing poor reproducibility of experimental data and impeding high-throughput drug screening. In order to provide a robust and effective platform for in vitro drug evaluation, we present an agarose scaffold prepared with the template containing uniform-sized micro-wells in commercially available cell culture plates. The agarose scaffold allows for good adjustment of MCTS size and large-scale production of MCTS. Transparent agarose scaffold also allows for monitoring of spheroid formation under an optical microscopy. The formation of MCTS from MCF-7 cells was prepared using different-size-well templates and systematically investigated in terms of spheroid growth curve, circularity, and cell viability. The doxorubicin cytotoxicity against MCF-7 spheroid and MCF-7 monolayer cells was compared. The drug penetration behavior, cell cycle distribution, cell apoptosis, and gene expression were also evaluated in MCF-7 spheroid. The findings of this study indicate that, compared with cellular monolayer, MCTS provides a valuable platform for the assessment of therapeutic candidates in an in vivo-mimic microenvironment, and thus has great potential for use in drug discovery and tumor biology research.

  2. Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM

    Science.gov (United States)

    2017-02-22

    Cytochrome P450 CYP2D6 Enzyme Deficiency; Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant; Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant; Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant; Cytochrome P450 CYP2C9 Enzyme Deficiency; Cytochrome P450 CYP2C19 Enzyme Deficiency; Drug Metabolism, Poor, CYP2D6-RELATED; Drug Metabolism, Poor, CYP2C19-RELATED; CYP2D6 Polymorphism

  3. Ear acupuncture in the control of migraine pain: selecting the right acupoints by the "needle-contact test".

    Science.gov (United States)

    Romoli, M; Allais, G; Airola, G; Benedetto, C

    2005-05-01

    There is increasing evidence that somatic acupuncture can be helpful in migraine treatment, but substantial data on ear acupuncture (EAP) are still lacking. EAP can be useful both in the diagnosis and in the treatment of many medical conditions. As regards the control of migrainous pain, we present a case report in which a procedure called the "needle-contact test" is described in detail. During a migraine attack, the patient undergoes an accurate search for tender points of the outer ear by means of a specific pressure algometer. Once the most sensitive point has been identified, an acupuncture needle is placed in contact with it for about 10 s, without skin penetration. The expected effect is a quick and evident reduction of acute pain. If no appreciable variation in pain intensity occurs within the following 60 s, a second or third attempt is made on other previously identified tender points, until the point at which the patient notices a clear remission of pain is found. In this positive case, the same testing needle can be immediately used for therapy, completely penetrating the skin, and then extracted after about 30 min. Alternatively, a temporary needle can be implanted and left in situ for a variable period of time (1-15 days). This innovative technique allows the identification, with maximum accuracy, of the most effective ear acupoints on migraine pain during acute attacks.

  4. Drug-induced hypotension SEP test and acetazolamide test using sup 133 Xe SPECT in patients with occlusive carotid disease; Selection of candidates for extracranial-intracranial bypass

    Energy Technology Data Exchange (ETDEWEB)

    Kuroda, Satoshi; Kamiyama, Hiroyasu; Abe, Hiroshi; Takigawa, Shugo [Hokkaido Univ., Sapporo (Japan). School of Medicine; Mitsumori, Kenji; Nomura, Mikio; Saitoh, Hisatoshi

    1991-01-01

    The correlation between the drug-induced hypotension somatosensory evoked potential (SEP) test and regional cerebral blood flow changes after acetazolamide administration was studied. Fourteen patients presenting with transient ischemic attack, reversible ischemic neurological deficits, or minor completed stroke were evaluated. All patients had no or only localized low-density areas on computed tomographic scans, and unilateral occlusion or severe stenosis of the internal carotid or middle cerebral artery on cerebral angiograms. The Diamox asymmetry enhancement (DAE) was studied to detect reduced cerebral perfusion reserve in the affected hemispheres. The DAE was 7.9+-5.8% in seven patients positive in the SEP test, significantly higher than -1.5+-2.9% in patients negative in the SEP test. Postoperative SEP tests were negative in all five patients who underwent extracranial-intracranial (EC-IC) bypass surgery, suggesting that the EC-IC bypass improved the cerebral perfusion reserve in the affected hemispheres. The DAE decreased significantly in four of these patients. This study disclosed a significant correlation between the drug-induced hypotension SEP test and DAE. These parameters are considered important for evaluating patients with hemodynamic compromise and/or suitable candidates for EC-IC bypass. (author).

  5. Isotope-labelled urea to test colon drug delivery devices in vivo : principles, calculations and interpretations

    NARCIS (Netherlands)

    Maurer, Marina; Schellekens, Reinout C. A.; Wutzke, Klaus D.; Stellaard, Frans

    2013-01-01

    This paper describes various methodological aspects that were encountered during the development of a system to monitor the in vivo behaviour of a newly developed colon delivery device that enables oral drug treatment of inflammatory bowel diseases. [C-13]urea was chosen as the marker substance.

  6. Zebrafish as a potential model organism for drug test against hepatitis C virus.

    Directory of Open Access Journals (Sweden)

    Cun-Bao Ding

    Full Text Available Screening and evaluating anti- hepatitis C virus (HCV drugs in vivo is difficult worldwide, mainly because of the lack of suitable small animal models. We investigate whether zebrafish could be a model organism for HCV replication. To achieve NS5B-dependent replication an HCV sub-replicon was designed and created with two vectors, one with HCV ns5b and fluorescent rfp genes, and the other containing HCV's 5'UTR, core, 3'UTR and fluorescent gfp genes. The vectors containing sub-replicons were co-injected into zebrafish zygotes. The sub-replicon amplified in liver showing a significant expression of HCV core RNA and protein. The sub-replicon amplification caused no abnormality in development and growth of zebrafish larvae, but induced gene expression change similar to that in human hepatocytes. As the amplified core fluorescence in live zebrafish was detectable microscopically, it rendered us an advantage to select those with replicating sub-replicon for drug experiments. Ribavirin and oxymatrine, two known anti-HCV drugs, inhibited sub-replicon amplification in this model showing reduced levels of HCV core RNA and protein. Technically, this method had a good reproducibility and is easy to operate. Thus, zebrafish might be a model organism to host HCV, and this zebrafish/HCV (sub-replicon system could be an animal model for anti-HCV drug screening and evaluation.

  7. From concept to in vivo testing: Microcontainers for oral drug delivery

    DEFF Research Database (Denmark)

    Mazzoni, Chiara; Tentor, Fabio; Andersen, Sophie Strindberg

    2017-01-01

    , ketoprofen, was loaded into the microcontainers using supercritical CO2 impregnation, followed by deposition of an enteric coating to protect the drug from the harsh gastric environment and to provide a fast release in the intestine. In vitro, in vivo and ex vivo studies were performed to assess...

  8. Voluntary, Randomized, Student Drug-Testing: Impact in a Rural, Low-Income, Community

    Science.gov (United States)

    Barrington, Kyle D.

    2008-01-01

    Illegal drug use and abuse by the nation's secondary school students is a continuing public health issue and this is especially true for students living in rural, low-income areas where access to intervention and treatment services is often limited. To address this issue, some school districts have implemented voluntary, randomized, student …

  9. Evaluation of GenoType® MTBDRplus assay for rapid detection of drug susceptibility testing of multi-drug resistance tuberculosis in Northern India

    Directory of Open Access Journals (Sweden)

    Anand Kumar Maurya

    2013-01-01

    Full Text Available Background: The problem of multi-drug resistance tuberculosis (MDR-TB is growing in several hotspots throughout the world. Rapid and accurate diagnosis of MDR-TB is crucial to facilitate early treatment and to reduce its spread in the community. The aim of the present study was to evaluate the new, novel GenoType® MTBDRplus assay for rapid detection of drug susceptibility testing (DST of MDR-TB cases in Northern India. Materials and Methods: A total of 550 specimens were collected from highly suspected drug resistant from pulmonary and extra-pulmonary TB cases. All the specimens were processed by Ziehl- Neelsen staining, culture, differentiation by the GenoType® CM assay, first line DST using BacT/ALERT 3D system and GenoType® MTBDRplus assay. The concordance of the GenoType® MTBDRplus assay was calculated in comparison with conventional DST results. Results: Overall the sensitivity for detection of rifampicin, isoniazid and MDR-TB resistance by GenoType® MTBDRplus assay was 98.0%, 98.4% and 98.2% respectively. Out of 55 MDR-TB strains, 45 (81.8%, 52 (94.5% and 17 (30.9% strains showed mutation in rpoB, katG and inhA genes respectively (P < 0.05. The most prominent mutations in rpoB, katG and inhA genes were; 37 (67.3% in S531L, 52 (94.5% in S315T1 and 11 (20% in C15T regions respectively (P < 0.05. Conclusions: Our study demonstrated a high concordance between the GenoType® MTBDRplus assay resistance patterns and those were observed by conventional DST with good sensitivity, specificity with short turnaround times and to control new cases of MDR-TB in countries with a high prevalence of MDR-TB.

  10. Question of Drug Workers under the Prism Theory of Axel Honneth recognition . Human Right to Work and his pretension of Universal Validity

    OpenAIRE

    Maria Cecília Máximo Teodoro; Sabrina Colares Nogueira

    2016-01-01

    Relate the theme regarding the Theory of Recognition Axel Honnet, the human right to work as a human right to claim to universal validity, from the perspective of the Declaration of Fundamental Principles and Rights at Work ILO, for purposes of setting parameters and recognition of social (re) integration of chemical class dependent workers is the main goal of this article. We will analyze the theoretical framework in which the pursuit of human dignity at work is the goal of the state to whic...

  11. Tailored dendritic core-multishell nanocarriers for efficient dermal drug delivery: A systematic top-down approach from synthesis to preclinical testing.

    Science.gov (United States)

    Hönzke, Stefan; Gerecke, Christian; Elpelt, Anja; Zhang, Nan; Unbehauen, Michael; Kral, Vivian; Fleige, Emanuel; Paulus, Florian; Haag, Rainer; Schäfer-Korting, Monika; Kleuser, Burkhard; Hedtrich, Sarah

    2016-11-28

    Drug loaded dendritic core-multishell (CMS) nanocarriers are of especial interest for the treatment of skin diseases, owing to their striking dermal delivery efficiencies following topical applications. CMS nanocarriers are composed of a polyglycerol core, connected by amide-bonds to an inner alkyl shell and an outer methoxy poly(ethylene glycol) shell. Since topically applied nanocarriers are subjected to biodegradation, the application of conventional amide-based CMS nanocarriers (10-A-18-350) has been limited by the potential production of toxic polyglycerol amines. To circumvent this issue, three tailored ester-based CMS nanocarriers (10-E-12-350, 10-E-15-350, 10-E-18-350) of varying inner alkyl chain length were synthesized and comprehensively characterized in terms of particle size, drug loading, biodegradation and dermal drug delivery efficiency. Dexamethasone (DXM), a potent drug widely used for the treatment of inflammatory skin diseases, was chosen as a therapeutically relevant test compound for the present study. Ester- and amide-based CMS nanocarriers delivered DXM more efficiently into human skin than a commercially available DXM cream. Subsequent in vitro and in vivo toxicity studies identified CMS (10-E-15-350) as the most biocompatible carrier system. The anti-inflammatory potency of DXM-loaded CMS (10-E-15-350) nanocarriers was assessed in TNFα supplemented skin models, where a significant reduction of the pro-inflammatory cytokine IL-8 was seen, with markedly greater efficacy than commercial DXM cream. In summary, we report the rational design and characterization of tailored, biodegradable, ester-based CMS nanocarriers, and their subsequent stepwise screening for biocompatibility, dermal delivery efficiency and therapeutic efficacy in a top-down approach yielding the best carrier system for topical applications. Copyright © 2016 Elsevier B.V. All rights reserved.

  12. Development and psychometric testing the Health of Body, Mind and Spirit Scale for assessing individuals who have drug abuse histories.

    Science.gov (United States)

    Sun, Fan-Ko; Chiang, Chun-Ying; Lu, Chu-Yun; Yu, Pei-Jane; Liao, Tzu-Chiao; Lan, Chu-Mei

    2018-03-01

    To develop the Health of Body, Mind and Spirit Scale (HBMSS), which was designed to assess drug abusers' health condition. Helping drug abusers to become healthy is important to healthcare professionals. However, no instrument exists to assess drug abusers' state of health. A cross-sectional questionnaire survey was implemented to examine the validity of the HBMSS. Data were collected from 2015-2016 at one drug abuse prevention centre in Taiwan. Participants (N = 320) who had abused drugs were invited to complete a preliminary 64-item version of the HBMSS. An item analysis, criterion-related validity analysis (using the Relapse Prediction Scale [RPS] score), split-half reliability testing and confirmatory factor analysis (CFA) were conducted to examine the psychometric properties of the HBMSS. The final version of the HBMSS contained 15 items that were divided into three subscales: the health of the body, mind and spirit. Cronbach's α and split-half reliability coefficients were all above .85. The factor loading of each item was between .74-.95. The HBMSS had satisfactory criterion-related validity with the RPS score (r = -.50, p < .001). A second-order CFA was conducted on the HBMSS. The fit indexes were good, χ 2  = 184.060, df = 94, χ 2 /df = 1.958 (p = .000). The entire HBMSS and the subscales had satisfactory reliability and validity. Healthcare professionals could use the HBMSS to evaluate the condition of the health of individuals with a drug abuse history. © 2017 John Wiley & Sons Ltd.

  13. Genotyping and drug susceptibility testing of mycobacterial isolates from population-based tuberculosis prevalence survey in Ghana.

    Science.gov (United States)

    Addo, Kennedy Kwasi; Addo, Samuel Ofori; Mensah, Gloria Ivy; Mosi, Lydia; Bonsu, Frank Adae

    2017-12-02

    Mycobacterium tuberculosis complex (MTBC) and Non-tuberculosis Mycobacterium (NTM) infections differ clinically, making rapid identification and drug susceptibility testing (DST) very critical for infection control and drug therapy. This study aims to use World Health Organization (WHO) approved line probe assay (LPA) to differentiate mycobacterial isolates obtained from tuberculosis (TB) prevalence survey in Ghana and to determine their drug resistance patterns. A retrospective study was conducted whereby a total of 361 mycobacterial isolates were differentiated and their drug resistance patterns determined using GenoType Mycobacterium Assays: MTBC and CM/AS for differentiating MTBC and NTM as well MTBDRplus and NTM-DR for DST of MTBC and NTM respectively. Out of 361 isolates, 165 (45.7%) MTBC and 120 (33.2%) NTM (made up of 14 different species) were identified to the species levels whiles 76 (21.1%) could not be completely identified. The MTBC comprised 161 (97.6%) Mycobacterium tuberculosis and 4 (2.4%) Mycobacterium africanum. Isoniazid and rifampicin monoresistant MTBC isolates were 18/165 (10.9%) and 2/165(1.2%) respectively whiles 11/165 (6.7%) were resistant to both drugs. Majority 42/120 (35%) of NTM were M. fortuitum. DST of 28 M. avium complex and 8 M. abscessus complex species revealed that all were susceptible to macrolides (clarithromycin, azithromycin) and aminoglycosides (kanamycin, amikacin, and gentamicin). Our research signifies an important contribution to TB control in terms of knowledge of the types of mycobacterium species circulating and their drug resistance patterns in Ghana.

