Sample records for drug industry
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New Zealand’s Drug Development Industry
Directory of Open Access Journals (Sweden)
Christopher Carswell
2013-09-01
Full Text Available The pharmaceutical industry’s profitability depends on identifying and successfully developing new drug candidates while trying to contain the increasing costs of drug development. It is actively searching for new sources of innovative compounds and for mechanisms to reduce the enormous costs of developing new drug candidates. There is an opportunity for academia to further develop as a source of drug discovery. The rising levels of industry outsourcing also provide prospects for organisations that can reduce the costs of drug development. We explored the potential returns to New Zealand (NZ from its drug discovery expertise by assuming a drug development candidate is out-licensed without clinical data and has anticipated peak global sales of $350 million. We also estimated the revenue from NZ’s clinical research industry based on a standard per participant payment to study sites and the number of industry-sponsored clinical trials approved each year. Our analyses found that NZ’s clinical research industry has generated increasing foreign revenue and appropriate policy support could ensure that this continues to grow. In addition the probability-based revenue from the out-licensing of a drug development candidate could be important for NZ if provided with appropriate policy and financial support.
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An assessment of drug testing within the construction industry.
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.
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2010-04-29
...] Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic... and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and...
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Industry Perspectives on Market Access of Innovative Drugs: The Relevance for Oncology Drugs
Pauwels, Kim; Huys, Isabelle; Casteels, Minne; Simoens, Steven
2016-01-01
Key Points - Representatives of the pharmaceutical industry call for a broader recognition of value within the assessment and appraisal of innovative drugs - Focus on value within the assessment and appraisal of drugs is jeopardized by financial drives as the side of industry and at the side of the payers - A well–considered value-framework, with attention for patient reported outcomes, societal preferences and dynamic approach on the drug life cycle, needs to be incorporated in ass...
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2012-04-06
...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...
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Industry perspectives on market access of innovative drugs
Directory of Open Access Journals (Sweden)
Kim ePauwels
2016-06-01
Full Text Available This study presents industry perspectives on the challenges related to market access of innovative drugs in general and oncology drugs in specific. Fifteen interviews were conducted with representatives of pharmaceutical companies and industry associations. Interviewees call for a broader recognition of value within the assessment and appraisal of drugs. According to interviewees, focus on value is jeopardized by the lack of a common value definition across Europe, poor availability and validity of value measures and cost-saving measures such as external reference price setting and cost-effectiveness analysis at the side of the payers. Centralized assessment of relative-effectiveness at European level would provide a common value estimate across member states, independent of financial drivers. Empirical evidence on patient reported outcomes and societal preferences is however essential in the development of a value definition. Furthermore, value-based pricing would imply a dynamic approach where the price is differentiated across indications and across the lifecycle of the drug, especially in fields such as oncology. Financial drivers however also threat the application of value-based pricing at the side of the industry, making value-based profitability a more appropriate term.
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2011-02-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...
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Perception of various stakeholders regarding clinical drug trial industry in India
Directory of Open Access Journals (Sweden)
Rakesh M Parikh
2011-01-01
Full Text Available Context: Though India has been thought to be an ideal destination for conduct of clinical drug trials, other smaller countries seem to be doing better. The pace of growth observed during 2005-2009 seems to be plateaued in 2010. Aims: There is an urgent need for introspection and corrective actions. Materials and Methods: An online survey was conducted among various stakeholders from clinical drug trial industry in India regarding their perception about clinical drug trial industry in India. Respondents were requested to rate training of investigator sites, industry, performance of regulatory, etc. Results: Majority of respondent felt that the clinical drug trial industry in India is growing, though India is not utilizing its full potential. Lack of trained investigators and delay in regulatory approvals came out as biggest hurdles. Conclusions: Urgent steps need to be taken in terms of proper training of all stakeholders. Regulatory bodies ought to bring about some radical changes in the system so as to match the other competing nations.
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Work-related injuries in a state trauma registry: relationship between industry and drug screening.
Bunn, Terry L; Slavova, Svetla; Bernard, Andrew C
2014-08-01
Work-related injuries exert a great financial and economic burden on the US population. The study objectives were to identify the industries and occupations associated with worker injuries and to determine the predictors for injured worker drug screening in trauma centers. Work-related injury cases were selected using three criteria (expected payer source of workers' compensation, industry-related e-codes, and work-related indicator) from the Kentucky Trauma Registry data set for years 2008 to 2012. Descriptive analyses and multiple logistic regression were performed on the work-related injury cases. The "other services" and construction industry sectors accounted for the highest number of work-related cases. Drugs were detected in 55% of all drug-screened work-related trauma cases. Higher percentages of injured workers tested positive for drugs in the natural resources and mining, transportation and public utilities, and construction industries. In comparison, higher percentages of injured workers in the other services as well as transportation and public utilities industries were drug screened. Treatment at Level I trauma centers and Glasgow Coma Scale (GCS) scores indicating a coma or severe brain injury were both significant independent predictors for being screened for drugs; industry was not a significant predictor for being drug screened. The injured worker was more likely to be drug screened if the worker had a greater than mild injury, regardless of whether the worker was an interfacility transfer. These findings indicate that there may be elevated drug use or abuse in natural resources and mining, transportation and public utilities, as well as construction industry workers; improved identification of the specific drug types in positive drug screen results of injured workers is needed to better target prevention efforts. Epidemiologic study, level III.
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2013-12-12
... Guidance for Industry (GFI) 209, ``The Judicious Use of Medically Important Antimicrobial Drugs in Food... of certain antimicrobial new animal drug products who are interested in revising conditions of use... Medically Important Antimicrobial Drugs in Food-Producing Animals,'' and to set timelines for stakeholders...
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Homochiral drugs: a demanding tendency of the pharmaceutical industry.
Núñez, María C; García-Rubiño, M Eugenia; Conejo-García, Ana; Cruz-López, Olga; Kimatrai, María; Gallo, Miguel A; Espinosa, Antonio; Campos, Joaquín M
2009-01-01
The issue of drug chirality is now a major theme in the design and development of new drugs, underpinned by a new understanding of the role of molecular recognition in many pharmacologically relevant events. In general, three methods are utilized for the production of a chiral drug: the chiral pool, separation of racemates, and asymmetric synthesis. Although the use of chiral drugs predates modern medicine, only since the 1980's has there been a significant increase in the development of chiral pharmaceutical drugs. An important commercial reason is that as patents on racemic drugs expire, pharmaceutical companies have the opportunity to extend patent coverage through development of the chiral switch enantiomers with desired bioactivity. Stimulated by the new policy statements issued by the regulatory agencies, the pharmaceutical industry has systematically begun to develop chiral drugs in enantiometrically enriched pure forms. This new trend has caused a tremendous change in the industrial small- and large-scale production to enantiomerically pure drugs, leading to the revisiting and updating of old technologies, and to the development of new methodologies of their large-scale preparation (as the use of stereoselective syntheses and biocatalyzed reactions). The final decision whether a given chiral drug will be marketed in an enantiomerically pure form, or as a racemic mixture of both enantiomers, will be made weighing all the medical, financial and social proficiencies of one or other form. The kinetic, pharmacological and toxicological properties of individual enantiomers need to be characterized, independently of a final decision.
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2013-02-19
...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...
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2010-11-29
...] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY... announcing the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration... single copies of the guidance document entitled ``Guidance for Industry and Food and Drug Administration...
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2010-03-29
...] Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical... industry entitled ``Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for... the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages.'' In the...
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Alcohol and drug policy model for the Canadian upstream petroleum industry
Energy Technology Data Exchange (ETDEWEB)
NONE
2007-09-15
This alcohol and drug policy model was developed to help employers manage and reduce the risks associated with drug and alcohol use in the workplace. The policy model outlined guidelines for establishing and implementing drug and alcohol policies, and discussed treatment programs and opportunities for re-employment. The model was developed by Enform, the upstream petroleum industry's safety and training arm, who used a previous guide developed by the Construction Owner's Association of Alberta (COAA) as a model. Enform's model provided a summary of key accountabilities across all levels of industry as well as the accepted minimum criteria for developing alcohol and drug policies. The model included guidelines and recommendations for employees, supervisors, and owners, employers, and contractors. The responsibilities of associations, organizations, and private companies were also outlined. An overview of recommended implementation plans was provided, as well as details of alcohol and drug use education programs and workplace rules. A supervisor's guide to implementation provided outlines of the causes of drug use among employees. tabs.
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Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984
Directory of Open Access Journals (Sweden)
Garth Boehm
2013-09-01
Full Text Available The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.
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2011-10-03
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...
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2011-11-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of...
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2013-01-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...
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2012-11-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals... Effectiveness of Anticoccidial Drugs in Food-Producing Animals.'' The guidance provides guidance to industry for...
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2012-02-23
...] Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal... industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug...). This updated draft guidance is intended to provide individuals in the human and animal food industries...
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2013-11-06
...] Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability...) is announcing the availability of a draft guidance for industry entitled ``Pulmonary Tuberculosis... of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the...
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2010-04-29
...] Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for... the Internet. To receive ``Draft Guidance for Industry and Food and Drug Administration Staff; User... and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and...
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2010-10-25
...] Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability AGENCY... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm...
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2012-03-19
... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...
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2011-05-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document... of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Class II...
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2011-12-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...
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2012-02-29
...] Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY: Food and... the availability of a guidance for industry entitled ``Size of Beads in Drug Products Labeled for... Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products...
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Redactions in protocols for drug trials: what industry sponsors concealed.
Marquardsen, Mikkel; Ogden, Michelle; Gøtzsche, Peter C
2018-04-01
Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.
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2010-06-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0281] Draft Guidance for Industry and Food and Drug Administration Staff; ```Harmful and Potentially Harmful... Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff...
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2011-01-19
...] Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Size of Beads in Drug Products... Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products...
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Directory of Open Access Journals (Sweden)
Tom L. Blundell
2017-07-01
Full Text Available The development of structure-guided drug discovery is a story of knowledge exchange where new ideas originate from all parts of the research ecosystem. Dorothy Crowfoot Hodgkin obtained insulin from Boots Pure Drug Company in the 1930s and insulin crystallization was optimized in the company Novo in the 1950s, allowing the structure to be determined at Oxford University. The structure of renin was developed in academia, on this occasion in London, in response to a need to develop antihypertensives in pharma. The idea of a dimeric aspartic protease came from an international academic team and was discovered in HIV; it eventually led to new HIV antivirals being developed in industry. Structure-guided fragment-based discovery was developed in large pharma and biotechs, but has been exploited in academia for the development of new inhibitors targeting protein–protein interactions and also antimicrobials to combat mycobacterial infections such as tuberculosis. These observations provide a strong argument against the so-called `linear model', where ideas flow only in one direction from academic institutions to industry. Structure-guided drug discovery is a story of applications of protein crystallography and knowledge exhange between academia and industry that has led to new drug approvals for cancer and other common medical conditions by the Food and Drug Administration in the USA, as well as hope for the treatment of rare genetic diseases and infectious diseases that are a particular challenge in the developing world.
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Blundell, Tom L
2017-07-01
The development of structure-guided drug discovery is a story of knowledge exchange where new ideas originate from all parts of the research ecosystem. Dorothy Crowfoot Hodgkin obtained insulin from Boots Pure Drug Company in the 1930s and insulin crystallization was optimized in the company Novo in the 1950s, allowing the structure to be determined at Oxford University. The structure of renin was developed in academia, on this occasion in London, in response to a need to develop antihypertensives in pharma. The idea of a dimeric aspartic protease came from an international academic team and was discovered in HIV; it eventually led to new HIV antivirals being developed in industry. Structure-guided fragment-based discovery was developed in large pharma and biotechs, but has been exploited in academia for the development of new inhibitors targeting protein-protein interactions and also antimicrobials to combat mycobacterial infections such as tuberculosis. These observations provide a strong argument against the so-called 'linear model', where ideas flow only in one direction from academic institutions to industry. Structure-guided drug discovery is a story of applications of protein crystallography and knowledge exhange between academia and industry that has led to new drug approvals for cancer and other common medical conditions by the Food and Drug Administration in the USA, as well as hope for the treatment of rare genetic diseases and infectious diseases that are a particular challenge in the developing world.
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2011-03-15
...] Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims... ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With...
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2013-05-31
... products. This guidance revises the guidance for industry entitled ``Clinical Development Programs for... Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave... (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville...
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2013-03-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...
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2013-02-08
...] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco... guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked... civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic...
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2011-07-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0530] Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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2012-02-24
...] Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for Treatment... Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (c...
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Removal of the nonconformities in the drug boxes packaging industry
Directory of Open Access Journals (Sweden)
Bălan Emilia
2017-01-01
Full Text Available The paper presents the specific quality aspects of cardboard drug boxes (folding boxes used as packaging in pharmaceutical industry. The types of defects and nonconformities that occur during offset printing and finishing of the packaging products are being identified and analyzed, such as: differences in color printing, scratches on the printed sheets, cracks during creasing, unparalleled gluing in respect to the closing flaps, ungluing, successive drug boxes stick to each other. The paper also focuses on aspects regarding the nonconformities removal of the drug boxes by establishing a control plan and preventive and corrective methods applicable in different technological stages of the production flow. Monitoring and analyzing activities for quality improvement of the drug boxes, in accordance with the quality specifications required by customers were performed for 20 months on a production line with Heidelberg machines. Nonconformities considered in this paper are also encountered in advertising printing.
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2013-03-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0168] Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G
2015-06-01
Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.
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2012-10-02
.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0971...
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2012-04-06
...] Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information...
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Lowering industry firewalls: pre-competitive informatics initiatives in drug discovery.
Barnes, Michael R; Harland, Lee; Foord, Steven M; Hall, Matthew D; Dix, Ian; Thomas, Scott; Williams-Jones, Bryn I; Brouwer, Cory R
2009-09-01
Pharmaceutical research and development is facing substantial challenges that have prompted the industry to shift funding from early- to late-stage projects. Among the effects is a major change in the attitude of many companies to their internal bioinformatics resources: the focus has moved from the vigorous pursuit of intellectual property towards exploration of pre-competitive cross-industry collaborations and engagement with the public domain. High-quality, open and accessible data are the foundation of pre-competitive research, and strong public-private partnerships have considerable potential to enhance public data resources, which would benefit everyone engaged in drug discovery. In this article, we discuss the background to these changes and propose new areas of collaboration in computational biology and chemistry between the public domain and the pharmaceutical industry.
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2010-04-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...
2011-01-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0635] Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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2011-08-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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2010-08-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...
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2010-07-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug...
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2011-11-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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2010-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0076] (formerly Docket No. 2007D-0387) Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies--Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS...
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2010-09-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0367] Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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2013-07-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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2012-12-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1161] Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...
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Academic-industrial partnerships in drug discovery in the age of genomics.
Harris, Tim; Papadopoulos, Stelios; Goldstein, David B
2015-06-01
Many US FDA-approved drugs have been developed through productive interactions between the biotechnology industry and academia. Technological breakthroughs in genomics, in particular large-scale sequencing of human genomes, is creating new opportunities to understand the biology of disease and to identify high-value targets relevant to a broad range of disorders. However, the scale of the work required to appropriately analyze large genomic and clinical data sets is challenging industry to develop a broader view of what areas of work constitute precompetitive research. Copyright © 2015 Elsevier Ltd. All rights reserved.
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Kinch, Michael S; Moore, Ryan
2016-06-23
The way new medicines are discovered and brought to market has fundamentally changed over the last 30 years. Our previous analysis showed that biotechnology companies had contributed significantly to the US Food and Drug Administration approval of new molecular entities up to the mid-1980s, when the trends started to decline. Although intriguing, the focus on biotechnology necessarily precluded the wider question of how the biopharmaceutical industry has been delivering on its goals to develop new drugs. Here, we present a comprehensive analysis of all biopharmaceutical innovators and uncover unexpected findings. The present biopharmaceutical industry grew steadily from 1800 to 1950 and then stagnated for two decades, before a burst of growth attributable to the biotechnology revolution took place; but consolidation has reduced the number of active and independent innovators to a level not experienced since 1945. The trajectories and trends we observe raise fundamental questions about biopharmaceutical innovators and the sustainability of the drug-development enterprise. Copyright © 2016 Elsevier Ltd. All rights reserved.
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2010-08-02
... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0125] Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an...
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2010-11-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0515] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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2011-02-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Drug and alcohol abuse: the bases for employee assistance programs in the nuclear-utility industry
Energy Technology Data Exchange (ETDEWEB)
Radford, L.R.; Rankin, W.L.; Barnes, V.; McGuire, M.V.; Hope, A.M.
1983-07-01
This report describes the nature, prevalence, and trends of drug and alcohol abuse among members of the US adult population and among personnel in non-nuclear industries. Analogous data specific to the nuclear utility industry are not available, so these data were gathered in order to provide a basis for regulatory planning. The nature, prevalence, and trend inforamtion was gathered using a computerized literature, telephone discussions with experts, and interviews with employee assistance program representatives from the Seattle area. This report also evaluates the possible impacts that drugs and alcohol might have on nuclear-related job performance, based on currently available nuclear utility job descriptions and on the scientific literature regarding the impairing effects of drugs and alcohol on human performance. Employee assistance programs, which can be used to minimize or eliminate job performance decrements resulting from drug or alcohol abuse, are also discussed.
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2013-12-05
... exposure measures is suitable for documenting BE (e.g., transdermal delivery systems and certain rectal and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1464] Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted...
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2012-07-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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2012-05-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0384] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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2011-07-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...
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2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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2011-09-27
...] Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products..., Reductions, and Refunds for Drug and Biological Products.'' This guidance provides recommendations to... ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This guidance provides...
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2012-06-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...
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2011-04-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0189] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS...
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2010-11-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0275] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability AGENCY: Food and Drug Administration, HHS. [[Page...
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2011-03-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0028] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS...
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2011-02-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0645] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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2011-04-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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2013-01-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...
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2011-07-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0500] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration...
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2011-08-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...
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2013-06-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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2013-11-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1279] Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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2012-04-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0094] Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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2011-12-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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2013-01-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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2011-04-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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2012-02-21
... industry entitled ``Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and... data analysis in the context of identifying potential drug interactions. The guidance also addresses... Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling.'' Comments were received...
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2011-03-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0457] Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated... other electrical continence devices; protective garment for incontinence; surgical mesh; electrosurgical...
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Onishi, Taku; Tsukamoto, Katsura; Matsumaru, Naoki; Waki, Takashi
2018-01-01
Efforts to promote the development of pediatric pharmacotherapy include regulatory frameworks and close collaboration between the US Food and Drug Administration and the European Medicines Agency. We characterized the current status of pediatric clinical trials conducted in the United States by the pharmaceutical industry, focusing on the involvement of the European Union member countries, to clarify the industry perspective. Data on US pediatric clinical trials were obtained from ClinicalTrials.gov . Binary regression analysis was performed to identify what factors influence the likelihood of involvement of European Union countries. A total of 633 US pediatric clinical trials that met inclusion criteria were extracted and surveyed. Of these, 206 (32.5%) involved a European Union country site(s). The results of binary regression analysis indicated that attribution of industry, phase, disease area, and age of pediatric participants influenced the likelihood of the involvement of European Union countries in US pediatric clinical trials. Relatively complicated or large pediatric clinical trials, such as phase II and III trials and those that included a broad age range of participants, had a significantly greater likelihood of the involvement of European Union countries ( P European Union countries, and (3) feasibility of clinical trials is mainly concerned by pharmaceutical industry for pediatric drug development. Additional incentives for high marketability may further motivate pharmaceutical industry to develop pediatric drugs.
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2012-08-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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2010-09-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0459] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori; Availability AGENCY: Food...
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Vertical Integration Heats Up in Drug Industry: Will Medication Price Hikes Cool Down as a Result?
Barlas, Stephen
2018-01-01
Is industry consolidation a response to President Donald Trump's repeated denunciation of high drug prices and congressional hearings on the issue? The author considers whether any of this corporate collaboration will get at some of the significant, underlying problems in the drug-pricing space.
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Wen, Ming Ming; El-Salamouni, Noha S; El-Refaie, Wessam M; Hazzah, Heba A; Ali, Mai M; Tosi, Giovanni; Farid, Ragwa M; Blanco-Prieto, Maria J; Billa, Nashiru; Hanafy, Amira S
2017-01-10
Alzheimer's disease (AD) is a neurodegenerative disease with high prevalence in the rapidly growing elderly population in the developing world. The currently FDA approved drugs for the management of symptomatology of AD are marketed mainly as conventional oral medications. Due to their gastrointestinal side effects and lack of brain targeting, these drugs and dosage regiments hinder patient compliance and lead to treatment discontinuation. Nanotechnology-based drug delivery systems (NTDDS) administered by different routes can be considered as promising tools to improve patient compliance and achieve better therapeutic outcomes. Despite extensive research, literature screening revealed that clinical activities involving NTDDS application in research for AD are lagging compared to NTDDS for other diseases such as cancers. The industrial perspectives, processability, and cost/benefit ratio of using NTDDS for AD treatment are usually overlooked. Moreover, active and passive immunization against AD are by far the mostly studied alternative AD therapies because conventional oral drug therapy is not yielding satisfactorily results. NTDDS of approved drugs appear promising to transform this research from 'paper to clinic' and raise hope for AD sufferers and their caretakers. This review summarizes the recent studies conducted on NTDDS for AD treatment, with a primary focus on the industrial perspectives and processability. Additionally, it highlights the ongoing clinical trials for AD management. Copyright © 2016 Elsevier B.V. All rights reserved.
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2013-04-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0642] Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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2013-08-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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2012-10-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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2011-08-09
... selection inclusion and exclusion criteria section. The revisions define and differentiate the required... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...
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2010-09-28
... method comparison section and the sample selection inclusion and exclusion criteria section. The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...
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2010-02-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0090] Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability... familiar and less familiar approaches. As more experience is obtained with the less familiar designs...
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2013-02-08
...] Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage... ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance outlines FDA... trials that are specifically focused on the treatment of patients with established Alzheimer's disease...
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2013-12-04
...] Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers... the guidance entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked... issuance of civil money penalties for violations of regulations issued under the Federal Food, Drug, and...
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2010-12-03
...] Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers... Solvents in Animal Drug Products; Questions and Answers.'' The draft questions and answers (Q&A) guidance addresses the United States Pharmacopeia (USP) General Chapter Residual Solvents that applies to both human...
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The year's new drugs & biologics, 2017, part II - News that shaped the industry in 2017.
Graul, A I; Dulsat, C; Pina, P; Tracy, M; D'Souza, P
2018-02-01
This eagle's-eye overview of the drug industry in 2017 provides insight into some of last year's top stories, including the growing opioid crisis affecting the U.S. and other developed countries and the 2017-2018 influenza epidemic, with a spotlight on the need for a universal flu vaccine. As in previous years, we also review orphan drug development, new agency-supported programs such as PRIME and RMAT, pipeline attrition and drug pricing, as well as pharma/biotech mergers and acquisitions of note. Finally, we take a glimpse into the crystal ball to anticipate the new drugs that will be approved in 2018. Copyright 2018 Clarivate Analytics.
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2013-01-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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2010-11-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0514] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance...
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2011-05-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-D-0102] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and...
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Stanley, A G; Jackson, D; Barnett, D B
2005-04-01
Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK.
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2011-06-22
.... FDA-2011-D-0404] Guidance for Industry on Topical Acne Drug Products for Over-the- Counter Human Use... entities entitled ``Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and... recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug...
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Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation.
Cosgrove, Lisa; Vannoy, Steven; Mintzes, Barbara; Shaughnessy, Allen F
2016-01-01
The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the "ghost management" of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased-rather than evidence-based-medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive "me-too" drugs with questionable risk/benefit profiles. We offer solutions for neutralizing these economies of influence.
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2010-11-12
... annually from approximately 25 application holders. FDA professionals familiar with Dear Health Care... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0319] Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters...
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2012-07-03
...] Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection Devices Applied... Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to... guidance, entitled ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device...
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2013-12-04
... information technology. Under the draft guidance, outsourcing facilities that elect to register should submit... guidance provides information on how an outsourcing facility should submit facility registration...] Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under...
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2013-02-26
... marketing applications, (2) what is meant by ``due diligence'' in obtaining financial disclosures from...: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...
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2013-09-25
... FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and...] Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability...) is announcing the availability of the guidance entitled ``Mobile Medical Applications.'' The FDA is...
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Löfgren, Hans
2007-06-01
This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products.
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Pharmacist-industry relationships.
Saavedra, Keene; O'Connor, Bonnie; Fugh-Berman, Adriane
2017-12-01
The purpose of this study was to document, in their own words, beliefs and attitudes that American pharmacists have towards the pharmaceutical industry and pharmacists' interactions with industry. An ethnographic-style qualitative study was conducted utilizing open-ended interviews with four hospital pharmacists, two independent pharmacists, two retail pharmacists and one administrative pharmacist in the Washington, DC, metropolitan area to elicit descriptions of and attitudes towards pharmacists' relationships with industry. Analysis of the qualitative material followed established ethnographic conventions of narrative thematic analysis. All pharmacists reported interactions with pharmaceutical company representatives. Most had received free resources or services from industry, including educational courses. Respondents uniformly believed that industry promotional efforts are primarily directed towards physicians. Although respondents felt strongly that drug prices were excessive and that 'me-too' drugs were of limited use, they generally had a neutral-to-positive view of industry-funded adherence/compliance programmes, coupons, vouchers, and copay payment programmes. Interviewees viewed direct-to-consumer advertising negatively, but had a generally positive view of industry-funded drug information. Pharmacists may represent a hitherto under-identified cohort of health professionals who are targeted for industry influence; expanding roles for pharmacists may make them even more attractive targets for future industry attention. Pharmacy schools should ensure that students learn to rely on unbiased information sources and should teach students about conflicts of interest and the risks of interacting with industry. Further research should be conducted on the extent to which pharmacists' attitudes towards their duties and towards drug assessment and recommendation are influenced by the pharmaceutical industry. © 2017 Royal Pharmaceutical Society.
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Orphan drugs: trends and issues in drug development.
Rana, Proteesh; Chawla, Shalini
2018-04-12
Research in rare diseases has contributed substantially toward the current understanding in the pathophysiology of the common diseases. However, medical needs of patients with rare diseases have always been neglected by the society and pharmaceutical industries based on their small numbers and unprofitability. The Orphan Drug Act (1983) was the first serious attempt to address the unmet medical needs for patients with rare diseases and to provide impetus for the pharmaceutical industry to promote orphan drug development. The process of drug development for rare diseases is no different from common diseases but involves significant cost and infrastructure. Further, certain aspect of drug research may not be feasible for the rare diseases. The drug-approving authority must exercise their scientific judgment and ensure due flexibility while evaluating data at various stages of orphan drug development. The emergence of patent cliff combined with the government incentives led the pharmaceutical industry to realize the good commercial prospects in developing an orphan drug despite the small market size. Indeed, many drugs that were given orphan designation ended up being blockbusters. The orphan drug market is projected to reach $178 billion by 2020, and the prospects of research and development in rare diseases appears to be quite promising and rewarding.
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Niquette , Manon
2012-01-01
International audience; The Exploitation of 'sicko-chatting' by the Pharmaceutical industry: a strategy for the Normalization of drug use Pharmaceutical drugs are consumer goods. As such, they inscribe the transition from normality to pathology within the ambit of health marketing (Duclos, 2008, p. 109). It is now widely acknowledged that this pathology is not just a mere quantitative modification of the normal state, but that it also implies the patient's qualitative assessment of his or her...
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THE ROLE OF PROMOTION ON MARKETING IN TURKISH DRUG INDUSTRY
Directory of Open Access Journals (Sweden)
Emrah Bilgener
2004-08-01
Full Text Available Abstract\tMarketing has an important role in modern life. Marketing provides economical and social bene-fits with correleating between producers and consumers.\tPromotional activities are necessary for better marketing strategies. Therefore, firms have to give more importance to promotional activities. Promotional activities are marketing instruments that an-nounced all the knowledges about the products and services to their consumers, for surviving and de-veloping the firms.\tNowadays drug producers are marketing their products all arround the world. But, drugs are not ordinary products, for this reason more importance must be given to drug marketing andpromotion.\tThe purpose of this study is to determine the role of promotion within the marketing in Turkish Drug Industry. The material of this study is an uniform questionnaire with 41 questions applied to about 190-200 medical representatives who work in Çorum, Yozgat, Amasya and Tokat cities for 37 firms which are the members of Federation of Employer’s Organization in Pharmaceutical Industry and 14 firms which are profited by the services of this federation.\tIn this study, SPSS program (ver7.5 has been used for evaluation of the data. According to the re-sults, medical represantatives think that the drug sales will increase and wait the data of IMS (Inform Medicines Statistics will rise about 60-80%. 90% of the medical represantatives believe that the pa-ramedical activities are effective and 73% of them carry out paramedical studies.\tÖzet\tPazarlama modern yasantida önemli bir role sahiptir. Pazarlama üreticiler ve tüketiciler arasinda bir iliski kurarak, ekonomik ve sosyal faydalar saglar. Tanitim faaliyetleri daha iyi bir pazarlama stratejisi için gereklidir. Bu nedenle sirketler daha iyi bir pazarlama stratejisi için tanitim faaliyetlerine önem vermelidir. Tanitim faaliyetleri, isletmenin ürettigi mal ve hizmetleri tüketicilere duyuran, isletmenin gelisimini ve yasamasini
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2013-06-07
... adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail... and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION... June 2013. FDA is providing this final guidance document to assist industry in developing technical and...
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Directory of Open Access Journals (Sweden)
Lončar Irma M.
2013-01-01
Full Text Available In this study, we collected and analyzed information on the importance of drug packaging quality to end users and pharmaceutical industry, as an indicator of the process of traceability and originality of drugs. Two surveys were conducted: one among the end users of drugs (252 patients and the other among professionals working in seven pharmaceutical companies in Serbia. For most end users (82.5% quality on the packaging of drugs was important, but only 41.8% of them thought that the appearance of the packaging could be an indicator of genuinity of drugs. The existence of the control marks (KM on drug packaging was not of great importance, since most of them (86.9% know, its function, but majority (60.2% would nevertheless decide to buy the drug without KM. Regarding the experts from the pharmaceutical industry, more then two-thirds of them (68.4% believed that the existence of KM did not contribute to efficient operations. Although a great number of pharmaceutical industry professionals (84.2% answered that the introduction of GS1 DataMatrix system would allow for complete traceability of the drug from the manufacturer to the end user, only 22.2% of them introduced this system to their products. This study also showed that domestic producers did not have a great interest for additional protection (special inks, holograms, special graphics, smart multicolor design, watermark, chemically labeled paper and cardboard etc.. on their products, given that only 15.8 % of them had some kind of additional protection against counterfeiting. Monitoring drug traceability from a manufacturer to end user is achieved by many complex activities regulated by law. A high percentage of responders said they were satisfied with the functionality of traceability systems used in their companies. As a way to increase the quality of drug packaging and business performance most responders saw in the continuous improvement of the system of traceability within the company
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2012-07-27
...] Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510(k... serious and sometimes fatal consequences to patients. This guidance provides recommendations to 510(k... unintended connections between enteral and nonenteral devices. This draft guidance is not final nor is it in...
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Siegfried, Elaine C; Jaworski, Jennifer C; Eichenfield, Lawrence F; Paller, Amy; Hebert, Adelaide A; Simpson, Eric L; Altman, Emily; Arena, Charles; Blauvelt, Andrew; Block, Julie; Boguniewicz, Mark; Chen, Suephy; Cordoro, Kelly; Hanna, Diane; Horii, Kimberly; Hultsch, Thomas; Lee, James; Leung, Donald Y; Lio, Peter; Milner, Joshua; Omachi, Theodore; Schneider, Christine; Schneider, Lynda; Sidbury, Robert; Smith, Timothy; Sugarman, Jeffrey; Taha, Sharif; Tofte, Susan; Tollefson, Megha; Tom, Wynnis L; West, Dennis P; Whitney, Lucinda; Zane, Lee
2018-05-01
Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for "the Agency's current thinking on a particular subject." Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices). © 2018 Wiley Periodicals, Inc.
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2012-02-27
... proposed information collected is necessary for the proper performance of FDA's functions, including... the draft guidance for industry entitled: ``Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products'' (Absenteeism Draft Guidance) published in the Federal...
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Directory of Open Access Journals (Sweden)
S Satyanarayan
2011-10-01
Full Text Available Considering the high pollution potential that the synthetic Bulk Drug industry Wastewater (BDW possesses due to the presence of variety of refractory organics, toxicity evaluation is of prime importance in assessing the efficiency of the applied wastewater treatment system and in establishing the discharge standards. Therefore, in this study the toxic effects of high strength bulk drug industry wastewater before and after electrochemical treatment on common fish Lebistes reticulatus-(peter were studied under laboratory conditions. Results indicated that wastewater being very strong in terms of color, COD and BOD is found to be very toxic to the studied fish. The LC50 values for raw wastewater and after electrochemical treatment with carbon and aluminium electrodes for 24, 48, 72 and 96 hours ranged between, 2.5-3.6%, 6.8-8.0%, 5.0-5.8% respectively. Carbon electrode showed marginally better removals for toxicity than aluminium electrode. It was evident from the studies that electrochemical treatment reduces toxicity in proportion to the removal efficiency shown by both the electrodes. The reduction in toxicity after treatment indicates the intermediates generated are not toxic than the parent compounds. Furthermore, as the electrochemical treatment did not result in achieving disposal standards it could be used only as a pre-treatment and the wastewater needs further secondary treatment before final disposal.
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2011-09-01
... (formerly Docket No. 00D-0892)] Guidance on Positron Emission Tomography Drug Applications-- Content and... the availability of a guidance for industry entitled ``PET Drug Applications--Content and Format for... guidance for industry entitled ``PET Drug Applications--Content and Format for NDAs and ANDAs.'' The...
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2012-03-13
...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review Program.'' This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term ``pre- dissemination review'' is used throughout the guidance to refer to review under the FD&C Act, which is entitled ``Prereview of Television Advertisements.'') The draft guidance describes which TV ads FDA intends to make subject to this provision, explains how FDA will notify sponsors that an ad is subject to review under this provision, and describes the general and center-specific procedures sponsors should follow to submit their TV ads to FDA for pre-dissemination review in compliance with the FD&C Act. These proposed TV ads will be subject to a 45-calendar day review clock by FDA.
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Watkins, Elizabeth Siegel
2012-08-01
Marketing decisions, rather than scientific innovations, have guided the development and positioning of contraceptive products in recent years. I review the stalled progress in contraceptive development in the decades following the advent of the Pill in 1960 and then examine the fine-tuning of the market for oral contraceptives in the 1990s and 2000s. Although birth control has been pitched in the United States as an individual solution, rather than a public health strategy, the purpose of oral contraceptives was understood by manufacturers, physicians, and consumers to be the prevention of pregnancy, a basic health care need for women. Since 1990, the content of that message has changed, reflecting a shift in the drug industry's view of the contraception business. Two factors contributed to bring about this change: first, the industry's move away from research and development in birth control and second, the growth of the class of medications known as lifestyle drugs.
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Industry sponsorship and research outcome
DEFF Research Database (Denmark)
Lundh, Andreas; Lexchin, Joel; Mintzes, Barbara
2017-01-01
BACKGROUND: Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical-industry sponsored studies are more often favorable to the sponsor's product compared...... on the association between sponsorship and research outcome. OBJECTIVES: To investigate whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship. SEARCH METHODS: In this update we searched MEDLINE (2010......, systematic reviews and meta-analyses that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. We had no language restrictions. DATA COLLECTION AND ANALYSIS: Two assessors screened abstracts and identified...
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van der Hoogte, Arjo Roersch; Pieters, Toine
2010-01-01
In this article we explore the historical development of drug advertisements for psychotropic drugs in the leading Dutch medical journal from 1900 to 1940. The advertisements for hypnotics and sedatives, in The Nederlands Tijdschrift voor Geneeskunde (Dutch medical journal) reflected the changes in the vocabulary and image promoted by the pharmaceutical companies. In the first two decades, the advertisements were sober and to the point, and included the trademark, company name, molecular formula and therapeutic properties of the medication. The emphasis was on creating a scientific image of reliable symptom control for the therapeutic drug. In doing so, the ethical drug companies tried (successfully) to distinguish themselves from the producers of patent medicines. Once scientific credibility was established, the form and content of the advertisements changed significantly. In the late 1920s and 1930s drug companies embraced modern advertising techniques, developing a figurative language to address the changing beliefs and practices of Dutch physicians. Instead of promoting therapeutic drugs as safe and scientific, the emphasis was on their effectiveness in comparison to similar drugs. In the process, scientific information was reduced to an indispensable standardized minimum, whereby therapeutic drugs were advertised according to the latest pharmacological taxonomy rather than molecular formulas. The image-making of 'ethical marketing' began during the interwar years when marketers applied modern advertising techniques and infotainment strategies. The scanty black and white informational bulletins transitioned into colourful advertisements. The pharmaceutical companies employed the same medical language as used by physicians, so that one word or image in an advertisement would suffice for the physician to recognize a drug and its therapeutic properties. These developments show the changing relationship between the modern ethical pharmaceutical industry and Dutch
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Evolution of camel CYP2E1 and its associated power of binding toxic industrial chemicals and drugs.
Kandeel, Mahmoud; Altaher, Abdullah; Kitade, Yukio; Abdelaziz, Magdi; Alnazawi, Mohamed; Elshazli, Kamal
2016-10-01
Camels are raised in harsh desert environment for hundreds of years ago. By modernization of live and the growing industrial revolution in camels rearing areas, camels are exposed to considerable amount of chemicals, industrial waste, environmental pollutions and drugs. Furthermore, camels have unique gene evolution of some genes to withstand living in harsh environments. In this work, the camel cytochrome P450 2E1 (CYP2E1) is compromised to detect its evolution rate and its power to bind with various chemicals, protoxins, procarcinogens, industrial toxins and drugs. In comparison with human CYP2E1, camel CYP2E1 more efficiently binds to small toxins as aniline, benzene, catechol, amides, butadiene, toluene and acrylamide. Larger compounds were more preferentially bound to the human CYP2E1 in comparison with camel CYP2E1. The binding of inhalant anesthetics was almost similar in both camel and human CYP2E1 coinciding with similar anesthetic effect as well as toxicity profiles. Furthermore, evolutionary analysis indicated the high evolution rate of camel CYP2E1 in comparison with human, farm and companion animals. The evolution rate of camel CYP2E1 was among the highest evolution rate in a subset of 57 different organisms. These results indicate rapid evolution and potent toxin binding power of camel CYP2E1. Copyright © 2016. Published by Elsevier Ltd.
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[Drugs in veterinary medicine. The role of the veterinary drug industry].