  14. Acceptability of rapid oral fluid HIV testing among male injection drug users in Taiwan, 1997 and 2007.

    Science.gov (United States)

    Lyu, Shu-Yu; Morisky, Donald E; Yeh, Ching-Ying; Twu, Shiing-Jer; Peng, Eugene Yu-Chang; Malow, Robert M

    2011-04-01

    Rapid oral fluid HIV testing (rapid oral testing) is in the process of being adapted in Taiwan and elsewhere given its advantages over prior HIV testing methods. To guide this process, we examined the acceptability of rapid oral testing at two time points (i.e., 1997 and 2007) among one of the highest risk populations, male injection drug users (IDUs). For this purpose, an anonymous self-administered survey was completed by HIV-negative IDUs involved in the criminal justice system in 1997 (N (1)=137 parolees) and 2007 (N (2)=106 prisoners). A social marketing model helped guide the design of our questionnaire to assess the acceptability of rapid oral testing. This included assessing a new product, across four marketing dimensions: product, price, promotion, and place. Results revealed that in both 1997 and 2007, over 90% indicated that rapid oral testing would be highly acceptable, particularly if the cost was under US$6, and that a pharmacy would be the most appropriate and accessible venue for selling the rapid oral testing kits. The vast majority of survey respondents believed that the cost of rapid oral testing should be federally subsidized and that television and newspaper advertisements would be the most effective media to advertise for rapid oral testing. Both the 1997 and 2007 surveys suggested that rapid oral HIV testing would be particularly accepted in Taiwan by IDUs after release from the criminal justice system.

  15. Culture and Next-generation sequencing-based drug susceptibility testing unveil high levels of drug-resistant-TB in Djibouti: results from the first national survey.

    Science.gov (United States)

    Tagliani, Elisa; Hassan, Mohamed Osman; Waberi, Yacine; De Filippo, Maria Rosaria; Falzon, Dennis; Dean, Anna; Zignol, Matteo; Supply, Philip; Abdoulkader, Mohamed Ali; Hassangue, Hawa; Cirillo, Daniela Maria

    2017-12-15

    Djibouti is a small country in the Horn of Africa with a high TB incidence (378/100,000 in 2015). Multidrug-resistant TB (MDR-TB) and resistance to second-line agents have been previously identified in the country but the extent of the problem has yet to be quantified. A national survey was conducted to estimate the proportion of MDR-TB among a representative sample of TB patients. Sputum was tested using XpertMTB/RIF and samples positive for MTB and resistant to rifampicin underwent first line phenotypic susceptibility testing. The TB supranational reference laboratory in Milan, Italy, undertook external quality assurance, genotypic testing based on whole genome and targeted-deep sequencing and phylogenetic studies. 301 new and 66 previously treated TB cases were enrolled. MDR-TB was detected in 34 patients: 4.7% of new and 31% of previously treated cases. Resistance to pyrazinamide, aminoglycosides and capreomycin was detected in 68%, 18% and 29% of MDR-TB strains respectively, while resistance to fluoroquinolones was not detected. Cluster analysis identified transmission of MDR-TB as a critical factor fostering drug resistance in the country. Levels of MDR-TB in Djibouti are among the highest on the African continent. High prevalence of resistance to pyrazinamide and second-line injectable agents have important implications for treatment regimens.

  16. Breast Milk and Hair Testing to Detect Illegal Drugs, Nicotine, and Caffeine in Donors to a Human Milk Bank.

    Science.gov (United States)

    Escuder-Vieco, Diana; Garcia-Algar, Óscar; Joya, Xavier; Marchei, Emilia; Pichini, Simona; Pacifici, Roberta; Pallás-Alonso, Carmen Rosa

    2016-08-01

    The use of illegal drugs and tobacco is an exclusion criteria for accepting a nursing mother as a milk donor. The detection window for human milk testing is typically a few hours. Hair testing has been considered the gold standard to assess chronic exposure to these toxic substances. The aim of this study was to determine the levels of illegal drugs, nicotine, and caffeine in breast milk and hair samples from donors to assess whether these substances were being used during the donation period and the months leading up to it. Thirty-six samples of hair and breast milk were obtained from 36 donors. The tests performed identified nicotine, caffeine, morphine, cocaine, cannabis, amphetamines, codeine, methadone, and other substances derived therefrom. No illegal drugs were found in any of the samples analyzed. Nicotine and cotinine were found in 33.3% (12/36) of all hair samples. Among these 12 samples, 10 had cotinine concentrations consistent with cutoff values for unexposed nonsmokers, 1 had concentrations consistent with cutoff values for passive smokers, and 1 had concentrations consistent with cutoff values for active smokers. Caffeine was found in 77.7% of the hair samples and in 50% of the donor milk samples. The correlation for caffeine between donor milk and hair samples was r = 0.288, P = .0881. Donors do not use illegal drugs during either the donation period or the months leading up to it. They are occasionally exposed to tobacco smoke and almost all of them consume caffeine. © The Author(s) 2016.

  17. Development and characterization of a human three-dimensional chondrosarcoma culture for in vitro drug testing.

    Science.gov (United States)

    Voissiere, Aurélien; Jouberton, Elodie; Maubert, Elise; Degoul, Françoise; Peyrode, Caroline; Chezal, Jean-Michel; Miot-Noirault, Élisabeth

    2017-01-01

    It has been suggested that chemoresistance of chondrosarcoma (CHS), the cartilage tumor, is caused by the phenotypic microenvironmental features of the tumor tissue, mainly the chondrogenic extracellular matrix (ECM), and hypoxia. We developed and characterized a multicellular tumor spheroid (MCTS) of human chondrosarcoma HEMC-SS cells to gain insight into tumor cell biology and drug response. At Day 7, HEMC-SS spheroids exhibited a homogeneous distribution of proliferative Ki-67 positive cells, whereas in larger spheroids (Day 14 and Day 20), proliferation was mainly localized in the periphery. In the core of larger spheroids, apoptotic cells were evidenced by TUNEL assay, and hypoxia by pimonidazole staining. Interestingly, VEGF excretion, evidenced by ELISA on culture media, was detectable from Day 14 spheroids, and increased as the spheroids grew in size. HEMC-SS spheroids synthesized a chondrogenic extracellular matrix rich in glycosaminoglycans and type-2 collagen. Finally, we investigated the sensitivity of Day 7 and Day 14 chondrosarcoma MCTS to hypoxia-activated prodrug TH-302 and doxorubicin compared with their 2D counterparts. As expected, TH-302 exhibited higher cytotoxic activity on larger hypoxic spheroids (Day 14) than on non-hypoxic spheroids (Day 7), with multicellular resistance index (MCRI) values of 7.7 and 9.1 respectively. For doxorubicin, the larger-sized spheroids exhibited higher drug resistance (MCRI of 5.0 for Day 7 and 18.3 for Day 14 spheroids), possibly due to impeded drug penetration into the deep layer of spheroids, evidenced by its auto-fluorescence property. We have developed a model of human chondrosarcoma MCTS that combines an ECM rich in glycosaminoglycans with a high hypoxic core associated with VEGF excretion. This model could offer a more predictive in vitro chondrosarcoma system for screening drugs targeting tumor cells and their microenvironment.

  18. [Drug susceptibility test guided therapy and novel empirical quadruple therapy for Helicobacter pylori infection: a network Meta-analysis].

    Science.gov (United States)

    Gou, Q Y; Yu, R B; Shi, R H

    2017-05-10

    Objective: To compare the efficacy and the risk of adverse effect of drug susceptibility test guided therapy and novel empirical quadruple therapy for Helicobacter ( H .) pylori infection. Methods: Literature retrieval was conducted by using major databases. Related papers published up to June 2015 were considered eligible if they were randomized control trials comparing different pharmacological formulations for H. pylori infection and used in a network Meta-analysis and a single rate Meta-analysis to evaluate the relative and absolute rates of H. pylori eradication and the risk of adverse effect. The Jadad score was used to evaluate the methodological quality. Funnel plot was constructed to evaluate the risk of publication bias. Begg's rank correlation test or Egger's regression intercept test was done for the asymmetry of funnel plot. Results: Twenty randomized control trials for the treatment of 6 753 initial treated patients with H. pylori infection were included. Drug susceptibility test guided therapy was significantly superior to concomitant therapy, hybrid therapy, sequential therapy and bismuth quadruple therapy. The culture-based therapy had the highest likelihood of improving clinical efficacy, with lowest risk of adverse effect. Concomitant therapy had the highest probability of causing adverse effect despite its effectiveness. Hybrid therapy and bismuth quadruple therapy were associated with lower risk of adverse effect and higher effectiveness. Conclusion: Drug susceptibility test guided therapy showed superiority to other 4 interventions for H. pylori eradication mentioned above. Hybrid therapy and bismuth quadruple therapy might be applied in the settings where the culture-based strategy is not available.

  19. Predicting psychopharmacological drug effects on actual driving performance (SDLP) from psychometric tests measuring driving-related skills.

    Science.gov (United States)

    Verster, Joris C; Roth, Thomas

    2012-03-01

    There are various methods to examine driving ability. Comparisons between these methods and their relationship with actual on-road driving is often not determined. The objective of this study was to determine whether laboratory tests measuring driving-related skills could adequately predict on-the-road driving performance during normal traffic. Ninety-six healthy volunteers performed a standardized on-the-road driving test. Subjects were instructed to drive with a constant speed and steady lateral position within the right traffic lane. Standard deviation of lateral position (SDLP), i.e., the weaving of the car, was determined. The subjects also performed a psychometric test battery including the DSST, Sternberg memory scanning test, a tracking test, and a divided attention test. Difference scores from placebo for parameters of the psychometric tests and SDLP were computed and correlated with each other. A stepwise linear regression analysis determined the predictive validity of the laboratory test battery to SDLP. Stepwise regression analyses revealed that the combination of five parameters, hard tracking, tracking and reaction time of the divided attention test, and reaction time and percentage of errors of the Sternberg memory scanning test, together had a predictive validity of 33.4%. The psychometric tests in this test battery showed insufficient predictive validity to replace the on-the-road driving test during normal traffic.

  20. Question of Drug Workers under the Prism Theory of Axel Honneth recognition . Human Right to Work and his pretension of Universal Validity

    Directory of Open Access Journals (Sweden)

    Maria Cecília Máximo Teodoro

    2016-06-01

    Full Text Available Relate the theme regarding the Theory of Recognition Axel Honnet, the human right to work as a human right to claim to universal validity, from the perspective of the Declaration of Fundamental Principles and Rights at Work ILO, for purposes of setting parameters and recognition of social (re integration of chemical class dependent workers is the main goal of this article. We will analyze the theoretical framework in which the pursuit of human dignity at work is the goal of the state to which we treat below the dignity of man as a right whose claim to universal validity is based on the recognition of the theory of Axel Honneth . That said, we analyze the possible dignity of man at work in a global context from the recognition of new rights, especially with regard to the category of workers who occupy the social portion of chemical-dependent, whose participation in the social process is prevented, creating a category of workers socially excluded, which is intended to overcome.

  1. Has introduction of rapid drug susceptibility testing at diagnosis impacted treatment outcomes among previously treated tuberculosis patients in Gujarat, India?

    Directory of Open Access Journals (Sweden)

    Paresh Dave

    Full Text Available Revised National TB Control Programme (RNTCP in India recommends that all previously-treated TB (PT patients are offered drug susceptibility testing (DST at diagnosis, using rapid diagnostics and screened out for rifampicin resistance before being treated with standardized, eight-month, retreatment regimen. This is intended to improve the early diagnosis of rifampicin resistance and its appropriate management and improve the treatment outcomes among the rest of the patients. In this state-wide study from Gujarat, India, we assess proportion of PT patients underwent rapid DST at diagnosis and the impact of this intervention on their treatment outcomes.This is a retrospective cohort study involving review of electronic patient-records maintained routinely under RNTCP. All PT patients registered for treatment in Gujarat during January-June 2013 were included. Information on DST and treatment outcomes were extracted from 'presumptive DR-TB patient register' and TB treatment register respectively. We performed a multivariate analysis to assess if getting tested is independently associated with unfavourable outcomes (death, loss-to-follow-up, failure, transfer out.Of 5,829 PT patients, 5306(91% were tested for drug susceptibility with rapid diagnostics. Overall, 71% (4,113 TB patients were successfully treated - 72% among tested versus 60% among non-tested. Patients who did not get tested at diagnosis had a 34% higher risk of unsuccessful outcomes as compared to those who got tested (aRR - 1.34; 95% CI 1.20-1.50 after adjusting for age, sex, HIV status and type of TB. Unfavourable outcomes (particularly failure and switched to category IV were higher among INH-resistant patients (39% as compared to INH-sensitive (29%.Offering DST at diagnosis improved the treatment outcomes among PT patients. However, even among tested, treatment outcomes remained suboptimal and were related to INH resistance and high loss-to-follow-up. These need to be addressed

  2. Dry blood spot testing for hepatitis C in people who injected drugs: reaching the populations other tests cannot reach.

    Science.gov (United States)

    Tait, J M; Stephens, Brian P; McIntyre, Paul G; Evans, Morgan; Dillon, John F

    2013-10-01

    The aim of the study was to evaluate the effectiveness of Dry Blood Spot testing (DBST) for hepatitis C within a geographical area. This is a prospective cohort study of all individuals living in Tayside who had received a hepatitis C virus (HCV) DBST between 2009 and 2011. During the study, 1123 DBSTs were carried out. 946 individuals had one test. 295 (31.2%) of these individuals were HCV antibody positive on their first test. Overall, 94.3% (902/956) individuals returned for the results of their test. During the course of the study 177 individuals were retested and 29 new cases of hepatitis C were detected. 249 individuals attended for further follow-up, and 164 (65.5%) were PCR positive. All 164 PCR-positive individuals were offered referral into specialist HCV services for further assessment. Data showed 62.5% were genotype 3, 65.1% had a low viral load (<600 000 iu/ml) and 77.5% had a Fibroscan score below 7 KPa. To date, 40 have commenced treatment and a further 16 are currently in the assessment period. Overall, we have retained in services or treated 63.6% (105/164) of patients who were initially referred and with effective support mechanisms in place we have achieved sustained viral response rates of 90%. The study has shown that DBST is a complementary technique to conventional venepuncture for the diagnosis of HCV. The majority of patients have low viral loads and low fibrosis scores, so that while this group of patients may be difficult to reach and may be challenging to maintain in therapy, they are easier to cure.

  3. Prevention of Hospital-Acquired Adverse Drug Reactions in Older People Using Screening Tool of Older Persons' Prescriptions and Screening Tool to Alert to Right Treatment Criteria: A Cluster Randomized Controlled Trial.

    Science.gov (United States)

    O'Connor, Marie N; O'Sullivan, David; Gallagher, Paul F; Eustace, Joseph; Byrne, Stephen; O'Mahony, Denis

    2016-08-01

    To determine whether use of the Screening Tool of Older Persons' Prescriptions (STOPP) and Screening Tool to Alert to Right Treatment (START) criteria reduces incident hospital-acquired adverse drug reactions (ADRs), 28-day medication costs, and median length of hospital stay in older adults admitted with acute illness. Single-blind cluster randomized controlled trial (RCT) of unselected older adults hospitalized over a 13-month period. Tertiary referral hospital in southern Ireland. Consecutively admitted individuals aged 65 and older (N = 732). Single time point presentation to attending physicians of potentially inappropriate medications according to the STOPP/START criteria. The primary outcome was the proportion of participants experiencing one or more ADRs during the index hospitalization. Secondary outcomes were median length of stay (LOS) and 28-day total medication cost. One or more ADRs occurred in 78 of the 372 control participants (21.0%; median age 78, interquartile range (IQR) 72-84) and in 42 of the 360 intervention participants (11.7%; median age 80, IQR 73-85) (absolute risk reduction = 9.3%, number needed to treat = 11). The median LOS in the hospital was 8 days (IQR 4-14 days) in both groups. At discharge, median medication cost was significantly lower in the intervention group (€73.16, IQR €38.68-121.72) than in the control group (€90.62, IQR €49.38-162.53) (Wilcoxon rank test Z statistic = -3.274, P older adults but did not affect median LOS. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

  4. Amount of self-reported illicit drug use compared to quantitative hair test results in community-recruited young drug users in Amsterdam

    NARCIS (Netherlands)

    Welp, Esther A. E.; Bosman, Ingrid; Langendam, Miranda W.; Totté, Maja; Maes, Robert A. A.; van Ameijden, Erik J. C.

    2003-01-01

    To assess the dose-effect relationship between self-reported drug intake and the concentration of drugs and/or their metabolites in hair and to examine factors that may mediate this relationship. A cohort study among young drug users (YDU) in Amsterdam, the Netherlands, which began in July 2000. At

  5. Culture and drug sensitivity testing among patients with pulmonary tuberculosis in Mexico: national data for 2009-2013.

    Science.gov (United States)

    Orejel, Ivonne; Castellanos, Martin; Marín, Diana; Mendoza, Alberto; Harries, Anthony D

    2016-01-01

    This study documented the number and results of mycobacterial culture and drug sensitivity testing (CDST) in Mexico from 2009-2013 and assessed whether states with a higher risk of multidrug-resistant tuberculosis (MDR-TB) performed more CDST and had more cultures showing MDR-TB. Data for this longitudinal, descriptive, operational research study came from the electronic records of 31 state public health laboratories in Mexico. The total number of CDSTs was 6 470, increasing from 2 143 in the first 2 years to 4 327 in the latter 3 years. There was a significant increase in the proportion of cultures showing sensitivity to all drugs, from 53.1% to 60.9% in 2011-2013 (P tuberculosis were Mexico, particularly in high-risk MDR-TB states where a higher proportion of cultures showed MDR-TB. Scale up and wider coverage of CDST should continue.

  6. A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria

    Science.gov (United States)

    Mbonye, Anthony K.; Magnussen, Pascal; Lal, Sham; Hansen, Kristian S.; Cundill, Bonnie; Chandler, Clare; Clarke, Siân E.

    2015-01-01

    Background Inappropriate treatment of malaria is widely reported particularly in areas where there is poor access to health facilities and self-treatment of fevers with anti-malarial drugs bought in shops is the most common form of care-seeking. The main objective of the study was to examine the impact of introducing rapid diagnostic tests for malaria (mRDTs) in registered drug shops in Uganda, with the aim to increase appropriate treatment of malaria with artemisinin-based combination therapy (ACT) in patients seeking treatment for fever in drug shops. Methods A cluster-randomized trial of introducing mRDTs in registered drug shops was implemented in 20 geographical clusters of drug shops in Mukono district, central Uganda. Ten clusters were randomly allocated to the intervention (diagnostic confirmation of malaria by mRDT followed by ACT) and ten clusters to the control arm (presumptive treatment of fevers with ACT). Treatment decisions by providers were validated by microscopy on a reference blood slide collected at the time of consultation. The primary outcome was the proportion of febrile patients receiving appropriate treatment with ACT defined as: malaria patients with microscopically-confirmed presence of parasites in a peripheral blood smear receiving ACT or rectal artesunate, and patients with no malaria parasites not given ACT. Findings A total of 15,517 eligible patients (8672 intervention and 6845 control) received treatment for fever between January-December 2011. The proportion of febrile patients who received appropriate ACT treatment was 72·9% versus 33·7% in the control arm; a difference of 36·1% (95% CI: 21·3 – 50·9), pshop vendors adhered to the mRDT results, reducing over-treatment of malaria by 72·6% (95% CI: 46·7– 98·4), pshop vendors using presumptive diagnosis (control arm). Conclusion Diagnostic testing with mRDTs compared to presumptive treatment of fevers implemented in registered drug shops substantially improved appropriate

  7. [Sensitivity and specificity of nested PCR pyrosequencing in hepatitis B virus drug resistance gene testing].

    Science.gov (United States)

    Sun, Shumei; Zhou, Hao; Zhou, Bin; Hu, Ziyou; Hou, Jinlin; Sun, Jian

    2012-05-01

    To evaluate the sensitivity and specificity of nested PCR combined with pyrosequencing in the detection of HBV drug-resistance gene. RtM204I (ATT) mutant and rtM204 (ATG) nonmutant plasmids mixed at different ratios were detected for mutations using nested-PCR combined with pyrosequencing, and the results were compared with those by conventional PCR pyrosequencing to analyze the linearity and consistency of the two methods. Clinical specimens with different viral loads were examined for drug-resistant mutations using nested PCR pyrosequencing and nested PCR combined with dideoxy sequencing (Sanger) for comparison of the detection sensitivity and specificity. The fitting curves demonstrated good linearity of both conventional PCR pyrosequencing and nested PCR pyrosequencing (R(2)>0.99, PNested PCR showed a better consistency with the predicted value than conventional PCR, and was superior to conventional PCR for detection of samples containing 90% mutant plasmid. In the detection of clinical specimens, Sanger sequencing had a significantly lower sensitivity than nested PCR pyrosequencing (92% vs 100%, Pnested PCR and Sanger sequencing method, nested PCR pyrosequencing has a higher sensitivity especially in clinical specimens with low viral copies, which can be important for early detection of HBV mutant strains and hence more effective clinical management.

  8. Performance of ARCHITECT HCV core antigen test with specimens from US plasma donors and injecting drug users.

    Science.gov (United States)

    Mixson-Hayden, Tonya; Dawson, George J; Teshale, Eyasu; Le, Thao; Cheng, Kevin; Drobeniuc, Jan; Ward, John; Kamili, Saleem

    2015-05-01

    Hepatitis C virus (HCV) core antigen is a serological marker of current HCV infection. The aim of this study was mainly to evaluate the performance characteristics of the ARCHITECT HCV core antigen assay with specimens from US plasma donors and injecting drug users. A total of 551 serum and plasma samples with known anti-HCV and HCV RNA status were tested for HCV core antigen using the Abbott ARCHITECT HCV core antigen test. HCV core antigen was detectable in 100% of US plasma donor samples collected during the pre-seroconversion phase of infection (anti-HCV negative/HCV RNA positive). Overall sensitivity of the HCV core antigen assay was 88.9-94.3% in samples collected after seroconversion. The correlation between HCV core antigen and HCV RNA titers was 0.959. HCV core antigen testing may be reliably used to identify current HCV infection. Published by Elsevier B.V.

  9. Applications of Dynamic Clamp to Cardiac Arrhythmia Research: Role in Drug Target Discovery and Safety Pharmacology Testing

    Directory of Open Access Journals (Sweden)

    Francis A. Ortega

    2018-01-01

    Full Text Available Dynamic clamp, a hybrid-computational-experimental technique that has been used to elucidate ionic mechanisms underlying cardiac electrophysiology, is emerging as a promising tool in the discovery of potential anti-arrhythmic targets and in pharmacological safety testing. Through the injection of computationally simulated conductances into isolated cardiomyocytes in a real-time continuous loop, dynamic clamp has greatly expanded the capabilities of patch clamp outside traditional static voltage and current protocols. Recent applications include fine manipulation of injected artificial conductances to identify promising drug targets in the prevention of arrhythmia and the direct testing of model-based hypotheses. Furthermore, dynamic clamp has been used to enhance existing experimental models by addressing their intrinsic limitations, which increased predictive power in identifying pro-arrhythmic pharmacological compounds. Here, we review the recent advances of the dynamic clamp technique in cardiac electrophysiology with a focus on its future role in the development of safety testing and discovery of anti-arrhythmic drugs.

  10. Procesos de estigma y exclusión en salud: Articulaciones entre estigmatización, derechos ciudadanos, uso de drogas y drogadependencia Processes of stigma and exclusion in health: Joints between stigmatization, civil rights, use of drugs and dependence of drugs

    Directory of Open Access Journals (Sweden)

    Andrea Vázquez

    2009-12-01

    Full Text Available El objetivo del trabajo es establecer articulaciones entre la estigmatización, los derechos ciudadanos, el uso de drogas y la drogadependencia, como un caso particular de exclusión en salud. La estigmatización produce grupos de personas que ven condicionado su ejercicio de ciudadanía al negárseles el cumplimiento de derechos tales como el derecho a la salud. Uno de estos grupos, lo configuran los usuarios de drogas y los drogadependientes. Es relevante estudiar los procesos de estigma como barrera de accesibilidad a la atención en salud, para identificar componentes que disminuyan dicha exclusión (OPS/OMS, 2005. La reducción de la estigmatización y la discriminación del uso de drogas y la drogadependencia, es fundamental para la elaboración de políticas de inclusión desde una lógica de respeto por los derechos humanos.The aim of the work is to establish joints between the stigmatization, the civil rights, drugs use and dependence of drug, as a particular case of exclusion in health. The stigmatization produces groups of persons who have problems for the exercise of citizenship. These persons are refused in the fulfillment of rights such as the right to the health. One of these groups, it is formed by the users of drugs and the dependents of drugs. It´s relevant to study the processes of stigma as accessibility barrier to the attention in health, to identify components that diminish the above mentioned exclusion. (OPS/OMS,2005. The reduction of the stigmatization and the discrimination of the use of drugs and dependence of drug, it's fundamental for the elaboration of policies of incorporation from logic of respect for the human rights.

  11. Culture and drug sensitivity testing among patients with pulmonary tuberculosis in Mexico: national data for 2009–2013

    Directory of Open Access Journals (Sweden)

    Ivonne Orejel

    Full Text Available ABSTRACT This study documented the number and results of mycobacterial culture and drug sensitivity testing (CDST in Mexico from 2009–2013 and assessed whether states with a higher risk of multidrug-resistant tuberculosis (MDR-TB performed more CDST and had more cultures showing MDR-TB. Data for this longitudinal, descriptive, operational research study came from the electronic records of 31 state public health laboratories in Mexico. The total number of CDSTs was 6 470, increasing from 2 143 in the first 2 years to 4 327 in the latter 3 years. There was a significant increase in the proportion of cultures showing sensitivity to all drugs, from 53.1% to 60.9% in 2011–2013 (P < 0.001 and a significant decrease in the proportion showing MDR-TB, from 28.2% in 2009 to 19.8% in 2013 (P < 0.001. Cases of extensively drug resistant tuberculosis were < 1% per year. In the 12 states with higher risk for MDR-TB, significantly more CDSTs (2 382 test were done in 2011–2013 than in the other 19 states (1 945 tests. Also, for each year the proportion of cultures showing MDR-TB was significantly higher in high risk MDR-TB states than in lower risk ones (P < 0.001. During the 5-year study period, CDST was scaled up in Mexico, particularly in high-risk MDR-TB states where a higher proportion of cultures showed MDR-TB. Scale up and wider coverage of CDST should continue.

  12. Whose Rights?

    DEFF Research Database (Denmark)

    Aktor, Mikael

    2016-01-01

    The debate over ritual infant male circumcision has increasingly been thematized as a Human Rights issue. But the claims on such rights seem highly conflicting. In particular, the rights of the child seems to conflict with the freedom of religion of parents, the rights of religious and ethnic...... minorities, and the rights of family and privacy. This disagreement is also present among scholars of religion. A reading of public statements by scholars of religion in the ongoing Danish (and Norwegian) debate reveals the lack of consensus of the study of religion when it comes to matters that are of great...... concern both for religious minorities and for individual citizens. This chapter examines the Law and Human Rights documents behind these conflicting claims and discusses the role of the scholar of religion in the debate....

  13. Expansion of Viral Load Testing and the Potential Impact on HIV Drug Resistance.

    Science.gov (United States)

    Raizes, Elliot; Hader, Shannon; Birx, Deborah

    2017-12-01

    The US President's Emergency Plan for AIDS Relief (PEPFAR) supports aggressive scale-up of antiretroviral therapy (ART) in high-burden countries and across all genders and populations at risk toward global human immunodeficiency virus (HIV) epidemic control. PEPFAR recognizes the risk of HIV drug resistance (HIVDR) as a consequence of aggressive ART scale-up and is actively promoting 3 key steps to mitigate the impact of HIVDR: (1) routine access to routine viral load monitoring in all settings; (2) optimization of ART regimens; and (3) routine collection and analysis of HIVDR data to monitor the success of mitigation strategies. The transition to dolutegravir-based regimens in PEPFAR-supported countries and the continuous evolution of HIVDR surveillance strategies are essential elements of PEPFAR implementation. Published by Oxford University Press for the Infectious Diseases Society of America 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  14. Introducing rapid diagnostic tests for malaria into drug shops in Uganda

    DEFF Research Database (Denmark)

    Mbonye, Anthony K; Magnussen, Pascal; Chandler, Clare Ir

    2014-01-01

    vendors and implemented supporting interventions to orientate local communities (patients) and the public sector (health facility staff and district officials) to the behavioral changes in diagnosis, treatment and referral being introduced in drug shops. The intervention was designed to be evaluated...... components drawing from a combination of epidemiological, social science and health economics methodologies. The trial was conducted in phases sequenced such that each benefited from the other. CONCLUSIONS: The main challenges in designing this trial were maintaining a balance between a robust intervention...... to support effective behaviour change and introducing practices that would be sustainable in a real-life situation in tropical Africa; as well as achieving a detailed evaluation without inadvertently influencing prescribing behaviour.Trial registration: Trial registration: NCT01194557 registered...

  15. Using the FFM to conceptualize psychopathy: a test using a drug abusing sample.

    Science.gov (United States)

    Derefinko, Karen J; Lynam, Donald R

    2007-12-01

    The present study examined whether psychopathy can be understood as a constellation of traits from the Five Factor Model (FFM) of personality. Using a prototype matching approach, we examined the ability of the Revised NEO Personality Inventory (NEO PI-R; Costa & McCrae, 1992) to represent psychopathy in a sample of 297 male and female known crack cocaine abusers. Importantly, we examined the convergence and divergence between FFM psychopathy and other personality disorders assessed using the FFM. FFM psychopathy was correlated with self-reports of antisocial behavior, drug use, risky sex, and externalizing and internalizing disorder symptoms. As expected, there was overlap in the relations between psychopathy and several Cluster B personality disorders, but there were also important points of divergence. These results further extend the nomological network of FFM psychopathy and provide additional support for considering psychopathy a constellation of personality traits from a general model.