Baars, J C
1984-02-01
Veterinary medicines constitute an unescapable element in the scheme of animal health and welfare. Nowadays, they are used more and more to improve health and productivity in farm animals. When a veterinary medicine is prescribed it must not only be effective but must also be safe for both animals and humans. Due to ever changing regulations and constant improvements in residue detection techniques it is necessary to conduct new investigations with existing products. It therefore costs a great deal of time and money to introduce, and maintain, a product in the market. In future, therefore, fewer medicines with more limited indications will be introduced and these will be to combat important production disorders in the more significant species only. In view of the above, research and production will be restricted to large, international, concerns. Due to our well structured agricultural industry and the existence of well organized and equipped veterinary research institutions, and practitioners, Holland is able to play an important role in the development of veterinary medicines. Close co-operation between all involved parties coupled with an efficient registration procedure is not ony of benefit to the veterinary pharmaceutical industry but also for international recognition of our national animal husbandry industry, ancillary industries and veterinary and other consultants. In this scheme of things the accent is not upon qualifications but upon the skills of veterinarians - wherever placed - who are involved in the administration of veterinary medicines.
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The Drug Discovery and Development Industry in India-Two Decades of Proprietary Small-Molecule R&D.
Differding, Edmond
2017-06-07
This review provides a comprehensive survey of proprietary drug discovery and development efforts performed by Indian companies between 1994 and mid-2016. It is based on the identification and detailed analysis of pharmaceutical, biotechnology, and contract research companies active in proprietary new chemical entity (NCE) research and development (R&D) in India. Information on preclinical and clinical development compounds was collected by company, therapeutic indication, mode of action, target class, and development status. The analysis focuses on the overall pipeline and its evolution over two decades, contributions by type of company, therapeutic focus, attrition rates, and contribution to Western pharmaceutical pipelines through licensing agreements. This comprehensive analysis is the first of its kind, and, in our view, represents a significant contribution to the understanding of the current state of the drug discovery and development industry in India. © 2017 The Author. Published by Wiley-VCH Verlag GmbH & Co. KGaA.
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Use of toxicogenomics in drug safety evaluation: Current status and an industry perspective.
Vahle, John L; Anderson, Ulf; Blomme, Eric A G; Hoflack, Jean-Christophe; Stiehl, Daniel P
2018-04-18
Toxicogenomics held great promise as an approach to enable early detection of toxicities induced by xenobiotics; however, there remain questions regarding the impact of the discipline on pharmaceutical nonclinical safety assessment. To understand the current state of toxicogenomics in the sector, an industry group surveyed companies to determine the frequency of toxicogenomics use in in vivo studies at various stages of drug discovery and development and to assess how toxicogenomics use has evolved over time. Survey data were compiled during 2016 from thirteen pharmaceutical companies. Toxicogenomic analyses were infrequently conducted in the development phase and when performed were done to address specific mechanistic questions. Prior to development, toxicogenomics use was more frequent; however, there were significant differences in approaches among companies. Across all phases, gaining mechanistic insight was the most frequent reason cited for pursing toxicogenomics with few companies using toxicogenomics to predict toxicities. These data were consistent with the commentary submitted in response to survey questions asking companies to describe the evolution of their toxicogenomics strategy. Overall, these survey data indicate that toxicogenomics is not widely used as a predictive tool in the pharmaceutical industry but is used regularly by some companies and serves a broader role in mechanistic investigations and as a complement to other technologies. Copyright © 2018. Published by Elsevier Inc.
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Gangagni Rao, A; Venkata Naidu, G; Krishna Prasad, K; Chandrasekhar Rao, N; Venkata Mohan, S; Jetty, Annapurna; Sarma, P N
2005-01-01
Studies were carried out on the treatment of wastewater from a bulk drug industry using an anaerobic fixed film reactor (AFFR) designed and fabricated in the laboratory. The chemical oxygen demand (COD) and total dissolved solids (TDS) of the wastewater were found to be very high with low biochemical oxygen demand (BOD) to COD ratio and high total suspended solid (TSS) concentration. Acclimatization of seed consortia and startup of the reactor was carried out by directly using the wastewater, which resulted in reducing the period of startup to 30 days. The reactor was studied at different organic loading rates (OLR) and it was found that the optimum OLR was 10 kg COD/m(3)/day. The wastewater under investigation, which had a considerable quantity of SS, was treated anaerobically without any pretreatment. COD and BOD of the reactor outlet wastewater were monitored and at steady state and optimum OLR 60-70% of COD and 80-90% of BOD were removed. The reactor was subjected to organic shock loads at two different OLR and the reaction could withstand the shocks and performance could be restored to normalcy at that OLR. The results obtained indicated that AFFR could be used efficiently for the treatment of wastewater from a bulk drug industry having high COD, TDS and TSS.
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Holden, Arthur L
2007-01-01
The International Serious Adverse Event Consortium (SAEC) is a pharmaceutical industry and FDA led international (501 c3 non-profit) consortium, focused on identifying and validating DNA-variants useful in predicting the risk of drug induced, rare serious adverse events (SAEs). As such, it functions with the explicit purpose of enhancing the 'public good'. Its members are (i) organizations engaged principally in the business of discovering, developing and marketing pharmaceutical products, or (ii) a charitable, governmental, or other non-profit organization with an interest in researching the molecular basis of drug response.Drug-induced, rare SAEs present significant health issues for patients; and pose challenges for the safe use of approved drugs and the development of new drugs. Examples of drug-induced, rare SAEs include hepatotoxicity, QT prolongation, rhabdomyolosis, serious skin rashes (e.g. SJS), edema, acute renal failure, acute hypersensitivity, anemias/neutropenias, excessive weigh gain, retinopathy, vasculitis, among others. The rarity of such drug induced SAEs and the absence of effective government surveillance/research networks, makes it extremely difficult for any one company or research entity to accrue enough SAE cases and controls to conduct effective whole genome studies. Central to the notion of the SAEC is industry, government and health care providers can join forces to make use of a variety of sample and data resources in researching the genetic basis of these events.The purpose of the SAEC is threefold:•To carry out research directed toward the discovery of DNA-variants clinically useful in understanding and predicting the risk of drug induced serious adverse events and similar scientific research.•To ensure the widespread availability of the results of such research to the scientific research community and the public at large for no charge through publication and web-based methods; and•To educate the scientific research and medical
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Keshava, Nirmal
2017-01-01
By the numbers, 2016 was not a good year for the U.S. pharmaceutical industry. As of early December, only 19 new drugs had been approved by the Food and Drug Administration (FDA), fewer than half of those approved in 2015 and the lowest number since 2007. Further, the FDA approved only 61% of submissions in 2016, compared to 95% in 2015 [1]. And, among the largest companies, the return on investment for research and development (R&D) fell to 3.7% [2].
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2011-07-28
...] Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop AGENCY... Administration (FDA) is announcing a public workshop regarding the approach of the Center for Drug Evaluation and..., and to gain additional insight from, professional societies, patient advocates, industry, consumer...
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78 FR 8544 - Training Program for Regulatory Project Managers; Information Available to Industry
2013-02-06
...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... Brum, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave... to industry's drug development processes and (2) a venue for sharing information about project...
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Collaboration between industry and academia--prospects for male fertility control.
Stock, G; Habenicht, U F
1999-12-01
Drug development within the pharmaceutical industry is probably the field with the highest level of regulations. Due to the complexity of the different components of drug development and drug surveillance the need for a sophisticated organization and infrastructure is obvious. In addition, there is a necessity for sufficient resources and long-term commitment as well as logistic and long-term knowledge management. In order to secure high professional standards at all levels of this highly complex value creating chain, the number of cooperative arrangements in the pharmaceutical industry are increasing. The identification of new targets in the drug finding process calls in particular for outside partners. At the same time the preparedness of non-industrial researchers to cooperate with industry has also increased significantly. The area of fertility control, especially male fertility control, provides an excellent example for this kind of cooperation between industrial and non-industrial partners. Here a cooperative network is described which probably meets practically all relevant criteria for both the non-industrial but also the industrial partner. Some principles for the management of such a cooperative network are discussed. We believe that this kind of network can serve as a model for similar networks in other fields.
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Photostability and Photostabilization of Drugs and Drug Products
Directory of Open Access Journals (Sweden)
Iqbal Ahmad
2016-01-01
Full Text Available Photostability studies of drugs and drug products are an integral part of the product development process in the pharmaceutical industry. These studies are carried out to ensure quality, efficacy, and safety of the formulated products during manufacture, storage, and use. This review deals with the concept of photostability and related aspects and the literature available in the field. It highlights the role of the photochemistry in the photostability studies, describes the functional groups important for the photoreactivity of drugs, explains photophysical processes, and deals with the kinetics of photochemical reactions. The various modes of photodegradation of drugs with examples of selected compounds are presented. The biological consequences of the effect of light on the drug degradation are described. The photostability testing of drugs and drug products and the requirements under ICH guideline are discussed. Some information on the packaging requirements for the formulated products is provided. The various methods used for the photostabilization of solid and liquid dosage forms are also discussed.
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Photostability and Photostabilization of Drugs and Drug Products
Ahmad, Iqbal; Ahmed, Sofia; Anwar, Zubair; Sheraz, Muhammad Ali; Sikorski, Marek
2016-01-01
Photostability studies of drugs and drug products are an integral part of the product development process in the pharmaceutical industry. These studies are carried out to ensure quality, efficacy, and safety of the formulated products during manufacture, storage, and use. This review deals with the concept of photostability and related aspects and the literature available in the field. It highlights the role of the photochemistry in the photostability studies, describes the functional groups ...
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76 FR 9028 - Training Program for Regulatory Project Managers; Information Available to Industry
2011-02-16
...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... Duvall-Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire... to provide the following: (1) Firsthand exposure to industry's drug development processes and (2) a...
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75 FR 10806 - Training Program for Regulatory Project Managers; Information Available to Industry
2010-03-09
...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug Evaluation and Research, Food and Drug Administration... to provide the following: (1) First hand exposure to industry's drug development processes and (2) a...
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77 FR 10538 - Training Program for Regulatory Project Managers; Information Available to Industry
2012-02-22
...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... Brum, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave...) Firsthand exposure to industry's drug development processes and (2) a venue for sharing information about...
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78 FR 35117 - Orphan Drug Regulations
2013-06-12
..., ``This [framework] affects the plasma protein therapeutics industry significantly because various drugs... orphan designated.'' Because many plasma protein therapies lack orphan-drug designation, they are... change in delivery system from intravenous (IV) to oral may, in some cases and for some drugs, constitute...
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Quality Performance of Drugs Analyzed in the Drug Analysis and ...
African Journals Online (AJOL)
ICT TEAM
performance of drug samples analyzed therein. Previous reports have ... wholesalers, non-governmental organizations, hospitals, analytical ..... a dispute concerning discharge of waste water ... Healthcare Industry in Kenya, December. 2008.
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Artese, Anna; Alcaro, Stefano; Moraca, Federica; Reina, Rocco; Ventura, Marzia; Costantino, Gabriele; Beccari, Andrea R; Ortuso, Francesco
2013-05-01
During the first edition of the Computationally Driven Drug Discovery meeting, held in November 2011 at Dompé Pharma (L'Aquila, Italy), a questionnaire regarding the diffusion and the use of computational tools for drug-design purposes in both academia and industry was distributed among all participants. This is a follow-up of a previously reported investigation carried out among a few companies in 2007. The new questionnaire implemented five sections dedicated to: research group identification and classification; 18 different computational techniques; software information; hardware data; and economical business considerations. In this article, together with a detailed history of the different computational methods, a statistical analysis of the survey results that enabled the identification of the prevalent computational techniques adopted in drug-design projects is reported and a profile of the computational medicinal chemist currently working in academia and pharmaceutical companies in Italy is highlighted.
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In defense of industry-physician relationships.
Nakayama, Don K
2010-09-01
The objective was to examine the economic, ethical, and legal foundations for conflict of interest restrictions between physicians and pharmaceutical and medical device industries ("industry"). Recently academic medical centers and professional organizations have adopted policies that restrict permissible interactions between industry and physicians. The motive is to avoid financial conflicts of interest that compromise core values of altruism and fiduciary relationships. Productive relationships between industry and physicians provide novel drugs and devices of immense benefit to society. The issues are opposing views of medical economics, profit motives, medical professionalism, and extent to which interactions should be lawfully restricted. Industry goals are congruent with those of physicians: patient welfare, safety, and running a profitable business. Profits are necessary to develop drugs and devices. Physician collaborators invent products, refine them, and provide feedback and so are appropriately paid. Marketing is necessary to bring approved products to patients. Economic realities limit the extent to which physicians treat their patients altruistically and as fiduciaries. Providing excellent service to patients may be a more realistic standard. Statements from industry and the American College of Surgeons appropriately guide professional behavior. Preservation of industry-physician relationships is vital to maintain medical innovation and progress.
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Umemura, Maki
2010-01-01
Unlike its automobile or electronics industries, Japan's pharmaceutical industry did not become a global leader. Japan remains a net importer of pharmaceuticals and has introduced few global blockbuster drugs. Alfred Chandler argued that Japan's pharmaceutical firms remained relatively weak because Western firms enjoyed an insurmountable first first-mover advantage. However, this case study of the anticancer drug sector illustrates that Chandler's explanation is incomplete. Japanese medical culture, government policy, and research environment also played a substantial role in shaping the industry. In the 1970s and 1980s, these factors encouraged firms to develop little few effective drugs with low side effects, and profit from Japan's domestic market. But, these drugs were unsuitable to foreign markets with more demanding efficacy standards. As a result, Japan not only lost more than a decade in developing ineffective drugs, but also neglected to create the infrastructure necessary to develop innovative drugs and build a stronger pharmaceutical industry.
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76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry
2011-01-07
...] FDA Transparency Initiative: Improving Transparency to Regulated Industry AGENCY: Food and Drug... the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The...
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Orphan drug: Development trends and strategies
Directory of Open Access Journals (Sweden)
Aarti Sharma
2010-01-01
Full Text Available The growth of pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will loose their exclusivity in next 5 years. Therefore, the current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies from the essential medicines to the new business model - niche busters, also called orphan drugs. Orphan drugs may help pharma companies to reduce the impact of revenue loss caused by patent expiries of blockbuster drugs. The new business model of orphan drugs could offer an integrated healthcare solution that enables pharma companies to develop newer areas of therapeutics, diagnosis, treatment, monitoring, and patient support. Incentives for drug development provided by governments, as well as support from the FDA and EU Commission in special protocols, are a further boost for the companies developing orphan drugs. Although there may still be challenges ahead for the pharmaceutical industry, orphan drugs seem to offer the key to recovery and stability within the market. In our study, we have compared the policies and orphan drug incentives worldwide alongwith the challenges faced by the pharmaceutical companies. Recent developments are seen in orphan drug approval, the various drugs in orphan drug pipeline, and the future prospectives for orphan drugs and diseases.
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2012-04-13
... resistance in human and animal bacterial pathogens when medically important antimicrobial drugs are used in... Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals'' and to set timelines... Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals'' (GFI 209) and (2) the...
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Superoxide dismutase: an industrial perspective.
Bafana, Amit; Dutt, Som; Kumar, Sanjay; Ahuja, Paramvir S
2011-03-01
The application of enzyme technologies to industrial research, development, and manufacturing has become a very important field. Since the production of crude rennet in 1874, several enzymes have been commercialized, and used for therapeutic, supplementary, and other applications. Recent advancements in biotechnology now allow companies to produce safer and less expensive enzymes with enhanced potency and specificity. Antioxidant enzymes are emerging as a new addition to the pool of industrial enzymes and are surpassing all other enzymes in terms of the volume of research and production. In the 1990s, an antioxidant enzyme--superoxide dismutase (SOD)--was introduced into the market. Although the enzyme initially showed great promise in therapeutic applications, it did not perform up to expectations. Consequently, its use was limited to non-drug applications in humans and drug applications in animals. This review summarizes the rise and fall of SOD at the industrial level, the reasons for this, and potential future thrust areas that need to be addressed. The review also focuses on other industrially relevant aspects of SOD such as industrial importance, enzyme engineering, production processes, and process optimization and scale-up.
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The industrial applications of ionizing radiations
International Nuclear Information System (INIS)
1992-10-01
This report presents all industrial applications of ionizing radiations in France, for food preservation, radiosterilization of drugs, medical materials and cosmetic products, for radiation chemistry of polymers. This report also describes the industrial plants of irradiation (electron, cobalt 60). Finally, it explains the legal and safety aspects
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Drug-free workplace programmes: New Zealand perspective.
Nolan, Susan
2008-01-30
New Zealand (NZ) companies have been introducing Drug & Alcohol Free Workplace Policies and Programmes, which include testing, since 1992. Most "safety-critical" industry sectors are now embracing drug and alcohol testing as part of comprehensive programmes which also have a strong focus on education and rehabilitation. Prison Inmate testing was also introduced in 1998. Lawful drug testing in NZ should be conducted to the strict medico-legal requirements of the Australian/New Zealand Standard, AS/NZS 4308:2001 "Procedures for the collection, detection and quantitation of drugs of abuse in urine." This paper gives an overview of the NZ experience, highlighting the mix of testing options employed, the industry sector trends, the categories of drugs misused, the influence of significant Employment Court Judgements, proposed changes to the AS/NZS 4308(2006), and current oral fluid research projects.
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2012-11-23
...] Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...
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Industrial recovery capability. Final report
International Nuclear Information System (INIS)
Gregg, D.W.
1984-12-01
This report provides an evaluation of the vulnerability - to a nuclear strike, terrorist attack, or natural disaster - of our national capacity to produce chlorine, beryllium, and a particular specialty alumina catalyst required for the production of sulfur. All of these industries are of critical importance to the United States economy. Other industries that were examined and found not to be particularly vulnerable are medicinal drugs and silicon wafers for electronics. Thus, only the three more vulnerable industries are addressed in this report
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Helmlinger, Gabriel; Al-Huniti, Nidal; Aksenov, Sergey; Peskov, Kirill; Hallow, Karen M; Chu, Lulu; Boulton, David; Eriksson, Ulf; Hamrén, Bengt; Lambert, Craig; Masson, Eric; Tomkinson, Helen; Stanski, Donald
2017-11-15
Modeling & simulation (M&S) methodologies are established quantitative tools, which have proven to be useful in supporting the research, development (R&D), regulatory approval, and marketing of novel therapeutics. Applications of M&S help design efficient studies and interpret their results in context of all available data and knowledge to enable effective decision-making during the R&D process. In this mini-review, we focus on two sets of modeling approaches: population-based models, which are well-established within the pharmaceutical industry today, and fall under the discipline of clinical pharmacometrics (PMX); and systems dynamics models, which encompass a range of models of (patho-)physiology amenable to pharmacological intervention, of signaling pathways in biology, and of substance distribution in the body (today known as physiologically-based pharmacokinetic models) - which today may be collectively referred to as quantitative systems pharmacology models (QSP). We next describe the convergence - or rather selected integration - of PMX and QSP approaches into 'middle-out' drug-disease models, which retain selected mechanistic aspects, while remaining parsimonious, fit-for-purpose, and able to address variability and the testing of covariates. We further propose development opportunities for drug-disease systems models, to increase their utility and applicability throughout the preclinical and clinical spectrum of pharmaceutical R&D. Copyright © 2017 Elsevier B.V. All rights reserved.
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Discontinued drugs in 2012: cardiovascular drugs.
Zhao, Hong-Ping; Jiang, Hong-Min; Xiang, Bing-Ren
2013-11-01
The continued high rate of cardiovascular morbidity and mortality has attracted wide concern and great attention of pharmaceutical industry. In order to reduce the attrition of cardiovascular drug R&D, it might be helpful recapitulating previous failures and identifying the potential factors to success. This perspective mainly analyses the 30 cardiovascular drugs dropped from clinical development in 2012. Reasons causing the termination of the cardiovascular drugs in the past 5 years are also tabulated and analysed. The analysis shows that the attrition is highest in Phase II trials and financial and strategic factors and lack of clinical efficacy are the principal reasons for these disappointments. To solve the four problems (The 'better than the Beatles' problem, the 'cautious regulator' problem, the 'throw money at it' tendency and the 'basic researchbrute force' bias) is recommended as the main measure to increase the number and quality of approvable products.
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Quantum mechanics implementation in drug-design workflows: does it really help?
Arodola, Olayide A; Soliman, Mahmoud Es
2017-01-01
The pharmaceutical industry is progressively operating in an era where development costs are constantly under pressure, higher percentages of drugs are demanded, and the drug-discovery process is a trial-and-error run. The profit that flows in with the discovery of new drugs has always been the motivation for the industry to keep up the pace and keep abreast with the endless demand for medicines. The process of finding a molecule that binds to the target protein using in silico tools has made computational chemistry a valuable tool in drug discovery in both academic research and pharmaceutical industry. However, the complexity of many protein-ligand interactions challenges the accuracy and efficiency of the commonly used empirical methods. The usefulness of quantum mechanics (QM) in drug-protein interaction cannot be overemphasized; however, this approach has little significance in some empirical methods. In this review, we discuss recent developments in, and application of, QM to medically relevant biomolecules. We critically discuss the different types of QM-based methods and their proposed application to incorporating them into drug-design and -discovery workflows while trying to answer a critical question: are QM-based methods of real help in drug-design and -discovery research and industry?
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2010-08-03
... drug substance than what is intended to be delivered to the patient. This excess amount of drug... issue not only to the patient, but also to others including family members, caregivers, children, and...
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Allan, M C
1992-01-01
To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text and additional readings are presented in an appendix. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction ;of the components
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Micro fabrication of biodegradable polymer drug delivery devices
DEFF Research Database (Denmark)
Nagstrup, Johan
The pharmaceutical industry is presently facing several obstacles in developing oral drug delivery systems. This is primarily due to the nature of the discovered drug candidates. The discovered drugs often have poor solubility and low permeability across the gastro intestinal epithelium. Furtherm......The pharmaceutical industry is presently facing several obstacles in developing oral drug delivery systems. This is primarily due to the nature of the discovered drug candidates. The discovered drugs often have poor solubility and low permeability across the gastro intestinal epithelium...... permeability and degradation. These systems are for the majority based on traditional materials used in micro technology, such as SU-8, silicon, poly(methyl methacrylate). The next step in developing these new drug delivery systems is to replace classical micro fabrication materials with biodegradable polymers....... In order to successfully do this, methods for fabricating micro structures in biodegradable polymers need to be developed. The goal of this project has been to develop methods for micro fabrication in biodegradable polymers and to use these methods to produce micro systems for oral drug delivery. This has...
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In Touch With Industry: ICAF Industry Studies, 1997
1997-01-01
Analysis and Critical Control Program ( HACCP ) food safety system will allow both the Food and Drug Administration and Food Safety and Inspection...actively prevent food safety problems. The HACCP system is a scientific, process-based analysis of potential hazards, a determination of where those...Figure 2.—U.S. Primary Production (Quadrillion Btu) jam . The energy industry is a highly aggregated construct that stretches the definition of
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Srivastava, Rajesh; Chandra, Ashish; Kumar, Girish
2004-01-01
The annual global pharmaceutical sales have grown over 466 billion dollars, almost 50% of which comes from North America. Among developing countries, India, with 16% of the world population, accounts for only a small percentage of the global pharmaceutical industry. Until recently, India has had virtually no pharmaceutical industry worth the name producing drugs from basic raw materials and it used to rely mostly on the imports from countries like the USA and England for all its requirements of drugs. On the other hand, India has seen a plethora of multinational pharmaceutical companies come and do business in India. This paper develops a matrix which provides a broad guidance to the mid- to large-size Indian pharmaceutical domestic companies, which should embark on the path to global expansion to establish their might as well.
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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.
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Nano-formulations of drugs: Recent developments, impact and challenges.
Jeevanandam, Jaison; Chan, Yen San; Danquah, Michael K
2016-01-01
Nano-formulations of medicinal drugs have attracted the interest of many researchers for drug delivery applications. These nano-formulations enhance the properties of conventional drugs and are specific to the targeted delivery site. Dendrimers, polymeric nanoparticles, liposomes, nano-emulsions and micelles are some of the nano-formulations that are gaining prominence in pharmaceutical industry for enhanced drug formulation. Wide varieties of synthesis methods are available for the preparation of nano-formulations to deliver drugs in biological system. The choice of synthesis methods depend on the size and shape of particulate formulation, biochemical properties of drug, and the targeted site. This article discusses recent developments in nano-formulation and the progressive impact on pharmaceutical research and industries. Additionally, process challenges relating to consistent generation of nano-formulations for drug delivery are discussed. Copyright © 2016 Elsevier B.V. and Société Française de Biochimie et Biologie Moléculaire (SFBBM). All rights reserved.
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DEFF Research Database (Denmark)
2015-01-01
NOVELTY - The method involves preparing a multi-layered film comprising a core layer and a barrier layer, where the core layer comprises active ingredient. The multi-layered film is subjected to a hot embossing step using an embossing stamp including protrusions that allows for generation...... delivery operation for a food and drug administration (FDA) application in a pharmaceutical industry. ADVANTAGE - The method enables allowing an individual micro-structure stuck in an embossing stamp to be demolded under the conditions such that demolding operation is done by treating elastically...
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Nuclear imaging drug development tools
International Nuclear Information System (INIS)
Buchanan, L.; Jurek, P.; Redshaw, R.
2007-01-01
This article describes the development of nuclear imaging as an enabling technology in the pharmaceutical industry. Molecular imaging is maturing into an important tool with expanding applications from validating that a drug reaches the intended target through to market launch of a new drug. Molecular imaging includes anatomical imaging of organs or tissues, computerized tomography (CT), magnetic resonance imaging (MRI) and ultrasound.
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Bioinformatics in translational drug discovery.
Wooller, Sarah K; Benstead-Hume, Graeme; Chen, Xiangrong; Ali, Yusuf; Pearl, Frances M G
2017-08-31
Bioinformatics approaches are becoming ever more essential in translational drug discovery both in academia and within the pharmaceutical industry. Computational exploitation of the increasing volumes of data generated during all phases of drug discovery is enabling key challenges of the process to be addressed. Here, we highlight some of the areas in which bioinformatics resources and methods are being developed to support the drug discovery pipeline. These include the creation of large data warehouses, bioinformatics algorithms to analyse 'big data' that identify novel drug targets and/or biomarkers, programs to assess the tractability of targets, and prediction of repositioning opportunities that use licensed drugs to treat additional indications. © 2017 The Author(s).
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Sabatier , Valérie; Kennard , Adrienne; Mangematin , Vincent
2012-01-01
Working paper serie RMT (WPS 12-04) - 39 p; International audience; An industry's dominant logic is the general scheme of value creation and capture shared by its actors. In high technology fields, technological discontinuities are not enough to disrupt an industry's dominant logic. Identifying the factors that might trigger change in that logic can help companies develop strategies to enable them to capture greater value from their innovations by disrupting that logic. Based on analyzing the...
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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.
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Drug-loaded erythrocytes: on the road toward marketing approval
Directory of Open Access Journals (Sweden)
Bourgeaux V
2016-02-01
Full Text Available Vanessa Bourgeaux,1 José M Lanao,2 Bridget E Bax,3 Yann Godfrin11ERYTECH Pharma, Lyon, France; 2Department of Pharmacy and Pharmaceutical Technology, University of Salamanca, Salamanca, Spain; 3Cardiovascular and Cell Sciences Research Institute, St George’s University of London, London, UKAbstract: Erythrocyte drug encapsulation is one of the most promising therapeutic alternative approaches for the administration of toxic or rapidly cleared drugs. Drug-loaded erythrocytes can operate through one of the three main mechanisms of action: extension of circulation half-life (bioreactor, slow drug release, or specific organ targeting. Although the clinical development of erythrocyte carriers is confronted with regulatory and development process challenges, industrial development is expanding. The manufacture of this type of product can be either centralized or bedside based, and different procedures are employed for the encapsulation of therapeutic agents. The major challenges for successful industrialization include production scalability, process validation, and quality control of the released therapeutic agents. Advantages and drawbacks of the different manufacturing processes as well as success key points of clinical development are discussed. Several entrapment technologies based on osmotic methods have been industrialized. Companies have already achieved many of the critical clinical stages, thus providing the opportunity in the future to cover a wide range of diseases for which effective therapies are not currently available.Keywords: red blood cell, encapsulation method, drug carrier, industrial development, clinical use
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The Economic Side Effects of Dangerous Drug Announcements.
Dranove, David; Olsen, Chris
1994-01-01
Immediately prior to the passage of the 1962 Food and Drug Administration Amendments, there were a number of drugs recalled from markets worldwide. Announcements about the dangerous side effects of these drugs were associated with lower-share prices for their manufacturers and the industry as a whole. We perform several analyses to sort out alternative explanations for the observed declines. We find that dangerous drug announcements had no effect on the sales of other drugs and didn't affect ...
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Rational drug design paradigms: the odyssey for designing better drugs.
Kellici, Tahsin; Ntountaniotis, Dimitrios; Vrontaki, Eleni; Liapakis, George; Moutevelis-Minakakis, Panagiota; Kokotos, George; Hadjikakou, Sotiris; Tzakos, Andreas G; Afantitis, Antreas; Melagraki, Georgia; Bryant, Sharon; Langer, Thierry; Di Marzo, Vincenzo; Mavromoustakos, Thomas
2015-01-01
Due to the time and effort requirements for the development of a new drug, and the high attrition rates associated with this developmental process, there is an intense effort by academic and industrial researchers to find novel ways for more effective drug development schemes. The first step in the discovery process of a new drug is the identification of the lead compound. The modern research tendency is to avoid the synthesis of new molecules based on chemical intuition, which is time and cost consuming, and instead to apply in silico rational drug design. This approach reduces the consumables and human personnel involved in the initial steps of the drug design. In this review real examples from our research activity aiming to discover new leads will be given for various dire warnings diseases. There is no recipe to follow for discovering new leads. The strategy to be followed depends on the knowledge of the studied system and the experience of the researchers. The described examples constitute successful and unsuccessful efforts and reflect the reality which medicinal chemists have to face in drug design and development. The drug stability is also discussed in both organic molecules and metallotherapeutics. This is an important issue in drug discovery as drug metabolism in the body can lead to various toxic and undesired molecules.
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Industrial system for producing iodine-123
International Nuclear Information System (INIS)
Brantley, J.C.
1985-01-01
An industrial system to produce iodine-123 required a complex set of steps involving new approaches by the Food and Drug Administration, difficult distribution procedures, and evidence from potential users that either very pure iodine-123 or inexpensive iodine-123 is needed. Industry has shown its willingness to invest in new radionuclides but needs strong evidence as to product potential to justify those investments
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Industry sponsorship and research outcome
DEFF Research Database (Denmark)
Lundh, Andreas; Sismondo, Sergio; Lexchin, Joel
2012-01-01
Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical industry sponsored studies are more often favorable to the sponsor's product compared with studies...
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Directory of Open Access Journals (Sweden)
Jeffrey Atkinson
2016-02-01
Full Text Available This paper looks at the way in which industrial pharmacists rank the fundamental competences for pharmacy practice. European industrial pharmacists (n = 135 ranked 68 competences for practice, arranged into 13 clusters of two types (personal and patient care. Results show that, compared to community pharmacists (n = 258, industrial pharmacists rank competences centering on research, development and production of drugs higher, and those centering on patient care lower. Competences centering on values, communication skills, etc. were ranked similarly by the two groups of pharmacists. These results are discussed in the light of the existence or not of an “industrial pharmacy” specialization.
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Factors influencing GPs’ choice between drugs in a therapeutic drug group. A qualitative study
DEFF Research Database (Denmark)
Buusman, Allan; Andersen, Morten; Merrild, Camilla Hoffmann
2007-01-01
(GPs) were selected with reference to variation in organizational structure, age, and gender. Main outcome measures. GPs' description of drug choice in relation to specific patient encounters involving a prescription. Results. All informants appeared to consider drug price important...... as it was a recurring theme during all interviews. External factors outside the GP's control such as governmental regulation on prescribing and the pharmaceutical industry influenced most GPs. Internal factors related to the actual consultation included characteristics of the GP and the patient, drug characteristics......, and repeat prescriptions. These factors interact in a non-linear and unpredictable way similar to complex adaptive systems. Conclusion. GPs balance both internal and external factors when choosing between analogues. Drug choice is a regulated process in the realm of complex prescribing behaviour with drug...
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The worldwide trend of using botanical drugs and strategies for developing global drugs.
Ahn, Kyungseop
2017-03-01
Natural product drugs, or botanical drugs, are drugs composed of natural substances which have constituents with healthenhancing or medicinal activities. In Korea, government-led projects brought attention to botanical drugs invigorating domestic botanical drug industry. Foreign markets, as well, are growing bigger as the significance of botanical drugs stood out. To follow along with the tendency, Korea puts a lot of effort on developing botanical drugs suitable for global market. However, standards for approving drug sales vary by countries. And also, thorough standardization, certification, clinical studies and data of these will be required as well as data confirming safety and effectiveness. Meanwhile, as an international exchange in botanical drug market continues, the importance of plant resources was emphasized. Thus countries' ownership of domestic natural resources became vital. Not only establishing a systematic method to secure domestic plant resources, but also cooperation with other countries on sharing natural resources is essential to procure natural resources effectively. Korea started to show visible results with botanical drugs, and asthma/COPD treatment made out of speedwell is one example. Sufficient investment and government's active support for basic infrastructure for global botanical drugs will bring Korea to much higher level of botanical drug development. [BMB Reports 2017; 50(3): 111-116].
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Gorovits, Boris; Alley, Stephen C; Bilic, Sanela; Booth, Brian; Kaur, Surinder; Oldfield, Phillip; Purushothama, Shobha; Rao, Chetana; Shord, Stacy; Siguenza, Patricia
2013-05-01
Antibody-drug conjugates (ADCs) typically consist of a cytotoxic drug covalently bound to an antibody by a linker. These conjugates have the potential to substantially improve efficacy and reduce toxicity compared with cytotoxic small-molecule drugs. Since ADCs are generally complex heterogeneous mixtures of multiple species, these novel therapeutic products present unique bioanalytical challenges. The growing number of ADCs being developed across the industry suggests the need for alignment of the bioanalytical methods or approaches used to assess the multiple species and facilitate consistent interpretation of the bioanalytical data. With limited clinical data, the current strategies that can be used to provide insight into the relationship between the multiple species and the observed clinical safety and efficacy are still evolving. Considerations of the bioanalytical strategies for ADCs based on the current industry practices that take into account the complexity and heterogeneity of ADCs are discussed.
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A vision of the pharmaceutical industry.
Muñio, S
1998-01-01
As the financial resources available for looking after the health of an aging population are limited, generic drugs (drugs that are no longer covered by a patent and marketed at a lower price) have come to be used in western countries as a means for meeting growing demand while leaving resources in the health budget for new drugs. In Spain, a law on product patents was introduced in 1992, which is much later than in other countries, and created difficulties in the definition and procedure for gaining approval for generic drugs. Circular 3/97 from the Ministry of Health finally resolved these issues. In this circular, generic pharmaceutical products (GPPs) are clearly defined and identified with a positive commitment towards guaranteeing the ability to interchange original drugs for other cheaper generic products and towards clarifying the Spanish vade mecum. The position of the pharmaceutical industry on generic drugs varies widely and consequently, it is impossible to make a general statement on the view of the industry. However, the commitment of Novartis, given the issues described above and in line with the company's global strategy, is to offer innovation and services to society. This is perfectly compatible with offering health professionals both innovative drugs and generic drugs of a high quality at a lower price, given that registering genetics requires less investment in research and development. In any case, GPPs face an uncertain future in Spain and market forecasts also differ widely, ranging from 15 billion to 80 billion pesetas in the year 2000. It will be necessary to get doctors and pharmacists positively involved, to set up fast structural measures, and to avoid rejection by patients through successful information and marketing.
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Economic Aspects of the Chemical Industry
Koleske, Joseph V.
Within the formal disciplines of science at traditional universities, through the years, chemistry has grown to have a unique status because of its close correspondence with an industry and with a branch of engineering—the chemical industry and chemical engineering. There is no biology industry, but aspects of biology have closely related disciplines such as fish raising and other aquaculture, animal cloning and other facets of agriculture, ethical drugs of pharmaceutical manufacture, genomics, water quality and conservation, and the like. Although there is no physics industry, there are power generation, electricity, computers, optics, magnetic media, and electronics that exist as industries. However, in the case of chemistry, there is a named industry. This unusual correspondence no doubt came about because in the chemical industry one makes things from raw materials—chemicals—and the science, manufacture, and use of chemicals grew up together during the past century or so.
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Organizational adoption of preemployment drug testing.
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.
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Protein Crystallography: A 'Must' Technology for Drug Design
International Nuclear Information System (INIS)
Matsuzaki, Takao
2004-01-01
The history of drug-related protein crystallography and drug design is reviewed to show that 'Lead Generation' is high-lighted in the pharmaceutical industry nowadays. A new drug design method has been developed. The method gave very high success rate; 10-60 % gave < 100 μM, 90 % gave < 10 mM. The crystal structures of drug-protein complexes have become even more important to give solid experimental bases for e.g. 1,000 designed structures and to find the new mechanisms of drug action
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Report raises questions about drug companies advertising budgets.
1999-08-06
A report by AIDS Action cites that data, indicates the pharmaceutical industry is spending more resources on marketing and advertising than on research and development (R&D). The pharmaceutical industry blames the high cost of AIDS drugs on R&D information compiled from annual reports and industry publications show excessive marketing as the source. A spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA) disputes the information in the AIDS Action report as misleading. According to PhRMA, research spending has been steadily increasing, and at a greater rate than any other industry. In addition, PhRMA noted that pharmaceutical companies have already dedicated money to fund initiatives in developing countries. Solutions proposed by AIDS Action include lowering drug prices or transferring funds from marketing to research, and reestablishing the "reasonable pricing clause" between National Institutes of Health and those companies seeking tax breaks for R&D.
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Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives
Directory of Open Access Journals (Sweden)
M Venkatesh
2011-01-01
Full Text Available Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20 th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.
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Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives
Venkatesh, M.; Bairavi, V. G.; Sasikumar, K. C.
2011-01-01
Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.. PMID:21430959
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Cancer Drugs: An International Comparison of Postlicensing Price Inflation.