  16. Illegal performance enhancing drugs and doping in sport: a picture-based brief implicit association test for measuring athletes’ attitudes

    Science.gov (United States)

    2014-01-01

    Background Doping attitude is a key variable in predicting athletes’ intention to use forbidden performance enhancing drugs. Indirect reaction-time based attitude tests, such as the implicit association test, conceal the ultimate goal of measurement from the participant better than questionnaires. Indirect tests are especially useful when socially sensitive constructs such as attitudes towards doping need to be described. The present study serves the development and validation of a novel picture-based brief implicit association test (BIAT) for testing athletes’ attitudes towards doping in sport. It shall provide the basis for a transnationally compatible research instrument able to harmonize anti-doping research efforts. Method Following a known-group differences validation strategy, the doping attitudes of 43 athletes from bodybuilding (representative for a highly doping prone sport) and handball (as a contrast group) were compared using the picture-based doping-BIAT. The Performance Enhancement Attitude Scale (PEAS) was employed as a corresponding direct measure in order to additionally validate the results. Results As expected, in the group of bodybuilders, indirectly measured doping attitudes as tested with the picture-based doping-BIAT were significantly less negative (η2 = .11). The doping-BIAT and PEAS scores correlated significantly at r = .50 for bodybuilders, and not significantly at r = .36 for handball players. There was a low error rate (7%) and a satisfactory internal consistency (r tt  = .66) for the picture-based doping-BIAT. Conclusions The picture-based doping-BIAT constitutes a psychometrically tested method, ready to be adopted by the international research community. The test can be administered via the internet. All test material is available “open source”. The test might be implemented, for example, as a new effect-measure in the evaluation of prevention programs. PMID:24479865

  17. Illegal performance enhancing drugs and doping in sport: a picture-based brief implicit association test for measuring athletes' attitudes.

    Science.gov (United States)

    Brand, Ralf; Heck, Philipp; Ziegler, Matthias

    2014-01-30

    Doping attitude is a key variable in predicting athletes' intention to use forbidden performance enhancing drugs. Indirect reaction-time based attitude tests, such as the implicit association test, conceal the ultimate goal of measurement from the participant better than questionnaires. Indirect tests are especially useful when socially sensitive constructs such as attitudes towards doping need to be described. The present study serves the development and validation of a novel picture-based brief implicit association test (BIAT) for testing athletes' attitudes towards doping in sport. It shall provide the basis for a transnationally compatible research instrument able to harmonize anti-doping research efforts. Following a known-group differences validation strategy, the doping attitudes of 43 athletes from bodybuilding (representative for a highly doping prone sport) and handball (as a contrast group) were compared using the picture-based doping-BIAT. The Performance Enhancement Attitude Scale (PEAS) was employed as a corresponding direct measure in order to additionally validate the results. As expected, in the group of bodybuilders, indirectly measured doping attitudes as tested with the picture-based doping-BIAT were significantly less negative (η2 = .11). The doping-BIAT and PEAS scores correlated significantly at r = .50 for bodybuilders, and not significantly at r = .36 for handball players. There was a low error rate (7%) and a satisfactory internal consistency (rtt = .66) for the picture-based doping-BIAT. The picture-based doping-BIAT constitutes a psychometrically tested method, ready to be adopted by the international research community. The test can be administered via the internet. All test material is available "open source". The test might be implemented, for example, as a new effect-measure in the evaluation of prevention programs.

  18. Righting wrongs and reforming rights.

    Science.gov (United States)

    Ivey, Laurie C

    2014-03-01

    Discusses issues faced by LGBT people, such as a lack of equal civil rights and the need for extra legal and financial protection for families because partners cannot be married. The author notes that, in our society, it is no longer acceptable to be racist, but it is still okay to be homophobic. The many campaigns against gay marriage and efforts in the legislature to prevent change toward equal civil rights and protections are prime examples. In our current political climate, two things are very clear: (a) homophobia is freely tolerated and (b) the times are changing as we inch closer to equal rights every day. We are "righting wrongs and reforming rights."

  19. Evaluation of the alcohol use disorders identification test and the drug use disorders identification test among patients at a Norwegian psychiatric emergency ward.

    Science.gov (United States)

    Gundersen, Oystein Hoel; Mordal, Jon; Berman, Anne H; Bramness, Jørgen G

    2013-01-01

    High rates of substance use disorders (SUD) among psychiatric patients are well documented. This study explores the usefulness of the Alcohol Use Disorders Identification Test (AUDIT) and the Drug Use Disorders Identification Test (DUDIT) in identifying SUD in emergency psychiatric patients. Of 287 patients admitted consecutively, 256 participants (89%) were included, and 61-64% completed the questionnaires and the Mini-International Neuropsychiatric Interview (MINI), used as the reference standard. Both AUDIT and DUDIT were valid (area under the curve above 0.92) and reliable (Cronbach's alpha above 0.89) in psychotic and nonpsychotic men and women. The suitable cutoff scores for AUDIT were higher among the psychotic than nonpsychotic patients, with 12 versus 10 in men and 8 versus 5 in women. The suitable cutoff scores for DUDIT were 1 in both psychotic and nonpsychotic women, and 5 versus 1 in psychotic and nonpsychotic men, respectively. This study shows that AUDIT and DUDIT may provide precise information about emergency psychiatric patients' problematic alcohol and drug use. Copyright © 2013 S. Karger AG, Basel.

  20. A rapid culture system uninfluenced by an inoculum effect increases reliability and convenience for drug susceptibility testing of Mycobacterium tuberculosis.

    Science.gov (United States)

    Jung, Yong-Gyun; Kim, Hyejin; Lee, Sangyeop; Kim, Suyeoun; Jo, EunJi; Kim, Eun-Geun; Choi, Jungil; Kim, Hyun Jung; Yoo, Jungheon; Lee, Hye-Jeong; Kim, Haeun; Jung, Hyunju; Ryoo, Sungweon; Kwon, Sunghoon

    2018-06-05

    The Disc Agarose Channel (DAC) system utilizes microfluidics and imaging technologies and is fully automated and capable of tracking single cell growth to produce Mycobacterium tuberculosis (MTB) drug susceptibility testing (DST) results within 3~7 days. In particular, this system can be easily used to perform DSTs without the fastidious preparation of the inoculum of MTB cells. Inoculum effect is one of the major problems that causes DST errors. The DAC system was not influenced by the inoculum effect and produced reliable DST results. In this system, the minimum inhibitory concentration (MIC) values of the first-line drugs were consistent regardless of inoculum sizes ranging from ~10 3 to ~10 8 CFU/mL. The consistent MIC results enabled us to determine the critical concentrations for 12 anti-tuberculosis drugs. Based on the determined critical concentrations, further DSTs were performed with 254 MTB clinical isolates without measuring an inoculum size. There were high agreement rates (96.3%) between the DAC system and the absolute concentration method using Löwenstein-Jensen medium. According to these results, the DAC system is the first DST system that is not affected by the inoculum effect. It can thus increase reliability and convenience for DST of MTB. We expect that this system will be a potential substitute for conventional DST systems.

  1. Comprehensive validation scheme for in situ fiber optics dissolution method for pharmaceutical drug product testing.

    Science.gov (United States)

    Mirza, Tahseen; Liu, Qian Julie; Vivilecchia, Richard; Joshi, Yatindra

    2009-03-01

    There has been a growing interest during the past decade in the use of fiber optics dissolution testing. Use of this novel technology is mainly confined to research and development laboratories. It has not yet emerged as a tool for end product release testing despite its ability to generate in situ results and efficiency improvement. One potential reason may be the lack of clear validation guidelines that can be applied for the assessment of suitability of fiber optics. This article describes a comprehensive validation scheme and development of a reliable, robust, reproducible and cost-effective dissolution test using fiber optics technology. The test was successfully applied for characterizing the dissolution behavior of a 40-mg immediate-release tablet dosage form that is under development at Novartis Pharmaceuticals, East Hanover, New Jersey. The method was validated for the following parameters: linearity, precision, accuracy, specificity, and robustness. In particular, robustness was evaluated in terms of probe sampling depth and probe orientation. The in situ fiber optic method was found to be comparable to the existing manual sampling dissolution method. Finally, the fiber optic dissolution test was successfully performed by different operators on different days, to further enhance the validity of the method. The results demonstrate that the fiber optics technology can be successfully validated for end product dissolution/release testing. (c) 2008 Wiley-Liss, Inc. and the American Pharmacists Association

  2. Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial.

    Science.gov (United States)

    Mbonye, Anthony K; Magnussen, Pascal; Chandler, Clare I R; Hansen, Kristian S; Lal, Sham; Cundill, Bonnie; Lynch, Caroline A; Clarke, Siân E

    2014-07-29

    An intervention was designed to introduce rapid diagnostics tests for malaria (mRDTs) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy (ACT). We conducted participatory training of drug shop vendors and implemented supporting interventions to orientate local communities (patients) and the public sector (health facility staff and district officials) to the behavioral changes in diagnosis, treatment and referral being introduced in drug shops. The intervention was designed to be evaluated through a cluster randomized trial. In this paper, we present detailed design, implementation and evaluation experiences in order to help inform future studies of a complex nature. Three preparatory studies (formative, baseline and willingness-to-pay) were conducted to explore perceptions on diagnosis and treatment of malaria at drug shops, and affordable prices for mRDTs and ACTs in order to inform the design of the intervention and implementation modalities. The intervention required careful design with the intention to be acceptable, sustainable and effective. Critical components of intervention were: community sensitization and creating awareness, training of drug shop vendors to diagnose malaria with mRDTs, treat and refer customers to formal health facilities, giving pre-referral rectal artesunate and improved record-keeping. The primary outcome was the proportion of patients receiving appropriately-targeted treatment with ACT, evaluated against microscopy on a research blood slide. Introducing mRDTs in drug shops may seem simple, but our experience of intervention design, conduct and evaluation showed this to be a complex process requiring multiple interventions and evaluation components drawing from a combination of epidemiological, social science and health economics methodologies. The trial was conducted in phases sequenced such that each benefited from the other. The main challenges

  3. The role of sedation tests in identifying sedative drug effects in healthy volunteers and their power to dissociate sedative-related impairments from memory dysfunctions

    NARCIS (Netherlands)

    Wezenberg, E.; Sabbe, B.G.C.; Hulstijn, W.; Ruigt, G.S.F.; Verkes, R.J.

    2007-01-01

    The study investigated whether four specified drugs would show similar patterns on tests considered to measure sedation. In addition, their drug-effect patterns on sedation and memory performance were compared to determine whether the sedative effects could be differentiated from the memory effects.

  4. The role of sedation tests in identifying sedative drug effects in healthy volunteers and their power to dissociate sedative-related impairments from memory dysfunctions.

    NARCIS (Netherlands)

    Wezenberg, E.; Sabbe, B.G.C.; Hulstijn, W.; Ruigt, G.S.F.; Verkes, R.J.

    2007-01-01

    The study investigated whether four specified drugs would show similar patterns on tests considered to measure sedation. In addition, their drug-effect patterns on sedation and memory performance were compared to determine whether the sedative effects could be differentiated from the memory

  5. Automated Low-Cost Smartphone-Based Lateral Flow Saliva Test Reader for Drugs-of-Abuse Detection.

    Science.gov (United States)

    Carrio, Adrian; Sampedro, Carlos; Sanchez-Lopez, Jose Luis; Pimienta, Miguel; Campoy, Pascual

    2015-11-24

    Lateral flow assay tests are nowadays becoming powerful, low-cost diagnostic tools. Obtaining a result is usually subject to visual interpretation of colored areas on the test by a human operator, introducing subjectivity and the possibility of errors in the extraction of the results. While automated test readers providing a result-consistent solution are widely available, they usually lack portability. In this paper, we present a smartphone-based automated reader for drug-of-abuse lateral flow assay tests, consisting of an inexpensive light box and a smartphone device. Test images captured with the smartphone camera are processed in the device using computer vision and machine learning techniques to perform automatic extraction of the results. A deep validation of the system has been carried out showing the high accuracy of the system. The proposed approach, applicable to any line-based or color-based lateral flow test in the market, effectively reduces the manufacturing costs of the reader and makes it portable and massively available while providing accurate, reliable results.

  6. Automated Low-Cost Smartphone-Based Lateral Flow Saliva Test Reader for Drugs-of-Abuse Detection

    Directory of Open Access Journals (Sweden)

    Adrian Carrio

    2015-11-01

    Full Text Available Lateral flow assay tests are nowadays becoming powerful, low-cost diagnostic tools. Obtaining a result is usually subject to visual interpretation of colored areas on the test by a human operator, introducing subjectivity and the possibility of errors in the extraction of the results. While automated test readers providing a result-consistent solution are widely available, they usually lack portability. In this paper, we present a smartphone-based automated reader for drug-of-abuse lateral flow assay tests, consisting of an inexpensive light box and a smartphone device. Test images captured with the smartphone camera are processed in the device using computer vision and machine learning techniques to perform automatic extraction of the results. A deep validation of the system has been carried out showing the high accuracy of the system. The proposed approach, applicable to any line-based or color-based lateral flow test in the market, effectively reduces the manufacturing costs of the reader and makes it portable and massively available while providing accurate, reliable results.

  7. Recourse right

    International Nuclear Information System (INIS)

    Lopes, M.R.M.

    1979-01-01

    The recourse right concerning nuclear power plants is analysed. It is emphasized that in the Brazilian civil liability legislation, the operator has this right against who admitted it through a written contract or against the individual who has acted or omitted to act whith the intent to provoke nuclear incidents. (A.L.S.L.) [pt

  8. Surface rights

    Directory of Open Access Journals (Sweden)

    Regina Célia Corrêa Landim

    2009-06-01

    Full Text Available In many cities of Brazil, social inequality is illustrated by violence, poverty, and unemployment located next to luxurious residential towers and armored passenger cars. In the face of this situation, the National Movement of Urban Reform encouraged the inclusion of the social function of property in Brazil's new constitution of 1988. Surface rights represent an urbanistic instrument in the city statute that is best aligned to the constitutional principles and urban policies. The current article compares two laws that govern the principle of surface rights and provides a brief history of the evolution of the state based on illuminism and the consequent change in paradigm affecting individual rights, including property and civil rights, and their interpretation under the Constitution. The article concludes by suggesting the use of land surface rights in a joint operation, matching the ownership of the property with urban planning policies and social interest.

  9. The Right of Privacy of Public School Employees.

    Science.gov (United States)

    Bullock, Angela; Faber, Charles F.

    A nationwide controversy over the right of privacy has arisen as a result of companies probing into their workers' habits and health through such means as mandatory drug tests, electronic databases, and lie detector tests. The legal claims arising from these civil suits against employers for invasion of privacy have established precedents that are…

  10. Teenagers and drugs

    Science.gov (United States)

    Teenagers and drugs; Symptoms of drug use in teenagers; Drug abuse - teenagers; Substance abuse - teenagers ... for a specialist who has experience working with teenagers. Do not hesitate, get help right away. The ...

  11. Use of Mycobacterium smegmatis deficient in ADP-ribosyltransferase as surrogate for Mycobacterium tuberculosis in drug testing and mutation analysis.

    Science.gov (United States)

    Agrawal, Priyanka; Miryala, Sandeep; Varshney, Umesh

    2015-01-01

    Rifampicin (Rif) is a first line drug used for tuberculosis treatment. However, the emergence of drug resistant strains has necessitated synthesis and testing of newer analogs of Rif. Mycobacterium smegmatis is often used as a surrogate for M. tuberculosis. However, the presence of an ADP ribosyltransferase (Arr) in M. smegmatis inactivates Rif, rendering it impractical for screening of Rif analogs or other compounds when used in conjunction with them (Rif/Rif analogs). Rifampicin is also used in studying the role of various DNA repair enzymes by analyzing mutations in RpoB (a subunit of RNA polymerase) causing Rif resistance. These analyses use high concentrations of Rif when M. smegmatis is used as model. Here, we have generated M. smegmatis strains by deleting arr (Δarr). The M. smegmatis Δarr strains show minimum inhibitory concentration (MIC) for Rif which is similar to that for M. tuberculosis. The MICs for isoniazid, pyrazinamide, ethambutol, ciprofloxacin and streptomycin were essentially unaltered for M. smegmatis Δarr. The growth profiles and mutation spectrum of Δarr and, Δarr combined with ΔudgB (udgB encodes a DNA repair enzyme that excises uracil) strains were similar to their counterparts wild-type for arr. However, the mutation spectrum of ΔfpgΔarr strain differed somewhat from that of the Δfpg strain (fpg encodes a DNA repair enzyme that excises 8-oxo-G). Our studies suggest M. smegmatis Δarr strain as an ideal model system in drug testing and mutation spectrum determination in DNA repair studies.

  12. Use of Mycobacterium smegmatis deficient in ADP-ribosyltransferase as surrogate for Mycobacterium tuberculosis in drug testing and mutation analysis.

    Directory of Open Access Journals (Sweden)

    Priyanka Agrawal

    Full Text Available Rifampicin (Rif is a first line drug used for tuberculosis treatment. However, the emergence of drug resistant strains has necessitated synthesis and testing of newer analogs of Rif. Mycobacterium smegmatis is often used as a surrogate for M. tuberculosis. However, the presence of an ADP ribosyltransferase (Arr in M. smegmatis inactivates Rif, rendering it impractical for screening of Rif analogs or other compounds when used in conjunction with them (Rif/Rif analogs. Rifampicin is also used in studying the role of various DNA repair enzymes by analyzing mutations in RpoB (a subunit of RNA polymerase causing Rif resistance. These analyses use high concentrations of Rif when M. smegmatis is used as model. Here, we have generated M. smegmatis strains by deleting arr (Δarr. The M. smegmatis Δarr strains show minimum inhibitory concentration (MIC for Rif which is similar to that for M. tuberculosis. The MICs for isoniazid, pyrazinamide, ethambutol, ciprofloxacin and streptomycin were essentially unaltered for M. smegmatis Δarr. The growth profiles and mutation spectrum of Δarr and, Δarr combined with ΔudgB (udgB encodes a DNA repair enzyme that excises uracil strains were similar to their counterparts wild-type for arr. However, the mutation spectrum of ΔfpgΔarr strain differed somewhat from that of the Δfpg strain (fpg encodes a DNA repair enzyme that excises 8-oxo-G. Our studies suggest M. smegmatis Δarr strain as an ideal model system in drug testing and mutation spectrum determination in DNA repair studies.

  13. Application of firefly luciferase assay for adenosine triphosphate (ATP) to antimicrobial drug sensitivity testing

    Science.gov (United States)

    Picciolo, G. L.; Tuttle, S. A.; Schrock, C. G.; Deming, J. W.; Barza, M. J.; Wienstein, L.; Chappelle, E. W.

    1977-01-01

    The development of a rapid method for determining microbial susceptibilities to antibiotics using the firefly luciferase assay for adenosine triphosphate (ATP) is documented. The reduction of bacterial ATP by an antimicrobial agent was determined to be a valid measure of drug effect in most cases. The effect of 12 antibiotics on 8 different bacterial species gave a 94 percent correlation with the standard Kirby-Buer-Agar disc diffusion method. A 93 percent correlation was obtained when the ATP assay method was applied directly to 50 urine specimens from patients with urinary tract infections. Urine samples were centrifuged first to that bacterial pellets could be suspended in broth. No primary isolation or subculturing was required. Mixed cultures in which one species was predominant gave accurate results for the most abundant organism. Since the method is based on an increase in bacterial ATP with time, the presence of leukocytes did not interfere with the interpretation of results. Both the incubation procedure and the ATP assays are compatible with automation.

  14. A Robust PCR Protocol for HIV Drug Resistance Testing on Low-Level Viremia Samples

    Directory of Open Access Journals (Sweden)

    Shivani Gupta

    2017-01-01

    Full Text Available The prevalence of drug resistance (DR mutations in people with HIV-1 infection, particularly those with low-level viremia (LLV, supports the need to improve the sensitivity of amplification methods for HIV DR genotyping in order to optimize antiretroviral regimen and facilitate HIV-1 DR surveillance and relevant research. Here we report on a fully validated PCR-based protocol that achieves consistent amplification of the protease (PR and reverse transcriptase (RT regions of HIV-1 pol gene across many HIV-1 subtypes from LLV plasma samples. HIV-spiked plasma samples from the External Quality Assurance Program Oversight Laboratory (EQAPOL, covering various HIV-1 subtypes, as well as clinical specimens were used to optimize and validate the protocol. Our results demonstrate that this protocol has a broad HIV-1 subtype coverage and viral load span with high sensitivity and reproducibility. Moreover, the protocol is robust even when plasma sample volumes are limited, the HIV viral load is unknown, and/or the HIV subtype is undetermined. Thus, the protocol is applicable for the initial amplification of the HIV-1 PR and RT genes required for subsequent genotypic DR assays.

  15. Research in Drug Development against Viral Diseases of Military Importance (Biological Testing). Volume 1

    Science.gov (United States)

    1991-03-01

    Rhabdoviridae family. Vaccinia Virus is currently employed as a representation of the DNA Virus (Poxviridae). This agent poses a threat to the military...Arenaviridae, Rhabdoviridae , Poxviridae, Adenoviridae and Retroviridae families. The test viruses consist of the following: (1) Vaccinia (VV) Virus, (2

  16. Integration of HIV testing in tuberculosis drug resistance surveillance in Kazakhstan and Kenya

    NARCIS (Netherlands)

    Klinkenberg, E.; van den Hof, S.; Tursynbayeva, A.; Kipruto, H.; Wahogo, J.; Pak, S.; Kutwa, A.; L'Herminez, R.

    2012-01-01

    In Kenya and Kazakhstan, integration of human immunodeficiency virus (HIV) testing results into the routine surveillance of multidrug-resistant tuberculosis (MDR-TB) proved feasible and useful. The integration process improved overall data quality and data validation capacity, and integrated data

  17. 77 FR 10509 - Agency Information Collection Activities; Proposed Collection; Comment Request; Drug Testing for...

    Science.gov (United States)

    2012-02-22

    ... that may potentially affect communities and the surrounding environment. Releases may be accidental... may be responsible for testing their employees for the use of marijuana, cocaine, opiates.... Respondents/Affected Entities: EPA contractor employees who work at sensitive sites. Estimated Number of...

  18. Direct nitrate reductase assay versus microscopic observation drug susceptibility test for rapid detection of MDR-TB in Uganda.

    Directory of Open Access Journals (Sweden)

    Freddie Bwanga

    Full Text Available The most common method for detection of drug resistant (DR TB in resource-limited settings (RLSs is indirect susceptibility testing on Lowenstein-Jensen medium (LJ which is very time consuming with results available only after 2-3 months. Effective therapy of DR TB is therefore markedly delayed and patients can transmit resistant strains. Rapid and accurate tests suitable for RLSs in the diagnosis of DR TB are thus highly needed. In this study we compared two direct techniques--Nitrate Reductase Assay (NRA and Microscopic Observation Drug Susceptibility (MODS for rapid detection of MDR-TB in a high burden RLS. The sensitivity, specificity, and proportion of interpretable results were studied. Smear positive sputum was collected from 245 consecutive re-treatment TB patients attending a TB clinic in Kampala, Uganda. Samples were processed at the national reference laboratory and tested for susceptibility to rifampicin and isoniazid with direct NRA, direct MODS and the indirect LJ proportion method as reference. A total of 229 specimens were confirmed as M. tuberculosis, of these interpretable results were obtained in 217 (95% with either the NRA or MODS. Sensitivity, specificity and kappa agreement for MDR-TB diagnosis was 97%, 98% and 0.93 with the NRA; and 87%, 95% and 0.78 with the MODS, respectively. The median time to results was 10, 7 and 64 days with NRA, MODS and the reference technique, respectively. The cost of laboratory supplies per sample was low, around 5 USD, for the rapid tests. The direct NRA and MODS offered rapid detection of resistance almost eight weeks earlier than with the reference method. In the study settings, the direct NRA was highly sensitive and specific. We consider it to have a strong potential for timely detection of MDR-TB in RLS.

  19. Orally inhaled drug performance testing for product development, registration, and quality control.

    Science.gov (United States)

    Lastow, Orest; Svensson, Mårten

    2014-12-01

    A DPI can be split into three different modules; device, formulation, process. These are developed in parallel, and together with the user they provide the performance of an inhalation product. During product development, these modules are evolving and changing, whereas the requirements on an inhalation product are always expressed in terms of the performance of the final commercial product. To do performance testing during development when the product is not finished presents many challenges and can be confusing and misleading. During development, the performance of the final product is typically being predicted by testing ever changing prototypes. This article describes methods and approaches to manage such development and to, during development, provide relevant predictions of the in vitro and in vivo performances of the final product.

  20. Real-world utilization of molecular diagnostic testing and matched drug therapies in the treatment of metastatic cancers.

    Science.gov (United States)

    Chawla, Anita; Peeples, Miranda; Li, Nanxin; Anhorn, Rachel; Ryan, Jason; Signorovitch, James

    2018-06-01

    To assess the frequency of biopsies and molecular diagnostic testing (human DNA/RNA analysis), anti-cancer drug use (genomically-matched targeted therapy [GMTT], unmatched targeted therapy [UTT], endocrine therapy [ET], and chemotherapy [CT]), and medical service costs among adults with metastatic cancer. Adults diagnosed with metastatic breast, non-small cell lung (NSCLC), colorectal, head and neck, ovarian, and uterine cancer (2010Q1-2015Q1) were identified in the OptumHealth Care Solutions claims database and followed from first metastatic diagnosis for ≥1 month and until the end of data availability. Utilization was assessed for each cancer cohort (all and patients aged ≥65 years); per-patient-per-month (PPPM) medical service costs were assessed for all patients. Testing frequency estimates were applied to Surveillance, Epidemiology, and End Results Program data to estimate the number of untested patients (2010-2014). Patients with metastatic cancer (n = 8,193; breast [n = 3,414], NSCLC [n = 2,231], colorectal [n = 1,611], head and neck [n = 511], ovarian [n = 275], and uterine [n = 151]) were 63 years old (mean), with 11.1-22.2 months of observation. Biopsy and molecular diagnostic testing frequencies ranged from 7% (uterine) to 73% (ovarian), and from 34% (head and neck) to 52% (breast), respectively. Few were treated with GMTT (breast, 11%; NSCLC, 9%; colorectal, 6%). Treatment with UTT ranged from 0.7% (uterine) to 21% (colorectal). Biopsy, diagnostic testing, and anti-cancer drug therapy were less frequent for those ≥65 years. Medical service costs (PPPM, mean) ranged from $6,618 (head and neck) to $9,940 (ovarian). The estimated number of untested new patients with metastatic cancer was 636,369 (all) and 341,397 (≥65). In addition to the limitations of claims analyses, diagnostic testing frequency may be under-estimated if patients underwent testing prior to study inclusion. The low frequency of molecular diagnostic

  1. Country-wide surveillance of molecular markers of antimalarial drug resistance in Senegal by use of positive Malaria Rapid Diagnostic Tests

    DEFF Research Database (Denmark)

    Ndiaye, Magatte; Sow, Doudou; Nag, Sidsel

    2017-01-01

    of drug resistance. Therefore, surveillance of drug resistance in the malaria parasites is essential. The objective of this pilot study was to test the feasibility of routinely sampled malaria rapid diagnostic tests (RDTs) at a national scale to assess the temporal changes in the molecular profiles...... of antimalarial drug resistance markers of Plasmodium falciparum parasites. Overall, 9,549 positive malaria RDTs were collected from 14 health facilities across the country. A limited random set of RDTs were analyzed regarding Pfcrt gene polymorphisms at codon 72-76. Overall, a high but varied prevalence (> 50...

  2. Treatment of fevers prior to introducing rapid diagnostic tests for malaria in registered drug shops in Uganda

    DEFF Research Database (Denmark)

    Mbonye, Anthony K.; Lal, Sham; Cundill, Bonnie

    2013-01-01

    questionnaire to capture data on drug shops (n=65) including provider characteristics, knowledge on treatment of malaria, previous training received, type of drugs stocked, reported drug sales, and record keeping practices; and a patient questionnaire to capture data from febrile patients (n=540) exiting drug...

  3. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Cigs Other Drugs Related Topics Addiction Science Adolescent Brain Comorbidity College-Age & Young Adults Criminal Justice Drugged Driving Drug Testing Drugs and the Brain Genetics Global Health Health Consequences of Drug Misuse ...

  4. Pharmacokinetic modeling of an induction regimen for in vivo combined testing of novel drugs against pediatric acute lymphoblastic leukemia xenografts.

    Directory of Open Access Journals (Sweden)

    Barbara Szymanska

    Full Text Available Current regimens for induction therapy of pediatric acute lymphoblastic leukemia (ALL, or for re-induction post relapse, use a combination of vincristine (VCR, a glucocorticoid, and L-asparaginase (ASP with or without an anthracycline. With cure rates now approximately 80%, robust pre-clinical models are necessary to prioritize active new drugs for clinical trials in relapsed/refractory patients, and the ability of these models to predict synergy/antagonism with established therapy is an essential attribute. In this study, we report optimization of an induction-type regimen by combining VCR, dexamethasone (DEX and ASP (VXL against ALL xenograft models established from patient biopsies in immune-deficient mice. We demonstrate that the VXL combination was synergistic in vitro against leukemia cell lines as well as in vivo against ALL xenografts. In vivo, VXL treatment caused delays in progression of individual xenografts ranging from 22 to >146 days. The median progression delay of xenografts derived from long-term surviving patients was 2-fold greater than that of xenografts derived from patients who died of their disease. Pharmacokinetic analysis revealed that systemic DEX exposure in mice increased 2-fold when administered in combination with VCR and ASP, consistent with clinical findings, which may contribute to the observed synergy between the 3 drugs. Finally, as proof-of-principle we tested the in vivo efficacy of combining VXL with either the Bcl-2/Bcl-xL/Bcl-w inhibitor, ABT-737, or arsenic trioxide to provide evidence of a robust in vivo platform to prioritize new drugs for clinical trials in children with relapsed/refractory ALL.

  5. [Use of pharmacogenetic testing to prevent adverse drug reactions during statin therapy].