Savage, Philip; Mahmoud, Sarah; Patel, Yogin; Kantarjian, Hagop
2017-06-01
The cost of cancer drugs forms a rising proportion of health care budgets worldwide. A number of studies have examined international comparisons of initial cost, but there is little work on postlicensing price increases. To examine this, we compared cancer drug prices at initial sale and subsequent price inflation in the United States and United Kingdom and also reviewed relevant price control mechanisms. The 10 top-selling cancer drugs were selected, and their prices at initial launch and in 2015 were compared. Standard nondiscounted prices were obtained from the relevant annual copies of the RED BOOK and the British National Formulary. At initial marketing, prices were on average 42% higher in the United States than in the United Kingdom. After licensing in the United States, all 10 drugs had price rises averaging an overall annual 8.8% (range, 1.4% to 24.1%) increase. In comparison, in the United Kingdom, six drugs had unchanged prices, two had decreased prices, and two had modest price increases. The overall annual increase in the United Kingdom was 0.24%. Cancer drug prices are rising substantially, both at their initial marketing price and, in the United States, at postlicensing prices. In the United Kingdom, the Pharmaceutical Price Regulation Scheme, an agreement between the government and the pharmaceutical industry, controls health care costs while allowing a return on investment and funds for research. The increasing costs of cancer drugs are approaching the limits of sustainability, and a similar government-industry agreement may allow stability for both health care provision and the pharmaceutical industry in the United States.
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Drug policy in United States of America
Stahl, Edmundo G.; Médico internista, President and Chief Executive Officer, LatAmScience. Florida, USA.
2009-01-01
The USA federal prescription drug policies are inconsistent. The federal government regulates the development, production, marketing and safety of prescription drugs in the country through various legal mechanisms as well as private and governmental institutions. Patent laws also play an important role in this process protecting the pharmaceutical industry. The government has no direct mechanism to control prices of prescription drugs nor does it have a policy to cover the whole US popula...
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Twine, Richard
2013-12-01
In this paper I revisit previous critiques that I have made of much, though by no means all, bioethical discourse. These pertain to faithfulness to dualistic ontology, a taken-for-granted normative anthropocentrism, and the exclusion of a consideration of how political economy shapes the conditions for bioethical discourse (Twine Medicine, Health Care and Philosophy 8(3):285-295, 2005; International Journal of Sociology of Agriculture and Food 16(3):1-18, 2007, 2010). Part of my argument around bioethical dualist ontology is to critique the assumption of a division between the "medical" (human) and "agricultural" (nonhuman) and to show various ways in which they are interrelated. I deepen this analysis with a focus on transnational pharmaceutical companies, with specific attention to their role in enhancing agricultural production through animal drug administration. I employ the topical case of antibiotics in order to speak to current debates in not only the interdisciplinary field of bioethics but also that of animal studies. More generally, the animal-industrial complex (Twine Journal for Critical Animal Studies 10(1):12-39, 2012) is underlined as a highly relevant bioethical object that deserves more conceptual and empirical attention.
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Spurious and counterfeit drugs: a growing industry in the developing world.
Gautam, C S; Utreja, A; Singal, G L
2009-05-01
Spread of spurious/counterfeit/substandard drugs is a modern day menace which has been recognised internationally, especially so in developing countries. The problem assumes added significance in view of rapid globalisation. The market of spurious and counterfeit drugs is a well-organised, white collar crime. Poverty, high cost of medicines, lack of an official supply chain, legislative lacunae, easy accessibility to computerised printing technology, ineffective law enforcement machinery, and light penalties provide the counterfeiters with an enormous economic incentive without much risk. The consequences of the use of such medicines may vary from therapeutic failure to the occurrence of serious adverse events and even death. Proper drug quality monitoring, enforcement of laws and legislation, an effective and efficient regulatory environment, and awareness and vigilance on part of all stakeholders can help tackle this problem.
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Scientific misconduct, the pharmaceutical industry, and the tragedy of institutions.
Cohen-Kohler, Jillian Clare; Esmail, Laura C
2007-09-01
This paper examines how current legislative and regulatory models do not adequately govern the pharmaceutical industry towards ethical scientific conduct. In the context of a highly profit-driven industry, governments need to ensure ethical and legal standards are not only in place for companies but that they are enforceable. We demonstrate with examples from both industrialized and developing countries how without sufficient controls, there is a risk that corporate behaviour will transgress ethical boundaries. We submit that there is a critical need for urgent drug regulatory reform. There must be robust regulatory structures in place which enforce corporate governance mechanisms to ensure that pharmaceutical companies maintain ethical standards in drug research and development and the marketing of pharmaceuticals. What is also needed is for the pharmaceutical industry to adopt authentic "corporate social responsibility" policies as current policies and practices are insufficient.
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Expanding lysine industry: industrial biomanufacturing of lysine and its derivatives.
Cheng, Jie; Chen, Peng; Song, Andong; Wang, Dan; Wang, Qinhong
2018-04-13
L-Lysine is widely used as a nutrition supplement in feed, food, and beverage industries as well as a chemical intermediate. At present, great efforts are made to further decrease the cost of lysine to make it more competitive in the markets. Furthermore, lysine also shows potential as a feedstock to produce other high-value chemicals for active pharmaceutical ingredients, drugs, or materials. In this review, the current biomanufacturing of lysine is first presented. Second, the production of novel derivatives from lysine is discussed. Some chemicals like L-pipecolic acid, cadaverine, and 5-aminovalerate already have been obtained at a lab scale. Others like 6-aminocaproic acid, valerolactam, and caprolactam could be produced through a biological and chemical coupling pathway or be synthesized by a hypothetical pathway. This review demonstrates an active and expansive lysine industry, and these green biomanufacturing strategies could also be applied to enhance the competitiveness of other amino acid industry.
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Microemulsions based transdermal drug delivery systems.
Vadlamudi, Harini C; Narendran, Hyndavi; Nagaswaram, Tejeswari; Yaga, Gowri; Thanniru, Jyotsna; Yalavarthi, Prasanna R
2014-01-01
Since the discovery of microemulsions by Jack H Schulman, there has been huge progress made in applying microemulsion systems in plethora of research and industrial process. Microemulsions are optically isotropic systems consisting of water, oil and amphiphile. These systems are beneficial due to their thermodynamic stability, optical clarity, ease of preparation, higher diffusion and absorption rates. Moreover, it has been reported that the ingredients of microemulsion can effectively overcome the diffusion barrier and penetrate through the stratum corneum of the skin. Hence it becomes promising for both transdermal and dermal drug delivery. However, low viscosity of microemulsion restrains its applicability in pharmaceutical industry. To overcome the above drawback, the low viscous microemulsions were added to viscous gel bases to potentiate its applications as topical drug delivery systems so that various drug related toxic effects and erratic drug absorption can be avoided. The present review deals with the microemulsions, various techniques involved in the development of organic nanoparticles. The review emphasized on microemulsion based systems such as hydrogels and organogels. The physicochemical characteristics, mechanical properties, rheological and stability principles involved in microemulsion based viscous gels were also explored.
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2013-04-04
... foundations, emerging technologies and innovations in regulatory science, as well as the current quality and... strategies, while industry professionals from some of today's leading pharmaceutical companies present case.... Drug Safety. Emerging Active Pharmaceutical Ingredients (API) Regulations. Investigations. Emerging API...
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2012-10-09
... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0375...
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Exposure to antineoplastic drugs outside the hospital environment.
Meijster, T; Fransman, W; Veldhof, R; Kromhout, H
2006-10-01
The objectives were (i) to identify occupational populations outside hospitals working with antineoplastic drugs, (ii) to determine the size of the populations 'at risk', (iii) to identify major determinants and routes of exposure outside hospitals and (iv) to estimate exposure levels and frequencies relative to levels found in hospitals. The survey consisted of two phases; (i) identification of activities with potential exposure to antineoplastic drugs by literature review, interviews, questionnaires and workplace visits, (ii) exploratory measurements of exposure and surface contamination in selected sectors. Eight sectors were identified with potential exposure to antineoplastic drugs: pharmaceutical industry, pharmacies, universities, veterinary medicine, nursing homes, home care, laundry facilities, and waste treatment. Four sectors were of primary concern: veterinary medicine, home care, nursing homes and industrial laundries. The populations potentially exposed in these sectors vary considerably (from several tens to thousands of workers), as do their levels of exposure. Exposure measurements collected in the veterinary medicine sector showed that workers are indeed exposed to antineoplastic drugs and, in some cases (on gloves after administration), levels were 15 times higher than levels measured during administration in hospitals. Workers sorting contaminated hospital laundry in industrial laundry facilities were exposed to antineoplastic drugs through inhalation. For the home care and nursing homes sectors the highest exposure levels were found when cleaning toilets and washing treated patients. These two sectors are expected to have the largest exposed population (5,000-10,000 individuals). This study has resulted in a comprehensive overview of populations with potential exposure to antineoplastic drugs. Exposure levels can potentially be high compared with the hospital environment, because exposure routes are complex and awareness of the hazard (and
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Arnold, Denis G; Oakley, James L
2013-06-01
As the pharmaceutical industry lobbies European regulators to permit direct-to-consumer advertising (DTCA) of prescription drugs in the European Union, we found that five leading companies violated industry-developed and -promulgated standards for ethical advertising in the United States. Utilizing multiple data sources and methods, we demonstrate a consistent failure by companies that market erectile dysfunction drugs to comply with the industry's guiding principles for ethical DTCA over a four-year period despite pledges of compliance by company leaders. Noncompliance resulted in children being exposed to sexually themed promotional messages more than 100 billion times. We argue that the guidelines are a coordinated effort by the industry to prevent unwanted federal regulation, and we introduce the concept of a blocking strategy to explain company behavior and to advance theoretical understanding of firms' public affairs strategies. We recommend policy responses to prevent deceptive practices, protect children from adult content, and promote genuine health care education.
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Directory of Open Access Journals (Sweden)
Gerson Rosenberg
2010-04-01
Full Text Available Este artigo analisa a evolução da estrutura do segmento de medicamentos de marca e genéricos no Brasil a partir de 1997. Após a entrada dos medicamentos genéricos, constatou-se que não houve diminuição significativa da concentração na indústria farmacêutica brasileira, porém, o mesmo não ocorreu em nível mundial, verificando-se um aumento da concentração a partir de 2001, impulsionado pelo expressivo processo de fusões e aquisições nos últimos anos da década de 1990. Em relação ao turnover, notou-se que este foi muito baixo para o grupo das maiores empresas em ambos os segmentos de medicamentos. Entretanto, observa-se um elevado turnover com a entrada dos genéricos, mostrando o fortalecimento da indústria nacional. Verifica-se que o processo de fusões e aquisições entre empresas nacionais é pouco significativo, o que pode ser uma alternativa para as pequenas empresas farmacêuticas aumentarem a sua participação no mercado brasileiro.This paper analyzes the evolution of brand-name and generic drugs structure in Brazil since 1997. After the introduction of generic drugs it was not verified a significant decrease in the concentration of Brazilian pharmaceutical industry. The process of mergers and acquisitions in the 90's enhanced the process of concentration in the international market. However, a non-expressive turnover can be demonstrated in both pharmaceutical and generic markets. At the same time, the entrance of the generic industry in Brazil explains the invigoration of the national industry. The mergers and acquisitions process in the pharmaceutical industry is quite intense in Europe and in the USA, although in Brazil it is still not significant.
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Directory of Open Access Journals (Sweden)
Cristiane Quental
2008-04-01
Full Text Available O presente artigo faz eco a trabalhos recentes da Abrasco¹, Gadelha² e Guimarães³, que enfatizam a necessidade de uma maior integração entre as políticas voltadas para o desenvolvimento do sistema de saúde e aquelas voltadas para a promoção do desenvolvimento industrial e da inovação, como forma de garantir para o país os benefícios econômicos gerados pelos gastos em saúde, assegurando a continuidade da política social, num círculo virtuoso. Embora apresente o caso dos medicamentos genéricos como uma experiência de sucesso na integração das políticas sociais voltadas para um maior acesso da população a medicamentos com qualidade garantida, com as políticas econômicas voltadas para o desenvolvimento industrial, discute os impactos e as limitações da política dialogando com a análise da competitividade da indústria de medicamentos genéricos brasileira realizada por Abreu4.This paper echoes recent works of Abrasco¹, Gadelha² and Guimarães³ emphasizing the need for a better integration between health policies and industrial development and innovation policies as the only way to keep the economic benefits generated by health expenditures in the country instead of letting them escape through imports and threaten the continuity of the social policy by growing trade deficits. Although presenting the generic drug policy as a successful case in integrating social policies aimed at a better access to quality drugs for the population with economic policies aimed at industrial development, this paper discusses the impacts and limitations of the referred policy in a dialog with Abreu's analysis of industrial competitiveness in the Brazilian generics industry.
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2010-11-29
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0584... Products.'' This guidance updates recommendations regarding degradation products and updates the draft... information on listing of degradation products, setting acceptance criteria, and qualifying degradation...
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2011-01-25
... and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug...] Guidance for Industry on Process Validation: General Principles and Practices; Availability AGENCY: Food... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...
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Determinants of Iran's BilateralIntra-industry Trade in Pharmaceutical Industry.
Aghlmand, Siamak; Rahimi, Bahlol; Farrokh-Eslamlou, Hamidreza; Nabilou, Bahram; Yusefzadeh, Hassan
2018-01-01
Among non-oil and in trade arena, drug has always been strategic importance and most government especially industrialized countries pay special attention to its production and trade issues. Thus, having a comprehensive view from economic perspective to this section is essential for suggesting intervention. This was a descriptive-analytical and panel study. In this study, gravity model is used to estimate Iran's bilateral intra-industry trade in pharmaceutical products in the 2001-2012 periods. To illustrate the extent of pharmaceutical's intra-industry trade between Iran and its major trading partners, the explanatory variables of market size, income, factor endowments, distance, cultural contributions, and similarities and also special trade arrangements have been applied. Analysis of factors affecting Iran's bilateral intra-industry trade in pharmaceutical industry showed that the average GDP and cultural similarities had a significant positive impact on Iran's bilateral IIT, while the difference in GDP has a negative and significant effect. Coefficients obtained for the geographical distance and the average ratio of total capital to the labor force is not consistent with theoretical expectations. Special trade arrangements did not have significant impact on the extent of bilateral intra-industry trade between Iran and its trading partners. The knowledge of the intra-industry trade between Iran and its trade partners make integration between the countries. Factors affecting this type of trade pattern underlie its development in trade relationship. Therefore, the findings of this study would be useful in helping to develop and implement policies for the expansion of the pharmaceutical trade.
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The Pharmaceutical Industry and the Canadian Government: Folie à Deux.
Lexchin, Joel
2017-08-01
The interest of the pharmaceutical industry is in achieving a profit for its shareholders while the interest of the Canadian government should be in protecting public health. However, over the course of the past few decades the actions of the Canadian government have been tilted in favour of industry in two areas. The first is in the relationship between industry and Health Canada and is manifested in the regulation of clinical trials, the drug approval system, drug safety and promotion. The second is in economic policy as it applies to policies about patent protection, the price of medications and measures taken to incentivize research and development. The problems in the relationship are structural and will only be solved through systemic changes. Copyright © 2017 Longwoods Publishing.
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Pilkington, Hilary; Sharifullina, El'vira
2009-05-01
The article contributes to the literature on the role of social networks and social capital in young people's drug use. It considers the structural and cultural dimensions of the 'risk environment' of post-Soviet Russia, the micro risk-environment of a de-industrializing city in the far north of the country and the kind of social capital that circulates in young people's social networks there. Its focus is thus on social capital at the micro-level, the 'bridging' networks of peer friendship groups and the norms that govern them. The research is based on a small ethnographic study of the friendship groups and social networks of young people in the city of Vorkuta in 2006-2007. It draws on data from 32 respondents aged 17-27 in the form of 17 semi-structured audio and video interviews and field diaries. Respondents were selected from friendship groups in which drug use was a regular and symbolically significant practice. The risk environment of the Russian far north is characterised by major de-industrialization, poor health indicators, low life expectancy and limited educational and employment opportunities. It is also marked by a 'work hard, play hard' cultural ethos inherited from the Soviet period when risk-laden manual labour was well-rewarded materially and symbolically. However, young people today often rely on informal economic practices to generate the resource needed to fulfil their expectations. This is evident from the social networks among respondents which were found to be focused around a daily routine of generating and spending income, central to which is the purchase, sale and use of drugs. These practices are governed by norms that often invert those normally ascribed to social networks: reciprocity is replaced by mutual exploitation and trust by cheating. Social networks are central to young people's management of the risk environment associated with post-Soviet economic transformation. However, such networks are culturally as well as structurally
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Quantitative decisions in drug development
Chuang-Stein, Christy
2017-01-01
This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. The latter include selecting appropriate metrics to formulate decisions criteria, determining go/no-go decisions for progressing a drug candidate to the next stage and predicting the effectiveness of a product. Lastly, it points out common mistakes made by drug developers under the current drug-development paradigm. The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support dru...
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78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...
2013-06-05
... Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and... 20852. FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug Evaluation and Research, Food...
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Biosensor: an emerging safety tool for meat industry.
Singh, Pradeep Kumar; Jairath, Gauri; Ahlawat, Satyavir Singh; Pathera, Ashok; Singh, Prashant
2016-04-01
The meat industry associated with the health hazards like deadly pathogens, veterinary drugs, pesticide residues, toxins and heavy metals is in need of a tool to tackle the awful situation and ensure safer product to consumer. The growth in the industry, global trade scenario, stringent laws and consumer awareness has placed an extra onus on the meat industry to meet out the expectations and demands. Biosensors are the latest tool of detection in the fast growing industries including the food industry. Hence an attempt is envisaged here to review the possibility of harnessing biosensors as tool of safety to safe guard the consumer health and address safety issues in reference to the common threats of concern in the meat industry.
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Drug abuse in the workplace: employee screening techniques
International Nuclear Information System (INIS)
Buzzeo, R.W.
1984-01-01
Recent studies show that as many as three to five percent of the employees of a medium- to large-sized plant may be dependent on drugs as a way of life. The detrimental effects of drug abuse in the workplace can be measured in lost productivity, poor quality control and other areas at an annual cost to the American economy of $30 billion. However, a price tag cannot be attached to the lives affected by this unrelenting problem. The purpose of this paper is to provide an overview of the employee screening and hiring techniques available to industry to detect and eliminate potentially dangerous or fatal situations involving drug abuse in the workplace. The techniques are universal and can be effectively applied by the nuclear industry as well as other businesses to ensure that its work force is a reputable and reliable one
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2011-08-24
...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug... FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug...
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Keinonen, Tuija; Keränen, Tapani; Klaukka, Timo; Saano, Veijo; Ylitalo, Pauli; Enlund, Hannes
2003-09-01
The objectives of our study were to explore the barriers, preferences and attitudes of the pharmaceutical industry towards conducting clinical trials in Finland. In-depth semi-structured interviews were conducted with 18 representatives of the pharmaceutical industry with different amounts of experience of clinical trials. The interviews were audiotaped, transcribed verbatim and analysed qualitatively. Overall, the respondents had a positive attitude towards conducting clinical trials in Finland. The major barriers seemed to occur at the beginning of the trial and mostly consisted of bureaucratic obstacles. The informants hoped for a more positive attitude of the public sector, more flexibility in hospitals and professionalism in practical implementation, e.g. having special research centres or site management services. The most dismotivating factors were the high costs and the constraints imposed by bureaucracy. The variety in practices of local ethics committees was considered problematic, and the need for common standard operating procedures was pointed out. The smallest barriers were encountered in subject recruitment by the investigators and their clinical work, documentation, investigational product logistics and communication with the regulatory authorities. The quality, know-how and reliability of the study personnel, the tightening of time lines in general, an investigator register/pool and collaboration with media in disseminating information about clinical trials to the general public were reported as the most appealing factors. Training in GCP, mainly incorporated in the medical education programme, and a certificate or equivalent were generally considered necessary, though a voluntary system was preferred. The barriers and preferences pointed out suggest various improvements and ways to produce high-quality, GCP-compliant clinical drug research and to ensure the availability of sufficient conditions to carry out clinical trials also in the future.
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2012-03-08
...] Guidance for Industry on Chemistry, Manufacturing, and Controls Information--Fermentation-Derived... (CMC) Information-- Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for... to submit to support the CMC information for fermentation-derived intermediates, drug substances, and...
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Screening for mental illness: the merger of eugenics and the drug industry.
Sharav, Vera Hassner
2005-01-01
The implementation of a recommendation by the President's New Freedom Commission (NFC) to screen the entire United States population--children first--for presumed, undetected, mental illness is an ill-conceived policy destined for disastrous consequences. The "pseudoscientific" methods used to screen for mental and behavioral abnormalities are a legacy from the discredited ideology of eugenics. Both eugenics and psychiatry suffer from a common philosophical fallacy that undermines the validity of their theories and prescriptions. Both are wed to a faith-based ideological assumption that mental and behavioral manifestations are biologically determined, and are, therefore, ameliorated by biological interventions. NFC promoted the Texas Medication Algorithm Project (TMAP) as a "model" medication treatment plan. The impact of TMAP is evident in the skyrocketing increase in psychotropic drug prescriptions for children and adults, and in the disproportionate expenditure for psychotropic drugs. The New Freedom Commission's screening for mental illness initiative is, therefore, but the first step toward prescribing drugs. The escalating expenditure for psychotropic drugs since TMAP leaves little doubt about who the beneficiaries of TMAP are. Screening for mental illness will increase their use.
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2011-08-17
... a larger amount of the drug substance than what is intended to be delivered to the patient. This... patient, but also to others, including family members, caregivers, children, and pets. For example...
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2011-03-14
...] Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information--Fermentation-Derived... Controls (CMC) Information-- Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products... documentation to submit to support the CMC information for fermentation-derived intermediates, drug substances...
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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...
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The paradigm shift to an “open” model in drug development
Directory of Open Access Journals (Sweden)
Regina Au
2014-12-01
Full Text Available The rising cost of healthcare, the rising cost for drug development, the patent cliff for Big pharma, shorter patent protection, decrease reimbursement, and the recession have made it more difficult for the pharmaceutical and biotechnology industry to develop drugs. Due to the unsustainable amount of time and money in developing a drug that will have a significant return on investment (ROI it has become hard to sustain a robust pipeline. The industry is transforming its business model to meet these challenges. In essence a paradigm shift is occurring; the old “closed” model is giving way to a new “open” business model.
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The use of drugs in food animals: benefits and risks
National Research Council Canada - National Science Library
...; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industries--poultry, dairy, beef, swine, and aquaculture...
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Determinants of Iran’s Bilateral Intra-industry Trade in Pharmaceutical Industry
Aghlmand, Siamak; Rahimi, Bahlol; Farrokh-Eslamlou, Hamidreza; Nabilou, Bahram; Yusefzadeh, Hassan
2018-01-01
Among non-oil and in trade arena, drug has always been strategic importance and most government especially industrialized countries pay special attention to its production and trade issues. Thus, having a comprehensive view from economic perspective to this section is essential for suggesting intervention. This was a descriptive-analytical and panel study. In this study, gravity model is used to estimate Iran’s bilateral intra-industry trade in pharmaceutical products in the 2001-2012 periods. To illustrate the extent of pharmaceutical’s intra-industry trade between Iran and its major trading partners, the explanatory variables of market size, income, factor endowments, distance, cultural contributions, and similarities and also special trade arrangements have been applied. Analysis of factors affecting Iran’s bilateral intra-industry trade in pharmaceutical industry showed that the average GDP and cultural similarities had a significant positive impact on Iran’s bilateral IIT, while the difference in GDP has a negative and significant effect. Coefficients obtained for the geographical distance and the average ratio of total capital to the labor force is not consistent with theoretical expectations. Special trade arrangements did not have significant impact on the extent of bilateral intra-industry trade between Iran and its trading partners. The knowledge of the intra-industry trade between Iran and its trade partners make integration between the countries. Factors affecting this type of trade pattern underlie its development in trade relationship. Therefore, the findings of this study would be useful in helping to develop and implement policies for the expansion of the pharmaceutical trade. PMID:29881438
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Target Essentiality and Centrality Characterize Drug Side Effects
Wang, Xiujuan; Thijssen, Bram; Yu, Haiyuan
2013-01-01
Author Summary The ultimate goal of medical research is to develop effective treatments for disease with minimal side effects. Currently, about 20% of drug candidates failed at clinical trial phases II and III due to safety issues. Therefore, understanding the determining factors of drug side effects is of paramount importance to human health and the pharmaceutical industry. Here, we present the first systematic study to uncover key factors leading to drug side effects within the framework of...
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2010-06-22
... Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug...
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Identifying Adverse Drug Events by Relational Learning.
Page, David; Costa, Vítor Santos; Natarajan, Sriraam; Barnard, Aubrey; Peissig, Peggy; Caldwell, Michael
2012-07-01
The pharmaceutical industry, consumer protection groups, users of medications and government oversight agencies are all strongly interested in identifying adverse reactions to drugs. While a clinical trial of a drug may use only a thousand patients, once a drug is released on the market it may be taken by millions of patients. As a result, in many cases adverse drug events (ADEs) are observed in the broader population that were not identified during clinical trials. Therefore, there is a need for continued, post-marketing surveillance of drugs to identify previously-unanticipated ADEs. This paper casts this problem as a reverse machine learning task , related to relational subgroup discovery and provides an initial evaluation of this approach based on experiments with an actual EMR/EHR and known adverse drug events.
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Kinase-Centric Computational Drug Development
Kooistra, Albert J.; Volkamer, Andrea
2017-01-01
Kinases are among the most studied drug targets in industry and academia, due to their involvement in a majority of cellular processes and, upon dysregulation, in a variety of diseases including cancer, inflammation, and autoimmune disorders. The high interest in this druggable protein family
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DYNAMICS OF THE ROMANIAN ILLEGAL DRUG MARKETS
Directory of Open Access Journals (Sweden)
Irina Caunic
2011-06-01
Full Text Available Globalization has led to an increase in commercial activities running on the illegal markets, its dynamics being largely determined by the balance between profitability and the major risks involved. Revenuesare significant, one example being those obtained from drug industry. In recent years, illicit drug trafficking has seen in Romania an unprecedented escalation, as a result of market liberalization and the movement of per sons and because of the extending the phenomenon both among producers and consumers. This article examines the size of the Romanian illegal drug markets, the countries of origin and drugtransit routes, as well as the profits made by the drug trafficking networks.
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Direct-to-consumer advertising of prescription drugs.
Frosch, Dominick L; Grande, David
2010-01-01
In 2007, the pharmaceutical industry spent more than $4.9 billion on direct-to-consumer advertising (DTCA) of prescription drugs in the U.S. Controversy over DTCA has grown since the Food and Drug Administration liberalized its regulations in 1997. Proponents claim that such advertising educates consumers, promotes patient participation in clinical decisions, and improves patient adherence to medication instructions. Opponents argue that such advertising is meant to persuade, not educate, and that it promotes inappropriate use of prescription drugs, or diverts consumers from better alternatives. This Issue Brief summarizes the evidence about the effects of DTCA, and proposes guidelines for improving the utility of prescription drug advertising.
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Industrial Biotechnology: Discovery to Delivery
Chotani, Gopal K.; Dodge, Timothy C.; Gaertner, Alfred L.; Arbige, Michael V.
Fermentation products have penetrated almost every sector of our daily lives. They are used in ethical and generic drugs, clinical and home diagnostics, defense products, nutritional supplements, personal care products, food and animal feed ingredients, cleaning and textile processing, and in industrial applications such as fuel ethanol production. Even before knowing about the existence of microorganisms, for thousands of years ancient people routinely used them for making cheese, soy sauces, yogurt, and bread. Although humans have used fermentation as the method of choice for manufacturing for a long time, it is only now being recognized for its potential towards sustainable industrial development.
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Pharmacogenetics of psychotropic drugs
National Research Council Canada - National Science Library
Lerer, Bernard
2002-01-01
... of pharmacogenetics with substance dependence and brain imaging, and consider the impact of pharmacogenetics on the biotechnology and pharmaceutical industries. This book defines the young field of pharmacogenetics as it applies to psychotropic drugs and is, therefore, an essential reference for all clinicians and researchers working in this findings field. Bernard ...
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Biomarkers of adverse drug reactions.
Carr, Daniel F; Pirmohamed, Munir
2018-02-01
Adverse drug reactions can be caused by a wide range of therapeutics. Adverse drug reactions affect many bodily organ systems and vary widely in severity. Milder adverse drug reactions often resolve quickly following withdrawal of the casual drug or sometimes after dose reduction. Some adverse drug reactions are severe and lead to significant organ/tissue injury which can be fatal. Adverse drug reactions also represent a financial burden to both healthcare providers and the pharmaceutical industry. Thus, a number of stakeholders would benefit from development of new, robust biomarkers for the prediction, diagnosis, and prognostication of adverse drug reactions. There has been significant recent progress in identifying predictive genomic biomarkers with the potential to be used in clinical settings to reduce the burden of adverse drug reactions. These have included biomarkers that can be used to alter drug dose (for example, Thiopurine methyltransferase (TPMT) and azathioprine dose) and drug choice. The latter have in particular included human leukocyte antigen (HLA) biomarkers which identify susceptibility to immune-mediated injuries to major organs such as skin, liver, and bone marrow from a variety of drugs. This review covers both the current state of the art with regard to genomic adverse drug reaction biomarkers. We also review circulating biomarkers that have the potential to be used for both diagnosis and prognosis, and have the added advantage of providing mechanistic information. In the future, we will not be relying on single biomarkers (genomic/non-genomic), but on multiple biomarker panels, integrated through the application of different omics technologies, which will provide information on predisposition, early diagnosis, prognosis, and mechanisms. Impact statement • Genetic and circulating biomarkers present significant opportunities to personalize patient therapy to minimize the risk of adverse drug reactions. ADRs are a significant heath issue
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The development of Bio-pharmaceutical industry in China: problems and solutions.
Yan, Gujun
2014-07-01
Known as the "sunrise industry" of the 21st century, bio-pharmaceutical industry has been a fast-growing global industry, and many countries have been developing this industry as the focus of their national economies. In China, there exists a huge market demand for the development of bio-pharmaceutical industry, but at the present stage the industry is faced with some problems, such as low level of R & D for innovative drugs, and inappropriate capital investment in the industrialization. In order to accelerate the development of China's bio-pharmaceutical industry, it is necessary to take strategic initiatives of improving the technology transfer system, developing the bio-pharmaceutical outsourcing, and building a diversified industrial financing system.
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[Drug advertisement in a medicine school in the Southern of Brazil].
Trevisol, Daisson José; Ferreira, Maria Beatriz Cardoso; Karnopp, Zuleica Maria Patrício
2010-11-01
This is a quali-quantitative study on drug advertisement in a Medicine school in Santa Catarina state. Participants were medicine students, faculty physicians and patients of school ambulatories, totaling 1,231 interviewees. The focal group technique was used to the qualitative research; the quantitative research with a semistructured questionnaire. 53.6% of the faculty physicians considered they were rarely or never influenced by the propaganda, and 53.7% claimed their colleagues are. Among the students, 43.2% believe that, after graduated, they will rarely or never be influenced; while 42.0% believe that graduated are always or frequently influenced. For 41.7%, the information given by the representatives of the pharmaceutical industry is good or excellent. Also, 74.8% reported that the pharmaceutical industry will be able to contribute for their professional practice. This study identified that the distribution of free drug samples are one of the main advertising and propaganda techniques used by the pharmaceutical industry; as there is a certain pressure of the medical preceptor upon the choice of the prescription; although no direct impact of the influence of the pharmaceutical industry on the ambulatories was observed. Drug prescription is usually not rational.
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Meador, Mark
2011-01-01
Pharmacy benefit management (PBM) companies are the middlemen of the pharmaceutical industry, designing plans for sponsors and insurers and pushing the products of manufacturers. Their unique position can often create conflicts of interest, which has been the basis of much litigation. This article reviews the structure of the PBM industry and analyzes concerns arising from its handling of prescription drug pricing, manufacturer rebates and discounts, and mail order pharmacies. After surveying several legislative proposals, it concludes with a comprehensive outline for legislation to eliminate underhanded dealing in the industry and lower the cost of prescription drugs.
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Development of radiopharmaceuticals and industrial constraints
International Nuclear Information System (INIS)
Zimmermann, R.
2005-01-01
The development process of a diagnostic or therapeutic radiopharmaceutical does not really differ from the development of a classical drug. Some specific properties of these nuclear medicine tools mainly linked to the ease to follow their distribution in the human body allow to save a couple of years out of the dozen of years required to bring a drug on the market. Overall development costs can be significantly reduced for the same reason. An industrial who wants to invest in such a business bases its analysis on other criteria that need to evaluate the medical, safety and regulatory environment at the time of drug launching. Competition is obviously a major decision criteria, but in order to evaluate the market potential, other data must be available such as the analysis of the medical landscape, the reimbursement issues, the technology evolution, the investment needs or the development of other imaging modalities, among others. In fact all these parameters concentrate toward a common criteria, the profitability of the project. Nuclear medicine moved from an art and crafts era towards the industrial era and hence plunged from the twentieth to the twenty first century in the economic reality with all its constraints and consequences. (author)
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Sustained Release Drug Delivery Applications of Polyurethanes
Directory of Open Access Journals (Sweden)
Michael B. Lowinger
2018-05-01
Full Text Available Since their introduction over 50 years ago, polyurethanes have been applied to nearly every industry. This review describes applications of polyurethanes to the development of modified release drug delivery. Although drug delivery research leveraging polyurethanes has been ongoing for decades, there has been renewed and substantial interest in the field in recent years. The chemistry of polyurethanes and the mechanisms of drug release from sustained release dosage forms are briefly reviewed. Studies to assess the impact of intrinsic drug properties on release from polyurethane-based formulations are considered. The impact of hydrophilic water swelling polyurethanes on drug diffusivity and release rate is discussed. The role of pore formers in modulating drug release rate is examined. Finally, the value of assessing mechanical properties of the dosage form and approaches taken in the literature are described.
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Pharmaceutical industry marketing: understanding its impact on women's health.
Sufrin, Carolyn B; Ross, Joseph S
2008-09-01
The delivery of modern health care entails significant involvement from the pharmaceutical industry, including developing and manufacturing drugs. However, the industry also has tremendous influence on the practice of medicine through its considerable marketing efforts, both to patients through direct to consumer advertising, and to physicians through detailing, providing samples, continuing medical education, and other efforts. This article will review the role that pharmaceutical marketing plays in health care, and the substantial evidence surrounding its influence on patient and physician behaviors, with additional discussion of the medical device industry, all with particular attention to women's health. Understanding the effects of pharmaceutical marketing on women's health, through discussion of relevant examples-including oral contraceptive pills, drugs for premenstrual dysphoric disorder, Pap smear cytology techniques, and neonatal herpes prophylaxis-will help ensure that women receive unbiased, evidenced-based care. We will conclude with a discussion of guidelines that have been proposed by professional organizations, policy makers, and universities, to assist physicians in managing exposure to pharmaceutical marketing.
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Qualitative Phenomenological Examination of IT Project Management in Pharmaceutical Industry
Ly, Phil
2013-01-01
The purpose of this study was to examine what caused IT projects to fail at a high rate in the pharmaceutical industry. IT projects failures delayed development of new drugs that can help save lives. It was imperative to evaluate what caused project failures because the collateral damage was delay in drug development. This qualitative…
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Emerging trends in contract research industry in India.
Drabu, Sushma; Gupta, Alka; Bhadauria, Anupama
2010-09-01
A Contract Research Organization (CRO) is a service organization that provides support to the pharmaceutical industry and offers a wide range of "outsourced" pharmaceutical research services to aid in R&D process and is thus an essential tool for undertaking clinical trials in the present scenario when high stakes are involved in the drug discovery process. This industry also offers a safe option of investment as the industry is largely recession-proof, with a significant upscale growth. Presently India occupies a very small pie of the global market share in the Clinical Trials Industry but it is estimated to conduct nearly 5% of global clinical trials by 2012. The global CRO industry valued $18 bn in 2008 and the market is expected to grow at an annual rate of 14% between 2009 and 13. Top multinational pharmaceuticals companies are venturing into the Indian business, in collaboration with the Indian Drug Companies. According to a recent study by Mckinsey & Company, the Indian Clinical Research Industry can attract $1.5 bn of revenue from US and EU by 2010. Such an increase in outsourcing from the western countries has led the global pharma companies and Indian entrepreneurs to set up Contract Research Organizations (CROs) in India. To bring this into realization and fulfil the market demand, while simultaneously aiding in improving the country's economical standards and market position, joint and well-coordinated efforts on part of the government, industry, and working professionals are needed in terms of regulatory affairs, audits, transparency in work affairs, garnering patient confidence, and pharmacovigilance. Copyright 2010 Elsevier Inc. All rights reserved.
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Rescuing drug discovery: In vivo systems pathology and systems pharmacology
Greef, J. van der; McBurney, R.N.
2005-01-01
The pharmaceutical industry is currently beleaguered by close scrutiny from the financial community, regulators and the general public. Productivity, in terms of new drug approvals, has generally been falling for almost a decade and the safety of a number of highly successful drugs has recently been
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2011-11-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...
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DEFF Research Database (Denmark)
Oprea, Tudor; Nielsen, Sonny Kim; Ursu, Oleg
2011-01-01
benefit from an integrated, semantic-web compliant computer-aided drug repurposing (CADR) effort, one that would enable deep data mining of associations between approved drugs (D), targets (T), clinical outcomes (CO) and SE. We report preliminary results from text mining and multivariate statistics, based...... on 7684 approved drug labels, ADL (Dailymed) via text mining. From the ADL corresponding to 988 unique drugs, the "adverse reactions" section was mapped onto 174 SE, then clustered via principal component analysis into a 5 x 5 self-organizing map that was integrated into a Cytoscape network of SE......Finding new uses for old drugs is a strategy embraced by the pharmaceutical industry, with increasing participation from the academic sector. Drug repurposing efforts focus on identifying novel modes of action, but not in a systematic manner. With intensive data mining and curation, we aim to apply...
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Nanodiamond and its application to drug delivery
Directory of Open Access Journals (Sweden)
Eiji Osawa
2012-08-01
Full Text Available Quasi-spherical diamond crystals having an average diameter of 3.7±0.6 nm are attracting much attention as an ideal material in carbon nanotechnology. In contrast to the other popular nanocarbons including fullerenes, carbon nanotubes and graphenes, our single-nanodiamond can be produced in uniform shape/size on industrial scale. Thus, the most serious problem in nanocarbon industry that persisted in the past 25 years, namely the technical failure to produce highly crystalline nanocarbons in narrow shape/size range does not exist in our diamond from the beginning. Among potential applications of the single-nanodiamond under development, this review concentrates on its highly promising role as a drug carrier, especially for therapeutic-resistant cancer. An interesting possibility of intercalation is proposed as the mechanism of drug transport through blood, which takes into accounts of the spontaneous formation of nanographene layer on the [111] facets, which is then extensively oxidized during oxidative soot removal process to give nanographene oxide partial surface, capable of intercalating drug molecules to prevent them from leaking and causing undesirable side effects during transportation to target malignant cells. A perspective of quantifying the drug delivery process by anticipating orders of magnitude in the number of administered detonation nanodiamond (DND particles is suggested.
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The cost of multiple sclerosis drugs in the US and the pharmaceutical industry
Bourdette, Dennis N.; Ahmed, Sharia M.; Whitham, Ruth H.