    Science.gov (United States)

    Rumyantsev, N A; Kukes, V G; Kazakov, R E; Rumyantsev, A A; Sychev, D A

    The number of patients receiving statins increases every year and due to the fact that they should take statins during their lives, the problem of their safety use comes to the forefront. The paper analyzes the safety of using the medications of this group and discusses the diagnosis of myopathies induced by statins and the occurrence of immune-mediated statin myopathies. It considers a personalized approach to prescribing statins, analyzes Russian and foreign experience in using pharmacogenetics to reduce the risk of myopathies, publishes the results of the authors' experience in clinically introducing pharmacogenetic testing at hospitals, and analyzes the long-term results of determining the polymorphism of the SLCO1B1 gene for the prediction of the risk of adverse events when using statins and estimating patient compliance to prescribed treatment.

  6. Human rights

    NARCIS (Netherlands)

    Gaay Fortman, B. de

    2006-01-01

    Human rights reflect a determined effort to protect the dignity of each and every human being against abuse of power. This endeavour is as old as human history. What is relatively new is the international venture for the protection of human dignity through internationally accepted legal standards

  7. Deconstructing Rights

    International Development Research Centre (IDRC) Digital Library (Canada)

    Karen Kershaw

    Kerala, India. Parallel Sessions II ... limits of a coming political community ... economies on women's rights & decentralization. Deconstructing ... resorts around all water sources inland and coastal, high-rise buildings ... None work in fishing industry (they have family links) ... ACCESS TO POWER gained by individual women ...

  8. Odour identification test and its relation to cardiac 123I‐metaiodobenzylguanidine in patients with drug induced parkinsonism

    Science.gov (United States)

    Lee, Phil Hyu; Yeo, Seung Hyeon; Yong, Seok Woo; Kim, Yun Joong

    2007-01-01

    We investigated olfactory function and its relation to cardiac 123I‐metaiodobenzylguanidine (MIBG) uptake in 15 patients with drug induced parkinsonism (DIP). The mean Cross Cultural Smell Identification (CCSI) score was significantly greater in patients with DIP than in those with Parkinson's disease (PD: 6.9 (1.6) vs 4.4 (2.2); p<0.001); however, the mean CCSI score in patients with DIP was not significantly different from controls. One patient with DIP, whose CCSI score was significantly reduced, also exhibited decreased cardiac MIBG uptake. DIP patients with CCSI scores within the normal range had normal cardiac MIBG uptake. Our study suggests that an olfactory function test may be a useful tool for detecting DIP unrelated to PD and for identifying patients with DIP who have subclinical PD. PMID:17557797

  9. The determination of phenazone in blood plasma for obtained sistem suitable test of monitoring drug level

    Directory of Open Access Journals (Sweden)

    Mochamad Lazuardi

    2007-09-01

    Full Text Available The determining of Phenazone to human blood plasma from healthy man after separated by solid phase extraction (SPE and spectroscopic measurements has been investigated. The objective of that research was to obtain system suitable test for determine the Phenazone level in biological fluids (human blood plasma, for new performed dosage regimented in clinical dentistry. The method can be divided into the following four steps. 1. Centrifugation the blood sample, 2. Extraction from blood plasma and, 3. Separation by SPE with manual pressured, 4. Elution to SPE followed by the measurement on a spectrophotometer in the ultra violet region. The critical value of  │t │at the 5% confidence level indicates that there is no systematic error in the linearity proposed method. Recoveries for this research were obtained at ranging 93.460 to 95.598%. The coefficient variation precision of this procedure was clearly good at smallest than 2%. The analytical procedure can be carried out in one working operation as a monitored therapeutic activity.

  10. Usefulness of lung and right ventricular thallium-201 uptake during single photon emission computed tomography in exercise testing of patients with coronary artery disease

    International Nuclear Information System (INIS)

    Matoh, Fumitaka; Tawarahara, Kei; Mikami, Naoshi

    2005-01-01

    Increased pulmonary or right ventricular 201 Tl uptake during the exercise test has been used as a marker of multivessel coronary artery disease. The most useful method for assessing the severity of coronary artery disease was evaluated among conventional evaluation of single photon emission computed tomography (SPECT), measurement of lung to heart uptake ratio (L/H), and right ventricular to left ventricular uptake ratio (RV/LV) on 201 Tl images during exercise testing. Regions-of-interest (4 x 4 pixels) were placed at the lung and the heart, and L/H was defined as mean lung uptake/mean heart uptake. Correspondingly, regions-of-interest (4 x 4 pixels) were placed at the RV and the LV, and RV/LV was defined as maximum RV uptake/maximum LV uptake. L/H and RV/LV on the initial image were analyzed in 216 patients (angiographically normal coronary arteries: 89, single-vessel disease: 82, multivessel disease: 45). The diagnostic value was evaluated using the receiver operating characteristic curve. All methods showed significantly higher values in patients with multivessel disease than in patients with no coronary artery disease or single-vessel disease. L/H was significantly higher in patients with prior myocardial infarction and RV/LV was significantly higher in patients without infarction. The sensitivity of only conventional SPECT evaluation for multivessel coronary artery disease was low (sensitivity 53%, specificity 94%). However, addition of evaluation of L/H and RV/LV to SPECT improved the sensitivity for multivessel coronary artery disease (sensitivity 93%, specificity 49%). The diagnostic sensitivity for multivessel coronary artery disease was improved by adding L/H and RV/LV to conventional evaluation of exercise 201 Tl SPECT. L/H and RV/LV during exercise 201 Tl imaging may provide additional information regarding the severity of coronary artery disease. (author)

  11. Geometric classification of scalp hair for valid drug testing, 6 more reliable than 8 hair curl groups.

    Directory of Open Access Journals (Sweden)

    K Mkentane

    Full Text Available Curly hair is reported to contain higher lipid content than straight hair, which may influence incorporation of lipid soluble drugs. The use of race to describe hair curl variation (Asian, Caucasian and African is unscientific yet common in medical literature (including reports of drug levels in hair. This study investigated the reliability of a geometric classification of hair (based on 3 measurements: the curve diameter, curl index and number of waves.After ethical approval and informed consent, proximal virgin (6cm hair sampled from the vertex of scalp in 48 healthy volunteers were evaluated. Three raters each scored hairs from 48 volunteers at two occasions each for the 8 and 6-group classifications. One rater applied the 6-group classification to 80 additional volunteers in order to further confirm the reliability of this system. The Kappa statistic was used to assess intra and inter rater agreement.Each rater classified 480 hairs on each occasion. No rater classified any volunteer's 10 hairs into the same group; the most frequently occurring group was used for analysis. The inter-rater agreement was poor for the 8-groups (k = 0.418 but improved for the 6-groups (k = 0.671. The intra-rater agreement also improved (k = 0.444 to 0.648 versus 0.599 to 0.836 for 6-groups; that for the one evaluator for all volunteers was good (k = 0.754.Although small, this is the first study to test the reliability of a geometric classification. The 6-group method is more reliable. However, a digital classification system is likely to reduce operator error. A reliable objective classification of human hair curl is long overdue, particularly with the increasing use of hair as a testing substrate for treatment compliance in Medicine.

  12. Improving patient safety and efficiency of medication reconciliation through the development and adoption of a computer-assisted tool with automated electronic integration of population-based community drug data: the RightRx project.

    Science.gov (United States)

    Tamblyn, Robyn; Winslade, Nancy; Lee, Todd C; Motulsky, Aude; Meguerditchian, Ari; Bustillo, Melissa; Elsayed, Sarah; Buckeridge, David L; Couture, Isabelle; Qian, Christina J; Moraga, Teresa; Huang, Allen

    2018-05-01

    Many countries require hospitals to implement medication reconciliation for accreditation, but the process is resource-intensive, thus adherence is poor. We report on the impact of prepopulating and aligning community and hospital drug lists with data from population-based and hospital-based drug information systems to reduce workload and enhance adoption and use of an e-medication reconciliation application, RightRx. The prototype e-medical reconciliation web-based software was developed for a cluster-randomized trial at the McGill University Health Centre. User-centered design and agile development processes were used to develop features intended to enhance adoption, safety, and efficiency. RightRx was implemented in medical and surgical wards, with support and training provided by unit champions and field staff. The time spent per professional using RightRx was measured, as well as the medication reconciliation completion rates in the intervention and control units during the first 20 months of the trial. Users identified required modifications to the application, including the need for dose-based prescribing, the role of the discharge physician in prescribing community-based medication, and access to the rationale for medication decisions made during hospitalization. In the intervention units, both physicians and pharmacists were involved in discharge reconciliation, for 96.1% and 71.9% of patients, respectively. Medication reconciliation was completed for 80.7% (surgery) to 96.0% (medicine) of patients in the intervention units, and 0.7% (surgery) to 82.7% of patients in the control units. The odds of completing medication reconciliation were 9 times greater in the intervention compared to control units (odds ratio: 9.0, 95% confidence interval, 7.4-10.9, P < .0001) after adjusting for differences in patient characteristics. High rates of medication reconciliation completion were achieved with automated prepopulation and alignment of community and hospital

  13. Forest rights

    DEFF Research Database (Denmark)

    Balooni, Kulbhushan; Lund, Jens Friis

    2014-01-01

    One of the proposed strategies for implementation of reducing emissions from deforestation and forest degradation plus (REDD+) is to incentivize conservation of forests managed by communities under decentralized forest management. Yet, we argue that this is a challenging road to REDD+ because...... conservation of forests under existing decentralized management arrangements toward a push for extending the coverage of forests under decentralized management, making forest rights the hard currency of REDD+....

  14. 13C- and 15N-labelled non-biogenic compounds used as stable isotope drugs for human liver function tests

    International Nuclear Information System (INIS)

    Krumbiegel, P.

    1989-01-01

    As a result of liver diseases, the elimination of certain drugs is retarded. After labelling a suitable drug with 13 C, the 13 CO 2 elimination rate serves as a liver function parameter. Current contributions to the 13 CO 2 breath test method are reviewed and related to the 14 CO 2 breath test proposals. In spite of several advantages of 13 C-labelled agents, some dissatisfaction has remained with the tests, especially at using them with infants. It is the necessity of face masks and the uncertainty to consider endogeneous CO 2 contributions diluting the exhaled 13 CO 2 . The problems are avoided if the other molecule site of the drug is labelled which is known to be eliminated via urine. With 15 N as a tracer, a suitable urine test using [ 15 N]-methacetin as agent has been proposed and put into practice. (author)

  15. Anti-tuberculosis drug combination for controlled oral delivery using 3D printed compartmental dosage forms: From drug product design to in vivo testing

    DEFF Research Database (Denmark)

    Genina, Natalja; Boetker, Johan Peter; Colombo, Stefano

    2017-01-01

    for treatment of tuberculosis (TB) that negatively interact with each other upon simultaneous release in acidic environment. The dcDUs were designed in silico by computer aided design (CAD) and fabricated in two steps; first three-dimensional (3D) printing of the outer structure, followed by hot-melt extrusion...... (HME) of the drug-containing filaments. The structure of the fabricated dcDUs was visualized by scanning electron microscopy (SEM). The 3D printed compartmentalized shells were loaded with filaments containing active pharmaceutical ingredient (API) and selectively sealed to modulate drug dissolution...

  16. Testing the antidepressant properties of the peptide ARA290 in a human neuropsychological model of drug action.

    Science.gov (United States)

    Cerit, Hilâl; Veer, Ilya M; Dahan, Albert; Niesters, Marieke; Harmer, Catherine J; Miskowiak, Kamilla W; Rombouts, Serge A R B; Van der Does, Willem

    2015-12-01

    Studies on the neural effects of Erythropoietin (EPO) indicate that EPO may have antidepressant effects. Due to its hematopoietic effects, EPO may cause serious side-effects with repeated administration if patients are not monitored extensively. ARA290 is an EPO-analog peptide without such hematopoietic side-effects but may have neurotrophic and antidepressant effects. The aim of this study was to investigate the possible antidepressant effects of ARA290 in a neuropsychological model of drug action. Healthy participants (N=36) received ARA290 (2mg) or placebo in a double-blind, randomized, parallel-group design. Neural and cognitive effects were assessed one week after administration. Primary outcome measures were the neural processing of fearful vs happy faces and the behavioral recognition of emotional facial expressions. ARA290-treated individuals displayed lower neural responses to happy faces in the fusiform gyrus. ARA290 tended to lower the recognition of happy and disgust facial expressions. Although ARA290 was not associated with a better memory for positive words, it was associated with faster categorization of positive vs negative words. Finally, ARA290 increased attention towards positive emotional pictures. No effects were observed on mood and affective symptoms. ARA290 may modulate some aspects of emotional processing, however, the direction and the strength of its effects do not unequivocally support an antidepressant-like profile for ARA290. Future studies may investigate the effects of different timing and dose. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.

  17. Diagnostic approach to drug-screening tests for fatal diabetic ketoacidosis: forensic autopsy of a methamphetamine abuser.

    Science.gov (United States)

    Kashiwagi, Masayuki; Hara, Kenji; Liu, Zhao; Kageura, Mitsuyoshi; Matsusue, Aya; Sugimura, Tomoko; Kubo, Shin-ichi

    2010-07-01

    To diagnose the cause of death in autopsy cases, systematic examinations, such as macroscopic, pathological, biochemical, and toxicological are important. In this case report, drug examinations also gave very useful information to diagnose the cause of death, fatal diabetic ketoacidosis (DKA). A female methamphetamine abuser in her forties was found dead lying on a hotel bed. Diagnosing her cause of death was difficult only from the macroscopic findings because there was no fatal and/or serious injury or disease. On toxicological examination, acetone was detected at a high concentration (682 microg/mL in blood, 887 microg/mL in urine) using gas chromatography (GC). Using gas chromatography-mass spectrometry (GC-MS), methamphetamine was detected in the blood, urine, hair, and visceral organs; however, these concentrations were low. At the same time, GC-MS examination revealed a high glucose peak. From the results of the biochemical examination of urine, acetoacetic acid was 1940 micromol/L, beta-hydroxybutyric acid was 14,720 micromol/L, and glucose was 4620 mg/dL. Histologically, Langerhans' islets in the pancreas were fibrotic and atrophic, and no insulin-immunoreactive cells were observed. The subsequent police investigation also revealed that she had contracted diabetes mellitus type 1; therefore, we concluded that her cause of death was DKA, due to a lack of insulin injection. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

  18. Genetic pharmacotherapy as an early CNS drug development strategy: testing glutaminase inhibition for schizophrenia treatment in adult mice

    Directory of Open Access Journals (Sweden)

    Susana eMingote

    2016-01-01

    Full Text Available Genetic pharmacotherapy is an early drug development strategy for the identification of novel CNS targets in mouse models prior to the development of specific ligands. Here for the first time, we have implemented this strategy to address the potential therapeutic value of a glutamate-based pharmacotherapy for schizophrenia involving inhibition of the glutamate recycling enzyme phosphate-activated glutaminase. Mice constitutively heterozygous for GLS1, the gene encoding glutaminase, manifest a schizophrenia resilience phenotype, a key dimension of which is an attenuated locomotor response to propsychotic amphetamine challenge. If resilience is due to glutaminase deficiency in adulthood, then glutaminase inhibitors should have therapeutic potential. However, this has been difficult to test given the dearth of neuroactive glutaminase inhibitors. So, we used genetic pharmacotherapy to test the therapeutic potential of glutaminase inhibition. We specifically asked whether adult induction of GLS1 heterozygosity would attenuate amphetamine responsiveness. We generated conditional floxGLS1 mice and crossed them with global CAG ERT2 cre/+ mice to produce GLS1 iHET mice, susceptible to tamoxifen induction of GLS1 heterozygosity. One month after tamoxifen treatment of adult GLS1 iHET mice, we found a 50% reduction in GLS1 allelic abundance and glutaminase mRNA levels in the brain. While GLS1 iHET mice showed some recombination prior to tamoxifen, there was no impact on mRNA levels. We then asked whether induction of GLS heterozygosity would attenuate the locomotor response to propsychotic amphetamine challenge. Before tamoxifen, control and GLS1 iHET mice did not differ in their response to amphetamine. One month after tamoxifen treatment, amphetamine-induced hyperlocomotion was blocked in GLS1 iHET mice. The block was largely maintained after 5 months. Thus, a genetically induced glutaminase reduction — mimicking pharmacological inhibition — strongly

  19. Screening tests in toxicity or drug effect studies with use of centrifichem general-purpose spectrophotometeric analyzer

    International Nuclear Information System (INIS)

    Nagy, B.; Bercz, J.P.

    1986-01-01

    CentrifiChem System 400 general-purpose spectrophotometric analyzer which can process simultaneously 30 samples and reads the reactions within milliseconds was used for toxicity studies. Organic and inorganic chemicals were screened for inhibitory action of the hydrolytic activity of sarcoplasmic reticulum (SR) Ca,Mg-ATPase and that of the sacrolemmal (SL) Na,K-ATPase, or mitochondrial ATPase (M). SR and SL were prepared from rabbit muscles, Na,K-ATPase from pig kidneys, M from pig hearts. Pseudosubstrates of paranitrophenyl phosphate and 2,4-dinitrophenyl phosphate, both proven high energy phosphate substitutes for ATPase coupled ion transfer were used. The reaction rates were followed spectrophotometrically at 405 nm measuring the accumulation of yellow nitrophenolate ions. The reported calcium transfer coupling ratio to hydrolysis of 2:1 was ascertained with use of 45 Ca in case of SR. Inhibition constants (pI) on SR, SL, and M for the pseudosubstrate hydrolysis will be given for over 20 chemicals tested. The applicability of the system to general toxicity testing and to general cardio-effective drug screening will be presented

  20. Cost-effectiveness analysis of microscopic observation drug susceptibility test versus Xpert MTB/Rif test for diagnosis of pulmonary tuberculosis in HIV patients in Uganda.

    Science.gov (United States)

    Walusimbi, Simon; Kwesiga, Brendan; Rodrigues, Rashmi; Haile, Melles; de Costa, Ayesha; Bogg, Lennart; Katamba, Achilles

    2016-10-10

    Microscopic Observation Drug Susceptibility (MODS) and Xpert MTB/Rif (Xpert) are highly sensitive tests for diagnosis of pulmonary tuberculosis (PTB). This study evaluated the cost effectiveness of utilizing MODS versus Xpert for diagnosis of active pulmonary TB in HIV infected patients in Uganda. A decision analysis model comparing MODS versus Xpert for TB diagnosis was used. Costs were estimated by measuring and valuing relevant resources required to perform the MODS and Xpert tests. Diagnostic accuracy data of the tests were obtained from systematic reviews involving HIV infected patients. We calculated base values for unit costs and varied several assumptions to obtain the range estimates. Cost effectiveness was expressed as costs per TB patient diagnosed for each of the two diagnostic strategies. Base case analysis was performed using the base estimates for unit cost and diagnostic accuracy of the tests. Sensitivity analysis was performed using a range of value estimates for resources, prevalence, number of tests and diagnostic accuracy. The unit cost of MODS was US$ 6.53 versus US$ 12.41 of Xpert. Consumables accounted for 59 % (US$ 3.84 of 6.53) of the unit cost for MODS and 84 % (US$10.37 of 12.41) of the unit cost for Xpert. The cost effectiveness ratio of the algorithm using MODS was US$ 34 per TB patient diagnosed compared to US$ 71 of the algorithm using Xpert. The algorithm using MODS was more cost-effective compared to the algorithm using Xpert for a wide range of different values of accuracy, cost and TB prevalence. The cost (threshold value), where the algorithm using Xpert was optimal over the algorithm using MODS was US$ 5.92. MODS versus Xpert was more cost-effective for the diagnosis of PTB among HIV patients in our setting. Efforts to scale-up MODS therefore need to be explored. However, since other non-economic factors may still favour the use of Xpert, the current cost of the Xpert cartridge still needs to be reduced further by more than

  1. Infection control, genetic assessment of drug resistance and drug susceptibility testing in the current management of multidrug/extensively-resistant tuberculosis (M/XDR-TB) in Europe

    DEFF Research Database (Denmark)

    Bothamley, Graham H.; Lange, Christoph; Albrecht, Dirk

    2017-01-01

    AIM: Europe has the highest documented caseload and greatest increase in multidrug and extensively drug-resistant tuberculosis (M/XDR-TB) of all World Health Organization (WHO) regions. This survey examines how recommendations for M/XDR-TB management are being implemented. METHODS: TBNET is a pan...

  2. An integrated device for magnetically-driven drug release and in situ quantitative measurements: Design, fabrication and testing

    Energy Technology Data Exchange (ETDEWEB)

    Bruvera, I.J. [Aragon Institute of Nanoscience (INA), University of Zaragoza, 50018 (Spain); Hernández, R.; Mijangos, C. [Instituto de Ciencia y Tecnología de Polímeros, CSIC, Juan Cierva 3, E-28006 Madrid (Spain); Goya, G.F., E-mail: goya@unizar.es [Aragon Institute of Nanoscience (INA), University of Zaragoza, 50018 (Spain); Condensed Matter Physics Department, Science Faculty, University of Zaragoza, 50009 (Spain)

    2015-03-01

    We have developed a device capable of remote triggering and in situ quantification of therapeutic drugs, based on magnetically-responsive hydrogels of poly (N-isopropylacrylamide) and alginate (PNiPAAm). The heating efficiency of these hydrogels measured by their specific power absorption (SPA) values showed that the values between 100 and 300 W/g of the material were high enough to reach the lower critical solution temperature (LCST) of the polymeric matrix within few minutes. The drug release through application of AC magnetic fields could be controlled by time-modulated field pulses in order to deliver the desired amount of drug. Using B12 vitamin as a concept drug, the device was calibrated to measure amounts of drug released as small as 25(2)×10{sup −9} g, demonstrating the potential of this device for very precise quantitative control of drug release. - Highlights: • A device for magnetically driven drug release was developed and constructed. • Thermally responsive PNiPAAm and Fe3O4 nanoparticles were usedas drug reservoir. • The device allowed repetitive, remote and precisely controlled drug release. • By in situ spectrometry we could detect released drug quantities as small as 25 ng. • Released drug was controlled through magnetic ac field parameters H, f and time.

  3. An integrated device for magnetically-driven drug release and in situ quantitative measurements: Design, fabrication and testing

    International Nuclear Information System (INIS)

    Bruvera, I.J.; Hernández, R.; Mijangos, C.; Goya, G.F.

    2015-01-01

    We have developed a device capable of remote triggering and in situ quantification of therapeutic drugs, based on magnetically-responsive hydrogels of poly (N-isopropylacrylamide) and alginate (PNiPAAm). The heating efficiency of these hydrogels measured by their specific power absorption (SPA) values showed that the values between 100 and 300 W/g of the material were high enough to reach the lower critical solution temperature (LCST) of the polymeric matrix within few minutes. The drug release through application of AC magnetic fields could be controlled by time-modulated field pulses in order to deliver the desired amount of drug. Using B12 vitamin as a concept drug, the device was calibrated to measure amounts of drug released as small as 25(2)×10 −9 g, demonstrating the potential of this device for very precise quantitative control of drug release. - Highlights: • A device for magnetically driven drug release was developed and constructed. • Thermally responsive PNiPAAm and Fe3O4 nanoparticles were usedas drug reservoir. • The device allowed repetitive, remote and precisely controlled drug release. • By in situ spectrometry we could detect released drug quantities as small as 25 ng. • Released drug was controlled through magnetic ac field parameters H, f and time

  4. Nurses' perception of the quality of care they provide to hospitalized drug addicts: testing the theory of reasoned action.

    Science.gov (United States)

    Natan, Merav Ben; Beyil, Valery; Neta, Okev

    2009-12-01

    A correlational design was used to examine nursing staff attitudes and subjective norms manifested in intended and actual care of drug users based on the Theory of Reasoned Action. One hundred and thirty-five nursing staff from three central Israeli hospitals completed a questionnaire examining theory-based variables as well as sociodemographic and professional characteristics. Most respondents reported a high to very high level of actual or intended care of drug users. Nurses' stronger intentions to provide quality care to drug users were associated with more positive attitudes. Nursing staff members had moderately negative attitudes towards drug users. Nurses were found to hold negative stereotypes of drug addict patients and most considered the management of this group difficult. Positive attitudes towards drug users, perceived expectations of others and perceived correctness of the behaviour are important in their effect on the intention of nurses to provide high-quality care to hospitalized patients addicted to drugs.

  5. Drug Resistance

    Science.gov (United States)

    ... Drug-resistance testing is also recommended for all pregnant women with HIV before starting HIV medicines and also in some pregnant women already taking HIV medicines. Pregnant women will work with their health ...

  6. IN VITRO MODELS TO EVALUATE DRUG-INDUCED HYPERSENSITIVITY: POTENTIAL TEST BASED ON ACTIVATION OF DENDRITIC CELLS

    Directory of Open Access Journals (Sweden)

    Valentina Galbiati

    2016-07-01

    Full Text Available Hypersensitivity drug reactions (HDRs are the adverse effect of pharmaceuticals that clinically resemble allergy. HDRs account for approximately 1/6 of drug-induced adverse effects, and include immune-mediated ('allergic' and non immune-mediated ('pseudo allergic' reactions. In recent years, the severe and unpredicted drug adverse events clearly indicate that the immune system can be a critical target of drugs. Enhanced prediction in preclinical safety evaluation is, therefore, crucial. Nowadays, there are no validated in vitro or in vivo methods to screen the sensitizing potential of drugs in the pre-clinical phase. The problem of non-predictability of immunologically-based hypersensitivity reactions is related to the lack of appropriate experimental models rather than to the lack of -understanding of the adverse phenomenon.We recently established experimental conditions and markers to correctly identify drug associated with in vivo hypersensitivity reactions using THP-1 cells and IL-8 production, CD86 and CD54 expression. The proposed in vitro method benefits from a rationalistic approach with the idea that allergenic drugs share with chemical allergens common mechanisms of cell activation. This assay can be easily incorporated into drug development for hazard identification of drugs, which may have the potential to cause in vivo hypersensitivity reactions. The purpose of this review is to assess the state of the art of in vitro models to assess the allergenic potential of drugs based on the activation of dendritic cells.

  7. The potential impact of density dependent fecundity on the use of the faecal egg count reduction test for detecting drug resistance in human hookworms.

    Directory of Open Access Journals (Sweden)

    Andrew C Kotze

    Full Text Available Current efforts to control human soil-transmitted helminth (STH infections involve the periodic mass treatment of people, particularly children, in all endemic areas, using benzimidazole and imidothiazole drugs. Given the fact that high levels of resistance have developed to these same drugs in roundworms of livestock, there is a need to monitor drug efficacy in human STHs. The faecal egg count reduction test (FECRT, in which faecal egg output is measured pre- and post-drug treatment, is presently under examination by WHO as a means of detecting the emergence of resistance. We have examined the potential impact of density dependent fecundity on FECRT data. Recent evidence with the canine hookworm indicates that the density dependent egg production phenomenon shows dynamic properties in response to drug treatment. This will impact on measurements of drug efficacy, and hence drug resistance. It is likely that the female worms that survive a FECRT drug treatment in some human cases will respond to the relaxation of density dependent constraints on egg production by increasing their egg output significantly compared to their pre-treatment levels. These cases will therefore underestimate drug efficacy in the FECRT. The degree of underestimation will depend on the ability of the worms within particular hosts to increase their egg output, which will in turn depend on the extent to which their egg output is constrained prior to the drug treatment. As worms within different human cases will likely be present at quite different densities prior to a proposed FECRT, there is potential for the effects of this phenomenon on drug efficacy measurements to vary considerably within any group of potential FECRT candidates. Measurement of relative drug efficacy may be improved by attempting to ensure a consistent degree of underestimation in groups of people involved in separate FECRTs. This may be partly achieved by omission of cases with the heaviest infections

  8. Drug discrimination: A versatile tool for characterization of CNS safety pharmacology and potential for drug abuse.

    Science.gov (United States)

    Swedberg, Michael D B

    2016-01-01

    clear discriminative effects when tested against classical drugs of abuse in drug discrimination studies, and were not self-administered by rats. However, these compounds did cause salient discriminative effects of their own in animals trained to discriminate them from no drug. Therefore, from a safety pharmacology perspective, novel compounds that do not cause discriminative effects similar to classical drugs of abuse, may still cause psychoactive effects in humans and carry the potential to maintain drug abuse, suggesting that proactive investigation of drug abuse potential is warranted (Swedberg, 2013). These and other findings will be discussed, and the application of drug discrimination procedures beyond the typical standard application of testing novel compounds against known and well characterized reference drugs will be addressed. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. A case of psychosis after use of a detoxification kit and a review of techniques, risks, and regulations associated with the subversion of urine drug tests.

    Science.gov (United States)

    Mittal, Moneeshindra Singh; Kalia, Rachna; Khan, Ahsan Y

    2011-01-01

    The practice of drug testing in the workplace has been adopted for US federal government employees, and many state and local governments as well as private businesses have followed suit. However, a parallel industry dedicated to subverting the results of urine drug testing has emerged with little or no regulation. First, the case of a 19-year-old man who developed psychosis after the use of a detoxification kit is presented. Second, a review of the existing literature on the techniques, risks, and regulations associated with the use of drug tampering kits is provided. PubMed, Cochrane Database, and Google Scholar were searched using the keywords UDS, urine toxicology, pass the drug test, and clean UA, with no restrictions on publication date. Case reports, letters to the editor, and original research and review articles in multiple languages were reviewed, as were federal regulations and acts on the topic. The search yielded 4,082 results, of which 49 articles were selected for relevance. Some articles were later omitted as they had cited the original article and had nothing new to offer. Three commonly used tampering techniques are in vivo adulteration, urine substitution, and in vitro adulteration. Review of the literature regarding the risks involved with use of tampering kits yielded no results. In 1986, an executive order was issued requiring all federal employees to refrain from illicit drug use, and the 1988 Drug-Free Workplace Act precipitated the Substance Abuse and Mental Health Services Administration guidelines and their subsequent revisions. Recently, many states have made regulatory efforts to bring drug test defrauding under the ambit of law. Clinicians need to be aware of the tampering techniques and the possibility of false-negative urine drug tests. Cognizance of inherent risks involved with using these techniques including psychiatric and/or medical complications is also warranted. The manufacture, sale, and use of these products have little or

  10. Feasibility of the fluorometric microculture cytotoxicity assay (FMCA) for cytotoxic drug sensitivity testing of tumor cells from patients with acute lymphoblastic leukemia.