2015-01-01
Objective: To examine the pricing trajectories in the United States of disease-modifying therapies (DMT) for multiple sclerosis (MS) over the last 20 years and assess the influences on rising prices. Methods: We estimated the trend in annual drug costs for 9 DMTs using published drug pricing data from 1993 to 2013. We compared changes in DMT costs to general and prescription drug inflation during the same period. We also compared the cost trajectories for first-generation MS DMTs interferon (IFN)–β-1b, IFN-β-1a IM, and glatiramer acetate with contemporaneously approved biologic tumor necrosis factor (TNF) inhibitors. Results: First-generation DMTs, originally costing $8,000 to $11,000, now cost about $60,000 per year. Costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%–60% higher than existing DMTs. Significant increases in the cost trajectory of the first-generation DMTs occurred following the Food and Drug Administration approvals of IFN-β-1a SC (2002) and natalizumab (reintroduced 2006) and remained high following introduction of fingolimod (2010). Similar changes did not occur with TNF inhibitor biologics during these time intervals. DMT costs in the United States currently are 2 to 3 times higher than in other comparable countries. Conclusions: MS DMT costs have accelerated at rates well beyond inflation and substantially above rates observed for drugs in a similar biologic class. There is an urgent need for clinicians, payers, and manufacturers in the United States to confront the soaring costs of DMTs. PMID:25911108
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Perestroika in pharma: evolution or revolution in drug development?
FitzGerald, Garret A
2010-01-01
New-drug approvals have remained roughly constant since 1950, while the cost of drug development has soared. It seems likely that a more modular approach to drug discovery and development will evolve, deriving some features from the not-for-profit sector. For this to occur, we must address the deficit in human capital with expertise in both translational medicine and therapeutics and also in regulatory science; utilize regulatory reform to incentivize innovation and the expansion of the precompetitive space; and develop an informatics infrastructure that permits the global, secure, and compliant sharing of heterogeneous data across academic and industry sectors. These developments, likely prompted by the perception of crisis rather than opportunity, will require linked initiatives among academia, the pharmaceutical industry, the US National Institutes of Health, and the US Food and Drug Administration, along with a more adventurous role for venture capital. A failure to respond threatens the United States' lead in biomedical science and in the development and regulation of novel therapeutics. 2010 Mount Sinai School of Medicine.
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Directory of Open Access Journals (Sweden)
George Charalambous
2012-01-01
Full Text Available Background: The provision of pharmaceutical drugs is of enormous significance in our lives. Notable progress made inthe domain of Public Health, combined with a general increase in the standard of living, has had a direct impact on thediscovery of new drugs and cures and has shifted pharmaceutical policies further in line with the current needs of boththe country’s health system and, its population.Aim: This research aims to both shed light on and analyse the current state of pharmaceutical policy in Cyprus, as well asto try to seek out its weaknesses, making suggestions, where possible, as to how to keep these to the minimum.Results, and Conclusions: The lack of both high level research and major industrial facilities relating to the discovery ofnew pharmaceutical drugs in Cyprus, has hindered the effectiveness of pharmaceutical policy in general domains such ascontrol over the circulation and production of pharmaceutical products in the country, their pricing and distribution andthe monitoring of our drug supplies. The lack of transparency in a number of pharmaceutical procedures, and ofinformation on drugs does not enhance the industry’s reliability, but rather exacerbates an underlying feeling of insecurityrelating to it among the population.
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2013-02-25
...; formerly 2005D-0183] Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug... 20852. FOR FURTHER INFORMATION CONTACT: Lisa K. Naeger, Center for Drug Evaluation and Research, Food...
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Drug promotion practices: A review.
Jacob, Nilan T
2018-01-18
Over the years, the pharmaceutical industry has been at the forefront of research and innovation in drug discovery and development. The process of drug discovery extending from preclinical studies to multicentric clinical trials and postmarketing phase is a costly affair running into billions of dollars. On the flip side, not all investigational molecules clear the trial phases and get approved, which puts pressure on the manufacturers to maximize the profit from approved drugs. It is in this key area that the practice of drug promotion plays its role. The World Health Organization defines drug promotion as "all informational and persuasive activities by manufacturers and distributors, the effect of which is to influence the prescription, supply, purchase or use of medicinal drugs". With its humble intent of creating awareness among healthcare professionals and updating their knowledge on recent advances in treatment options, drug promotion has been an important tool, but gradually it has evolved to embrace aggressive marketing strategies and sometimes unethical business and scientific practices where the need for profit-making eclipses commitment to patient care and scientific exploration. In this review, we discuss the evolution of drug promotion practices, the various types, its merits and demerits, the influence of drug promotion on physician prescribing behaviour, the role of regulatory bodies, unethical promotional practices and finally summarize with future directions. © 2018 The British Pharmacological Society.
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Patel, Puja; Spears, David; Eriksen, Betina Østergaard; Lollike, Karsten; Sacco, Michael
2018-03-01
Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients' knowledge of pharmaceutical manufacturers' responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported "more confidence" in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Learning about drug safety departments elevates consumers' confidence in manufacturers' safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.
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Lee, Annisa Lai
2009-06-01
This study tracks the changes of the effects of 4 information sources for direct-to-consumer drug advertising on patients' requests for prescription drugs from physicians since the inception of the "Guidance for Industry about Consumer-directed Broadcast Advertisements." The Guidance advises pharmaceuticals to use four information sources for consumers to seek further information to supplement broadcast drug advertisements: small-print information, the Internet, a toll-free number, and health-care providers (nurses, doctors, and pharmacists). Logistic models were created by using survey data collected by the Food and Drug Administration in 1999 and 2002. Results show that throughout the years, health-care providers remain the most used and strongest means associated with patients' direct requests for nonspecific and specific prescription drugs from doctors. The small-print information source gains power and changes from an indirect means associated with patients' discussing drugs with health-care providers to a direct means associated with patients' asking about nonspecific and specific drugs from their doctors. The Internet is not directly related to drug requests, but the effect of its association with patients seeking information from health-care providers grew 11-fold over the course of the study. The toll-free number lost its power altogether for both direct request for a prescription drug and further discussion with health-care providers. Patient demographics will be considered for specific policy implications.
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Chou, Li-Fang
2014-01-01
While most drug policy researches paid attention to the financial impact of expensive drugs, the market situation of low-priced drugs in a country was seldom analyzed. We used the nationally representative claims datasets to explore the status within the National Health Insurance (NHI) in Taiwan. In 2007, a total of 12,443 distinct drug items had been prescribed 853,250,147 times with total expenditure of 105,216,950,198 new Taiwan dollars (NTD). Among them, 7,366 oral drug items accounted for 701,353,383 prescribed items and 68,133,988,960 NTD. Besides, 2,887 items (39.2% of oral drug items) belonged to cheap drugs with the unit price ≤1 NTD (about 0.03 of US dollar). While the top one item among all oral drugs had already a market share of 5.0%, 30 items 30.3% and 107 items 50.0%, the cheap drugs with aggregate 332,893,462 prescribed items (47.5% of all prescribed oral drug items) only accounted for 2,750,725,433 NTD (4.0% of expenditure for oral drugs and 2.6% of total drug expenditure). The drug market of Taiwan's NHI was abundant in cheap drugs. The unreasonably low prices of drugs might not guarantee the quality of pharmaceutical care and the sustainability of a healthy pharmaceutical industry in the long run. PMID:24719568
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Barneh, Farnaz; Jafari, Mohieddin; Mirzaie, Mehdi
2016-11-01
Network pharmacology elucidates the relationship between drugs and targets. As the identified targets for each drug increases, the corresponding drug-target network (DTN) evolves from solely reflection of the pharmaceutical industry trend to a portrait of polypharmacology. The aim of this study was to evaluate the potentials of DrugBank database in advancing systems pharmacology. We constructed and analyzed DTN from drugs and targets associations in the DrugBank 4.0 database. Our results showed that in bipartite DTN, increased ratio of identified targets for drugs augmented density and connectivity of drugs and targets and decreased modular structure. To clear up the details in the network structure, the DTNs were projected into two networks namely, drug similarity network (DSN) and target similarity network (TSN). In DSN, various classes of Food and Drug Administration-approved drugs with distinct therapeutic categories were linked together based on shared targets. Projected TSN also showed complexity because of promiscuity of the drugs. By including investigational drugs that are currently being tested in clinical trials, the networks manifested more connectivity and pictured the upcoming pharmacological space in the future years. Diverse biological processes and protein-protein interactions were manipulated by new drugs, which can extend possible target combinations. We conclude that network-based organization of DrugBank 4.0 data not only reveals the potential for repurposing of existing drugs, also allows generating novel predictions about drugs off-targets, drug-drug interactions and their side effects. Our results also encourage further effort for high-throughput identification of targets to build networks that can be integrated into disease networks. © The Author 2015. Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.
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2013-04-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0258] Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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Problems in the regulatory policy of the drug market
Miziara, Nathália Molleis; Coutinho, Diogo Rosenthal
2015-01-01
OBJECTIVE Analyze the implementation of drug price regulation policy by the Drug Market Regulation Chamber. METHODS This is an interview-based study, which was undertaken in 2012, using semi-structured questionnaires with social actors from the pharmaceutical market, the pharmaceuticals industry, consumers and the regulatory agency. In addition, drug prices were compiled based on surveys conducted in the state of Sao Paulo, at the point of sale, between February 2009 and May 2012. RESULTS The mean drug prices charged at the point of sale (pharmacies) were well below the maximum price to the consumer, compared with many drugs sold in Brazil. Between 2009 and 2012, 44 of the 129 prices, corresponding to 99 drugs listed in the database of compiled prices, showed a variation of more than 20.0% in the mean prices at the point of sale and the maximum price to the consumer. In addition, many laboratories have refused to apply the price adequacy coefficient in their sales to government agencies. CONCLUSIONS The regulation implemented by the pharmaceutical market regulator was unable to significantly control prices of marketed drugs, without succeeding to push them to levels lower than those determined by the pharmaceutical industry and failing, therefore, in its objective to promote pharmaceutical support for the public. It is necessary reconstruct the regulatory law to allow market prices to be reduced by the regulator as well as institutional strengthen this government body. PMID:26083945
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Accessing external innovation in drug discovery and development.
Tufféry, Pierre
2015-06-01
A decline in the productivity of the pharmaceutical industry research and development (R&D) pipeline has highlighted the need to reconsider the classical strategies of drug discovery and development, which are based on internal resources, and to identify new means to improve the drug discovery process. Accepting that the combination of internal and external ideas can improve innovation, ways to access external innovation, that is, opening projects to external contributions, have recently been sought. In this review, the authors look at a number of external innovation opportunities. These include increased interactions with academia via academic centers of excellence/innovation centers, better communication on projects using crowdsourcing or social media and new models centered on external providers such as built-to-buy startups or virtual pharmaceutical companies. The buzz for accessing external innovation relies on the pharmaceutical industry's major challenge to improve R&D productivity, a conjuncture favorable to increase interactions with academia and new business models supporting access to external innovation. So far, access to external innovation has mostly been considered during early stages of drug development, and there is room for enhancement. First outcomes suggest that external innovation should become part of drug development in the long term. However, the balance between internal and external developments in drug discovery can vary largely depending on the company strategies.
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Industry funded clinical trials: bias and quality.
Del Parigi, Angelo
2012-01-01
The quality of the clinical data supporting the development and ultimately the approval for medical use of new drugs is often challenged. Many share the perception that the business goals of the pharmaceutical industry overrule the best scientific efforts to accrue critical knowledge on a new molecule, in order to inform investment of resources, regulatory approvals and appropriate use by patients. Despite this common belief, few scientists have attempted to assess objectively the quality of industry funded (IF) clinical trials by measuring it and comparing it with non-industry funded (NIF) clinical trials in a data-driven fashion. Overall, the average quality of IF clinical research has been reported to be higher than the quality of NIF clinical research.
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Tuberculosis drug issues: prices, fixed-dose combination products and second-line drugs.
Laing, R O; McGoldrick, K M
2000-12-01
Access to tuberculosis drugs depends on multiple factors. Selection of a standard list of TB drugs to procure is the first step. This paper reviews the advantages and disadvantages of procuring and using fixed-dose combination (FDC) products for both the intensive and continuation phases of treatment. The major advantages are to prevent the emergence of resistance, to simplify logistic management and to reduce costs. The major disadvantage is the need for the manufacturers to assure the quality of these FDCs by bioavailability testing. The paper reports on the inclusion of second-line TB drugs in the 1999 WHO Essential Drug List (EDL). The need to ensure that these drugs are used within established DOTS-Plus programs is stressed. The price of TB drugs is determined by many factors, including producer prices, local taxes and duties as well as mark-ups and fees. TB drug prices for both the public and private sectors from industrialized and developing countries are reported. Price trends over time are also reported. The key findings of this study are that TB drug prices have generally declined in developing countries while they have increased in developed countries, both for the public and private sectors. Prices vary between countries, with the US paying as much as 95 times the price paid in a specific developing country. The prices of public sector first-line TB drugs vary little between countries, although differences do exist due to the procurement methods used. The price of tuberculin, a diagnostic agent, has increased dramatically in the US, with substantial inter-country variations in price. The paper suggests that further research is necessary to identify the reasons for the price disparities and changes over time, and suggests methods which can be used by National Tuberculosis Programme managers to ensure availability of quality assured TB drugs at low prices.
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Open Drug Discovery Toolkit (ODDT): a new open-source player in the drug discovery field.
Wójcikowski, Maciej; Zielenkiewicz, Piotr; Siedlecki, Pawel
2015-01-01
There has been huge progress in the open cheminformatics field in both methods and software development. Unfortunately, there has been little effort to unite those methods and software into one package. We here describe the Open Drug Discovery Toolkit (ODDT), which aims to fulfill the need for comprehensive and open source drug discovery software. The Open Drug Discovery Toolkit was developed as a free and open source tool for both computer aided drug discovery (CADD) developers and researchers. ODDT reimplements many state-of-the-art methods, such as machine learning scoring functions (RF-Score and NNScore) and wraps other external software to ease the process of developing CADD pipelines. ODDT is an out-of-the-box solution designed to be easily customizable and extensible. Therefore, users are strongly encouraged to extend it and develop new methods. We here present three use cases for ODDT in common tasks in computer-aided drug discovery. Open Drug Discovery Toolkit is released on a permissive 3-clause BSD license for both academic and industrial use. ODDT's source code, additional examples and documentation are available on GitHub (https://github.com/oddt/oddt).
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Bhardwaj, Anshu; Scaria, Vinod; Raghava, Gajendra Pal Singh; Lynn, Andrew Michael; Chandra, Nagasuma; Banerjee, Sulagna; Raghunandanan, Muthukurussi V; Pandey, Vikas; Taneja, Bhupesh; Yadav, Jyoti; Dash, Debasis; Bhattacharya, Jaijit; Misra, Amit; Kumar, Anil; Ramachandran, Srinivasan; Thomas, Zakir; Brahmachari, Samir K
2011-09-01
It is being realized that the traditional closed-door and market driven approaches for drug discovery may not be the best suited model for the diseases of the developing world such as tuberculosis and malaria, because most patients suffering from these diseases have poor paying capacity. To ensure that new drugs are created for patients suffering from these diseases, it is necessary to formulate an alternate paradigm of drug discovery process. The current model constrained by limitations for collaboration and for sharing of resources with confidentiality hampers the opportunities for bringing expertise from diverse fields. These limitations hinder the possibilities of lowering the cost of drug discovery. The Open Source Drug Discovery project initiated by Council of Scientific and Industrial Research, India has adopted an open source model to power wide participation across geographical borders. Open Source Drug Discovery emphasizes integrative science through collaboration, open-sharing, taking up multi-faceted approaches and accruing benefits from advances on different fronts of new drug discovery. Because the open source model is based on community participation, it has the potential to self-sustain continuous development by generating a storehouse of alternatives towards continued pursuit for new drug discovery. Since the inventions are community generated, the new chemical entities developed by Open Source Drug Discovery will be taken up for clinical trial in a non-exclusive manner by participation of multiple companies with majority funding from Open Source Drug Discovery. This will ensure availability of drugs through a lower cost community driven drug discovery process for diseases afflicting people with poor paying capacity. Hopefully what LINUX the World Wide Web have done for the information technology, Open Source Drug Discovery will do for drug discovery. Copyright © 2011 Elsevier Ltd. All rights reserved.
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[Rational use of psychotropic drugs and social communication role].
Montero, F
1994-06-01
Extra-clinical factors about the influences affecting the prescription and use of drugs are reviewed. Special attention is given to regulatory agencies, the pharmaceutical industry, and mass media. The problems and public health consequences of the irrational use of drugs are rarely documented in Latin America. Analysis of these factors, information sources, and rational use of psychotropic drugs will require multiple strategies such as social communication and policy formulation to define goals and objectives related to population information, doctors' and individual citizens' decision making processes, and participation of consumers in improving the use of psychotropic drugs.
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Health and Wellness Lifestyles of Private Industrial Workers in Kumasi, Ghana
ABASS, Ademola Olasupo; MOSES, Monday Omoniyi
2016-01-01
Adherence to good health and wellness lifestyles by workers is essential if industries would be maximally productive. This study examined exercise and fitness adherence, nutritional practices, tobacco smoking, alcohol and drugs use, emotional stress, safety practices and disease prevention lifestyles among industrial workers in Kumasi. 222 workers (mean age = 29.9±8.6years) sampled among ten allied industries participated in the study. Modified and revalidated questionnaire using split half t...
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[Development of new drugs: opportunities and benefits for Peru].
Bayona, Andrés; Fajardo, Natalia
2012-01-01
The development of innovative drugs allows coming up with new medicines to prevent and better treat illnesses. This improves people's quality of life and makes it more productive. Therefore, the mission of pharmaceutical research is to develop safe and effective drugs. Clinical trials allow the evaluation of the safety and efficacy profiles of new medicines, medical devices and diagnostic tests. Research and development (R&D) of new drugs is a long and costly process, where out of every 5000 to 10000 new components that enter preclinical testing, only one is approved. Compared to 2011, drug development has increased by 7.6%. According to ClinicalTrials.gov, 5% of the trials take place in Latin America, and Peru is in the fifth position. On the other hand, according to the Global Competitiveness Report issued by the World Economic Forum, Peru ranks 61st, its biggest challenges being the functioning of its public institutions, investment in R&D and technological capacity. The complexity of drug R&D results in a search for competitive places to develop clinical trials. Clinical Research is a humanized industry due to its ethical platform, stated in the guidelines of good clinical practices. This industry demands our country to develop a differentiating value that contributes to the development of knowledge and its competitiveness.
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Prices, profits, and innovation: examining criticisms of new psychotropic drugs' value.
Huskamp, Haiden A
2006-01-01
High profits and high drug costs have brought increased scrutiny of the pharmaceutical industry over the issue of whether the drugs they produce are worth the costs. I examine several related complaints, including the proliferation of me-too drugs and product reformulations, which some argue have little value relative to their cost; the baseless promotion of newer drug classes as more effective than existing, less expensive drugs; legal strategies to extend market exclusivity that result in high brand-name drug prices for an extended period of time; and large promotional expenditures that result in higher prices.
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Abbreviated New Drug Applications (ANDAS): Future trend in radiopharmaceuticals
International Nuclear Information System (INIS)
Kishore, R.
1990-01-01
The Drug Price Competition and Patent Term Restoration Act (commonly called Waxman Hatch Amendment) of 1984, to the Federal Food, Drug, and Cosmetic Act provided for abbreviated new drug applications (ANDAs) if the conditions specified in the Code of Federal Regulations (CFR) Title 21, subsection 312.55 are met. Under this subsection, reports of nonclinical laboratory studies and clinical investigations can be omitted. New drugs approved under these regulations are so called generic drugs as opposed to listed or pioneer (innovator) drugs. As the patents on more and more radiopharmaceuticals reach their expiration, the radiopharmaceutical industry is likely to produce more of these generic versions of innovator drugs. The ANDAs are required to contain information specified under subsections 314.50(a), (b), (d)(1) and (3), (e), and (g)
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Double pharmacological challenge on repolarization opens new avenues for drug safety research
DEFF Research Database (Denmark)
Thomsen, Morten Bækgaard
2007-01-01
pointes (TdP) arrhythmia. Both the pharmaceutical industry and the regulatory bodies are neglecting the available proarrhythmia models. In vitro studies have suggested that combined pharmacological hits on repolarization will produce a superior substrate for in vivo proarrhythmia, compared to the single......-drug assessment. By using consecutive pharmacological challenges, a simple model is proposed, in which combinatorial pharmacology is employed to provoke TdP in the conscious dog. The pharmaceutical industry interested in evaluating the proarrhythmic potential of their present and future drugs now has a simple...
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Nonclinical statistics for pharmaceutical and biotechnology industries
2016-01-01
This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The cha...
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International Nuclear Information System (INIS)
Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M. Stacey; McGuinn, W. David; Verbois, S. Leigh
2010-01-01
The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.
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Hardwicke, Caroline J
2002-01-01
No article published in the scientific press in the last 10 years reviews the various areas of interest common to the World Health Organization (WHO) and the pharmaceutical industry. Despite a vast amount of information in the public domain, the policies expound the views only of the bodies they represent rather than comparing differing views. An understanding of the factors which affect the interaction between these organisations as well as the organisational structures and the actual areas of intersecting interest, may help to find ways for the industry to assist the WHO in its endeavours in developing countries. Modern drug development is performed initially in and for western society, leaving the areas of infectious or tropical diseases with relatively less industry investment than cancer and cardiovascular disorders. Aspects of the development of an ethical drug, regardless of its therapeutic class (selection of drug name, intellectual property rights, drug safety, marketing and pricing, quality assurance and counterfeiting, generic use, emerging drug donations) are influenced to varying degrees by the triad of money, politics and medical need and the perspectives (each defensible) placed thereon by the WHO and industry. Instead of simply defending their positions combining the best of these strategies to optimise drug development for the needs of developing countries appears logical. Similarly, via its philanthropic initiatives, industry will have donated over $US1 billion in drug and research aid in the period 1995 to 2005. These charitable projects should yield useful information for planning and organising future aid efforts. Global warming, only recently given serious governmental consideration, is an area not yet addressed in drug development policy although along with geographical effects, it is likely to have an impact on the epidemiology of diseases e.g. malaria returning to the Mediterranean, worldwide. With changing disease patterns (and
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Translations on Narcotics and Dangerous Drugs, Number 281.
1977-01-21
Mr F. Potts, said the State’s industry was of economic and national strategic importance. He said Australia would soon become one of the world’s...have their headquarters in those highly industrialized nations. These statements made by Pedro Ojeda Paullada (currently Secretary of Labor and...involved in the drug traffic. She lives on Tepanco Street, Parque San Andres District, Coyoacan where the marihuana was found. Jovita Ramirez Garcia
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Medication monitoring and drug testing ethics project.
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.
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Organic synthesis provides opportunities to transform drug discovery
Blakemore, David C.; Castro, Luis; Churcher, Ian; Rees, David C.; Thomas, Andrew W.; Wilson, David M.; Wood, Anthony
2018-03-01
Despite decades of ground-breaking research in academia, organic synthesis is still a rate-limiting factor in drug-discovery projects. Here we present some current challenges in synthetic organic chemistry from the perspective of the pharmaceutical industry and highlight problematic steps that, if overcome, would find extensive application in the discovery of transformational medicines. Significant synthesis challenges arise from the fact that drug molecules typically contain amines and N-heterocycles, as well as unprotected polar groups. There is also a need for new reactions that enable non-traditional disconnections, more C-H bond activation and late-stage functionalization, as well as stereoselectively substituted aliphatic heterocyclic ring synthesis, C-X or C-C bond formation. We also emphasize that syntheses compatible with biomacromolecules will find increasing use, while new technologies such as machine-assisted approaches and artificial intelligence for synthesis planning have the potential to dramatically accelerate the drug-discovery process. We believe that increasing collaboration between academic and industrial chemists is crucial to address the challenges outlined here.
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2012-10-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1010] Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical... certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs...
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in OECD countries concerning biological drugs
African Journals Online (AJOL)
Jane
2011-08-22
Aug 22, 2011 ... the pharmaceutical sector about biological drugs come under the umbrella of innovation system of each country. ... The cost of biotechnology R and D within public research centres and ... Existence of a suitable system to protect intellectual property ... biotechnology that provide the capital for industry and.
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Critical gases for critical issues: CO2 technologies for oral drug delivery.
Danan, Hana; Esposito, Pierandrea
2014-02-01
In recent years, CO2-based technologies have gained considerable interest in the pharmaceutical industry for their potential applications in drug formulation and drug delivery. The exploitation of peculiar properties of gases under supercritical conditions has been studied in the last 20 years with mixed results. Promising drug-delivery technologies, based on supercritical CO2, have mostly failed when facing challenges of industrial scaleability and economical viability. Nevertheless, a 'second generation' of processes, based on CO2 around and below critical point has been developed, possibly offering technology-based solutions to some of the current issues of pharmaceutical development. In this review, we highlight the most recent advancements in this field, with a particular focus on the potential of CO2-based technologies in addressing critical issues in oral delivery, and briefly discuss the future perspectives of dense CO2-assisted processes as enabling technologies in drug delivery.
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A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran.
Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Ebadifard Azar, Farbod; Nabilo, Bahram; Abolghasem Gorji, Hassan; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh
2015-04-23
Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world's greatest businesses. The aim of this study was to analyze Iran's comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran's trade in this field. To identify Iran's comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran's intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran's Customs Administration, Iran's pharmaceutical Statistics, World Bank and International Trade Center. The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world's total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran's pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran's intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade.
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Archaeal Enzymes and Applications in Industrial Biocatalysts.
Littlechild, Jennifer A
2015-01-01
Archaeal enzymes are playing an important role in industrial biotechnology. Many representatives of organisms living in "extreme" conditions, the so-called Extremophiles, belong to the archaeal kingdom of life. This paper will review studies carried by the Exeter group and others regarding archaeal enzymes that have important applications in commercial biocatalysis. Some of these biocatalysts are already being used in large scale industrial processes for the production of optically pure drug intermediates and amino acids and their analogues. Other enzymes have been characterised at laboratory scale regarding their substrate specificity and properties for potential industrial application. The increasing availability of DNA sequences from new archaeal species and metagenomes will provide a continuing resource to identify new enzymes of commercial interest using both bioinformatics and screening approaches.
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Experiences in fragment-based drug discovery.
Murray, Christopher W; Verdonk, Marcel L; Rees, David C
2012-05-01
Fragment-based drug discovery (FBDD) has become established in both industry and academia as an alternative approach to high-throughput screening for the generation of chemical leads for drug targets. In FBDD, specialised detection methods are used to identify small chemical compounds (fragments) that bind to the drug target, and structural biology is usually employed to establish their binding mode and to facilitate their optimisation. In this article, we present three recent and successful case histories in FBDD. We then re-examine the key concepts and challenges of FBDD with particular emphasis on recent literature and our own experience from a substantial number of FBDD applications. Our opinion is that careful application of FBDD is living up to its promise of delivering high quality leads with good physical properties and that in future many drug molecules will be derived from fragment-based approaches. Copyright © 2012 Elsevier Ltd. All rights reserved.
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2013-10-23
...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6360, Silver...
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77 FR 75896 - Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2013
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...
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Allan, M C
1992-01-01
To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part II of this series discusses specific issues regarding product labeling, such as developing the labeling, changing the labeling, and the legal as well as commercial ramifications of the contents of the labeling. An adverse event report scenario is further analyzed and suggestions are offered for maintaining the product labeling as an accurate reflection of the drug safety surveillance data. This article also emphasizes the necessity of product knowledge in adverse event database management. Both scientific and proprietary knowledge are required. Acquiring product knowledge is a part of the day-to-day activities of drug safety surveillance. A knowledge of the history of the product may forestall adverse publicity, as shown in the illustration. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered
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Transparency in the pharmaceutical industry - A cost accounting approach to the prices of drugs
Broekhof, Martijn
2002-01-01
The WTO TRIPS agreement grants pharmaceutical companies patent rights on new innovative drugs. Patents give these companies the opportunity to charge higher prices for their drugs in order to recover their R&D expenses. For developing countries this is one of the reasons why people in developing
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Institutional corruption of pharmaceuticals and the myth of safe and effective drugs.
Light, Donald W; Lexchin, Joel; Darrow, Jonathan J
2013-01-01
Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board. © 2013 American Society of Law, Medicine & Ethics, Inc.
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Murteira, Susana; Millier, Aurélie; Toumi, Mondher
2014-01-01
Drug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and combination. This study aimed to identify the determinants of successful market access outcome for drug repurposing in the United States of America (USA) and in Europe. The case studies of repurposing strategies were identified through a systematic review of the literature. Price information and reimbursement conditions for all the case studies were collected mainly through access of public datasources. A list of attributes that could be associated with market access outcome (price level and reimbursement conditions) was developed, discussed, and validated by an external expert group. Detailed information for all attributes was researched and collected for each case study. Bivariate regression models were conducted to identify factors associated with price change for all repurposing cases. A similar analysis was performed for reformulation and repositioning cases, in the USA and in Europe, separately. A significance level of 5% was used for all analyses. A total of 144 repurposing case studies were included in the statistical analysis for evaluation of mean price change. Combination cases (the combination of two or more individual drug components) were excluded from the statistical analysis due to the low number of cases retrieved. The main attributes associated with a significant price increase for overall repurposing cases were 'change in administration setting to hospital' (374%, ptarget product had a different administration route than the source product, and having a similar brand name for repurposed and original products, were variables that impacted a positive price change for repurposed drugs overall. Our research results also suggested that orphan designation could have a positive impact for repositioning in the USA, in particular. Although a change
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Energy Technology Data Exchange (ETDEWEB)
NONE
2001-03-01
Research is conducted concerning the possibility of anti-gene engineering basic to the application of DNA (deoxyribonucleic acid) drugs capable of serving as functional DNAs to the control of the expression of industrially useful substance producing genes or of anomalous genes and concerning the possibility of novel industry creation on the strength of the said engineering. The specific research items are described below. Technical seeds are investigated relating to the tissue- and cell-specific drug delivery system for the expression of the molecular device function of the DNA drug. Concerning molecular target technologies such as the anti-sense method, possibilities are studied of utilizing the currently available technical seeds for the eventual creation of novel industries. Concerning novel designing methods utilizing genome information such as SNPs (single nucleotide polymorphisms), investigations are conducted to determine if they would help novel technology development and novel material development. The domestic state is surveyed in relation to DNA drugs, and possibilities are investigated of novel substance production and novel medicine creation with the aid of anti-gene engineering. (NEDO)
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DISAIN PROSES KEAMANAN PANGAN PADA SISTEM MANAJEMEN INDUSTRI PAKAN UNGGAS
Directory of Open Access Journals (Sweden)
Legis Tsaniyah
2017-11-01
Full Text Available The feed industry shall maintain quality and food safety of their products. The research conducted in the year of 2015-2016 was to design the optimum condition of food safety consideration for feed industries in Indonesia. Feed for livestock was formulated by using corn meal, soya protein, fish meals, rice bran, veterinary drugs, steam, and other ingredients. Growth promotor materials were formulated from vitamin, antibiotics, amino acid, methylene blue, and other trace elements also were added in the formulation. The feed ingredients are potential sources of food safety hazard in feed products. Result of model analysis found the major sources of food safety risks, i.e.1 veterinary drugs residues (X1; 2 aflatoxin potential in humid corn meals (X2, and3 alfatoxin potential in humid soya meal (X3. Minimisation model formulated for food safety in feed production was Z = 13.78 X1 + 10.00 X2 + 7.67 X3. The optimisation model by using simplex solution found maximum bioaccumulation value index of 93.33 per ton feed production. The verification model done for two feed industries and calculated bioaccumulation index were 20.16 and 24.43 per ton livestock feed production. The result concluded that the feed produced by both industries have been recommended safe to consume. The optimum condition for food safety in livestock feed industry interpreted from this optimal conditions.
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Learning lessons from drugs that have recently entered the market.
Teague, Simon J
2011-05-01
Which projects in the drug discovery field are most likely to be successful? In this article, I provide guidelines for answering this question by examining recent drug market entrants in detail, in particular their route of administration, trial design, novelty, therapeutic target and toxicities. I identify targets, trials and organizations as the key issues that are currently leading to the poor productivity in the pharmaceutical industry. Here, I outline some solutions and reasons for optimism, and suggest that the key determinants for success in drug discovery can be defined by studying recently launched drugs. Copyright © 2011 Elsevier Ltd. All rights reserved.
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[India: an expensive and dangerous drug].
Astrup, N
1992-12-16
India has launched a liberalization of its economy with restructuring, privatization, and increased imports in order to achieve higher economic performance. This drive also affected the pharmaceutical industry and drug distribution, but in a negative manner. In the 1980s there were 9000 drug manufacturers that together produced up to 60,000 different preparations. In 1992, only 20,000 drugs were produced. The Voluntary Health Organization of India (VHAI) has fought for 10 years for a rational policy on medicines to halt the production of worthless or outright harmful products. For instance, anabolic steroids are sold as nutritional supplements to children, and the banned clioquinol is regularly used against diarrhea despite an international boycott. In recent years unscrupulous manufacturers have sold contaminated water as glucose for infusion bags and anti-D-immunoglobulin which was contaminated with HIV-infected blood. In northern India, a criminal organization bought up used cannulas from hospitals and repacked them for resale as new supplies. While a new medicine policy is formulated, there is a serious shortage of life-saving drugs such as insulin and rifampicin. In the last years, prices have exploded as some products have become six times more expensive. The whole national health system has undergone cost cuts to comply with an ultimatum from the World Bank and the International Monetary Fund; otherwise, sorely needed dollar loans would not be forthcoming. Funds for fighting tuberculosis and malaria have been trimmed, although AIDS and family planning budgets have been increased. One-fourth of the state health expenditures go to combat AIDS, since about 1 million people are infected with HIV. The pharmaceutical industry has also been embroiled in a patent protection wrangle with American drug exporters who claim that Retrovir or AZT (developed by Burroughs Wellcome) was pirated by the Cipla firm, whereas Cipla countered that it was ferreted out from
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Obesity and Pediatric Drug Development.
Vaughns, Janelle D; Conklin, Laurie S; Long, Ying; Zheng, Panli; Faruque, Fahim; Green, Dionna J; van den Anker, John N; Burckart, Gilbert J
2018-05-01
There is a lack of dosing guidelines for use in obese children. Moreover, the impact of obesity on drug safety and clinical outcomes is poorly defined. The paucity of information needed for the safe and effective use of drugs in obese patients remains a problem, even after drug approval. To assess the current incorporation of obesity as a covariate in pediatric drug development, the pediatric medical and clinical pharmacology reviews under the Food and Drug Administration (FDA) Amendments Act of 2007 and the FDA Safety and Innovation Act (FDASIA) of 2012 were reviewed for obesity studies. FDA labels were also reviewed for statements addressing obesity in pediatric patients. Forty-five drugs studied in pediatric patients under the FDA Amendments Act were found to have statements and key words in the medical and clinical pharmacology reviews and labels related to obesity. Forty-four products were identified similarly with pediatric studies under FDASIA. Of the 89 product labels identified, none provided dosing information related to obesity. The effect of body mass index on drug pharmacokinetics was mentioned in only 4 labels. We conclude that there is little information presently available to provide guidance related to dosing in obese pediatric patients. Moving forward, regulators, clinicians, and the pharmaceutical industry should consider situations in drug development in which the inclusion of obese patients in pediatric trials is necessary to facilitate the safe and effective use of new drug products in the obese pediatric population. © 2018, The American College of Clinical Pharmacology.
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THE JUST DRUG DISTRIBUTION IN THE PERSPECTIVE OF WELFARE STATE
Directory of Open Access Journals (Sweden)
Aktieva Tri Tjitrawati
2014-03-01
Full Text Available States have obligations to improve equitability of welfare and prosperity of the community. Pharmaceutical is one of the important and strategic industries because of its vital role to support the development of health sector. Lack of regulation on pricing-products, and diversion of social aspects in the drugs trade, either by government or industry, are associated with the paradigm that underlies regulation of the distributions. Prospective policy analysis and functional approach of law are used to find a level of balance of various interest related to the subject, and to find concepts as a basis to construct new paradigm on drugs distribution. Negara berkewajiban untuk meningkatkan kesejahteraan dan kemakmuran masyarakat secara berkeadilan. Industri farmasi merupakan salah satu industri penting dan strategis karena perannya yang vital menunjang pembangunan bidang kesehatan.Terdapat kecenderungan kurangnya peran Pemerintah dalam pricing policy obat, serta diabaikannya aspek sosial dalam perdagangan produk farmasi, baik oleh Pemerintah maupun industri farmasi. Carut marut ini berkaitan dengan ketidakjelasan paradigma yang berujung pada ketidakjelasan kebijakan yang melandasi tatanan distribusi obat. Makalah ini menggunakan analisis kebijakan prospektif dan pendekatan fungsional hukum untuk mengkaji kebijakan distribusi obat yang bersifat multi disiplin dan menemukan konsep baru untuk menemukan titik keseimbangan dari berbagai kepentingan terkait.
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Interventions to Encourage and Facilitate Greener Industrial Chemicals Selection
Faulkner, David
2017-01-01
Despite their ubiquity in modern life, industrial chemicals are poorly regulated in the United States. Statutory law defines industrial chemicals as chemicals that are not foods, drugs, cosmetics, nor pesticides, but may be used in consumer products, and this distinction places them under the purview of the Toxic Substances Control Act (TSCA), which received a substantial update when the US congress passed a revision of the act in 2016. The revised law, the Frank R. Lautenberg Chemical Safety...
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2013-03-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0205 (Formerly 2007D-0252)] Pulse Oximeters--Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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Recent developments in oral lipid-based drug delivery
DEFF Research Database (Denmark)
Thomas, N.; Rades, T.; Müllertz, A.
2013-01-01
The increasing number of poorly water-soluble drugs in development in the pharmaceutical industry has sparked interest in novel drug delivery options such as lipid-based drug delivery systems (LbDDS). Several LbDDS have been marketed successfully and have shown superior and more reliable...... bioavailability compared to conventional formulations. However, some reluctance in the broader application of LbDDS still appears, despite the growing commercial interest in lipids as a drug delivery platform. This reluctance might at least in part be related to the complexity associated with the development...... and characterization of LbDDS. In particular, the lack of standardized test protocols can be identified as the major obstacles for the broader application of LbDDS. This review seeks to summarize recent approaches in the field of lipid-based drug delivery that try to elucidate some critical steps in their development...
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Stamatakis, Emmanuel; Weiler, Richard; Ioannidis, John P A
2013-05-01
Expenditure on industry products (mostly drugs and devices) has spiraled over the last 15 years and accounts for substantial part of healthcare expenditure. The enormous financial interests involved in the development and marketing of drugs and devices may have given excessive power to these industries to influence medical research, policy, and practice. Review of the literature and analysis of the multiple pathways through which the industry has directly or indirectly infiltrated the broader healthcare systems. We present the analysis of the industry influences at the following levels: (i) evidence base production, (ii) evidence synthesis, (iii) understanding of safety and harms issues, (iv) cost-effectiveness evaluation, (v) clinical practice guidelines formation, (vi) healthcare professional education, (vii) healthcare practice, (viii) healthcare consumer's decisions. We located abundance of consistent evidence demonstrating that the industry has created means to intervene in all steps of the processes that determine healthcare research, strategy, expenditure, practice and education. As a result of these interferences, the benefits of drugs and other products are often exaggerated and their potential harms are downplayed, and clinical guidelines, medical practice, and healthcare expenditure decisions are biased. To serve its interests, the industry masterfully influences evidence base production, evidence synthesis, understanding of harms issues, cost-effectiveness evaluations, clinical practice guidelines and healthcare professional education and also exerts direct influences on professional decisions and health consumers. There is an urgent need for regulation and other action towards redefining the mission of medicine towards a more objective and patient-, population- and society-benefit direction that is free from conflict of interests. © 2013 Stichting European Society for Clinical Investigation Journal Foundation. Published by Blackwell Publishing Ltd.
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Tilney, N L; Guttmann, R D; Daar, A S; Hoffenberg, R; Kennedy, I; Lock, M; Radcliffe-Richards, J; Sells, R A
2001-03-15
Clinical organ transplantation has evolved through advances in patient care in parallel with investigations in associated biologies. It has developed from a cottage industry to an important medical specialty driven increasingly by the availability of newer and more effective immunosuppressive drugs, and dependent on consistently close collaborations between university-based clinical scientists and the pharmaceutical industry. Particularly during the past decade, however, this industry has undergone striking changes, consolidating into huge multi-national corporations, each competing for patients, their doctors, and for support of the allied hospitals. Because of the growth of "Big Pharma," the relationship between academia and industry has changed. There have been many advantages to such mutually dependent interactions. A combination of university-based expertise and the specialized knowledge and resources of industry have produced important scientific gains in drug development. Commercial sponsorship of applied research has been crucial. The orchestration of multicenter controlled clinical drug trials has provided invaluable information about the effectiveness of newer agents. But there are also disadvantages of increasing concern. Indeed, the power of "Big Pharma" in many medical fields including transplantation is such that presentation of data can be delayed, adverse results withheld, and individual investigations hampered. Clinical trials may be protracted to stifle competition. Monetary considerations may transcend common sense. Several measures to enhance the clinical relationship between the pharmaceutical industry and those involved with organ transplantation are suggested, particularly the use of third party advisors in the production of clinical trials, support for more basic research and in the dissemination of results. In this way, the increasingly problematic phenomenon of commercialization of the field of transplantation can be tempered and
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Chitosan nanoparticles as drug delivery carriers for biomedical engineering
International Nuclear Information System (INIS)
Shi, L.E.S.; Chen, M.; XINF, L.Y.; Guo, X.F.; Zhao, L.M.
2011-01-01
Chitosan is a rather abundant material, which has been widely used in food industrial and bioengineering aspects, including in encapsulating active food ingredients, in enzyme immobilization, and as a carrier for drug delivery, due to its significant biological and chemical properties such as biodegradable, biocompatible, bioactive and polycationic. This review discussed preparation and applications of chitosan nanoparticles in the biomedical engineering field, namely as a drug delivery carrier for biopharmaceuticals. (author)
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75 FR 1547 - Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2010
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...
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A lay prescription for tailor-made drugs--focus group reflections on pharmacogenomics
DEFF Research Database (Denmark)
Almarsdóttir, Anna Birna; Björnsdóttir, Ingunn; Traulsen, Janine Morgall
2005-01-01
the consequences of the Human Genome Project over the next 40 years, and asked to give advice to politicians and the pharmaceutical industry. A dominating theme in the focus groups was the expectation that drugs developed based on pharmacogenomics will be more expensive than conventional mass produced drugs...
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African Journal of Drug and Alcohol Studies
African Journals Online (AJOL)
The African Journal of Drug & Alcohol Studies is an international scientific journal published by the African Centre for Research and Information on Substance ... Anywhere, everywhere: alcohol industry promotion strategies in Nigeria and their influence on young people · EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT
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Hernandez, J Javier; Pryszlak, Michael; Smith, Lindsay; Yanchus, Connor; Kurji, Naheed; Shahani, Vijay M; Molinski, Steven V
2017-01-01
The repositioning or "repurposing" of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these "new" medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.
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Directory of Open Access Journals (Sweden)
J. Javier Hernandez
2017-11-01
Full Text Available The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.
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Murteira, Susana; Millier, Aurélie; Toumi, Mondher
2014-01-01
Background Drug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and combination. Objective This study aimed to identify the determinants of successful market access outcome for drug repurposing in the United States of America (USA) and in Europe. Methods The case studies of repurposing strategies were identified through a systematic review of the literature. Price information and reimbursement conditions for all the case studies were collected mainly through access of public datasources. A list of attributes that could be associated with market access outcome (price level and reimbursement conditions) was developed, discussed, and validated by an external expert group. Detailed information for all attributes was researched and collected for each case study. Bivariate regression models were conducted to identify factors associated with price change for all repurposing cases. A similar analysis was performed for reformulation and repositioning cases, in the USA and in Europe, separately. A significance level of 5% was used for all analyses. Results A total of 144 repurposing case studies were included in the statistical analysis for evaluation of mean price change. Combination cases (the combination of two or more individual drug components) were excluded from the statistical analysis due to the low number of cases retrieved. The main attributes associated with a significant price increase for overall repurposing cases were ‘change in administration setting to hospital’ (374%, ptarget product had a different administration route than the source product, and having a similar brand name for repurposed and original products, were variables that impacted a positive price change for repurposed drugs overall. Our research results also suggested that orphan designation could have a positive impact for repositioning in
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2011-10-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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Introduction to fragment-based drug discovery.
Erlanson, Daniel A
2012-01-01
Fragment-based drug discovery (FBDD) has emerged in the past decade as a powerful tool for discovering drug leads. The approach first identifies starting points: very small molecules (fragments) that are about half the size of typical drugs. These fragments are then expanded or linked together to generate drug leads. Although the origins of the technique date back some 30 years, it was only in the mid-1990s that experimental techniques became sufficiently sensitive and rapid for the concept to be become practical. Since that time, the field has exploded: FBDD has played a role in discovery of at least 18 drugs that have entered the clinic, and practitioners of FBDD can be found throughout the world in both academia and industry. Literally dozens of reviews have been published on various aspects of FBDD or on the field as a whole, as have three books (Jahnke and Erlanson, Fragment-based approaches in drug discovery, 2006; Zartler and Shapiro, Fragment-based drug discovery: a practical approach, 2008; Kuo, Fragment based drug design: tools, practical approaches, and examples, 2011). However, this chapter will assume that the reader is approaching the field with little prior knowledge. It will introduce some of the key concepts, set the stage for the chapters to follow, and demonstrate how X-ray crystallography plays a central role in fragment identification and advancement.
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A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran
Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Azar, Farbod Ebadifard; Nabilo, Bahram; Gorji, Hassan Abolghasem; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh
2015-01-01
Background: Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world’s greatest businesses. The aim of this study was to analyze Iran’s comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran’s trade in this field. Methods: To identify Iran’s comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran’s intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran’s Customs Administration, Iran’s pharmaceutical Statistics, World Bank and International Trade Center. Results: The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world’s total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran’s pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran’s intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. Conclusions: The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade. PMID:26153184
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CURRENT TRENDS AND PROSPECTS OF THE RUSSIAN PHARMACEUTICAL INDUSTRY AND THE FOREIGN EXPERIENCE
Directory of Open Access Journals (Sweden)
Z. A. Mamedyarov
2017-01-01
Full Text Available Purpose: the purpose of this article is to study the current state of the pharmaceutical industry in Russia, to identify trends in Russian pharmaceutical market, and to provide preliminary analysis of the state support policy for pharmaceuticals in Russia, focusing on the federal target program "Pharma-2020".Methods: the study is based on a quantitative study of the characteristics and trends of the Russian pharmaceutical market. The emphasis was put on the period 2008–2017. The volume of the market, the structure of imports and exports are considered, and expenditures under the federal program "Pharma-2020" are studied. A qualitative comparative comparison with the tendencies of the global development of the industry is conducted and recommendations are made on further stimulating the growth of the pharma industry in Russia.Results: in the past 5 years, the pharmaceutical industry in Russia did receive special attention from the government, significant funds have been allocated for to support domestic producers, and import substitution policies have been launched. Financial results of the industry show slight improvement in a number of indicators: the market share of domestic medicines is growing, the generics production increased, production standards became tighter controlled. Nevertheless, Russia remains on the periphery of the world pharmaceutical science, import retains two thirds of the market share by value, while innovative novel drugs are now launched primarily by MNEs from the US and the EU.Conclusions and relevance: the challenges and development factors of Russia's pharmaceutical industry identified in this research require effective regulatory tools. First of all, it is necessary to reduce the gap between Russia and the developed countries in the R&D standards and their market implementation. Statistical data has showed the progress in the production of drugs from the VED list (Vital and Essential Drugs, but it is necessary to
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Approaching the social control of drugs, I: Construction of the problem
Radulović Dragan
2008-01-01
The paper aims at outlining the social process whereby drug use has been defined as a major problem of contemporary society. The beginning of profane use of drugs is located in modern industrial society, while their global spread and the establishment of the prohibition system took place in the second half of 20th century. The generalized notion of drugs has dissolved into three different groups: some substances (coffee, tea, alcohol, tobacco) are socially accepted; others, like barbiturates ...
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2011-09-29
... monograph need not obtain FDA approval before marketing if their drug product meets the conditions in part... introduce into the United States an OTC drug product that had been marketed solely in a foreign country...
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Morgan, Steve; McMahon, Meghan; Greyson, Devon
2008-08-01
Policy-makers worldwide struggle to balance health with industrial policy objectives in the pharmaceutical sector. Tensions arise over pricing and reimbursement in particular. What health plans view as necessary to maintain equitable access to medicines, industry views as inimical to R&D and innovation. Australia has grappled with this issue for years, even incorporating the goal of "maintaining a responsible and viable medicines industry" into its National Medicines Policy. This case study was conducted via a narrative review that examined Australia's experiences balancing health and industrial policy objectives in the pharmaceutical sector. The review included electronic databases, grey literature and government publications for reports on relevant Australian policy published over the period 1985-2007. While pharmaceutical companies claim that Australia's pricing and reimbursement policies suppress drug prices and reduce profits, national policy audits indicate these claims are misguided. Australia appears to have secured relatively low prices for generics and "me-too drugs" while paying internationally competitive prices for "breakthrough" medicines. Simultaneously, Australia has focused efforts on local pharmaceutical investment through a variety of industry-targeted R&D incentive policies. Despite the fact that policy reviews suggest that Australia has achieved balance between health and industrial policy objectives, the country continues to face criticism from industry that its health goals harm innovation and R&D. Recent reforms raise the question whether Australia can sustain the apparent balance.
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Fragment-based drug discovery and its application to challenging drug targets.
Price, Amanda J; Howard, Steven; Cons, Benjamin D
2017-11-08
Fragment-based drug discovery (FBDD) is a technique for identifying low molecular weight chemical starting points for drug discovery. Since its inception 20 years ago, FBDD has grown in popularity to the point where it is now an established technique in industry and academia. The approach involves the biophysical screening of proteins against collections of low molecular weight compounds (fragments). Although fragments bind to proteins with relatively low affinity, they form efficient, high quality binding interactions with the protein architecture as they have to overcome a significant entropy barrier to bind. Of the biophysical methods available for fragment screening, X-ray protein crystallography is one of the most sensitive and least prone to false positives. It also provides detailed structural information of the protein-fragment complex at the atomic level. Fragment-based screening using X-ray crystallography is therefore an efficient method for identifying binding hotspots on proteins, which can then be exploited by chemists and biologists for the discovery of new drugs. The use of FBDD is illustrated here with a recently published case study of a drug discovery programme targeting the challenging protein-protein interaction Kelch-like ECH-associated protein 1:nuclear factor erythroid 2-related factor 2. © 2017 The Author(s). Published by Portland Press Limited on behalf of the Biochemical Society.
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Janero, David R
2014-11-01
The significant contribution of substance-use disorders (SUDs) to the global-disease burden and associated unmet medical needs has not engendered a commensurate level of pharma-industry research and development (R&D) for novel SUD therapeutics invention. Analysis of contextual factors shaping this position suggests potential routes toward incentivizing R&D commitment for that purpose. This article considers multiple primary factors that have consorted to disincentivize pharma industry's operating in the SUD space: ill-understood pathology; variegated treatments and patient profiles; involved clinical trials; and - with particular reference to SUDs-negative cultural/business stigmas and shallow commercial precedent. Industry incentivization for SUD drug innovation requires progress on several fronts, including: translational experimental data and systems; personalized, holistic SUD treatment approaches; interactions among pharma, nonindustry constituencies, and the medical profession with vested interests in countering negative stereotypes and expanding SUD treatment options; and public-private alliances focused on improving SUD pharmacotherapy. Given the well-entrenched business stance whereby the prospect of future profits in major markets largely determines drug-company R&D investment trajectory, strategic initiatives offering substantial reductions in the risks and opportunity (i.e., time and money) costs associated with SUD drug discovery are likely to be the most potent drivers for encouraging mainstream industry positioning in this therapeutic area. Such initiatives could originate from front-loaded R&D operational and back-loaded patent, regulatory, marketing and health-care policy reforms. These may be too involved and protracted for the turbulent pharmaceutical industry to entertain amid its recent retrenchment from psychiatric/CNS diseases and intense pressures to increase productivity and shareholder value.
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Novel opportunities for computational biology and sociology in drug discovery☆
Yao, Lixia; Evans, James A.; Rzhetsky, Andrey
2013-01-01
Current drug discovery is impossible without sophisticated modeling and computation. In this review we outline previous advances in computational biology and, by tracing the steps involved in pharmaceutical development, explore a range of novel, high-value opportunities for computational innovation in modeling the biological process of disease and the social process of drug discovery. These opportunities include text mining for new drug leads, modeling molecular pathways and predicting the efficacy of drug cocktails, analyzing genetic overlap between diseases and predicting alternative drug use. Computation can also be used to model research teams and innovative regions and to estimate the value of academy–industry links for scientific and human benefit. Attention to these opportunities could promise punctuated advance and will complement the well-established computational work on which drug discovery currently relies. PMID:20349528
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Novel opportunities for computational biology and sociology in drug discovery
Yao, Lixia
2009-01-01
Drug discovery today is impossible without sophisticated modeling and computation. In this review we touch on previous advances in computational biology and by tracing the steps involved in pharmaceutical development, we explore a range of novel, high value opportunities for computational innovation in modeling the biological process of disease and the social process of drug discovery. These opportunities include text mining for new drug leads, modeling molecular pathways and predicting the efficacy of drug cocktails, analyzing genetic overlap between diseases and predicting alternative drug use. Computation can also be used to model research teams and innovative regions and to estimate the value of academy-industry ties for scientific and human benefit. Attention to these opportunities could promise punctuated advance, and will complement the well-established computational work on which drug discovery currently relies. PMID:19674801
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Systems biology-embedded target validation: improving efficacy in drug discovery.
Vandamme, Drieke; Minke, Benedikt A; Fitzmaurice, William; Kholodenko, Boris N; Kolch, Walter
2014-01-01
The pharmaceutical industry is faced with a range of challenges with the ever-escalating costs of drug development and a drying out of drug pipelines. By harnessing advances in -omics technologies and moving away from the standard, reductionist model of drug discovery, there is significant potential to reduce costs and improve efficacy. Embedding systems biology approaches in drug discovery, which seek to investigate underlying molecular mechanisms of potential drug targets in a network context, will reduce attrition rates by earlier target validation and the introduction of novel targets into the currently stagnant market. Systems biology approaches also have the potential to assist in the design of multidrug treatments and repositioning of existing drugs, while stratifying patients to give a greater personalization of medical treatment. © 2013 Wiley Periodicals, Inc.
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Looking at CER from the pharmaceutical industry perspective.
Dubois, Robert W
2012-05-01
Comparative effectiveness research (CER) is increasing as an element of health care reform in the United States. By comparing drugs against other drugs or other therapies instead of just to placebo, CER has the potential to improve decisions about the appropriate treatment for patients. But the growth of CER also brings an array of questions and decisions for purchasers and policy makers that will not be easy to answer and which require significant dialogue to fully understand and address. To describe some of the impact, both positive and negative, that comparative effectiveness research (CER) may have on the pharmaceutical industry. As CER data proliferate, questions are being raised about who can access the data, who can discuss it, and in what forums. Regulations place different communication restrictions on the pharmaceutical industry than on other health care stakeholders, which creates a potential inequality. Another CER consideration will be the tendency to apply average results to individuals, even if not every individual experiences the average result. Policy makers should implement CER findings carefully with a goal toward accommodating flexibility. A final impact to consider is whether greater expectations for CER will have a negative or positive effect on incentives for drug innovation. In some cases, CER may increase development costs or decrease market size. In other cases, better targeting of trial populations could result in lower development costs. The rising expectations and growth in CER raise questions about information access, communication restrictions, flexible implementation policies, and incentives for innovation. Members of the pharmaceutical industry should be cognizant of the questions and should be participating in dialogues now to pave the way for future solutions.
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Prices, Profits and Innovation: Examining Criticisms of the Value of New Psychotropic Drugs
Huskamp, Haiden A.
2008-01-01
High profits and high drug costs have brought increased scrutiny of the pharmaceutical industry over the issue of whether the drugs they produce are worth the costs. I examine several related complaints, including the proliferation of me-too drugs and product reformulations, which some argue have little value relative to their cost; promotion of newer drug classes as more effective than existing, less expensive drugs in the absence of evidence of superior effectiveness; legal strategies to extend market exclusivity that result in high brand drug prices for an extended period of time; and large promotional expenditures that result in higher prices. PMID:16684726
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2012-08-15
...] Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in... ``Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials.'' The purpose of... suicidal ideation and behavior in clinical trials of drug and biological products, including drugs for...
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Paving roads for new drugs in oncology.
Zaenker, Kurt S; Entschladen, Frank
2009-06-01
Low productivity and the escalating costs of drug development have been well documented over the past years. A fraction of new pre-clinical compounds successfully pass experimental test batteries, and less than 10% of these compounds that enter clinical trials ultimately make it to the market. These challenges in the "critical path" of drug development will be discussed for drugs in the field of oncology, regarding the i) the impact of FDA and EMEA guidelines, and ii) microdosing studies/phase 0 trials before a drug enters phase I to III, to inform drug development, compressing drug development timelines and decision-making for continuation into clinical trials. Moreover, this review should embark on i) how to find new key molecules involved in life-and-death decision of a cell, how ii) old drugs will have a revival for new indications, because of novel information for their mode of action, and iii) how the revolutionary advances - high-throughput technologies, gene therapy and the deciphering of the human genome - do have their potential to develop personalized therapy. Therapy has progressed from an age of administering herbal remedies and organ extracts to an era of meticulously planned drug discovery, when pharmaceutical industry was born in a Western understanding. The relevant patents are discussed.
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Nanocomposite thin films for triggerable drug delivery.
Vannozzi, Lorenzo; Iacovacci, Veronica; Menciassi, Arianna; Ricotti, Leonardo
2018-05-01
Traditional drug release systems normally rely on a passive delivery of therapeutic compounds, which can be partially programmed, prior to injection or implantation, through variations in the material composition. With this strategy, the drug release kinetics cannot be remotely modified and thus adapted to changing therapeutic needs. To overcome this issue, drug delivery systems able to respond to external stimuli are highly desirable, as they allow a high level of temporal and spatial control over drug release kinetics, in an operator-dependent fashion. Areas covered: On-demand drug delivery systems actually represent a frontier in this field and are attracting an increasing interest at both research and industrial level. Stimuli-responsive thin films, enabled by nanofillers, hold a tremendous potential in the field of triggerable drug delivery systems. The inclusion of responsive elements in homogeneous or heterogeneous thin film-shaped polymeric matrices strengthens and/or adds intriguing properties to conventional (bare) materials in film shape. Expert opinion: This Expert Opinion review aims to discuss the approaches currently pursued to achieve an effective on-demand drug delivery, through nanocomposite thin films. Different triggering mechanisms allowing a fine control on drug delivery are described, together with current challenges and possible future applications in therapy and surgery.
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2011-10-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0733] Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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2012-12-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1002] Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) AGENCY... announcing the availability of a guidance for industry entitled ``Questions and Answers Regarding Food...
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2011-06-21
... Action'' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act... the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug... statutory definitions for these terms set forth in sections 201(g) and 201(h) of the Federal Food, Drug, and...
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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.
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Riera-Fernández, Pablo; Munteanu, Cristian R; Dorado, Julian; Martin-Romalde, Raquel; Duardo-Sanchez, Aliuska; González-Diaz, Humberto
2011-12-01
Complex Networks are useful in solving problems in drug research and industry, developing mathematical representations of different systems. These systems move in a wide range from relatively simple graph representations of drug molecular structures to large systems. We can cite for instance, drug-target protein interaction networks, drug policy legislation networks, or drug treatment in large geographical disease spreading networks. In any case, all these networks have essentially the same components: nodes (atoms, drugs, proteins, microorganisms and/or parasites, geographical areas, drug policy legislations, etc.) and edges (chemical bonds, drug-target interactions, drug-parasite treatment, drug use, etc.). Consequently, we can use the same type of numeric parameters called Topological Indices (TIs) to describe the connectivity patterns in all these kinds of Complex Networks despite the nature of the object they represent. The main reason for this success of TIs is the high flexibility of this theory to solve in a fast but rigorous way many apparently unrelated problems in all these disciplines. Another important reason for the success of TIs is that using these parameters as inputs we can find Quantitative Structure-Property Relationships (QSPR) models for different kind of problems in Computer-Aided Drug Design (CADD). Taking into account all the above-mentioned aspects, the present work is aimed at offering a common background to all the manuscripts presented in this special issue. In so doing, we make a review of the most common types of complex networks involving drugs or their targets. In addition, we review both classic TIs that have been used to describe the molecular structure of drugs and/or larger complex networks. Next, we use for the first time a Markov chain model to generalize Galvez TIs to higher order analogues coined here as the Markov-Galvez TIs of order k (MGk). Lastly, we illustrate the calculation of MGk values for different classes of
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Translational informatics: an industry perspective.
Cantor, Michael N
2012-01-01
Translational informatics (TI) is extremely important for the pharmaceutical industry, especially as the bar for regulatory approval of new medications is set higher and higher. This paper will explore three specific areas in the drug development lifecycle, from tools developed by precompetitive consortia to standardized clinical data collection to the effective delivery of medications using clinical decision support, in which TI has a major role to play. Advancing TI will require investment in new tools and algorithms, as well as ensuring that translational issues are addressed early in the design process of informatics projects, and also given higher weight in funding or publication decisions. Ultimately, the source of translational tools and differences between academia and industry are secondary, as long as they move towards the shared goal of improving health.
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Drug repurposing based on drug-drug interaction.
Zhou, Bin; Wang, Rong; Wu, Ping; Kong, De-Xin
2015-02-01
Given the high risk and lengthy procedure of traditional drug development, drug repurposing is gaining more and more attention. Although many types of drug information have been used to repurpose drugs, drug-drug interaction data, which imply possible physiological effects or targets of drugs, remain unexploited. In this work, similarity of drug interaction was employed to infer similarity of the physiological effects or targets for the drugs. We collected 10,835 drug-drug interactions concerning 1074 drugs, and for 700 of them, drug similarity scores based on drug interaction profiles were computed and rendered using a drug association network with 589 nodes (drugs) and 2375 edges (drug similarity scores). The 589 drugs were clustered into 98 groups with Markov Clustering Algorithm, most of which were significantly correlated with certain drug functions. This indicates that the network can be used to infer the physiological effects of drugs. Furthermore, we evaluated the ability of this drug association network to predict drug targets. The results show that the method is effective for 317 of 561 drugs that have known targets. Comparison of this method with the structure-based approach shows that they are complementary. In summary, this study demonstrates the feasibility of drug repurposing based on drug-drug interaction data. © 2014 John Wiley & Sons A/S.
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New Antimicrobial Approaches: Reuse of Old Drugs.
Savoia, Dianella
2016-01-01
The global situation of antibiotic resistance and the reduction of investments in antibiotics research by the pharmaceutical industry suggest the need for specific cost-effective approaches in order to identify drugs for the therapy of many microbial infections. Among the viable alternative anti-infective compounds, drug repurposing, i.e. to find new uses for previously approved medicines, revealed some encouraging in vitro and in vivo results. In this article the reader has a panoramic view of the updated references on the strategies encountered during the repositioning process. New findings are reported about the anti-microbial efficacy of antipsychotic, cardiovascular, anti-inflammatory and anti-neoplastic drugs. This approach may enhance the portfolio of pharmaceutical companies reducing the need for pharmacokinetic and toxicity studies; the development of new uses of old drugs for different infectious diseases, leading to better health for patients, also in poor, tropical countries, appears to be having better results.
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Drug interactions evaluation: An integrated part of risk assessment of therapeutics
International Nuclear Information System (INIS)
Zhang, Lei; Reynolds, Kellie S.; Zhao, Ping; Huang, Shiew-Mei
2010-01-01
Pharmacokinetic drug interactions can lead to serious adverse events or decreased drug efficacy. The evaluation of a new molecular entity's (NME's) drug-drug interaction potential is an integral part of risk assessment during drug development and regulatory review. Alteration of activities of enzymes or transporters involved in the absorption, distribution, metabolism, or excretion of a new molecular entity by concomitant drugs may alter drug exposure, which can impact response (safety or efficacy). The recent Food and Drug Administration (FDA) draft drug interaction guidance ( (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072101.pdf)) highlights the methodologies and criteria that may be used to guide drug interaction evaluation by industry and regulatory agencies and to construct informative labeling for health practitioner and patients. In addition, the Food and Drug Administration established a 'Drug Development and Drug Interactions' website to provide up-to-date information regarding evaluation of drug interactions ( (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm080499.htm)). This review summarizes key elements in the FDA drug interaction guidance and new scientific developments that can guide the evaluation of drug-drug interactions during the drug development process.
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Managing the pharmaceutical industry-health system interface.
Zarowitz, B J; Muma, B; Coggan, P; Davis, G; Barkley, G L
2001-12-01
Direct-to-consumer advertising, media, and Internet marketing to physicians and patients, as well as enticing marketing strategies, are used by the pharmaceutical industry to ensure market share growth of new drugs. Our health system adopted a strict vendor policy governing detailing and sampling activities of pharmaceutical representatives, but realized that further analysis of vendor influence in our system was needed. An assessment of tangible benefits, ethical concerns, and financial liabilities and gains was conducted to reassess the need for further vendor restriction. Based on our findings, several recommendations have been made. Medical practices and health systems are encouraged to establish and enforce explicit vendor policies, measure their effectiveness, partner proactively with representatives to deliver a drug-detailing message consistent with system initiatives, monitor and regulate continuing medical education funding, and implement strategies to ensure appropriate drug use.
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O'Brady, Sean; Gagnon, Marc-André; Cassels, Alan
2015-02-01
Prescription drugs are the highest single cost component for employees' benefits packages in Canada. While industry literature considers cost-containment for prescription drug costs to be a priority for insurers and employers, the implementation of cost-containment measures for private drug plans in Canada remains more of a myth than a reality. Through 18 semi-structured phone interviews conducted with experts from private sector companies, unions, insurers and plan advisors, this study explores the reasons behind this incapacity to implement cost-containment measures by examining how private sector employers negotiate drug benefit design in unionized settings. Respondents were asked questions on how employee benefits are negotiated; the relationships between the players who influence drug benefit design; the role of these players' strategies in influencing plan design; the broad system that underpins drug benefit design; and the potential for a universal pharmacare program in Canada. The study shows that there is consensus about the need to educate employees and employers, more collaboration and data-sharing between these two sets of players, and for external intervention from government to help transform established norms in terms of private drug plan design. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.
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Sequencing: Targeting Insurgents and Drugs in Colombia
2007-03-01
p. 73. 24 initiated by previous administrations coupled with declining prices in the late 1990s for coffee and oil—two of Colombia’s major...whose involvement in the illicit drug industry gained them notoriety in the 1970s with the production of cannabis . In the 1980s, Colombia became the
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Fitness for duty in the nuclear power industry: A review of technical issues
International Nuclear Information System (INIS)
Barnes, V.; Fleming, I.; Grant, T.
1988-09-01
This report presents information gathered and analyzed in support of the United States Nuclear Regulatory Commission's (NRC's) efforts to develop a rule that will ensure that workers with unescorted access to protected areas in nuclear power plants are fit for duty. The primary potential fitness-for-duty concern addressed in the report is impairment caused by substance abuse, although other sources of impairment on the job are discussed. The report examines the prevalence of fitness-for-duty problems and discusses the use and effects of illicit drugs, prescription drugs, over-the-counter preparations and alcohol. The ways in which fitness-for-duty concerns are being addressed in both public- and private-sector industries are reviewed, and a description is provided of fitness-for-duty practices in six organizations that, like the nuclear industry, are regulated and whose operations can affect public health and safety. Methods of ensuring fitness for duty in the nuclear industry are examined in detail. The report also addresses methods of evaluating the effectiveness of fitness-for-duty programs in the nuclear power industry
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Recent trends in drug delivery system using protein nanoparticles.
Sripriyalakshmi, S; Jose, Pinkybel; Ravindran, Aswathy; Anjali, C H
2014-09-01
Engineered nanoparticles that can facilitate drug formulation and passively target tumours have been under extensive research in recent years. These successes have driven a new wave of significant innovation in the generation of advanced particles. The fate and transport of diagnostic nanoparticles would significantly depend on nonselective drug delivery, and hence the use of high drug dosage is implemented. In this perspective, nanocarrier-based drug targeting strategies can be used which improve the selective delivery of drugs to the site of action, i.e. drug targeting. Pharmaceutical industries majorly focus on reducing the toxicity and side effects of drugs but only recently it has been realised that carrier systems themselves may pose risks to the patient. Proteins are compatible with biological systems and they are biodegradable. They offer a multitude of moieties for modifications to tailor drug binding, imaging or targeting entities. Thus, protein nanoparticles provide outstanding contributions as a carrier for drug delivery systems. This review summarises recent progress in particle-based therapeutic delivery and discusses important concepts in particle design and biological barriers for developing the next generation of particles drug delivery systems.
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2013-02-25
...--Implementing the Physician Labeling Rule Content and Format Requirements; Availability AGENCY: Food and Drug...--Implementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological...
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2013-01-01
In late September 2010, Members of the European Parliament (MEPs) issued their verdict on European Commission proposals aimed at lifting the ban on pharmaceutical companies communicating directly with the general public about prescription drugs. The MEPs were able to limit the scope of some of the more harmful aspects of these proposals, in particular by proposing that drug regulatory agencies should pre-screen the "information" produced by drug companies before it is made available to the public. In December 2010, faced with ongoing opposition from European Member States, the Commission appeared to back down, announcing that it was drawing up "amended proposals". They were publicly released in February 2012 but still leave the door open to direct-to-consumer advertising of prescription drugs, particularly "reminder advertising". As of 4 July 2012, the amended proposals had not yet been examined by Member States, thus obstructing the legislative process. Public health and management of the costs of social services for Member States are at stake. The Medicines in Europe Forum (MiEF) and the International Society of Drug Bulletins (ISDB) urge Member States to continue to refuse to examine the Commission's proposals, and have drawn up concrete counterproposals that would enable the general public to obtain relevant health information.
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Funding of Parkinson research from industry and US federal and foundation sources.
Dorsey, E Ray; Thompson, Joel P; Frasier, Mark; Sherer, Todd; Fiske, Brian; Nicholson, Sean; Johnston, S Claiborne; Holloway, Robert G; Moses, Hamilton
2009-04-15
Funding for biomedical and neuroscience research has increased over the last decade but without a concomitant increase in new therapies. This study's objectives were to determine the level and principal sources of recent funding for Parkinson disease (PD) research and to determine the current state of PD drug development. We determined the level and principal sources of recent funding for PD research from the following sources: US federal agencies, large PD foundations based in the United States, and global industry. We assessed the status of PD drug development through the use of a proprietary drug pipeline database. Funding for PD research from the sources examined was approximately $1.1 billion in 2003 and $1.2 billion in 2005. Industry accounted for 77% of support from 2003 to 2005. The number of drugs in development for PD increased from 67 in 2003 to 97 in 2007. Of the companies with at least one compound in development for PD in 2007, most were small (62% had annual revenue of less than $100 million), and most (53%) were based outside the United States. These companies will likely require partnerships to drive successful development of new PD therapies.
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Electrosprayed nanoparticles for drug delivery and pharmaceutical applications
Sridhar, Radhakrishnan; Ramakrishna, Seeram
2013-01-01
Nanotechnology based Pharma has emerged significantly and has influenced the Pharma industry up to a considerable extent. Nanoparticles technology holds a good share of the nanotech Pharma and is significant in comparison with the other domains. Electrospraying technology answers the potential needs of nanoparticle production such as scalability, reproducibility, effective encapsulation etc. Many drugs have been electrosprayed with and without polymer carriers. Drug release characteristics are improved with the incorporation of biodegradable polymer carriers which sustain the release of encapsulated drug. Electrospraying is acknowledged as an important technique for the preparation of nanoparticles with respect to pharmaceutical applications. Herein we attempted to consolidate the reports pertaining to electrospraying and their corresponding therapeutic application area. PMID:23512013
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Drug Discovery in an Academic Setting: Playing to the Strengths
Huryn, Donna M.
2013-01-01
Drug discovery and medicinal chemistry initiatives in academia provide an opportunity to create a unique environment that is distinct from the traditional industrial model. Two characteristics of a university setting that are not usually associated with pharma are the ability to pursue high-risk projects and a depth of expertise, infrastructure, and capabilities in focused areas. Encouraging, supporting, and fostering drug discovery efforts that take advantage of these an...
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High performance in silico virtual drug screening on many-core processors
Price, James; Sessions, Richard B; Ibarra, Amaurys A
2015-01-01
Drug screening is an important part of the drug development pipeline for the pharmaceutical industry. Traditional, lab-based methods are increasingly being augmented with computational methods, ranging from simple molecular similarity searches through more complex pharmacophore matching to more computationally intensive approaches, such as molecular docking. The latter simulates the binding of drug molecules to their targets, typically protein molecules. In this work, we describe BUDE, the Bristol University Docking Engine, which has been ported to the OpenCL industry standard parallel programming language in order to exploit the performance of modern many-core processors. Our highly optimized OpenCL implementation of BUDE sustains 1.43 TFLOP/s on a single Nvidia GTX 680 GPU, or 46% of peak performance. BUDE also exploits OpenCL to deliver effective performance portability across a broad spectrum of different computer architectures from different vendors, including GPUs from Nvidia and AMD, Intel’s Xeon Phi and multi-core CPUs with SIMD instruction sets. PMID:25972727
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High performance in silico virtual drug screening on many-core processors.
McIntosh-Smith, Simon; Price, James; Sessions, Richard B; Ibarra, Amaurys A
2015-05-01
Drug screening is an important part of the drug development pipeline for the pharmaceutical industry. Traditional, lab-based methods are increasingly being augmented with computational methods, ranging from simple molecular similarity searches through more complex pharmacophore matching to more computationally intensive approaches, such as molecular docking. The latter simulates the binding of drug molecules to their targets, typically protein molecules. In this work, we describe BUDE, the Bristol University Docking Engine, which has been ported to the OpenCL industry standard parallel programming language in order to exploit the performance of modern many-core processors. Our highly optimized OpenCL implementation of BUDE sustains 1.43 TFLOP/s on a single Nvidia GTX 680 GPU, or 46% of peak performance. BUDE also exploits OpenCL to deliver effective performance portability across a broad spectrum of different computer architectures from different vendors, including GPUs from Nvidia and AMD, Intel's Xeon Phi and multi-core CPUs with SIMD instruction sets.
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The Critical Role of Organic Chemistry in Drug Discovery.
Rotella, David P
2016-10-19
Small molecules remain the backbone for modern drug discovery. They are conceived and synthesized by medicinal chemists, many of whom were originally trained as organic chemists. Support from government and industry to provide training and personnel for continued development of this critical skill set has been declining for many years. This Viewpoint highlights the value of organic chemistry and organic medicinal chemists in the complex journey of drug discovery as a reminder that basic science support must be restored.
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European healthcare policies for controlling drug expenditure.
Ess, Silvia M; Schneeweiss, Sebastian; Szucs, Thomas D
2003-01-01
In the last 20 years, expenditures on pharmaceuticals - as well as total health expenditures - have grown faster than the gross national product in all European countries. The aim of this paper was to review policies that European governments apply to reduce or at least slow down public expenditure on pharmaceutical products. Such policies can target the industry, the wholesalers and retailers, prescribers, and patients. The objectives of pharmaceutical policies are multidimensional and must take into account issues relating to public health, public expenditure and industrial incentives. Both price levels and consumption patterns determine the level of total drug expenditure in a particular country, and both factors vary greatly across countries. Licensing and pricing policies intend to influence the supply side. Three types of pricing policies can be recognised: product price control, reference pricing and profit control. Profit control is mainly used in the UK. Reference pricing systems were first used in Germany and The Netherlands and are being considered in other countries. Product price control is still the most common method for establishing the price of drugs. For the aim of fiscal consolidation, price-freeze and price-cut measures have been frequently used in the 1980s and 1990s. They have affected all types of schemes. For drug wholesalers and retailers, most governments have defined profit margins. The differences in price levels as well as the introduction of a Single European Pharmaceutical Market has led to the phenomenon of parallel imports among member countries of the European Union. This may be facilitated by larger and more powerful wholesalers and the vertical integration between wholesalers and retailers. To control costs, the use of generic drugs is encouraged in most countries, but only few countries allow pharmacists to substitute generic drugs for proprietary brands. Various interventions are used to reduce the patients' demand for drugs by
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Legal Drugs Are Good Drugs And Illegal Drugs Are Bad Drugs
Directory of Open Access Journals (Sweden)
Dina Indrati
2011-07-01
Full Text Available ABSTRACT : Labelling drugs are important issue nowadays in a modern society. Although it is generally believed that legal drugs are good drugs and illegal drugs are bad drugs, it is evident that some people do not aware about the side effects of drugs used. Therefore, a key contention of this philosophical essay is that explores harms minimisation policy, discuss whether legal drugs are good drugs and illegal drugs are bad drugs and explores relation of drugs misuse in a psychiatric nursing setting and dual diagnosis.Key words: Legal, good drugs, illegal, bad drugs.