    Science.gov (United States)

    Nygren, P; Kristensen, J; Jonsson, B; Sundström, C; Lönnerholm, G; Kreuger, A; Larsson, R

    1992-11-01

    The automated fluorometric microculture cytotoxicity assay (FMCA) was used for chemotherapeutic drug sensitivity testing of fresh and cryopreserved tumor cells from patients with acute lymphoblastic leukemia (ALL) at diagnosis and relapse. The technique success rate was 87% for fresh and 81% for cryopreserved samples. Up to 16 different cytotoxic drugs were routinely tested, but neither asparaginase nor methotrexate produced dose-response related cell kill. FMCA data showed good correlation to the well established Disc assay and the drug sensitivity reported by the FMCA was in good agreement with known clinical activity. Samples from children and initial ALL tended to be more drug sensitive than those from adults and ALL at relapse, respectively. For 36 samples clinical outcome was correlated to the quartile position in comparison to all other samples for the most in vitro active drug actually given to the patient. For patients with samples in the first, second, third, and fourth quartiles, the probabilities of complete remission were 89, 57, 38, and 0%, respectively. Using the median value as cut-off line, the sensitivity and specificity of the assay were 87 and 62%, respectively. It is concluded that the FMCA with a minimum of effort and with high success rate report clinically relevant drug sensitivity profiles for ALL.

  11. In vitro drug sensitivity testing of tumor cells from patients with non-Hodgkin's lymphoma using the fluorometric microculture cytotoxicity assay.

    Science.gov (United States)

    Nygren, P; Hagberg, H; Glimelius, B; Sundström, C; Kristensen, J; Christiansen, I; Larsson, R

    1994-01-01

    Tumor cell drug sensitivity is an important determinant of chemotherapy response. Its measurement in vitro would aid in therapy individualization and new drug development. The fluorometric microculture cytotoxicity assay (FMCA), based on production by viable cells of fluorescent fluorescein after 3 days of culture, was used for cytotoxic drug sensitivity testing of 73 samples of tumor cells from patients with non-Hodgkin's lymphoma (NHL). The technical success rate was 92%, and FMCA data showed good correlation to the Disc assay. NHL samples were considerably more drug sensitive than were samples from in vivo resistant tumors. There was no obvious difference in drug sensitivity for high- vs. low-grade or untreated vs. previously treated low-grade NHL. For 26 patients, clinical outcome was correlated to in vitro response giving a sensitivity and specificity of 93 and 48%, respectively. Cross-resistance between standard drugs was frequent in vitro. Resistance modulators potentiated the effect of vincristine and doxorubicin in 10-29% of the samples, most frequently from previously treated patients. The FMCA seems to report clinically relevant drug sensitivity data for NHL, and thus it could serve as a tool for optimization of chemotherapy in the future.

  12. [Orphan drugs].

    Science.gov (United States)

    Golocorbin Kon, Svetlana; Vojinović, Aleksandra; Lalić-Popović, Mladena; Pavlović, Nebojsa; Mikov, Momir

    2013-01-01

    Drugs used for treatment of rare diseases are known worldwide under the term of orphan drugs because pharmaceutical companies have not been interested in "adopting" them, that is in investing in research, developing and producing these drugs. This kind of policy has been justified by the fact that these drugs are targeted for small markets, that only a small number of patients is available for clinical trials, and that large investments are required for the development of drugs meant to treat diseases whose pathogenesis has not yet been clarified in majority of cases. The aim of this paper is to present previous and present status of orphan drugs in Serbia and other countries. THE BEGINNING OF ORPHAN DRUGS DEVELOPMENT: This problem was first recognized by Congress of the United States of America in January 1983, and when the "Orphan Drug Act" was passed, it was a turning point in the development of orphan drugs. This law provides pharmaceutical companies with a series of reliefs, both financial ones that allow them to regain funds invested into the research and development and regulatory ones. Seven years of marketing exclusivity, as a type of patent monopoly, is the most important relief that enables companies to make large profits. There are no sufficient funds and institutions to give financial support to the patients. It is therefore necessary to make health professionals much more aware of rare diseases in order to avoid time loss in making the right diagnosis and thus to gain more time to treat rare diseases. The importance of discovery, development and production of orphan drugs lies in the number of patients whose life quality can be improved significantly by administration of these drugs as well as in the number of potential survivals resulting from the treatment with these drugs.

  13. Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use; delay of compliance dates. Final rule; delay of compliance dates; request for comments.

    Science.gov (United States)

    2012-05-11

    The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.

  14. Test of Antifibrotic Drugs in a Cellular Model of Fibrosis Based on Muscle-Derived Fibroblasts from Duchenne Muscular Dystrophy Patients.

    Science.gov (United States)

    Zanotti, Simona; Mora, Marina

    2018-01-01

    An in vitro model of muscle fibrosis, based on the use of primary human fibroblasts isolated from muscle biopsies of patients affected by Duchenne muscular dystrophies (DMD) and cultivated in monolayer and 3D conditions, is used to test the potential antifibrotic activity of pirfenidone (PFD). This in vitro model may be usefully also to evaluate the toxicity and efficacy of other candidate molecules for the treatment of fibrosis. The drug toxicity is evaluated using a colorimetric assay based on the conversion of tetrazolium salt (MTT) to insoluble formazan, while the effect of the drug on cell proliferation is measured with the bromodeoxyuridine incorporation assay. The efficacy of the drug is evaluated in fibroblast monolayers by quantitating synthesis and deposition of intracellular collagen with a spectrophotometric picrosirius red-based assay, and by quantitating cell migration using a "scratch" assay. The efficacy of PFD as antifibrotic drug is also evaluated in a 3D fibroblast model by measuring diameters and number of nodules.

  15. The Right Administrative Stuff

    Science.gov (United States)

    Dustin, Dan; McDonald, Cary; Harper, Jack; Lamke, Gene; Murphy, James

    2014-01-01

    This article is intended to provoke thought and discussion about what it takes to be a department chair and what it feels like to be a department chair. To accomplish our purpose, we draw an analogy between test pilots and department chairs based on Tom Wolfe's "The Right Stuff" (1979). We reason that test pilots and department…

  16. [Effects of nootropic drugs on behavior of BALB/c and C57BL/6 mice in the exploratory cross-maze test].

    Science.gov (United States)

    Vasil'eva, E V; Salimov, R M; Kovalev, G I

    2012-01-01

    Exploratory behavior, locomotor activity, and anxiety in inbred mice of C57BL/6 and BALB/c strains subchronically treated with placebo or various types of nootropic (cognition enhancing) drugs (piracetam, phenotropil, noopept, semax, pantogam, nooglutil) have been evaluated using the exploratory cross-maze test. It was found that BALB/c mice in comparison to C57BL/6 mice are characterized by greater anxiety and lower efficiency of exploratory behavior in the previously unfamiliar environment. All tested drugs clearly improved the exploratory behavior in BALB/c mice only. In BALB/c mice, piracetam, phenotropil, noopept, and semax also reduced anxiety, while phenotropil additionally increased locomotor activity. Thus, the nootropic drugs displayed clear positive modulation of spontaneous orientation in the mice strain with initially low exploratory efficiency (BALB/c) in the cross-maze test. Some drugs (pantogam, nooglutil) exhibited only nootropic properties, while the other drugs exhibited both nootropic effects on the exploratory activity and produced modulation of the anxiety level (piracetam, fenotropil, noopept, semax) and locomotor activity (fenotropil).

  17. The effect of mental alerting on peripheral vestibular nystagmus during spontaneous, gaze (30 degrees left, 30 degrees right) and body positional (left & right lateral lying) testing using electronystagmography (ENG).

    Science.gov (United States)

    McGovern, Tracey N; Fitzgerald, John E

    2008-10-01

    The performance of mental alerting during caloric testing has always been considered important, however its use/benefit during electronystagmography (ENG)/videonystagmography (VNG) testing has been questioned. The aim of this study was to investigate the effect of mental alerting tasks on peripheral type vestibular nystagmus recorded during ENG. Thirty patients with significant spontaneous/gaze or positional nystagmus (slow phase velocity >or= 6 degrees /s) were recruited from consecutive referrals for vestibular assessment. Nystagmus was recorded by ENG both in the presence and absence of mental alerting for each patient. Investigation of nystagmus by analysis of variance (ANOVA) revealed significantly larger nystagmus (higher value SPV) with mental alerting than with no alerting (p<0.001), and for some patients nystagmus traces were reduced to a flat line (no nystagmus) with no alerting. The study demonstrates the importance of mental alerting in helping overcome central suppression of nystagmus and highlights its importance to help identify peripheral type nystagmus during ENG.

  18. Major Reduction in Anti-Malarial Drug Consumption in Senegal after Nation-Wide Introduction of Malaria Rapid Diagnostic Tests

    Science.gov (United States)

    Thiam, Sylla; Thior, Moussa; Faye, Babacar; Ndiop, Médoune; Diouf, Mamadou Lamine; Diouf, Mame Birame; Diallo, Ibrahima; Fall, Fatou Ba; Ndiaye, Jean Louis; Albertini, Audrey; Lee, Evan; Jorgensen, Pernille; Gaye, Oumar; Bell, David

    2011-01-01

    Background While WHO recently recommended universal parasitological confirmation of suspected malaria prior to treatment, debate has continued as to whether wide-scale use of rapid diagnostic tests (RDTs) can achieve this goal. Adherence of health service personnel to RDT results has been poor in some settings, with little impact on anti-malarial drug consumption. The Senegal national malaria control programme introduced universal parasite-based diagnosis using malaria RDTs from late 2007 in all public health facilities. This paper assesses the impact of this programme on anti-malarial drug consumption and disease reporting. Methods and Findings Nationally-collated programme data from 2007 to 2009 including malaria diagnostic outcomes, prescription of artemisinin-based combination therapy (ACT) and consumption of RDTs in public health facilities, were reviewed and compared. Against a marked seasonal variation in all-cause out-patient visits, non-malarial fever and confirmed malaria, parasite-based diagnosis increased nationally from 3.9% of reported malaria-like febrile illness to 86.0% over a 3 year period. The prescription of ACT dropped throughout this period from 72.9% of malaria-like febrile illness to 31.5%, reaching close equivalence to confirmed malaria (29.9% of 584873 suspect fever cases). An estimated 516576 courses of inappropriate ACT prescription were averted. Conclusions The data indicate high adherence of anti-malarial prescribing practice to RDT results after an initial run-in period. The large reduction in ACT consumption enabled by the move from symptom-based to parasite-based diagnosis demonstrates that effective roll-out and use of malaria RDTs is achievable on a national scale through well planned and structured implementation. While more detailed information on management of parasite-negative cases is required at point of care level to assess overall cost-benefits to the health sector, considerable cost-savings were achieved in ACT

  19. Precision-cut liver slices as a model for the early onset of liver fibrosis to test antifibrotic drugs

    Energy Technology Data Exchange (ETDEWEB)

    Westra, Inge M. [Division of Pharmacokinetics, Toxicology and Targeting, Department of Pharmacy, University of Groningen (Netherlands); Oosterhuis, Dorenda [Division of Pharmaceutical Technology and Biopharmacy, Department of Pharmacy, University of Groningen (Netherlands); Groothuis, Geny M.M. [Division of Pharmacokinetics, Toxicology and Targeting, Department of Pharmacy, University of Groningen (Netherlands); Olinga, Peter, E-mail: p.olinga@rug.nl [Division of Pharmaceutical Technology and Biopharmacy, Department of Pharmacy, University of Groningen (Netherlands)

    2014-01-15

    Induction of fibrosis during prolonged culture of precision-cut liver slices (PCLS) was reported. In this study, the use of rat PCLS was investigated to further characterize the mechanism of early onset of fibrosis in this model and the effects of antifibrotic compounds. Rat PCLS were incubated for 48 h, viability was assessed by ATP and gene expression of PDGF-B and TGF-β1 and the fibrosis markers Hsp47, αSma and Pcol1A1 and collagen1 protein expressions were determined. The effects of the antifibrotic drugs imatinib, sorafenib and sunitinib, PDGF-pathway inhibitors, and perindopril, valproic acid, rosmarinic acid, tetrandrine and pirfenidone, TGFβ-pathway inhibitors, were determined. After 48 h of incubation, viability of the PCLS was maintained and gene expression of PDGF-B was increased while TGF-β1 was not changed. Hsp47, αSma and Pcol1A1 gene expressions were significantly elevated in PCLS after 48 h, which was further increased by PDGF-BB and TGF-β1. The increased gene expression of fibrosis markers was inhibited by all three PDGF-inhibitors, while TGFβ-inhibitors showed marginal effects. The protein expression of collagen 1 was inhibited by imatinib, perindopril, tetrandrine and pirfenidone. In conclusion, the increased gene expression of PDGF-B and the down-regulation of fibrosis markers by PDGF-pathway inhibitors, together with the absence of elevated TGF-β1 gene expression and the limited effect of the TGFβ-pathway inhibitors, indicated the predominance of the PDGF pathway in the early onset of fibrosis in PCLS. PCLS appear a useful model for research of the early onset of fibrosis and for testing of antifibrotic drugs acting on the PDGF pathway. - Highlights: • During culture, fibrosis markers increased in precision-cut liver slices (PCLS). • Gene expression of PDGF-β was increased, while TGFβ was not changed in rat PCLS. • PDGF-pathway inhibitors down-regulated this increase of fibrosis markers. • TGFβ-pathway inhibitors had only

  20. The role of sedation tests in identifying sedative drug effects in healthy volunteers and their power to dissociate sedative-related impairments from memory dysfunctions.

    Science.gov (United States)

    Wezenberg, E; Sabbe, B G C; Hulstijn, W; Ruigt, G S F; Verkes, R J

    2007-08-01

    The study investigated whether four specified drugs would show similar patterns on tests considered to measure sedation. In addition, their drug-effect patterns on sedation and memory performance were compared to determine whether the sedative effects could be differentiated from the memory effects. Two double-blind, placebo-controlled, crossover studies, each with 16 healthy volunteers, were performed, one testing lorazepam (2.5 mg) and mirtazapine (15 mg) and the other olanzapine (10 mg) and haloperidol (2.5 mg). Subjective sedation was assessed by means of visual analogue scales (VAS) and objective sedation using a simple-reaction-time (SRT) task and a choice-reaction-time (CRT) task, code substitution (symbol digit substitution test (SDST)) and the peak velocity of saccadic eye movements (SEM). A verbal memory test (VMT) was administered to evaluate memory capacity. Apart from haloperidol, all drugs proved to impair performance on all five sedation indices. Contrary to the VAS, the objective measures yielded different response profiles. Two types of drug-effect patterns emerged: one for greater impairments in response speed (SRT, SEM) and one for greater impairments in information processing (CRT, SDST). Lorazepam and olanzapine impeded memory performance, whereas mirtazapine did not. With the use of standardized scores it proved possible to differentiate between the size of the effects of the drugs on the sedation and memory tests. To accurately assess the level and nature of sedation and to differentiate sedation from memory impairments different types of sedation measures are required. Besides studying the subjective effects, it is recommended to also test psychomotor responses and information processing speed.