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2010-06-22
...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD...-0002, 301- 796-2280; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM- 17), Food...
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Orphan diseases: state of the drug discovery art.
Volmar, Claude-Henry; Wahlestedt, Claes; Brothers, Shaun P
2017-06-01
Since 1983 more than 300 drugs have been developed and approved for orphan diseases. However, considering the development of novel diagnosis tools, the number of rare diseases vastly outpaces therapeutic discovery. Academic centers and nonprofit institutes are now at the forefront of rare disease R&D, partnering with pharmaceutical companies when academic researchers discover novel drugs or targets for specific diseases, thus reducing the failure risk and cost for pharmaceutical companies. Considerable progress has occurred in the art of orphan drug discovery, and a symbiotic relationship now exists between pharmaceutical industry, academia, and philanthropists that provides a useful framework for orphan disease therapeutic discovery. Here, the current state-of-the-art of drug discovery for orphan diseases is reviewed. Current technological approaches and challenges for drug discovery are considered, some of which can present somewhat unique challenges and opportunities in orphan diseases, including the potential for personalized medicine, gene therapy, and phenotypic screening.
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Priority setting for orphan drugs: an international comparison.
Rosenberg-Yunger, Zahava R S; Daar, Abdallah S; Thorsteinsdóttir, Halla; Martin, Douglas K
2011-04-01
To describe the process of priority setting for two orphan drugs - Cerezyme and Fabrazyme - in Canada, Australia and Israel, in order to understand and improve the process based on stakeholder perspectives. We conducted qualitative case studies of how three independent drug advisory committees made decisions relating to the funding of Cerezyme and Fabrazyme. Interviews were conducted with 22 informants, including committee members, patient groups and industry representatives. (1) DESCRIPTION: Orphan drugs reimbursement recommendations by expert panels were based on clinical evidence, cost and cost-effectiveness analysis. (2) EVALUATION: Committee members expressed an overall preference for the current drug review process used by their own committee, but were concerned with the fairness of the process particularly for orphan drugs. Other informants suggested the inclusion of other relevant values (e.g. lack of alternative treatments) in order to improve the priority setting process. Some patient groups suggested the use of an alternative funding mechanism for orphan drugs. Priority setting for drugs is not solely a technical process (involving cost-effective analysis, evidence-based medicine, etc.). Understanding the process by which reimbursement decisions are made for orphan drugs may help improve the system for future orphan drugs. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.
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Cyclodextrins in drug carrier systems.
Uekama, K; Otagiri, M
1987-01-01
One of the important characteristics of cyclodextrins is the formation of an inclusion complex with a variety of drug molecules in solution and in the solid state. As a consequence of intensive basic research, exhaustive toxic studies, and realization of industrial production during the past decade, there seem to be no more barriers for the practical application of natural cyclodextrins in the biomedical field. Recently, a number of cyclodextrin derivatives and cyclodextrin polymers have been prepared to obtain better inclusion abilities than parent cyclodextrins. The natural cyclodextrins and their synthetic derivatives have been successfully utilized to improve various drug properties, such as solubility, dissolution and release rates, stability, or bioavailability. In addition, the enhancement of drug activity, selective transfer, or the reduction of side effects has been achieved by means of inclusion complexation. The drug-cyclodextrin complex is generally formed outside of the body and, after administration, it dissociates, releasing the drug into the organism in a fast and nearly uniform manner. In the biomedical application of cyclodextrins, therefore, particular attention should be directed to the magnitude of the stability constant of the inclusion complex. In the case of parenteral application, a rather limited amount of work has been done because the cyclodextrins in the drug carrier systems have to be more effectively designed to compete with various biological components in the circulatory system. However, the works published thus far apparently indicate that the inclusion phenomena of cyclodextrin analogs may allow the rational design of drug formulation and that the combination of molecular encapsulation with other carrier systems will become a very effective and valuable method for the development of a new drug delivery system in the near future.
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Legal Drugs Are Good Drugs and Illegal Drugs Are Bad Drugs
Indrati, Dina; Prasetyo, Herry
2011-01-01
ABSTRACT : Labelling drugs are important issue nowadays in a modern society. Although it is generally believed that legal drugs are good drugs and illegal drugs are bad drugs, it is evident that some people do not aware about the side effects of drugs used. Therefore, a key contention of this philosophical essay is that explores harms minimisation policy, discuss whether legal drugs are good drugs and illegal drugs are bad drugs and explores relation of drugs misuse in a psychiatric nursing s...
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A European Competence Framework for Industrial Pharmacy Practice in Biotechnology
Directory of Open Access Journals (Sweden)
Jeffrey Atkinson
2015-07-01
Full Text Available The PHAR-IN (“Competences for industrial pharmacy practice in biotechnology” looked at whether there is a difference in how industrial employees and academics rank competences for practice in the biotechnological industry. A small expert panel consisting of the authors of this paper produced a biotechnology competence framework by drawing up an initial list of competences then ranking them in importance using a three-stage Delphi process. The framework was next evaluated and validated by a large expert panel of academics (n = 37 and industrial employees (n = 154. Results show that priorities for industrial employees and academics were similar. The competences for biotechnology practice that received the highest scores were mainly in: “Research and Development”, ‘“Upstream” and “Downstream” Processing’, “Product development and formulation”, “Aseptic processing”, “Analytical methodology”, “Product stability”, and “Regulation”. The main area of disagreement was in the category “Ethics and drug safety” where academics ranked competences higher than did industrial employees.
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Problems with drugs in Croatia.
Vrhovac, B
1997-01-01
Croatia has 4.8 million inhabitants, 11,800 physicians, 2000 pharmacists, two now shareholding, pharmaceutical companies (about 6500 employees, total sales of about 350 million US dollars). There are a number of problems due to the war (GNP fell from 3800 to about 1500 US dollars), occupation of 25% of its territory, 0.5 million refugees and lack of resources (139 US dollars/capita for health, about 40 US dollars i.e. 30%!! for drugs)--about three times less than before the aggression. The drug situation is controlled with the help of: (1) donations (approximate value of 600 million US dollars since 1991 from Europe and US), (2) (essential) drug formularies--250 for outpatients, and 580 generic names for various levels of hospital use, (3) special efforts to purchase drugs of good quality at a reasonable price (a kind of tender), (4) control of prescribing (prescriptions, specialists referral) especially by GPs. A new Medicines Act is in preparation and about 1000 generic names are on the market. DRUG EDUCATION: Pharmaca: the Croatian journal of pharmacotherapy has been published since 1962, there are several Drug bulletins (one published since 1975); special chapters on clinical pharmacology in textbooks, translation of three editions of Laurence's textbook with special commentary and adaptation to local needs; ADR spontaneous and intensive monitoring (WHO programme) with a personal feedback to the reporters and regular articles on drug use in a number of periodicals. Data on drug consumption indicates that there is room for improvement of prescribing. There is an enthusiasm for 'vasoactive drugs'--after dipirydamole came oxpentifylline and antimicrobials are always overprescribed. All these problems will hopefully decrease when the war finally stops and when industry (especially tourism) starts being fruitful again. In any case the importance of teaching of pharmacotherapy at the under- and postgraduate level should be recognized. Copyright 1997 by John Wiley
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BPS Pharmacology 2014 - Drug Discovery Pathways symposium Report
Marsh, Andrew
2015-01-01
Report on BPS Pharmacology 2014, BPS Industry Committe and Learned Societies Drug Discovery Pathways Group symposium: "Realizing the potential of new approaches to target identification and validation" by Dr Andrew Marsh Associate Professor Department of Chemistry University of Warwick go.warwick.ac.uk/marshgroup Twitter @marshgroup
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Can open-source R&D reinvigorate drug research?
Munos, Bernard
2006-09-01
The low number of novel therapeutics approved by the US FDA in recent years continues to cause great concern about productivity and declining innovation. Can open-source drug research and development, using principles pioneered by the highly successful open-source software movement, help revive the industry?
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2013-12-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0928] Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive... for industry (GFI 221) entitled ``Recommendations for Preparation and Submission of Animal Food...
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Yeh, James S; Franklin, Jessica M; Avorn, Jerry; Landon, Joan; Kesselheim, Aaron S
2016-06-01
Pharmaceutical industry payments to physicians may affect prescribing practices and increase costs if more expensive medications are prescribed. Determine the association between industry payments to physicians and the prescribing of brand-name as compared with generic statins for lowering cholesterol. Cross-sectional linkage of the Part D Medicare prescriptions claims data with the Massachusetts physicians payment database including all licensed Massachusetts physicians who wrote prescriptions for statins paid for under the Medicare drug benefit in 2011. The exposure variable was a physician's industry payments as listed in the Massachusetts database. The outcome was the physician's rate of prescribing brand-name statins. We used linear regression to analyze the association between the intensity of physicians' industry relationships (as measured by total payments) and their prescribing practices, as well as the effects of specific types of payments. Among the 2444 Massachusetts physicians in the Medicare prescribing database in 2011, 899 (36.8%) received industry payments. The most frequent payment was for company-sponsored meals (n = 639 [71.1%]). Statins accounted for 1 559 003 prescription claims; 356 807 (22.8%) were for brand-name drugs. For physicians with no industry payments listed, the median brand-name statin prescribing rate was 17.8% (95% CI, 17.2%-18.4%). For every $1000 in total payments received, the brand-name statin prescribing rate increased by 0.1% (95% CI, 0.06%-0.13%; P associated with a 4.8% increase in the rate of brand-name prescribing (P = .004); other forms of payments were not. Industry payments to physicians are associated with higher rates of prescribing brand-name statins. As the United States seeks to rein in the costs of prescription drugs and make them less expensive for patients, our findings are concerning.
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Fugh-Berman, Adriane; Brown, Steven R; Trippett, Rachel; Bell, Alicia M; Clark, Paige; Fleg, Anthony; Siwek, Jay
2011-05-01
To assess the extent and type of interactions U.S. family medicine residencies permit industry to have with medical students and residents. In 2008, the authors e-mailed a four-question survey to residency directors or coordinators at all 460 accredited U.S. family medicine residencies concerning the types of industry support and interaction permitted. The authors conducted quantitative and qualitative analyses of survey responses and written comments. Residencies that did not permit any industry food, gifts, samples, or support of residency activities were designated "pharma-free." The survey response rate was 62.2% (286/460). Among responding family medicine residencies, 52.1% refused drug samples, 48.6% disallowed industry gifts or food, 68.5% forbade industry-sponsored residency activities, and 44.1% denied industry access to students and residents at the family medicine center. Seventy-five residencies (26.2%) were designated as "pharma-free." Medical-school-based and medical-school-administered residencies were no more likely than community-based residencies to be pharma-free. Among the 211 programs that permitted interaction, 68.7% allowed gifts or food, 61.1% accepted drug samples, 71.1% allowed industry representatives access to trainees in the family medicine center, and 37.9% allowed industry-sponsored residency activities. Respondents commented on challenges inherent to limiting industry interactions. Many programs noted recent changes in plans or practices. Most family medicine residencies limit industry interaction with trainees. Because industry interactions can have adverse effects on rational prescribing, residency programs should assess the benefits and harms of these relationships. Copyright © by the Association of American medical Colleges.
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Staud, Frantisek; Cerveny, Lukas; Ceckova, Martina
2012-11-01
Pharmacotherapy during pregnancy is often inevitable for medical treatment of the mother, the fetus or both. The knowledge of drug transport across placenta is, therefore, an important topic to bear in mind when deciding treatment in pregnant women. Several drug transporters of the ABC and SLC families have been discovered in the placenta, such as P-glycoprotein, breast cancer resistance protein, or organic anion/cation transporters. It is thus evident that the passage of drugs across the placenta can no longer be predicted simply on the basis of their physical-chemical properties. Functional expression of placental drug transporters in the trophoblast and the possibility of drug-drug interactions must be considered to optimize pharmacotherapy during pregnancy. In this review we summarize current knowledge on the expression and function of ABC and SLC transporters in the trophoblast. Furthermore, we put this data into context with medical conditions that require maternal and/or fetal treatment during pregnancy, such as gestational diabetes, HIV infection, fetal arrhythmias and epilepsy. Proper understanding of the role of placental transporters should be of great interest not only to clinicians but also to pharmaceutical industry for future drug design and development to control the degree of fetal exposure.
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Web-based drug repurposing tools: a survey.
Sam, Elizabeth; Athri, Prashanth
2017-10-06
Drug repurposing (a.k.a. drug repositioning) is the search for new indications or molecular targets distinct from a drug's putative activity, pharmacological effect or binding specificities. With the ever-increasing rates of termination of drugs in clinical trials, drug repositioning has risen as one of the effective solutions against the risk of drug failures. Repositioning finds a way to reverse the grim but real trend that Eroom's law portends for the pharmaceutical and biotech industry, and drug discovery in general. Further, the advent of high-throughput technologies to explore biological systems has enabled the generation of zeta bytes of data and a massive collection of databases that store them. Computational analytics and mining are frequently used as effective tools to explore this byzantine series of biological and biomedical data. However, advanced computational tools are often difficult to understand or use, thereby limiting their accessibility to scientists without a strong computational background. Hence it is of great importance to build user-friendly interfaces to extend the user-base beyond computational scientists, to include life scientists who may have deeper chemical and biological insights. This survey is focused on systematically presenting the available Web-based tools that aid in repositioning drugs. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
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Open-access public-private partnerships to enable drug discovery--new approaches.
Müller, Susanne; Weigelt, Johan
2010-03-01
The productivity of the pharmaceutical industry, as assessed by the number of NMEs produced per US dollar spent in R&D, has been in steady decline during the past 40 years. This decline in productivity not only poses a significant challenge to the pharmaceutical industry, but also to society because of the importance of developing drugs for the treatment of unmet medical needs. The major challenge in progressing a new drug to the market is the successful completion of clinical trials. However, the failure rate of drugs entering trials has not decreased, despite various technological and scientific breakthroughs in recent decades, and despite intense target validation efforts. This lack of success suggests limitations in the fundamental understanding of target biology and human pharmacology. One contributing factor may be the traditional secrecy of the pharmaceutical sector, a characteristic that does not promote scientific discovery in an optimal manner. Access to broader knowledge relating to target biology and human pharmacology is difficult to obtain because interactions between researchers in industry and academia are typically restricted to closed collaborations in which the knowledge gained is confidential.However, open-access collaborative partnerships are gaining momentum in industry, and are also favored by funding agencies. Such open-access collaborations may be a powerful alternative to closed collaborations; the sharing of early-stage research data is expected to enable scientific discovery by engaging a broader section of the scientific community in the exploration of new findings. Potentially, the sharing of data could contribute to an increased understanding of biological processes and a decrease in the attrition of clinical programs.
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2010-05-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0236] Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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[Drugs in the European Union: the health-market complex].
Antoñanzas, Fernando; Rodríguez, Roberto; Sacristán, José Antonio; Illa, Rafael
2005-01-01
To characterize the peculiar economic nature of the pharmaceutical market in the EU, to study potential groupings of countries based on several pharmaceutical variables, to analyze some recent regulations designed to create the single market, and to present some thoughts on the decision making process in public health from the perspective of current public health budgets. We performed an economic analysis of health and pharmaceutical macrovariables, cluster analysis, review of EU pharmaceutical and industrial regulations and review of pharmaceutical budgeting legislation in the member states. The pharmaceutical market of the EU was characterized and EU countries were classified into two principal groups according to 5 selected variables. EU regulations tend to promote R + D and drug production and thus the EU industrial sector is backed up. National regulations differ in terms of pricing and drugs reimbursement. The creation of a single market for drugs in the EU should take this regulatory diversity into account and seek equilibrium between economic factors and public health. This single market may be a dangerous strategy if it becomes a general dogma and even more so if deadlines are fixed and short.
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How can attrition rates be reduced in cancer drug discovery?
Moreno, Lucas; Pearson, Andrew D J
2013-04-01
Attrition is a major issue in anticancer drug development with up to 95% of drugs tested in Phase I trials not reaching a marketing authorisation making the drug development process enormously costly and inefficient. It is essential that this problem is addressed throughout the whole drug development process to improve efficiency which will ultimately result in increased patient benefit with more profitable drugs. The approach to reduce cancer drug attrition rates must be based on three pillars. The first of these is that there is a need for new pre-clinical models which can act as better predictors of success in clinical trials. Furthermore, clinical trials driven by tumour biology with the incorporation of predictive and pharmacodynamic biomarkers would be beneficial in drug development. Finally, there is a need for increased collaboration to combine the unique strengths between industry, academia and regulators to ensure that the needs of all stakeholders are met.
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Ask the experts: the challenges and benefits of flow chemistry to optimize drug development.
Anderson, Neal; Gernaey, Krist V; Jamison, Timothy F; Kircher, Manfred; Wiles, Charlotte; Leadbeater, Nicholas E; Sandford, Graham; Richardson, Paul
2012-09-01
Against a backdrop of a struggling economic and regulatory climate, pharmaceutical companies have recently been forced to develop new ways to provide more efficient technology to meet the demands of a competitive drug industry. This issue, coupled with an increase in patent legislation and a rising generics market, makes these themes common issues in the growth of drug development. As a consequence, the importance of process chemistry and scale-up has never been more under the spotlight. Future Medicinal Chemistry wishes to share the thoughts and opinions of a variety of experts from this field, discussing issues concerning the use of flow chemistry to optimize drug development, the potential regulatory and environmental challenges faced with this, and whether the academic and industrial sectors could benefit from a more harmonized system relevant to process chemistry.
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From Drug Safety to Drug Security: A Contemporary Shift in the Policing of Health.
Hornberger, Julia
2018-01-29
The counterfeiting of medication is increasingly seen as a major threat to health, especially in the light of both the everyday reliance on and a broadening of world-wide access to pharmaceuticals. Exaggerated or real, this threat has inaugurated, this article argues, a shift from a drug safety regime to a drug security regime that governs the flow of pharmaceuticals and brings together markets, police, and health actors in new ways. This entails a shift from soft disciplinary means aimed at incremental and continued inclusion of defaulters, to one of drastically sovereign measures of exclusion and banishment aimed at fake goods and the people associated with them, in the name of health. Through a multi-sited ethnographic study, this article shows how such new drug security efforts play themselves out especially in (South) Africa, highlighting a modus operandi of spectacular performativity and of working through suspicion and association rather than factuality, producing value less so for those in need of health than for a petty security industry itself. © 2018 by the American Anthropological Association.
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How to revive breakthrough innovation in the pharmaceutical industry.
Munos, Bernard H; Chin, William W
2011-06-29
Over the past 20 years, pharmaceutical companies have implemented conservative management practices to improve the predictability of therapeutics discovery and success rates of drug candidates. This approach has often yielded compounds that are only marginally better than existing therapies, yet require larger, longer, and more complex trials. To fund them, companies have shifted resources away from drug discovery to late clinical development; this has hurt innovation and amplified the crisis brought by the expiration of patents on many best-selling drugs. Here, we argue that more breakthrough therapeutics will reach patients only if the industry ceases to pursue "safe" incremental innovation, re-engages in high-risk discovery research, and adopts collaborative innovation models that allow sharing of knowledge and costs among collaborators.
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An industry update: the latest developments in Therapeutic delivery.
Steinbach, Oliver C
2018-05-01
The present industry update covers the period of 1 January-31 January 2018, with information sourced from company press releases, regulatory and patent agencies as well as scientific literature. Several public offerings (Gecko, Insmed), licensing (Foresee) and commercialization agreements (Alnylam, Collegium Pharmaceutical) as well as patent filings (Elute) continue to prove the sustained investments in the drug delivery market. In increasing numbers, more effective ways to deliver the active ingredient to the right location and the right dose through devices (Boehringer Ingelheim's Respimat, Medtronics' SynchroMedII) or improved compound properties through formulation (Aquestive Therapeutics' PharmFilm, Noven Pharmaceuticals' transdermal patch) are reaching the market. Furthering biologics and gene delivery (Avacta, Bracco) proves that novel drug delivery technologies are successfully addressing more challenging drug formats.
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2013-09-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 501 [Docket No. FDA-2013-D-1088] Guidance for Industry 223: Small Entity Compliance Guide--Declaring Color Additives... industry 223 entitled ``Small Entity Compliance Guide--Declaring Color Additives in Animal Foods.'' This...
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2013-09-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0928] Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive... guidance for industry (GFI 221) entitled ``Recommendations for Preparation and Submission of Animal Food...
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2013-11-20
...] Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and... entitled ``Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.'' When... promotional labeling and advertising for prescription human drugs, including biological drug products, and...
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Cunha-Filho, Marcilio; Araújo, Maísa Rp; Gelfuso, Guilherme M; Gratieri, Tais
2017-11-01
The production process of 3D-printed drugs offers unique advantages such as the possibility of individualizing the drug therapy and easily associating different drugs and release technologies in the same pharmaceutical unit. Fused deposition modeling, a 3D printing technique, seems especially interesting for pharmaceutical applications, due to its low cost, precise and reproducible control of the printed structures, and versatility for industrial and laboratory scale. This technique combined with another technology already adapted for the pharmaceutical industry, the hot melt extrusion, is able to incorporate various mechanisms of modified drug release. This special report aims to bring together data of the experimental progress achieved using the fused deposition modeling 3D printing combined with hot melt extrusion technique and its potential in drug delivery. [Formula: see text].
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iADRs: towards online adverse drug reaction analysis.
Lin, Wen-Yang; Li, He-Yi; Du, Jhih-Wei; Feng, Wen-Yu; Lo, Chiao-Feng; Soo, Von-Wun
2012-12-01
Adverse Drug Reaction (ADR) is one of the most important issues in the assessment of drug safety. In fact, many adverse drug reactions are not discovered during limited pre-marketing clinical trials; instead, they are only observed after long term post-marketing surveillance of drug usage. In light of this, the detection of adverse drug reactions, as early as possible, is an important topic of research for the pharmaceutical industry. Recently, large numbers of adverse events and the development of data mining technology have motivated the development of statistical and data mining methods for the detection of ADRs. These stand-alone methods, with no integration into knowledge discovery systems, are tedious and inconvenient for users and the processes for exploration are time-consuming. This paper proposes an interactive system platform for the detection of ADRs. By integrating an ADR data warehouse and innovative data mining techniques, the proposed system not only supports OLAP style multidimensional analysis of ADRs, but also allows the interactive discovery of associations between drugs and symptoms, called a drug-ADR association rule, which can be further developed using other factors of interest to the user, such as demographic information. The experiments indicate that interesting and valuable drug-ADR association rules can be efficiently mined.
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Nasal-to-CNS drug delivery: where are we now and where are we heading? An industrial perspective.
Landis, Margaret S; Boyden, Tracey; Pegg, Simon
2012-02-01
Delivery of drug therapeutics across the blood-brain barrier is a challenging task for pharmaceutical scientists. Nasal-to-CNS drug delivery has shown promising results in preclinical efficacy models and investigatory human clinical trials. The further development of this technology with respect to the establishment of valid, predictable preclinical species models, translatable pharmacokinetic-pharmacodynamic relationships and definition of toxicology impact will help attract additional pharmaceutical investment in this drug-delivery approach. Further discoveries in nasal nanotechnology, targeted delivery devices and diagnostic olfactory imaging will serve to fuel the advancements in this area of drug delivery.
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Carbon Nanotubes in Drug and Gene Delivery
Karimi, Mahdi; Ghasemi, Amir; Mirkiani, Soroush; Moosavi Basri, Seyed Masoud; Hamblin, Michael R.
2017-10-01
Recent important discoveries and developments in nanotechnology have had a remarkable and ever-increasing impact on many industries, especially materials science, pharmaceuticals, and biotechnology. Within this book, the authors describe different features of carbon nanotubes, survey the properties of both the multi-walled and single-walled varieties, and cover their applications in drug and gene delivery.
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Zetterqvist, Anna V.; Merlo, Juan; Mulinari, Shai
2015-01-01
companies were in serious violation more than ten times each. A qualitative content analysis of serious violations pertaining to diabetes drugs (UK, n = 15; Sweden, n = 6; 10% of serious violations) and urologics (UK, n = 6; Sweden, n = 13; 9%) revealed various types of violations: misleading claims (n = 23; 58%); failure to comply with undertakings (n = 9; 23%); pre-licensing (n = 7; 18%) or off-label promotion (n = 2; 5%); and promotion of prescription drugs to the public (n = 6; 15%). Violations that go undetected or unpunished by self-regulatory bodies are the main limitation of this study, since they are likely to lead to an underestimate of industry misconduct. Conclusions The prevalence and severity of breaches testifies to a discrepancy between the ethical standard codified in industry Codes of Conduct and the actual conduct of the industry. We discuss regulatory reforms that may improve the quality of medicines information, such as pre-vetting and intensified active monitoring of promotion, along with larger fines, and giving greater publicity to rulings. But despite the importance of improving regulatory arrangements in an attempt to ensure unbiased medicines information, such efforts alone are insufficient because simply improving oversight and increasing penalties fail to address additional layers of industry bias. PMID:25689460
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Challenges and perspective of drug repurposing strategies in early phase clinical trials.
Kato, Shumei; Moulder, Stacy L; Ueno, Naoto T; Wheler, Jennifer J; Meric-Bernstam, Funda; Kurzrock, Razelle; Janku, Filip
2015-01-01
Despite significant investments in the development of new agents only 5% of cancer drugs entering Phase I clinical trials are ultimately approved for routine clinical cancer care. Drug repurposing strategies using novel combinations of previously tested anticancer agents could reduce the cost and improve treatment outcomes. At MD Anderson Cancer Center, early phase clinical trials with drug repurposing strategies demonstrated promising outcomes in patients with both rare and common treatment refractory advanced cancers. Despite clinical efficacy advancing drug repurposing strategies in the clinical trial trajectory beyond early phase studies has been challenging mainly due to lack of funding and interest from the pharmaceutical industry. In this review, we delineate our experience and challenges with drug repurposing strategies.
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On mechanisms of reactive metabolite formation from drugs.
Claesson, Alf; Spjuth, Ola
2013-04-01
Idiosyncratic adverse drug reactions (IADRs) cause a broad range of clinically severe conditions of which drug induced liver injury (DILI) in particular is one of the most frequent causes of safety-related drug withdrawals. The underlying cause is almost invariably formation of reactive metabolites (RM) which by attacking macromolecules induc eorgan injuries. Attempts are being made in the pharmaceutical industry to lower the risk of selecting unfit compounds as clinical candidates. Approaches vary but do not seem to be overly successful at the initial design/synthesis stage. We review here the most frequent categories of mechanisms for RM formation and propose that many cases of RMs encountered within early ADME screening can be foreseen by applying chemical and metabolic knowledge. We also mention a web tool, SpotRM, which can be used for efficient look-up and learning about drugs that have recognized IADRs likely caused by RM formation.
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Reporting of conflicts of interest from drug trials in Cochrane reviews: cross sectional study.
Roseman, Michelle; Turner, Erick H; Lexchin, Joel; Coyne, James C; Bero, Lisa A; Thombs, Brett D
2012-08-16
To investigate the degree to which Cochrane reviews of drug interventions published in 2010 reported conflicts of interest from included trials and, among reviews that reported this information, where it was located in the review documents. Cross sectional study. Cochrane Database of Systematic Reviews. Systematic reviews of drug interventions published in 2010 in the Cochrane Database of Systematic Reviews, with review content classified as up to date in 2008 or later and with results from one or more randomised controlled trials. Of 151 included Cochrane reviews, 46 (30%, 95% confidence interval 24% to 38%) reported information on the funding sources of included trials, including 30 (20%, 14% to 27%) that reported information on trial funding for all included trials and 16 (11%, 7% to 17%) that reported for some, but not all, trials. Only 16 of the 151 Cochrane reviews (11%, 7% to 17%) provided any information on trial author-industry financial ties or trial author-industry employment. Information on trial funding and trial author-industry ties was reported in one to seven locations within each review, with no consistent reporting location observed. Most Cochrane reviews of drug trials published in 2010 did not provide information on trial funding sources or trial author-industry financial ties or employment. When this information was reported, location of reporting was inconsistent across reviews.
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[Risk behaviour in association with addictive drugs - data and insights on treatment].
Böning, J
2004-02-01
About one third of the economical costs, which are due to death, sickness and life quality deficits in higher developed industrial countries, are caused by pollutants such as nicotine, alcohol and false eating habits. Within a period of one year 183,000 people in Germany die on tobacco associated sickness effects, 73,000 on direct or indirect aftermath of alcohol usage and a proportional amount of mostly adipoptic people on the hereoff resulting sickness effects. These risk trias, decided by every person mainly for himself by his own behaviour or mis-behaviour, are even aggravated by the free enterprise sanctioned drug politics of the highly profitable mega markets of the tobacco-, alcohol- and fast-food-industry. Health orientated drug politic, which is based on independence and solidarity and an exhaustive primary prevention within the scope of early nationalization authorities can therefore only have a limited effect. Even though, standardized, therapeutic short interventions used by hazardous alcohol- and drug usage, the qualified detoxification on addiction illness and an way to little used meanwhile time- and cost optimized withdrawal treatment have been proven to be quite effective. Exhaustive established ambulant smoking-withdrawal treatment programs are of special importance, because with continuously sinking of first contact, nicotine is know to be the "gate way drug" with the strongest addiction potential among all legalized and non-legalized drugs. In canon of mean while worldwide (except for Germany) started drug-control politics one will be able to start a health orientated drug politic in the future, which is including especially the drug economic aspects for the benefit of all as well as for the national budgets.
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Recent advances and versatility of MAGE towards industrial applications.
Singh, Vijai; Braddick, Darren
2015-12-01
The genome engineering toolkit has expanded significantly in recent years, allowing us to study the functions of genes in cellular networks and assist in over-production of proteins, drugs, chemicals and biofuels. Multiplex automated genome engineering (MAGE) has been recently developed and gained more scientific interest towards strain engineering. MAGE is a simple, rapid and efficient tool for manipulating genes simultaneously in multiple loci, assigning genetic codes and integrating non-natural amino acids. MAGE can be further expanded towards the engineering of fast, robust and over-producing strains for chemicals, drugs and biofuels at industrial scales.
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Physician access to drug profiles to reduce adverse reactions
Yasnoff, William A.; Tomkins, Edward L.; Dunn, Louise M.
1995-10-01
Adverse drug reactions (ADRs) are a major source of preventable morbidity and mortality, especially among the elderly, who use more drugs and are more sensitive to them. The insurance industry has recently addressed this problem through the implementation of drug interaction alerts to pharmacists in conjunction with immediate online claims adjudication for almost 60% of prescriptions (expected to reach 90% within 5 years). These alerts are based on stored patient drug profiles maintained by pharmacy benefit managers (PBMs) which are updated whenever prescriptions are filled. While these alerts are very helpful, the pharmacist does not prescribe, resulting in time-consuming and costly delays to contact the physician and remedy potential interactions. We have developed and demonstrated the feasibility of the PINPOINT (Pharmaceutical Information Network for prevention of interactions) system for making the drug profile and interaction information easily available to the physician before the prescription is written. We plan to test the cost-effectiveness of the system in a prospective controlled clinical trial.
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In silico pharmacology for a multidisciplinary drug discovery process.
Ortega, Santiago Schiaffino; Cara, Luisa Carlota López; Salvador, María Kimatrai
2012-01-01
The process of bringing new and innovative drugs, from conception and synthesis through to approval on the market can take the pharmaceutical industry 8-15 years and cost approximately $1.8 billion. Two key technologies are improving the hit-to-drug timeline: high-throughput screening (HTS) and rational drug design. In the latter case, starting from some known ligand-based or target-based information, a lead structure will be rationally designed to be tested in vitro or in vivo. Computational methods are part of many drug discovery programs, including the assessment of ADME (absorption-distribution-metabolism-excretion) and toxicity (ADMET) properties of compounds at the early stages of discovery/development with impressive results. The aim of this paper is to review, in a simple way, some of the most popular strategies used by modelers and some successful applications on computational chemistry to raise awareness of its importance and potential for an actual multidisciplinary drug discovery process.
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2012-08-27
... generic drugs program. GDUFA will also significantly improve global supply chain transparency by requiring... promote global supply chain transparency. The information provided through self-identification will enable... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD...
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RFID in the pharmaceutical industry: addressing counterfeits with technology.
Taylor, Douglas
2014-11-01
The use of Radio Frequency Identification (RFID) in the pharmaceutical industry has grown in recent years. The technology has matured from its specialized tracking and retail uses to a systemic part of supply chain management in international pharmaceutical production and distribution. Counterfeit drugs, however, remain a significant challenge for governments, pharmaceutical companies, clinicians, and patients and the use of RFID to track these compounds represents an opportunity for development. This paper discusses the medical, technological, and economic factors that support widespread adoption of RFID technology in the pharmaceutical industry in an effort to prevent counterfeit medicines from harming patients and brand equity.
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Can biochemistry drive drug discovery beyond simple potency measurements?
Chène, Patrick
2012-04-01
Among the fields of expertise required to develop drugs successfully, biochemistry holds a key position in drug discovery at the interface between chemistry, structural biology and cell biology. However, taking the example of protein kinases, it appears that biochemical assays are mostly used in the pharmaceutical industry to measure compound potency and/or selectivity. This limited use of biochemistry is surprising, given that detailed biochemical analyses are commonly used in academia to unravel molecular recognition processes. In this article, I show that biochemistry can provide invaluable information on the dynamics and energetics of compound-target interactions that cannot be obtained on the basis of potency measurements and structural data. Therefore, an extensive use of biochemistry in drug discovery could facilitate the identification and/or development of new drugs. Copyright © 2012 Elsevier Ltd. All rights reserved.
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2010-05-25
...] Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry 188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for...
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The development of China's medical biotech industry needs to be driven by innovation.
Yu, Zailin; Dai, Yuehan
2006-11-01
The Chinese biotech industry is going through a period of fast growth, and with its huge population, China is predicted to be the biggest single-country market in the world. However, the Chinese biotech industry has to tackle the critical issue of innovation, which should be the driving force for China's development into an advanced and responsible country. Here, in this article, the authors review the history of the Chinese biotech industry, exemplified by the development of genetically engineered drugs during the last 20 years, and also point out its the future.
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Pricing of drugs with heterogeneous health insurance coverage.
Ferrara, Ida; Missios, Paul
2012-03-01
In this paper, we examine the role of insurance coverage in explaining the generic competition paradox in a two-stage game involving a single producer of brand-name drugs and n quantity-competing producers of generic drugs. Independently of brand loyalty, which some studies rely upon to explain the paradox, we show that heterogeneity in insurance coverage may result in higher prices of brand-name drugs following generic entry. With market segmentation based on insurance coverage present in both the pre- and post-entry stages, the paradox can arise when the two types of drugs are highly substitutable and the market is quite profitable but does not have to arise when the two types of drugs are highly differentiated. However, with market segmentation occurring only after generic entry, the paradox can arise when the two types of drugs are weakly substitutable, provided, however, that the industry is not very profitable. In both cases, that is, when market segmentation is present in the pre-entry stage and when it is not, the paradox becomes more likely to arise as the market expands and/or insurance companies decrease deductibles applied on the purchase of generic drugs. Copyright © 2012 Elsevier B.V. All rights reserved.
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Preparative Scale Resolution of Enantiomers Enables Accelerated Drug Discovery and Development
Directory of Open Access Journals (Sweden)
Hanna Leek
2017-01-01
Full Text Available The provision of pure enantiomers is of increasing importance not only for the pharmaceutical industry but also for agro-chemistry and biotechnology. In drug discovery and development, the enantiomers of a chiral drug depict unique chemical and pharmacological behaviors in a chiral environment, such as the human body, in which the stereochemistry of the chiral drugs determines their pharmacokinetic, pharmacodynamic and toxicological properties. We present a number of challenging case studies of up-to-kilogram separations of racemic or enriched isomer mixtures using preparative liquid chromatography and super critical fluid chromatography to generate individual enantiomers that have enabled the development of new candidate drugs within AstraZeneca. The combination of chromatography and racemization as well as strategies on when to apply preparative chiral chromatography of enantiomers in a multi-step synthesis of a drug compound can further facilitate accelerated drug discovery and the early clinical evaluation of the drug candidates.
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Four disruptive strategies for removing drug discovery bottlenecks.
Ekins, Sean; Waller, Chris L; Bradley, Mary P; Clark, Alex M; Williams, Antony J
2013-03-01
Drug discovery is shifting focus from industry to outside partners and, in the process, creating new bottlenecks. Technologies like high throughput screening (HTS) have moved to a larger number of academic and institutional laboratories in the USA, with little coordination or consideration of the outputs and creating a translational gap. Although there have been collaborative public-private partnerships in Europe to share pharmaceutical data, the USA has seemingly lagged behind and this may hold it back. Sharing precompetitive data and models may accelerate discovery across the board, while finding the best collaborators, mining social media and mobile approaches to open drug discovery should be evaluated in our efforts to remove drug discovery bottlenecks. We describe four strategies to rectify the current unsustainable situation. Copyright © 2012 Elsevier Ltd. All rights reserved.
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Near-infrared imaging spectroscopy for counterfeit drug detection
Arnold, Thomas; De Biasio, Martin; Leitner, Raimund
2011-06-01
Pharmaceutical counterfeiting is a significant issue in the healthcare community as well as for the pharmaceutical industry worldwide. The use of counterfeit medicines can result in treatment failure or even death. A rapid screening technique such as near infrared (NIR) spectroscopy could aid in the search for and identification of counterfeit drugs. This work presents a comparison of two laboratory NIR imaging systems and the chemometric analysis of the acquired spectroscopic image data. The first imaging system utilizes a NIR liquid crystal tuneable filter and is designed for the investigation of stationary objects. The second imaging system utilizes a NIR imaging spectrograph and is designed for the fast analysis of moving objects on a conveyor belt. Several drugs in form of tablets and capsules were analyzed. Spectral unmixing techniques were applied to the mixed reflectance spectra to identify constituent parts of the investigated drugs. The results show that NIR spectroscopic imaging can be used for contact-less detection and identification of a variety of counterfeit drugs.
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[A fine line between legal and illegal oral drug repackaging].
Casanova, Heberto Arboleya; Sánchez, Héctor Marino Zavala; Fernández, Angélica María Hernández; Herrera, Dulce Janeth González
2016-06-01
In 2009, with the implementation of the National Hospital Pharmacy Model, Mexico began regulating single-dose drugs. The repackaging of oral drugs is fundamental and critical and should be standardized by Mexican health legislation to enable quality drugs to be dispensed. Data is required on stability, compatibility, drug interactions, containers, and repackaging methods, in order to establish a new expiration date. The literature on health regulations applicable to repackaging was analyzed, revealing major conceptual imprecisions since there is no legislation in Mexico that regulates repackaging; rather, everything is carried out according to pharmacists' recommendations and criteria. The conclusion is that the regulations need to be rewritten to establish minimum single-dose oral drug criteria for dispensing hospitals-regulations that cover infrastructure, equipment, and professionals complying with good practices in oral drug repackaging. A proposal is offered to implement an official Mexican standard that regulates single-dose repackaging and unifies concepts, criteria, and means of verification, while the pharmaceutical industry would be responsible for the technology and resources for single-dose drug packaging designed for the health sector.
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Synthetic biology for pharmaceutical drug discovery
Directory of Open Access Journals (Sweden)
Trosset JY
2015-12-01
Full Text Available Jean-Yves Trosset,1 Pablo Carbonell2,3 1Bioinformation Research Laboratory, Sup’Biotech, Villejuif, France; 2Faculty of Life Sciences, SYNBIOCHEM Centre, Manchester Institute of Biotechnology, University of Manchester, Manchester, UK; 3Department of Experimental and Health Sciences (DCEXS, Research Programme on Biomedical Informatics (GRIB, Hospital del Mar Medical Research Institute (IMIM, Universitat Pompeu Fabra (UPF, Barcelona, Spain Abstract: Synthetic biology (SB is an emerging discipline, which is slowly reorienting the field of drug discovery. For thousands of years, living organisms such as plants were the major source of human medicines. The difficulty in resynthesizing natural products, however, often turned pharmaceutical industries away from this rich source for human medicine. More recently, progress on transformation through genetic manipulation of biosynthetic units in microorganisms has opened the possibility of in-depth exploration of the large chemical space of natural products derivatives. Success of SB in drug synthesis culminated with the bioproduction of artemisinin by microorganisms, a tour de force in protein and metabolic engineering. Today, synthetic cells are not only used as biofactories but also used as cell-based screening platforms for both target-based and phenotypic-based approaches. Engineered genetic circuits in synthetic cells are also used to decipher disease mechanisms or drug mechanism of actions and to study cell–cell communication within bacteria consortia. This review presents latest developments of SB in the field of drug discovery, including some challenging issues such as drug resistance and drug toxicity. Keywords: metabolic engineering, plant synthetic biology, natural products, synthetic quorum sensing, drug resistance
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The chemical industry - friend to the environment?
International Nuclear Information System (INIS)
1992-01-01
''The Chemical Industry - Friend to the Environment?'' was a symposium organised by the North East Region committee of the Industrial Division of the Royal Society of Chemistry. This volume contains typescripts from all the lectures given at the symposium. The general public appreciate the material comforts the Chemical Industry provides, for example textiles, ceramics, steel, speciality chemicals, drugs, prosthetics etc. However, for many their comfort is spoiled by the chemical poisoning of the environment through slag heaps, beaches and countryside littered with non-biodegradable unsightly plastic containers, poor air quality through NO x , CO 2 and chlorofluorocarbon emissions, and of course, nuclear waste. The occasional spillage of hazardous chemicals through road, rail and sea accidents do nothing to improve the Industry's image. The majority of these topics were discussed, though no one presumed to know how to remove the problems entirely but many suggestions were put forward as to how this might be achieved. Of the 13 papers presented three were specifically concerned with recycling of plastics, 9 with the environmental impacts of chemicals and one, which is indexed separately, was concerned with radioactive discharges into the environment from the Sellafield reprocessing plant. (Author)
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Lübbert, Christoph; Baars, Christian; Dayakar, Anil; Lippmann, Norman; Rodloff, Arne C; Kinzig, Martina; Sörgel, Fritz
2017-08-01
High antibiotic and antifungal concentrations in wastewater from anti-infective drug production may exert selection pressure for multidrug-resistant (MDR) pathogens. We investigated the environmental presence of active pharmaceutical ingredients and their association with MDR Gram-negative bacteria in Hyderabad, South India, a major production area for the global bulk drug market. From Nov 19 to 28, 2016, water samples were collected from the direct environment of bulk drug manufacturing facilities, the vicinity of two sewage treatment plants, the Musi River, and habitats in Hyderabad and nearby villages. Samples were analyzed for 25 anti-infective pharmaceuticals with liquid chromatography-tandem mass spectrometry and for MDR Gram-negative bacteria using chromogenic culture media. In addition, specimens were screened with PCR for bla VIM , bla KPC , bla NDM , bla IMP-1 , and bla OXA-48 resistance genes. All environmental specimens from 28 different sampling sites were contaminated with antimicrobials. High concentrations of moxifloxacin, voriconazole, and fluconazole (up to 694.1, 2500, and 236,950 µg/L, respectively) as well as increased concentrations of eight other antibiotics were found in sewers in the Patancheru-Bollaram industrial area. Corresponding microbiological analyses revealed an extensive presence of extended-spectrum beta-lactamase and carbapenemase-producing Enterobacteriaceae and non-fermenters (carrying mainly bla OXA-48 , bla NDM , and bla KPC ) in more than 95% of the samples. Insufficient wastewater management by bulk drug manufacturing facilities leads to unprecedented contamination of water resources with antimicrobial pharmaceuticals, which seems to be associated with the selection and dissemination of carbapenemase-producing pathogens. The development and global spread of antimicrobial resistance present a major challenge for pharmaceutical producers and regulatory agencies.
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2010-03-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0260] Guidance for Industry on Submitting a Report for Multiple Facilities to the Reportable Food Electronic... Act of 2007.'' The document provides guidance to the industry in complying with the Reportable Food...
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[The pharmaceutical industry in scandal: Mercury or Aesculapius?].
Offerhaus, L
2004-12-18
During the last decade public sympathy for the pharmaceutical industry has gradually been eroded because of excessive protectionism and profit margins. Its reputation as a healthy, profitable and prosperous industry has recently been seriously damaged by several errors of judgement. Data from early trials proved to be less positive than expected. The responsible drug manufacturers decided to cover the results up. So far the pharmaceutical industry has managed to weather the criticism, but recently a multitude of damaging data was published by an unexpected outsider. Angell, a former editor in chief of one of the most respected, peer-reviewed medical journals in the world, the New England Journal of Medicine, decided to collect such data and to analyze them critically. She also used this analysis to draw up recommendations for improving of what she regarded as an unhealthy situation. The book gained bestseller status on the American market and received much praise from reviewers. Although quickly denounced by the industry as controversial and excessively negative, it contains a lot of data, opinions and conclusions that also apply directly to the European situation.
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Generic medicines: solutions for a sustainable drug market?
Dylst, Pieter; Vulto, Arnold; Godman, Brian; Simoens, Steven
2013-10-01
Generic medicines offer equally high-quality treatment as originator medicines do at much lower prices. As such, they represent a considerable opportunity for authorities to obtain substantial savings. At the moment, the pharmaceutical landscape is changing and many pharmaceutical companies have altered their development and commercial strategies, combining both originator and generic divisions. In spite of this, the generic medicines industry is currently facing a number of challenges: delayed market access; the limited price differential with originator medicines; the continuous downwards pressure on prices; and the negative perception regarding generic medicines held by some key stakeholder groups. This could jeopardize the long-term sustainability of the generic manufacturing industry. Therefore, governments must focus on demand-side policies, alongside policies to accelerate market access, as the generic medicines industry will only be able to deliver competitive and sustainable prices if they are ensured a high volume. In the future, the generic medicines industry will increasingly look to biosimilars and generic versions of orphan drugs to expand their business.
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Prediction of potential drug targets based on simple sequence properties
Directory of Open Access Journals (Sweden)
Lai Luhua
2007-09-01
Full Text Available Abstract Background During the past decades, research and development in drug discovery have attracted much attention and efforts. However, only 324 drug targets are known for clinical drugs up to now. Identifying potential drug targets is the first step in the process of modern drug discovery for developing novel therapeutic agents. Therefore, the identification and validation of new and effective drug targets are of great value for drug discovery in both academia and pharmaceutical industry. If a protein can be predicted in advance for its potential application as a drug target, the drug discovery process targeting this protein will be greatly speeded up. In the current study, based on the properties of known drug targets, we have developed a sequence-based drug target prediction method for fast identification of novel drug targets. Results Based on simple physicochemical properties extracted from protein sequences of known drug targets, several support vector machine models have been constructed in this study. The best model can distinguish currently known drug targets from non drug targets at an accuracy of 84%. Using this model, potential protein drug targets of human origin from Swiss-Prot were predicted, some of which have already attracted much attention as potential drug targets in pharmaceutical research. Conclusion We have developed a drug target prediction method based solely on protein sequence information without the knowledge of family/domain annotation, or the protein 3D structure. This method can be applied in novel drug target identification and validation, as well as genome scale drug target predictions.
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Supply Network Planning for New Product Market Entry in the Pharmaceutical Industry
DEFF Research Database (Denmark)
Hansen, Klaus Reinholdt Nyhuus; Grunow, Martin
2011-01-01
uncertainty and the risk of a forced label change and includes solution robustness. While considering limited shelf life of the drug, the supply of packaging material and outsourcing, the objective of our model is to reduce supply chain cost including lost peak sales from delayed market entry....... planning before and during the market entry of the drug after the drug has been approved. Production of the active pharmaceutical ingredient [API] is characterized by long change-over times due to cleaning requirements. Production planning is long term, multiple batches of each drug are produced...... industry, reimbursement negotiations have to be carried out before a drug can be marketed. These negotiations both necessitate time phasing market entries and introduce a series of uncertainties e.g. varying allowed price and awarded subsidy. Also if the label is not approved for marketing, all packaged...
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Silva, Patrick J; Ramos, Kenneth S
2018-04-17
Innovation ecosystems tied to academic medical centers (AMCs) are inextricably linked to policy, practices, and infrastructure resulting from the passage of the Bayh-Dole Act in 1980. Bayh-Dole smoothed the way to patenting and licensing new drugs, and to some degree, medical devices and diagnostic reagents. Property rights under Bayh-Dole provided a significant incentive for industry investments in clinical trials, clinical validation, and industrial scale-up of products that advanced health care. Bayh-Dole amplified private investment in biotechnology drug development, and from the authors' perspective did not significantly interfere with the ability of AMCs to produce excellent peer-reviewed science. In today's policy environment, it is increasingly difficulty to patent and license products based on the laws of nature - as the scope of patentability has been narrowed by case law and development of a suitable clinical and business case for the technology is increasingly a gating consideration for licensees. Consequently, fewer academic patents are commercially valuable. The role of technology transfer organizations in engaging industry partners has thus become increasingly complex. The partnering toolbox and the organizational mandate for commercialization must evolve toward novel collaborative models that exploit opportunities for future patent creation (early drug discovery), data exchange (precision medicine using big data), cohort assembly (clinical trials), and decision rule validation (clinical trials). These inputs all contribute to intellectual property rights, and their clinical exploitation manifests the commercialization of translational science. New collaboration models between AMCs and industry must be established to leverage the assets within AMCs that industry partners deem valuable.
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Conter, Henry J; Chu, Quincy S C
2012-03-01
Pharmaceutical development involves substantial financial risk. This risk, rising development costs, and the promotion of continued research and development have been cited as major drivers in the progressive increase in drug prices. Currently, cost-effective analyses are being used to determine the value of treatment. However, cost-effective analyses practically function as a threshold for value and do not directly address the rationale for drug prices. We set out to create a functional model for industry price decisions and clarify the minimum acceptable profitability of new drugs. Assuming that industry should only invest in profitable ventures, we employed a linear cost-volume-profit breakeven analysis to equate initial capital investment and risk and post-drug-approval profits, where drug development represents the bulk of investment. A Markov decision analysis model was also used to define the relationships between investment events risk. A systematic literature search was performed to determine event probabilities, clinical trial costs, and total expenses as inputs into the model. Disease-specific inputs, current market size across regions, and lengths of treatment for cancer types were also included. With development of single novel chemotherapies costing from $802 to $1,042 million (2002 US dollars), pharmaceutical profits should range from $4.3 to $5.2 billion, with an expected rate of return on investment of 11% annually. However, diversification across cancer types for chemotherapy can reduce the minimum required profit to less than $3 billion. For optimal diversification, industry should study four tumor types per drug; however, nonprofit organizations could tolerate eight parallel development tracks to minimize the risk of development failure. Assuming that pharmaceutical companies hold exclusive rights for drug sales for only 5 years after market approval, the minimum required profit per drug per month per patient ranges from $294 for end-stage lung
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Conter, Henry J.; Chu, Quincy S.C.
2012-01-01
Purpose: Pharmaceutical development involves substantial financial risk. This risk, rising development costs, and the promotion of continued research and development have been cited as major drivers in the progressive increase in drug prices. Currently, cost-effective analyses are being used to determine the value of treatment. However, cost-effective analyses practically function as a threshold for value and do not directly address the rationale for drug prices. We set out to create a functional model for industry price decisions and clarify the minimum acceptable profitability of new drugs. Methods: Assuming that industry should only invest in profitable ventures, we employed a linear cost-volume-profit breakeven analysis to equate initial capital investment and risk and post–drug-approval profits, where drug development represents the bulk of investment. A Markov decision analysis model was also used to define the relationships between investment events risk. A systematic literature search was performed to determine event probabilities, clinical trial costs, and total expenses as inputs into the model. Disease-specific inputs, current market size across regions, and lengths of treatment for cancer types were also included. Results: With development of single novel chemotherapies costing from $802 to $1,042 million (2002 US dollars), pharmaceutical profits should range from $4.3 to $5.2 billion, with an expected rate of return on investment of 11% annually. However, diversification across cancer types for chemotherapy can reduce the minimum required profit to less than $3 billion. For optimal diversification, industry should study four tumor types per drug; however, nonprofit organizations could tolerate eight parallel development tracks to minimize the risk of development failure. Assuming that pharmaceutical companies hold exclusive rights for drug sales for only 5 years after market approval, the minimum required profit per drug per month per patient ranges
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The U.S. Chemical Industry, the Products It Makes
Chemical and Engineering News, 1972
1972-01-01
This section of the annual report on the chemical industry presents data on these areas of chemical production: growth rates, man-made fibers; the 50 largest volume chemicals, major inorganics and organics, plastics, drugs, magnesium, and paint. Includes production figures for 1961, 1969, 1970, 1971 and percent change for 1970-71 and for 1961-71.…
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Directory of Open Access Journals (Sweden)
José Augusto C. Barros
1983-10-01
Full Text Available Dentro do processo de ampliação crescente do âmbito de intervenção da Medicina (a chamada "medicalização", o uso abusivo de medicamentos industrializados assume papel de destaque. Entre as diversas práticas mercadológicas de que a Indústria Farmacêutica se vale para incrementar os seus lucros - via estímulo ao consumo - sobressai-se a propaganda, particularmente junto ao médico. A despeito da automedicação, dependente, por sua vez, em grande parte, da influência inclusive "legitimadora" do médico, é sobre esse profissional que recai, direta ou indiretamente, através da prescrição medicamentosa, a responsibilidade por ação significativa do consumo. Propõe-se, com base em diversos estudos já realizados, a análise crítica do papel da propaganda, com ênfase no papel do propagandista de laboratório e na sua eficácia como instrumento preferencial de que lançam mão os produtores de medicamentos para influenciar os hábitos de prescrição dos médicos, dirigindo-os prioritariamente à satisfação dos interesses dos produtores, em detrimento daqueles dos consumidores.The overuse of manufactured drugs plays an important role in the process of the growing intervention of Medicine (the phenomenon called "medicalization". Among the different promotional practices used by pharmaceutical manufacturers to increase their profits - by means of the stimulation of the use of drugs advertising directed specially at physicians is particularly prominent. Notwithstanding drugs sold "over the counter", the use of which also depends, in great measure, in the last analysis, on the legitimation given them by physicians, these latter are responsible, through their prescriptions, for the larger part of all drug consumption. An attempt is made a critical analysis of the role of advertising, highlighting the role of drug companies' representatives and their efficacy as the means favored by manufacturers in their attempts to influence
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2013-11-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1994-D-0007] Guidance for Industry: Studies To Evaluate the Utility of Anti- Salmonella Chemical Food Additives in Feeds... Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds,'' and is...
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SAN FRANCISCO – Computational drug design company Numerate has signed a letter of intent to join an open consortium of scientists staffed from two U.S. national laboratories, industry, and academia working to transform drug discovery and developmen
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The role of bioethics in the international prescription drug market: economics and global justice.
Newland, Shelby E
2006-01-01
In terms of health care access, bioethics has an important role to inform and shape policy issues and develop interdisciplinary ideas and interventions. The rising price of prescription drugs presents one of the most looming barriers to health care access in the world today. Including both theoretical and practical features of the pharmaceutical industry's behavior is necessary to find ethical solutions towards increasing access. Bioethics can evaluate global justice by weighing human rights theory and future innovation at the macro level, and by addressing market forces and responsibilities at the micro level. Inherent structural features of pharmaceuticals, such as its reliance on research and development, cause the industry to employ pricing strategies that seem counter-intuitive to conventional wisdom, but that result in producing a just allocation as defined by market forces. Parallel trade and drug exportation/reimportation threaten the saliency of the industry's differential pricing scheme; a case-study of a single "Euro-price" within the European Union illustrates how this will actually create harm to the most needy member states. This complex situation requires solutions weighing arguments from human rights theory with those from economic theory to arrive at the most globally just allocation of prescription drugs in the global marketplace, as well as to ensure future innovation and scientific progress. Bioethicists as well as economists need to partake urgently in this discourse for the betterment of the global injustices in the international prescription drug market.
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Otsubo, Yasuto; Ishiguro, Akihiro; Uyama, Yoshiaki
2013-01-01
Pharmacogenomics-guided drug development has been implemented in practice in the last decade, resulting in increased labeling of drugs with pharmacogenomic information. However, there are still many challenges remaining in utilizing this process. Here, we describe such remaining challenges from the regulatory perspective, specifically focusing on sample collection, biomarker qualification, ethnic factors, codevelopment of companion diagnostics and means to provide drugs for off-target patients. To improve the situation, it is important to strengthen international harmonization and collaboration among academia, industries and regulatory agencies, followed by the establishment of an international guideline on this topic. Communication with a regulatory agency from an early stage of drug development is also a key to success.
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Process industry properties in nuclear industry
International Nuclear Information System (INIS)
Zheng Hualing
2005-01-01
In this article the writer has described the definition of process industry, expounded the fact classifying nuclear industry as process industry, compared the differences between process industry and discrete industry, analysed process industry properties in nuclear industry and their important impact, and proposed enhancing research work on regularity of process industry in nuclear industry. (authors)
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Combinations of drugs in the Treatment of Obesity
Directory of Open Access Journals (Sweden)
Marcio C. Mancini
2010-07-01
Full Text Available Obesity is a chronic disease associated with excess morbidity and mortality. Clinical treatment, however, currently offers disappointing results, with very high rates of weight loss failure or weight regain cycles, and only two drugs (orlistat and sibutramine approved for long-term use. Drugs combinations can be an option for its treatment but, although widely used in clinical practice, very few data are available in literature for its validation. Our review focuses on the rationale for their use, with advantages and disadvantages; on combinations often used, with or without studies; and on new perspectives of combinations being studied mainly by the pharmaceutical industry.
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Production of drug-loaded polymeric nanoparticles by electrospraying technology.
Sosnik, Alejandro
2014-09-01
The pharmaceutical industry struggles with high attrition. The outbreak of pharmaceutical micro/nanotechnology has been fundamental to overcome several (bio)pharmaceutic drawbacks of drugs such as poor aqueous solubility, physicochemical instability, short half life, inappropriate biodistribution and toxicity. The spatiotemporal release of drugs directly in the site of action and the restriction of the systemic exposure by means of nanotechnology has notoriously improved drug safety ratios. At the same time, the development of production methods that are cost-effective, scalable and reproducible under industrial settings becomes crucial to ensure the clinical translation of any development. The electrospraying process, also known as electrohydrodynamic atomization (EHDA), is a single-stage technique of liquid atomization by means of electrical forces that enables the generation of micro/nanoparticles with especially narrow size distribution. EHDA is based on the ability of an electric field to deform the interface of a liquid drop and break it into smaller mono-disperse droplets. The main advantageous features over conventional methods are the possibility to produce particles without the use of surfactants, at ambient temperature and pressure and with maximum encapsulation efficiency due to the absence of an external medium that allows the migration and/or dissolution of water-soluble cargos. In addition, the mild conditions are optimal for the encapsulation of thermo-sensitive cargos. The present article overviews the applications of this technology for the production of nano-drug delivery systems and discusses its key role to support the transfer of a broad spectrum of nanomedicines to the market.
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Directory of Open Access Journals (Sweden)
Nazrul Haq
2017-02-01
Full Text Available Green RP-HPLC method for a rapid analysis of olmesartan medoxomil (OLM in bulk drugs, self-microemulsifying drug delivery system (SMEDDS and marketed tablets was developed and validated in the present investigation. The chromatographic identification was achieved on Lichrosphere 250 × 4.0 mm RP C8 column having a 5 μm packing as a stationary phase using a combination of green solvents ethyl acetate:ethanol (50:50% v/v as a mobile phase, at a flow rate of 1.0 mL/min with UV detection at 250 nm. The proposed method was validated for linearity, selectivity, accuracy, precision, reproducibility, robustness, sensitivity and specificity. The utility of the proposed method was verified by an assay of OLM in SMEDDS and commercial tablets. The proposed method was found to be selective, precise, reproducible, accurate, robust, sensitive and specific. The amount of OLM in SMEDDS and commercial tablets was found to be 101.25% and 98.67% respectively. The proposed method successfully resolved OLM peak in the presence of its degradation products which indicated stability-indicating property of the proposed method. These results indicated that the proposed method can be successfully employed for a routine analysis of OLM in bulk drugs and commercial formulations.
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Claims in advertisements for antihypertensive drugs in a Dutch medical journal
Greving, Jacoba P; Denig, Petra; de Zeeuw, Dick; Haaijer-Ruskamp, Flora M
2007-01-01
BACKGROUND: Advertising claims must not conflict with the official summary of product characteristics. After a drug has been approved, new clinical evidence may become available. AIMS: To determine how the pharmaceutical industry deals with evolving clinical evidence in advertising claims for
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Should tobacco and alcohol companies be allowed to influence Australia's National Drug Strategy?
Freeman, Becky; MacKenzie, Ross; Daube, Mike
2017-04-27
Formation of Australia's National Drug Strategy (NDS) included an extensive consultation process that was open not only to community and public health stakeholders, but also to representatives of the tobacco and alcohol industries. Australia is bound by the World Health Organization Framework Convention on Tobacco Control, which requires governments to protect tobacco control measures from interference by the tobacco industry. NDS consultation submissions made by these conflicted industries are not publicly available for scrutiny. The NDS goals are at odds with the commercial agenda of industries that support regulatory stagnation, oppose and undermine effective action, ignore and distort evidence, and prioritise profits over health.
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The drugs industry and peasant self-defence in a Peruvian cocaine enclave.
van Dun, Mirella
2012-11-01
This article gives a detailed account of the cocaine industry and the related violence in the Peruvian Upper Huallaga. It is argued that in this cocaine producing region violence increased during state-led forced eradication operations of the coca plants. Most of the violent incidents were closely related to the diminishing cocaine industry, but they were also related to the actions of the state security forces. Instead of receiving support from the state's security apparatus, the population mobilized its own forces to fight the violence. As will be argued, the causes of violence in this cocaine enclave are part of a dynamic interaction amongst many factors - an interaction that is influenced by the local context, a partial state vacuum, and the social utility and the economic advantages of violence. One needs to be aware that motivations of those who engage in the violent behaviour can change over time, as underlying power structures are influenced by changes in local conditions. The study covers an in-depth account of events taking place in the Upper Huallaga during the years 2003-2007. The research material was collected by several ethnographical fieldwork methods. Copyright © 2012 Elsevier B.V. All rights reserved.
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International Nuclear Information System (INIS)
Gordey, T.; Sunstrum, M.
2006-01-01
Worker absenteeism due to substance abuse costs the Alberta economy approximately $720 million a year. It is estimated that 20 per cent of all drivers in fatal crashes were using alcohol, and the use of cannabis and cocaine in Alberta has more than doubled over the last 15 years. In addition, 1 in 10 Alberta workers have reported using alcohol while at work and 4 per cent have reported using alcohol 4 hours prior to coming to work during the previous 12 months. In an effort to ensure appropriate health and safety for workers in the Canadian petroleum industry, 6 trade associations in the sector have joined together as the Enform Alcohol and Drug Initiative and are now working to develop a common approach to drug and alcohol guidelines and workplace rules. The task group will determine if existing policies and guidelines are sufficient to ensure a safe workplace and will consider standardizing the testing, application and rehabilitation of workers with respect to the use of drugs and alcohol. In the past, disciplinary actions have often been reversed because employers have not been consistent or did not follow established alcohol and drug policies or test to specific standards. Various work rules for inappropriate alcohol and drug use were reviewed, as well as education and communication strategies regarding policy content. Standards for testing criteria were discussed, as well as issues concerning duty-to-accommodate circumstances. An excerpt of concentration standards was presented. It was concluded that a matrix for companies to assess and determine safety sensitive positions is needed. refs., tabs., figs
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Energy Technology Data Exchange (ETDEWEB)
Gordey, T [ConocoPhillips Canada Resources Corp., Calgary, AB (Canada); Sunstrum, M [Enform, Calgary, AB (Canada)
2006-07-01
Worker absenteeism due to substance abuse costs the Alberta economy approximately $720 million a year. It is estimated that 20 per cent of all drivers in fatal crashes were using alcohol, and the use of cannabis and cocaine in Alberta has more than doubled over the last 15 years. In addition, 1 in 10 Alberta workers have reported using alcohol while at work and 4 per cent have reported using alcohol 4 hours prior to coming to work during the previous 12 months. In an effort to ensure appropriate health and safety for workers in the Canadian petroleum industry, 6 trade associations in the sector have joined together as the Enform Alcohol and Drug Initiative and are now working to develop a common approach to drug and alcohol guidelines and workplace rules. The task group will determine if existing policies and guidelines are sufficient to ensure a safe workplace and will consider standardizing the testing, application and rehabilitation of workers with respect to the use of drugs and alcohol. In the past, disciplinary actions have often been reversed because employers have not been consistent or did not follow established alcohol and drug policies or test to specific standards. Various work rules for inappropriate alcohol and drug use were reviewed, as well as education and communication strategies regarding policy content. Standards for testing criteria were discussed, as well as issues concerning duty-to-accommodate circumstances. An excerpt of concentration standards was presented. It was concluded that a matrix for companies to assess and determine safety sensitive positions is needed. refs., tabs., figs.
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PP22. PROGRESSING RADIOTHERAPY-DRUG COMBINATIONS TOWARDS EARLY PHASE CLINICAL TRIALS
Jones, Dr Hazel; Stock, Dr Julie; Chalmers, Prof Anthony
2017-01-01
Abstract The Radiotherapy-Drug Combinations consortium (RaDCom) works with UK-based investigators to design and deliver high quality preclinical projects evaluating specific radiotherapy-drug combinations. We have several collaborations with industry, from in vitro projects to understand the novel agent in the context of radiobiology, through to preclinical studies that will generate data to support the development of radiotherapy combination trials. RaDCom facilitates the coordination of industry interactions, triage new proposals, monitor active projects, and engages with the radiotherapy community to promote collaboration and networking (via a capability map). The CRUK New Agents Committee Preclinical Combination Grant scheme provides one of the funding options for these studies, with the potential to feed into early phase clinical trials via the ECMC Combinations Alliance. RaDCom also supports broader radiotherapy research initiatives, by working to improve preclinical quality assurance and identifying a route to registration for radiotherapy-drug treatments. These activities will place the UK at the forefront of radiotherapy-drug preclinical research and provide a significant incentive for pharmaceutical companies to invest in this area and utilise the RaDCom network. Further information can be found on our webpage: http://ctrad.ncri.org.uk/research-support/radiation-drug-combinations-radcom Successful projects from RaDCom can then move into early phase combinations trials within the Combinations Alliance. The Combinations Alliance supports early phase combination studies in the UK via the ECMC (Experimental Cancer Medicine Centres) network. It focuses on translational research, and enables clinical project teams to work with disease experts to set up investigator led trials. The CRUK Centre of Drug Development (CDD) supports these studies with further management and coordination ensuring more robust timelines and delivery. The Combinations Alliance framework
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New paradigm for drug developments--from emerging market statistical perspective.
Quan, Hui; Chen, Xun; Zhang, Ji; Zhao, Peng-Liang
2013-11-01
Paradigm for new drug development has changed dramatically over the last decade. Even though new technology increases efficiency in many aspects, partially due to much more stringent regulatory requirements, it actually now takes longer and costs more to develop a new drug. To deal with challenge, some initiatives are taken by the pharmaceutical industry. These initiatives include exploring emerging markets, conducting global trials and building research and development centers in emerging markets to curb spending. It is particularly the current trend that major pharmaceutical companies offshore a part of their biostatistical support to China. In this paper, we first discuss the skill set for trial statisticians in the new era. We then elaborate on some of the approaches for acquiring statistical talent and capacity in general, particularly in emerging markets. We also make some recommendations on the use of the PDUFA strategy and collaborations among industry, health authority and academia from emerging market statistical perspective. © 2013.
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Live demonstration: Screen printed, microwave based level sensor for automated drug delivery
Karimi, Muhammad Akram; Arsalan, Muhammad; Shamim, Atif
2018-01-01
Level sensors find numerous applications in many industries to automate the processes involving chemicals. Recently, some commercial ultrasound based level sensors are also being used to automate the drug delivery process [1]. Some of the most
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Thomas, Craig E; Will, Yvonne
2012-02-01
Attrition in the drug industry due to safety findings remains high and requires a shift in the current safety testing paradigm. Many companies are now positioning safety assessment at each stage of the drug development process, including discovery, where an early perspective on potential safety issues is sought, often at chemical scaffold level, using a variety of emerging technologies. Given the lengthy development time frames of drugs in the pharmaceutical industry, the authors believe that the impact of new technologies on attrition is best measured as a function of the quality and timeliness of candidate compounds entering development. The authors provide an overview of in silico and in vitro models, as well as more complex approaches such as 'omics,' and where they are best positioned within the drug discovery process. It is important to take away that not all technologies should be applied to all projects. Technologies vary widely in their validation state, throughput and cost. A thoughtful combination of validated and emerging technologies is crucial in identifying the most promising candidates to move to proof-of-concept testing in humans. In spite of the challenges inherent in applying new technologies to drug discovery, the successes and recognition that we cannot continue to rely on safety assessment practices used for decades have led to rather dramatic strategy shifts and fostered partnerships across government agencies and industry. We are optimistic that these efforts will ultimately benefit patients by delivering effective and safe medications in a timely fashion.
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Drug discovery in an academic setting: playing to the strengths.
Huryn, Donna M
2013-03-14
Drug discovery and medicinal chemistry initiatives in academia provide an opportunity to create a unique environment that is distinct from the traditional industrial model. Two characteristics of a university setting that are not usually associated with pharma are the ability to pursue high-risk projects and a depth of expertise, infrastructure, and capabilities in focused areas. Encouraging, supporting, and fostering drug discovery efforts that take advantage of these and other distinguishing characteristics of an academic setting can lead to novel and innovative therapies that might not be discovered otherwise.
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Vargas, Marco; Gadelha, Carlos Augusto Grabois; Costa, Laís Silveira; Maldonado, José
2012-12-01
Pharmaceutical and biotechnology industries comprise a major production subsystem of the health industrial complex in Brazil. It stands out for both its economic importance and its prominent role in developing new technologies in strategic areas. Strengthening the local production of generic drugs in the last decade has significantly increased the number of Brazilian companies in the local pharmaceutical market and has been an important turning point for this industry's growth. However, there remain major structural bottlenecks both in terms of production and continuous innovation. These bottlenecks reveal the high vulnerability of the Brazilian National Health System and point to the need of public policies that promote strengthening the production base and innovation in the pharmaceutical industry and that at the same time meet health-related social demands in health in Brazil.
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The impact of TRIPS on innovation and exports: a case study of the pharmaceutical industry in India.
Malhotra, Prabodh
2008-01-01
Currently, there is a debate on what impact the implementation of the Trade Related Aspects of Intellectual Property Rights (TRIPS) in India would have on its pharmaceutical industry and health care. The debate hinges primarily on two major questions. First, will the new patent regime provide an impetus for innovation in the pharmaceutical industry? Second, how far will India's pharmaceutical exports of copied versions of patented drugs to developing countries be restricted under the new regime? The first question seeks to find out if TRIPS will increase India's innovative capabilities to fill the current vacuum to develop drugs for tropical diseases. The large multinational companies (MNCs) that dominate the global pharmaceutical industry have no interest in commercial ventures that have little potential for great returns on investment. The second question attempts to find a solution to the lack of access to medicine in most developing countries. Indian manufacturers' supply of reverse-engineered drugs, which cost only a fraction of the prices charged by MNCs, may be coming to an end under the new regime. Against this backdrop, this article attempts to analyse the impact of strengthening intellectual property rights in India.
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Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich
2017-01-01
Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are
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Skrepnek, Grant H
2004-01-01
Accounting-based profits have indicated that pharmaceutical firms have achieved greater returns relative to other sectors. However, partially due to the theoretically inappropriate reporting of research and development (R&D) expenditures according to generally accepted accounting principles, evidence suggests that a substantial and upward bias is present in accounting-based rates of return for corporations with high levels of intangible assets. Given the intensity of R&D in pharmaceutical firms, accounting-based profit metrics in the drug sector may be affected to a greater extent than other industries. The aim of this work was to address measurement issues associated with corporate performance and factors that contribute to the bias within accounting-based rates of return. Seminal and broadly cited works on the subject of accounting- versus economic-based rates of return were reviewed from the economic and finance literature, with an emphasis placed on issues and scientific evidence directly related to the drug development process and pharmaceutical industry. With international convergence and harmonization of accounting standards being imminent, stricter adherence to theoretically sound economic principles is advocated, particularly those based on discounted cash-flow methods. Researchers, financial analysts, and policy makers must be cognizant of the biases and limitations present within numerous corporate performance measures. Furthermore, the development of more robust and valid economic models of the pharmaceutical industry is required to capture the unique dimensions of risk and return of the drug development process. Empiric work has illustrated that estimates of economic-based rates of return range from approximately 2 to approximately 11 percentage points below various accounting-based rates of return for drug companies. Because differences in the nature of risk and uncertainty borne by drug manufacturers versus other sectors make comparative assessments
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[Industrialization condition and development strategy of Notopterygii Rhizoma et Radix].
Jiang, Shun-Yuan; Sun, Hui; Wang, Hong-Lan; Ma, Xiao-Jun; Qin, Ji-Hong; Xin, Jun; Sun, Hong-Bing; Du, Jiu-Zhen; Yin, Li
2017-07-01
Notopterygii Rhizoma et Radix, the underground part of Notopterygium incisum and N. franchetii, is used as a classical traditional Chinese medicine, and as raw materials for 262 Chinese patent drugs production in 694 pharmaceutical factories currently. It plays an important role in the whole Chinese medicine industry with irreplaceable important economic and social values. However, wild resource of was abruptly depleted, and large-scale artificial cultivation has been inapplicable. In this study, Utilization history and the industrialization status of Notopterygii Rhizoma et Radix were summarized. Resource distribution, ecological suitability of Notopterygii Rhizoma et Radix and core technologies for seeds production, seedling breeding, large-scale cultivation has been reported by current studies, and basic conditions are already available for industrialization production of Notopterygii Rhizoma et Radix. However, there still some key technical problems need to be solved in the further research, and some policy dimensions need to be focused on in the coming industrialization cultivation of Notopterygii Rhizoma et Radix. Copyright© by the Chinese Pharmaceutical Association.
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Drug Familiarization and Therapeutic Misconception Via Direct-to-Consumer Information.
Bélisle-Pipon, Jean-Christophe; Williams-Jones, Bryn
2015-06-01
Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising (DTCA). However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information (DTCI) campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA.
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Solubilization of poorly water-soluble drugs using solid dispersions.
Tran, Thao T-D; Tran, Phuong H-L; Khanh, Tran N; Van, Toi V; Lee, Beom-Jin
2013-08-01
Many new drugs have been discovered in pharmaceutical industry and exposed their surprised potential therapeutic effects. Unfortunately, these drugs possess low absorption and bioavailability since their solubility limitation in water. Solid dispersion (SD) is the current technique gaining so many attractions from scientists due to its effect on improving solubility and dissolution rate of poorly water-soluble drugs. A number of patents including the most recent inventions have been undertaken in this review to address various respects of this strategy in solubilization of poorly watersoluble drugs including type of carriers, preparation methods and view of technologies used to detect SD properties and mechanisms with the aim to accomplish a SD not only effective on enhanced bioavailability but also overcome difficulties associated with stability and production. Future prospects are as well discussed with an only hope that many developments and researches in this field will be successfully reached and contributed to commercial use for treatment as much as possible.
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2013-04-17
... for Preventing Cross- Contamination; Availability AGENCY: Food and Drug Administration, HHS. ACTION... require separation of manufacturing facilities to avoid cross-contamination, the only class of products... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0104...
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Industrial Production of Therapeutic Proteins: Cell Lines, Cell Culture, and Purification
Zhu, Marie M.; Mollet, Michael; Hubert, Rene S.
The biotechnology and pharmaceutical industries have seen a recent surge in the development of biological drug products manufactured from engineered mammalian cell lines. Since the hugely successful launch of human tissue plasminogen activator in 1987 and erythropoietin in 1988, the biopharmaceutical market has grown immensely. Global sales in 2003 exceeded US 30 billion.1 Currently, a total of 108 biotherapeutics are approved and available to patients (Table 32.1). In addition, 324 medically related, biotechnology-derived medicines for nearly 150 diseases are in clinical trials or under review by the U.S. Food and Drug Administration.2 These biopharmaceutical candidates promise to bring more and better treatments to patients. Compared to small molecule drugs, biotherapeutics show exquisite specificity with fewer off-target interactions and improved safety profiles.
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Physician-industry relations. Part 1: individual physicians.
Coyle, Susan L
2002-03-05
This is part 1 of a 2-part paper on ethics and physician-industry relationships. Part 1 offers advice to individual physicians; part 2 gives recommendations to medical education providers and medical professional societies. Physicians and industry have a shared interest in advancing medical knowledge. Nonetheless, the primary ethic of the physician is to promote the patient's best interests, while the primary ethic of industry is to promote profitability. Although partnerships between physicians and industry can result in impressive medical advances, they also create opportunities for bias and can result in unfavorable public perceptions. Many physicians and physicians-in-training think they are impervious to commercial influence. However, recent studies show that accepting industry hospitality and gifts, even drug samples, can compromise judgment about medical information and subsequent decisions about patient care. It is up to the physician to judge whether a gift is acceptable. A very general guideline is that it is ethical to accept modest gifts that advance medical practice. It is clearly unethical to accept gifts or services that obligate the physician to reciprocate. Conflicts of interest can arise from other financial ties between physicians and industry, whether to outside companies or self-owned businesses. Such ties include honorariums for speaking or writing about a company's product, payment for participating in clinic-based research, and referrals to medical resources. All of these relationships have the potential to influence a physician's attitudes and practices. This paper explores the ethical quandaries involved and offers guidelines for ethical business relationships.
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Microneedle-based drug delivery systems for transdermal route.
Pierre, Maria Bernadete Riemma; Rossetti, Fabia Cristina
2014-03-01
Transdermal delivery offers an attractive, noninvasive administration route but it is limited by the skin's barrier to penetration. Minimally invasive techniques, such as the use of microneedles (MNs), bypass the stratum corneum (SC) barrier to permit the drug's direct access to the viable epidermis. These novel micro devices have been developed to puncture the skin for the transdermal delivery of hydrophilic drugs and macromolecules, including peptides, DNA and other molecules, that would otherwise have difficulty passing the outermost layer of the skin, the SC. Using the tools of the microelectronics industry, MNs have been fabricated with a range of sizes, shapes and materials. MNs have been shown to be robust enough to penetrate the skin and dramatically increase the skin permeability of several drugs. Moreover, MNs have reduced needle insertion pain and tissue trauma and provided controlled delivery across the skin. This review focuses on the current state of the art in the transdermal delivery of drugs using various types of MNs and developments in the field of microscale devices, as well as examples of their uses and clinical safety.
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2011-05-05
... are manufacturing, marketing, or distributing orally ingested over-the-counter (OTC) liquid drug... overdoses that can result from the use of dosage delivery devices with markings that are inconsistent or... because of ongoing concerns about potentially serious accidental drug overdoses that can result from the...
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Puteanus, U
2000-10-01
In Germany, drug advertising of non-prescription drugs is a controversial subject. On the one hand, consumer organisations plead for placing a ban on advertising or at least to offer a detailed description of medical risks in respect of protection. On the other hand, the pharmaceutical industry is keen on liberalizing the specific advertising law for drugs. A representative telephone survey among the population of North Rhine-Westphalia was conducted in April and May 1999. It showed consumer interest in advertising, the value of information on risks, the institution with maximum credibility in drug information for consumers, the importance of the now obligatory sentence after every advertisement: Regarding risks and side effects read the leaflet in the package and ask your physician or pharmacist, and to what extend the consumer would take advice from independent experts over the telephone about drugs. It was found that, in particular women, about 30% are occasionally interested in advertising, younger people are more open-minded about advertising than older people; and that doctors and pharmacists have the most credibility and are consulted for further information. It was also found that more than 80% of the population demanded precise information on the side effects of drugs. One-third of the consumers declared that the obligatory sentence (see above) led to greater demand for information from doctors or to read attentively the instruction leaflet. Nevertheless, there is a need for more information from more than half of the consumers, who would take advantage of an independent advice centre if this should exist.
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Production of Enzymes From Agricultural Wastes and Their Potential Industrial Applications.
Bharathiraja, S; Suriya, J; Krishnan, M; Manivasagan, P; Kim, S-K
Enzymatic hydrolysis is the significant technique for the conversion of agricultural wastes into valuable products. Agroindustrial wastes such as rice bran, wheat bran, wheat straw, sugarcane bagasse, and corncob are cheapest and plentifully available natural carbon sources for the production of industrially important enzymes. Innumerable enzymes that have numerous applications in industrial processes for food, drug, textile, and dye use have been produced from different types of microorganisms from agricultural wastes. Utilization of agricultural wastes offers great potential for reducing the production cost and increasing the use of enzymes for industrial purposes. This chapter focuses on economic production of actinobacterial enzymes from agricultural wastes to make a better alternative for utilization of biomass generated in million tons as waste annually. © 2017 Elsevier Inc. All rights reserved.
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2010-11-22
... Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0571] Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and the Use of...
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International Nuclear Information System (INIS)
Braga, Antonio Luiz; Luedtke, Diogo Seibert; Schneider, Paulo Henrique; Andrade, Leandro Helgueira; Paixao, Marcio Weber
2013-01-01
The preparation of enantiomerically pure or enriched substances is of fundamental importance to pharmaceutical, food, agrochemical, and cosmetics industries and involves a growing market of hundreds of billions of dollars. However, most chemical processes used for their production are not environmentally friendly because in most cases, stoichiometric amounts of chiral inductors are used and substantial waste is produced. In this context, asymmetric catalysis has emerged as an efficient tool for the synthesis of enantiomerically enriched compounds using chiral catalysts. More specifically, considering the current scenario in the Brazilian chemical industry, especially that of pharmaceuticals, the immediate prospect for the use of synthetic routes developed in Brazil in an enantioselective fashion or even the discovery of new drugs is practically null. Currently, the industrial production of drugs in Brazil is primarily focused on the production of generic drugs and is basically supported by imports of intermediates from China and India. In order to change this panorama and move forward toward the gradual incorporation of genuinely Brazilian synthetic routes, strong incentive policies, especially those related to continuous funding, will be needed. These incentives could be a breakthrough once we establish several research groups working in the area of organic synthesis and on the development and application of chiral organocatalysts and ligands in asymmetric catalysis, thus contributing to boost the development of the Brazilian chemical industry. Considering these circumstances, Brazil can benefit from this opportunity because we have a wide biodiversity and a large pool of natural resources that can be used as starting materials for the production of new chiral catalysts and are creating competence in asymmetric catalysis and related areas. This may decisively contribute to the growth of chemistry in our country. (author)
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Financial aspects and the future of the pharmaceutical industry in the United States of america.
Karamehic, Jasenko; Ridic, Ognjen; Ridic, Goran; Jukic, Tomislav; Coric, Jozo; Subasic, Djemo; Panjeta, Mirsad; Saban, Aida; Zunic, Lejla; Masic, Izet
2013-12-01
The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as "companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use". Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers' lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one of the major problems fuelling aggregate health care cost inflation. Pharmaceuticals have created huge benefits for public health and economic productivity by the means of saving lives, increasing life expectancy, reducing illness related suffering, preventing surgeries and decreasing hospital stays. The goal of this review paper is to show the present conditions and future trends of the pharmaceutical industry in the U.S. THIS PAPER REPRESENTS A THOROUGH LITERATURE REVIEW OF THE MULTIFACETED SOURCES INCLUDING: studies, books, peer reviewed journals, U.S. government sources (i.e. U.S. Census Bureau, U.S. Bureau of Economic Analysis, etc.). In the thirty years pharmaceutical companies have consistently developed and launched new medicines, bringing hope to sick or - at risk patients. They also usually provide above the average financial returns for its shareholders. U.S. pharmaceutical companies had as their goal to discover blockbuster drugs. Blockbuster drugs are generally defined as drugs that solve medical problems common to hundreds of millions of people and, at the same time generate large sales increases and profits for the pharmaceutical companies. The main approach of these companies includes huge investments in research and development (R&D), innovation, marketing and sales. The trend analysis shows that for the most part the era of blockbuster drugs is nearing an end. Numerous blockbuster drugs will be coming off patent in the next few years, opening the way to generics and
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Energy Technology Data Exchange (ETDEWEB)
Ball, C.
2004-12-06
Drug dependency among personnel in the oil industry, and the measures taken by industry trying to cope with it, are discussed. Because drug users are five times more likely to be in an accident, many companies have instituted regular drug testing programs. Such programs are considered to be particularly effective when combined with a program designed to educate personnel, but also managers and supervisors of the dangers of drug use and best practices to deal with them. It should be noted that firing an employee found to be using drugs is not a solution since drug dependency is considered to be a disability under the Human Rights Code, and employers are not allowed to discriminate against someone with a disability. The policy followed by most employers is immediate suspension upon discovery of drug use, followed by intensive supportive treatment, aimed at getting the individual to address his addiction, and putting him back to work as soon as it is deemed safe to do so. Wherever possible, voluntary admission of having a drug problem, and an enlightened, sincere effort to treat the problem as a disease in a non-judgmental way, is considered far superior to programs relying chiefly on drug testing.
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Public enemy number one: the US Advertising Council's first drug abuse prevention campaign.
Niesen, Molly
2011-01-01
This article explores the Advertising Council's first national drug abuse prevention campaign in the 1970s. Scholarship thus far has demonstrated the ways in which the issue of drug abuse represented a chief political strategy for President Nixon. Evidence from major trade press publications, congressional hearings, and an array of archival sources suggest that this campaign was also part of a public relations crusade on behalf of the advertising industry in response to public criticism of its role in abetting a culture of drug dependence. These institutional and political pressures helped shape drug abuse prevention in the 1970 s and for the decades that followed. Copyright © 2011 Informa Healthcare USA, Inc.
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A review of the impact of commercial drug advertising on the ...
African Journals Online (AJOL)
Introduction: Today, the phenomenon of commercial advertising is not a simple information tool to link consumer to producers. The pharmaceutical industry is increasingly influenced by commercial advertising. Self-medication may be one of the major consequences of drug advertising. Methodology: This review article was ...
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Compliance revisited: pharmaceutical drug trials in the era of the contract research organization.
Jonvallen, Petra
2009-12-01
Over the past decade, the management of clinical trials of pharmaceuticals has become a veritable industry, as evidenced by the emergence and proliferation of contract research organizations (CROs) that co-ordinate and monitor trials. This article focuses on work performed by one CRO involved in the introduction of new software, modelled on industrial production processes, into clinical trial practices. It investigates how this new management technique relates to the work performed in the clinic to ensure that trial participants comply with the protocol. Using an analytical distinction between 'classical' management work and invisible work, the article contextualizes the meaning of compliance in the clinic and suggests that the work involved in producing compliance should be taken into consideration by those concerned with validity of trials, as clinical trials are put under private industrial management. The article builds on participant observation at a Swedish university hospital and interviews the nurses, dieticians, doctors and a software engineer, all part of a team involved in pharmaceutical drug trials on a potential obesity drug.
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Gretton, Linda Burak
2009-01-01
The current pharmaceutical industry, whose origins date from the early 20th century, and the biotechnology industry, which emerged in the 1980s both have foundations built on the modern scientific method and share a mission to develop new drugs for humans and animals. At the same time, they are also made distinct by size (small biotechs versus…
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From Composition to Cure: A Systems Engineering Approach to Anticancer Drug Carriers.
MacEwan, Sarah R; Chilkoti, Ashutosh
2017-06-06
The molecular complexity and heterogeneity of cancer has led to a persistent, and as yet unsolved, challenge to develop cures for this disease. The pharmaceutical industry focuses the bulk of its efforts on the development of new drugs, but an alternative approach is to improve the delivery of existing drugs with drug carriers that can manipulate when, where, and how a drug exerts its therapeutic effect. For the treatment of solid tumors, systemically delivered drug carriers face significant challenges that are imposed by the pathophysiological barriers that lie between their site of administration and their site of therapeutic action in the tumor. Furthermore, drug carriers face additional challenges in their translation from preclinical validation to clinical approval and adoption. Addressing this diverse network of challenges requires a systems engineering approach for the rational design of optimized carriers that have a realistic prospect for translation from the laboratory to the patient. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.
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[Three types of brand name loyalty strategies set up by drug manufacturers].
PréMont, Marie-Claude; Gagnon, Marc-André
2014-11-01
The recent restructuring of the pharmaceutical industry has led to three new types of promotional strategies to build patient loyalty to brand name drugs: loyalty through rebates, patient support, and compassion programs. Loyalty through rebates seeks to keep patients on a brand name drug and prevent their switch to the generic equivalent. Loyalty through patient support provides aftersales services to help and support patients (by phone or home visits) in order to improve adherence to their treatments. Finally, compassion programs offer patients access to drugs still awaiting regulatory approval or reimbursement by insurers. When and if the approval process is successful, the manufacturer puts an end to the compassion program and benefits from a significant cohort of patients already taking a very expensive drug for which reimbursement is assured. The impact of these programs on public policies and patients' rights raises numerous concerns, among which the direct access to patients and their health information by drug manufacturers and upward pressure on costs for drug insurance plans.
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Radiation sterilization of traditional medicine drugs in Vietnam
International Nuclear Information System (INIS)
Hang, N.D.; Canh, T.T.; Thuy, T.T.
1995-01-01
With the application of Gamma Co-60 radiation sterilization in pharmaceutical industry, attention should be paid to the possibilities of sterilizing traditional medicine drugs produced in Vietnam. In this paper the opinion which traditional medicine drugs can be satisfactorily sterilized by irradiation is based on the changes of physical and chemical properties of the products and microbiological examinations. The sterilizing radiation dose were calculated and the results are the following (in Mrad) Rheumatine-2.2, Hasinh-3.3, snake extract-1.8, Samcotgiao-2.2. The changes of physical and chemical properties of the products and their toxicity after irradiation have been shown to be not over the levels of allowance. (Author)
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An Ontology for Description of Drug Discovery Investigations
Directory of Open Access Journals (Sweden)
Qi Da
2010-12-01
Full Text Available The paper presents an ontology for the description of Drug Discovery Investigation (DDI. This has been developed through the use of a Robot Scientist “Eve”, and in consultation with industry. DDI aims to define the principle entities and the relations in the research and development phase of the drug discovery pipeline. DDI is highly transferable and extendable due to its adherence to accepted standards, and compliance with existing ontology resources. This enables DDI to be integrated with such related ontologies as the Vaccine Ontology, the Advancing Clinico-Genomic Trials on Cancer Master Ontology, etc. DDI is available at http://purl.org/ddi/wikipedia or http://purl.org/ddi/home
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Radiation sterilization of traditional medicine drugs in Vietnam
Energy Technology Data Exchange (ETDEWEB)
Hang, N.D.; Canh, T.T.; Thuy, T.T. [Nuclear Research Inst., Da Lat (Viet Nam)
1995-10-01
With the application of Gamma Co-60 radiation sterilization in pharmaceutical industry, attention should be paid to the possibilities of sterilizing traditional medicine drugs produced in Vietnam. In this paper the opinion which traditional medicine drugs can be satisfactorily sterilized by irradiation is based on the changes of physical and chemical properties of the products and microbiological examinations. The sterilizing radiation dose were calculated and the results are the following (in Mrad) Rheumatine-2.2, Hasinh-3.3, snake extract-1.8, Samcotgiao-2.2. The changes of physical and chemical properties of the products and their toxicity after irradiation have been shown to be not over the levels of allowance. (Author).
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Should tobacco and alcohol companies be allowed to influence Australia’s National Drug Strategy?
Directory of Open Access Journals (Sweden)
Becky Freeman
2017-04-01
Full Text Available Formation of Australia’s National Drug Strategy (NDS included an extensive consultation process that was open not only to community and public health stakeholders, but also to representatives of the tobacco and alcohol industries. Australia is bound by the World Health Organization Framework Convention on Tobacco Control, which requires governments to protect tobacco control measures from interference by the tobacco industry. NDS consultation submissions made by these conflicted industries are not publicly available for scrutiny. The NDS goals are at odds with the commercial agenda of industries that support regulatory stagnation, oppose and undermine effective action, ignore and distort evidence, and prioritise profits over health.
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New Product Introduction in the Pharmaceutical Industry
DEFF Research Database (Denmark)
Hansen, Klaus Reinholdt Nyhuus
Due to the limited time of the monopoly provided by patent protection that is used for recouping the R&D investment, pharmaceutical companies focus on keeping time-to-market for new products as short as possible. This process is however getting more uncertain, as the outcome of clinical trials...... is unknown and negotiations with authorities have become harder, making market introduction more difficult. This dissertation treats the new product introduction process in the pharmaceutical industry from an operations perspective. The overarching aim of this dissertation is to improve the planning...... uncertainty and several important industry characteristics. The model is used to gain several insights on the use of risk packaging and on keeping time-to-market short. As capacity in secondary pharmaceutical production is critical for product availability, a capacity planning model for a new drug delivery...
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The health and economic effects of counterfeit drugs.
Blackstone, Erwin A; Fuhr, Joseph P; Pociask, Steve
2014-06-01
Counterfeit drugs comprise an increasing percentage of the US drug market and even a larger percentage in less developed countries. Counterfeit drugs involve both lifesaving and lifestyle drugs. To review the health and economic consequences of counterfeit drugs on the US public and on the healthcare system as a whole. This comprehensive review of the literature encompassed a search of MEDLINE/PubMed, Google Scholar, and ProQuest using the keywords "counterfeit drugs," "counterfeit medicines," "fake drugs," and "fake medicines." A search of the various FiercePharma daily newsletter series on the healthcare market was also conducted. In addition, the US Food and Drug Administration and the World Health Organization websites were reviewed for additional information. The issue of counterfeit drugs has been growing in importance in the United States, with the supply of these counterfeit drugs coming from all over the world. Innovation is important to economic growth and US competitiveness in the global marketplace, and intellectual property protections provide the ability for society to prosper from innovation. Especially important in terms of innovation in healthcare are the pharmaceutical and biopharmaceutical industries. In addition to taking income from consumers and drug companies, counterfeit drugs also pose health hazards to patients, including death. The case of bevacizumab (Avastin) is presented as one recent example. Internet pharmacies, which are often the source of counterfeit drugs, often falsely portray themselves as Canadian, to enhance their consumer acceptance. Adding to the problems are drug shortages, which facilitate access for counterfeits. A long and convoluted supply chain also facilitates counterfeits. In addition, the wholesale market involving numerous firms is a convenient target for counterfeit drugs. Trafficking in counterfeits can be extremely profitable; detection of counterfeits is difficult, and the penalties are modest. Counterfeit
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Application of radiation in industrial processes (Paper No. IT-01)
International Nuclear Information System (INIS)
Murthy, T.S.
1990-02-01
The application of radiations both from gamma irradiation sources and electron beams has immense potential in diverse fields of industry and public health care programmes. The technical and economic effectiveness of radiation technology has been well demonstrated in different parts of the world and in India over last few years. The major applications for using this technology favourably considered all over the world include radiation sterilisation of medical products, hygienisation of sewage sludge, radiation processing of wood plastic composites, vulcanisation of natural rubber latex, cross linking of wires and cables using radiation, production of bio materials and drugs release systems and treatment of flue gases. Some of the areas which have been successfully exploited on an industrial or semi industrial scale in India and the current status of this programme is high lighted in this paper. (author). 9 refs
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Apollonio, Dorie; Glantz, Stanton A
2017-10-01
Nicotine replacement therapy (NRT) is recommended for tobacco cessation on the basis of pharmaceutical industry research showing its effectiveness when combined with counseling. The tobacco industry opposed NRT when it first appeared in the 1980s but by 2016 was marketing its own NRT products. We used internal tobacco industry documents dated 1960 through 2010 to identify the industry's perceptions of NRT. As early as the 1950s, tobacco companies developed nonsmoked nicotine replacements for cigarettes, but they stopped out of concern that marketing such products would trigger Food and Drug Administration regulation of cigarettes. In the 1990s, after pharmaceutical companies began selling prescription NRT, tobacco companies found that many smokers used NRT to supplement smoking rather than to quit. In 2009, once the Food and Drug Administration began regulating tobacco, tobacco companies restarted their plans to capture the nicotine market. Although the tobacco industry initially viewed NRT as a threat, it found that smokers often combined NRT with smoking rather than using it as a replacement and began marketing their own NRT products.
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Hoffmann, Torsten; Bishop, Cheryl
2010-04-01
At Roche, we set out to think about the future role of medicinal chemistry in drug discovery in a project involving both Roche internal stakeholders and external experts in drug discovery chemistry. To derive a coherent strategy, selected scientists were asked to take extreme positions and to derive two orthogonal strategic options: chemistry as the traditional mainstream science and chemistry as the central entrepreneurial science. We believe today's role of medicinal chemistry in industry has remained too narrow. To provide the innovation that industry requires, medicinal chemistry must play its part and diversify at pace with our increasing understanding of chemical biology and network pharmacology. 2010 Elsevier Ltd. All rights reserved.
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Ranjit Thakuria; Bipul Sarma
2018-01-01
The pre-formulation of pharmaceutical cocrystals and salts is a concept of crystal engineering that has emerged as a promising technique for drug development in pharmaceutical industry. Recent introduction of pharmaceutical cocrystals in regulatory guidelines of US Food and Drug Administration (FDA) made them one of the potential alternatives when salt preparation is not feasible. Apart from generally regarded as safe (GRAS) coformers, drug‑drug and drug‑nutraceutical cocrystals are recent ad...
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Lethal drugs in capital punishment in USA: History, present, and future perspectives.
Kas, Kristen; Yim, Richard; Traore, Salematou; ElFadaly, Marwa; Lang, Lynn; Freeman, Robert A; Parmar, Jayesh R; Kharel, Madan K
Lethal injection is the preferred method for the execution of condemned prisoners in the United States. A recent decision of The European Union to prohibit the export of drugs used in capital punishment to the USA along with domestic firms ceasing to manufacture these drugs has resulted in a drug shortage and a search for alternative drugs and new drug combinations that have not been previously validated for inducing death. As a consequence, some of the executions did not proceed as expected and sparked public debate regarding whether recent executions by lethal injection serve the purpose of avoiding "cruel and unusual punishment" in executions. Moreover, a cottage industry comprised of compounding pharmacies as emerged as a source of drug combinations used in capital punishment. Although there is a growing trend toward the abolishment of capital punishment in United States, the controversy concerning the efficacy of drug and involvement of health care professionals in the execution procedure is far from over. Copyright © 2015 Elsevier Inc. All rights reserved.
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Pharmacotherapy of schizophrenic patients: preponderance of off-label drug use.
Directory of Open Access Journals (Sweden)
David Pickar
Full Text Available Multiple drug class combinations are often prescribed for the treatment of schizophrenia, although antipsychotic monotherapy reflects FDA labeling and scientific justification for combinations is highly variable. This study was performed to gain current data regarding drug treatment of schizophrenia as practiced in the community and to assess the frequencies of off-label drug class combinations. 200 DSM IV-diagnosed schizophrenic patients recruited from community treatment sources participated in this cross-sectional study of community based schizophrenic patients. Drug class categories include First and Second Generation Antipsychotic drugs (FGA and SGA, respectively, mood stabilizers, antidepressants and anti-anxiety drugs. 25.5% of patients received antipsychotic monotherapy; 70% of patients received an antipsychotic and another drug class. A total of 42.5% of patients received more than one antipsychotic drug. The most common drug class combination was antipsychotic and a mood stabilizer. Stepwise linear discriminant function analysis identified the diagnosis of schizoaffective schizophrenia, history of having physically hurt someone and high scores on the General Portion of the PANSS rating scale predicted the combined use of an antipsychotic drug and a mood stabilizer. "Real world" pharmacotherapy of schizophrenia has developed its own established practice that is predominantly off-label and may have outstripped current data support. The economic implications for public sector payers are substantial as well as for the revenue of the pharmaceutical industry, whose promotion of off-label drug use is an increasingly problematic. These data are consistent with the recognition of the therapeutic limitations of both first and second generation antipsychotic drugs.
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Marketing pharmaceutical drugs to women in magazines: a content analysis.
Sokol, Jennifer; Wackowski, Olivia; Lewis, M J
2010-01-01
To examine the prevalence and content of pharmaceutical ads in demographically different women's magazines. A content analysis was conducted using one year's worth of 5 different women's magazines of varying age demographics. Magazines differed in the proportion of drug ads for different health conditions (eg, cardiovascular) and target audience by age demographic. Use of persuasive elements (types of appeals, evidence) varied by condition promoted (eg, mental-health drug ads more frequently used emotional appeals). Ads placed greater emphasis on direction to industry information resources than on physician discussions. Prevalence of pharmaceutical advertising in women's magazines is high; continued surveillance is recommended.
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Liposome Technology for Industrial Purposes
Directory of Open Access Journals (Sweden)
Andreas Wagner
2011-01-01
Full Text Available Liposomes, spherical vesicles consisting of one or more phospholipid bilayers, were first described in the mid 60s by Bangham and coworkers. Since then, liposomes have made their way to the market. Today, numerous lab scale but only a few large-scale techniques are available. However, a lot of these methods have serious limitations in terms of entrapment of sensitive molecules due to their exposure to mechanical and/or chemical stress. This paper summarizes exclusively scalable techniques and focuses on strengths, respectively, limitations in respect to industrial applicability. An additional point of view was taken to regulatory requirements concerning liposomal drug formulations based on FDA and EMEA documents.
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Qi, Xiaole; Wang, Lishuang; Zhu, Jiabi; Hu, Zhenyi; Zhang, Jie
2011-05-16
Water-in-oil-in-water (w/o/w) double emulsions are potential for enhancing oral bioavailability of drugs with high solubility and low permeability, but their industrial application is limited due to the instability. Herein, we developed a novel formulation, self-double-emulsifying drug delivery systems (SDEDDS) by formulating mixtures of hydrophilic surfactants and water-in-oil (w/o) emulsions, which were easier to be stable through formulations optimization. SDEDDS can spontaneously emulsify to water-in-oil-in-water (w/o/w) double emulsions in the mixed aqueous gastrointestinal environment, with drugs encapsulated in the internal water phase of the double emulsions. We employed SDEDDS to improve the oral absorption of pidotimod, a peptide-like drug with high solubility and low permeability. The optimized pidotimod-SDEDDS were found to be stable up to 6 months under 25°C. Plasma concentration-time profiles from pharmacokinetic studies in rats dosed with SDEDDS showed 2.56-fold (p<0.05) increased absorption of pidotimod, compared to the pidotimod solution. Histopathologic studies confirmed that SDEDDS exerted absorption promoting effect without serious local damages. These studies demonstrate that SDEDDS may be a promising strategy for peroral delivery of peptide and peptidomimetic drugs. Copyright © 2011 Elsevier B.V. All rights reserved.
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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.
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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.
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Claims in advertisements for anti hypertensive drugs in a Dutch medical journal
Greving, Jacoba P.; Denig, Petra; de Zeeuw, Dick; Haaijer-Ruskamp, Flora M.
Background Advertising claims must not conflict with the official summary of product characteristics. After a drug has been approved, new clinical evidence may become available. Aims To determine how the pharmaceutical industry deals with evolving clinical evidence in advertising claims for anti
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Directory of Open Access Journals (Sweden)
Anna Nowacka
2010-12-01
Full Text Available This article refers to the phenomenon of an increasing number of people abusing drugs in the 20th century. In addition to the natural types of narcotics there are many other semi-synthetic and fully synthetic substances made available to the market by chemical and pharmaceutical industries. The use of narcotics and psychoactive substances usually causes adverse and often irreversible health effects. In Department of Laboratory Diagnostics of the Institute of Occupational Medicine and Environmental Health in Sosnowiec tests for presence of drugs are among routinely conducted analyses. The presence of drugs has been revealed in 898 cases between the years 2004 and 2008. On top of the list of the most frequently detected narcotics were: amphetamine, cannabis, opiates, methamphetamine and cocaine. At the same time the most popular psychoactive substances are atropine, scopolamine and psilocybin. Additionally, the laboratory analyses indicated in many cases the presence of derivatives of benzodiazepines, trycyclic antidepressants and alcohol. Regional Centre of Acute Intoxication in Sosnowiec, Poland, hospitalized 78 patients due to overdose of drugs, narcotics or psychoactive substances as a result of experimenting with such substances. Half of the hospitalized cases patients have tried to commit suicide; one of the attempts has led to death. According to patients’ history their problems with reaching out for the use of psychoactive substances and narcotics were mainly caused by socio-psychological disorders.
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5-FU Metabolism in Cancer and Orally-Administrable 5-FU Drugs
Directory of Open Access Journals (Sweden)
Iwao Sasaki
2010-09-01
Full Text Available 5-Fluorouracil (5-FU is a key anticancer drug that for its broad antitumor activity, as well as for its synergism with other anticancer drugs, has been used to treat various types of malignancies. In chemotherapeutic regimens, 5-FU has been combined with oxaliplatin, irinotecan and other drugs as a continuous intravenous infusion. Recent clinical chemotherapy studies have shown that several of the regimens with oral 5-FU drugs are not inferior compared to those involving continuous 5-FU infusion chemotherapy, and it is probable that in some regimens continuous 5-FU infusion can be replaced by oral 5-FU drugs. Historically, both the pharmaceutical industry and academia in Japan have been involved in the development of oral 5-FU drugs, and this review will focus on the current knowledge of 5-FU anabolism and catabolism, and the available information about the various orally-administrable 5-FU drugs, including UFT, S-1 and capecitabine. Clinical studies comparing the efficacy and adverse events of S-1 and capecitabine have been reported, and the accumulated results should be utilized to optimize the treatment of cancer patients. On the other hand, it is essential to elucidate the pharmacokinetic mechanism of each of the newly-developed drugs, to correctly select the drugs for each patient in the clinical setting, and to further develop optimized drug derivatives.
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A History of Drug Advertising: The Evolving Roles of Consumers and Consumer Protection
Donohue, Julie
2006-01-01
Direct-to-consumer advertising (DTCA) of prescription drugs in the United States is controversial. Underlying the debate are disagreements over the role of consumers in medical decision making, the appropriateness of consumers engaging in self-diagnosis, and the ethics of an industry promoting potentially dangerous drugs. Drug advertising and federal policy governing drug advertising have both responded to and reinforced changes in the consumer's role in health care and in the doctor-patient relationship over time. This article discusses the history of DTCA in the context of social movements to secure rights for health care patients and consumers, the modern trend toward consumer-oriented medicine, and the implications of DTCA and consumer-oriented medicine for contemporary health policy debates about improving the health care system. PMID:17096638
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A history of drug advertising: the evolving roles of consumers and consumer protection.
Donohue, Julie
2006-01-01
Direct-to-consumer advertising (DTCA) of prescription drugs in the United States is controversial. Underlying the debate are disagreements over the role of consumers in medical decision making, the appropriateness of consumers engaging in self-diagnosis, and the ethics of an industry promoting potentially dangerous drugs. Drug advertising and federal policy governing drug advertising have both responded to and reinforced changes in the consumer's role in health care and in the doctor-patient relationship over time. This article discusses the history of DTCA in the context of social movements to secure rights for health care patients and consumers, the modern trend toward consumer-oriented medicine, and the implications of DTCA and consumer-oriented medicine for contemporary health policy debates about improving the health care system.
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[AIDS and social justice: pharmaceutical industry and economics].
López Guzmán, José
2008-01-01
This article takes a broad look at the complicated framework of relationships between the third world and pharmaceutical companies. In the first part of the work reference is made to the poverty of these countries, their lack of education in terms of health, the scarcity of basic hygiene, and their greatly limited access to medicines, especially those for treating AIDS. The article then proceeds to the issue of the pharmaceutical companies' degree of responsibility for the reduced availability of medicines in certain areas of the world. One of the factors that most limits access to medicines is their price, and many sectors of society propose taking action on the patents of drugs (rescinding or limiting them) in order to lower their price. However, the problem of patent exemption is more complicated than it seems at first glance, and comes with its own risks. If, for lack of funds or the uncertainty concerning a return on the capital invested, pharmaceutical companies discontinue research and development of new drugs, AIDS therapy would worsen. It is imperative and urgent to develop new drugs against the AIDS because of its resistance to the drugs currently available. The article concludes with the pharmaceutical industry's effort to look for possible forms of collaboration with developing countries.
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A side-effect free method for identifying cancer drug targets.
Ashraf, Md Izhar; Ong, Seng-Kai; Mujawar, Shama; Pawar, Shrikant; More, Pallavi; Paul, Somnath; Lahiri, Chandrajit
2018-04-27
Identifying effective drug targets, with little or no side effects, remains an ever challenging task. A potential pitfall of failing to uncover the correct drug targets, due to side effect of pleiotropic genes, might lead the potential drugs to be illicit and withdrawn. Simplifying disease complexity, for the investigation of the mechanistic aspects and identification of effective drug targets, have been done through several approaches of protein interactome analysis. Of these, centrality measures have always gained importance in identifying candidate drug targets. Here, we put forward an integrated method of analysing a complex network of cancer and depict the importance of k-core, functional connectivity and centrality (KFC) for identifying effective drug targets. Essentially, we have extracted the proteins involved in the pathways leading to cancer from the pathway databases which enlist real experimental datasets. The interactions between these proteins were mapped to build an interactome. Integrative analyses of the interactome enabled us to unearth plausible reasons for drugs being rendered withdrawn, thereby giving future scope to pharmaceutical industries to potentially avoid them (e.g. ESR1, HDAC2, F2, PLG, PPARA, RXRA, etc). Based upon our KFC criteria, we have shortlisted ten proteins (GRB2, FYN, PIK3R1, CBL, JAK2, LCK, LYN, SYK, JAK1 and SOCS3) as effective candidates for drug development.
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Directory of Open Access Journals (Sweden)
Ahmed TA
2016-02-01
Full Text Available Tarek A Ahmed1,2 1Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia; 2Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt Abstract: In this study, optimized freeze-dried finasteride nanoparticles (NPs were prepared from drug nanosuspension formulation that was developed using the bottom–up technique. The effects of four formulation and processing variables that affect the particle size and solubility enhancement of the NPs were explored using the response surface optimization design. The optimized formulation was morphologically characterized using transmission electron microscopy (TEM. Physicochemical interaction among the studied components was investigated. Crystalline change was investigated using X-ray powder diffraction (XRPD. Crystal growth of the freeze-dried NPs was compared to the corresponding aqueous drug nanosuspension. Freeze-dried NPs formulation was subsequently loaded into hard gelatin capsules that were examined for in vitro dissolution and pharmacokinetic behavior. Results revealed that in most of the studied variables, some of the quadratic and interaction effects had a significant effect on the studied responses. TEM image illustrated homogeneity and shape of the prepared NPs. No interaction among components was noticed. XRPD confirmed crystalline state change in the optimized NPs. An enhancement in the dissolution rate of more than 2.5 times from capsules filled with optimum drug NPs, when compared to capsules filled with pure drug, was obtained. Crystal growth, due to Ostwald ripening phenomenon and positive Gibbs free energy, was reduced following lyophilization of the nanosuspension formulation. Pharmacokinetic parameters from drug NPs were superior to that of pure drug and drug microparticles. In conclusion, freeze-dried NPs based on drug nanosuspension formulation is a successful
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Groves, K E M; Sketris, I; Tett, S E
2003-08-01
Prescription drug samples, as used by the pharmaceutical industry to market their products, are of current interest because of their influence on prescribing, and their potential impact on consumer safety. Very little research has been conducted into the use and misuse of prescription drug samples, and the influence of samples on health policies designed to improve the rational use of medicines. This is a topical issue in the prescription drug debate, with increasing costs and increasing concerns about optimizing use of medicines. This manuscript critically evaluates the research that has been conducted to date about prescription drug samples, discusses the issues raised in the context of traditional marketing theory, and suggests possible alternatives for the future.
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The rise of fragment-based drug discovery.
Murray, Christopher W; Rees, David C
2009-06-01
The search for new drugs is plagued by high attrition rates at all stages in research and development. Chemists have an opportunity to tackle this problem because attrition can be traced back, in part, to the quality of the chemical leads. Fragment-based drug discovery (FBDD) is a new approach, increasingly used in the pharmaceutical industry, for reducing attrition and providing leads for previously intractable biological targets. FBDD identifies low-molecular-weight ligands (∼150 Da) that bind to biologically important macromolecules. The three-dimensional experimental binding mode of these fragments is determined using X-ray crystallography or NMR spectroscopy, and is used to facilitate their optimization into potent molecules with drug-like properties. Compared with high-throughput-screening, the fragment approach requires fewer compounds to be screened, and, despite the lower initial potency of the screening hits, offers more efficient and fruitful optimization campaigns. Here, we review the rise of FBDD, including its application to discovering clinical candidates against targets for which other chemistry approaches have struggled.
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A comparison of machine learning techniques for detection of drug target articles.
Danger, Roxana; Segura-Bedmar, Isabel; Martínez, Paloma; Rosso, Paolo
2010-12-01
Important progress in treating diseases has been possible thanks to the identification of drug targets. Drug targets are the molecular structures whose abnormal activity, associated to a disease, can be modified by drugs, improving the health of patients. Pharmaceutical industry needs to give priority to their identification and validation in order to reduce the long and costly drug development times. In the last two decades, our knowledge about drugs, their mechanisms of action and drug targets has rapidly increased. Nevertheless, most of this knowledge is hidden in millions of medical articles and textbooks. Extracting knowledge from this large amount of unstructured information is a laborious job, even for human experts. Drug target articles identification, a crucial first step toward the automatic extraction of information from texts, constitutes the aim of this paper. A comparison of several machine learning techniques has been performed in order to obtain a satisfactory classifier for detecting drug target articles using semantic information from biomedical resources such as the Unified Medical Language System. The best result has been achieved by a Fuzzy Lattice Reasoning classifier, which reaches 98% of ROC area measure. Copyright © 2010 Elsevier Inc. All rights reserved.
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Integrating scientific data for drug discovery and development using the Life Sciences Grid.
Dow, Ernst R; Hughes, James B; Stephens, Susie M; Narayan, Vaibhav A; Bishop, Richard W
2009-06-01
There are many daunting challenges for companies who wish to bring novel drugs to market. The information complexity around potential drug targets has increased greatly with the introduction of microarrays, high-throughput screening and other technological advances over the past decade, but has not yet fundamentally increased our understanding of how to modify a disease with pharmaceuticals. Further, the bar has been raised in getting a successful drug to market as just being new is no longer enough: the drug must demonstrate improved performance compared with the ever increasing generic pharmacopeia to gain support from payers and government authorities. In addition, partly as a consequence of a climate of concern regarding the safety of drugs, regulatory authorities have approved fewer new molecular entities compared to historical norms over the past few years. To overcome these challenges, the pharmaceutical industry must fully embrace information technology to bring better understood compounds to market. An important first step in addressing an unmet medical need is in understanding the disease and identifying the physiological target(s) to be modulated by the drug. Deciding which targets to pursue for a given disease requires a multidisciplinary effort that integrates heterogeneous data from many sources, including genetic variations of populations, changes in gene expression and biochemical assays. The Life Science Grid was developed to provide a flexible framework to integrate such diverse biological, chemical and disease information to help scientists make better-informed decisions. The Life Science Grid has been used to rapidly and effectively integrate scientific information in the pharmaceutical industry and has been placed in the open source community to foster collaboration in the life sciences community.
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Gut microbiota in toxicological risk assessment of drugs and chemicals: The need of hour.
Velmurugan, Ganesan
2018-03-06
The advent of industrial revolution caused a large inflow of synthetic chemicals for medical, agricultural, industrial and other purposes in the world. In general, these chemicals were subjected to toxicological risk assessment for human health and ecology before release for public use. But today we are witnessing a negative impact of some of these chemicals on human health and environment indicating an underestimation of toxic effects by current risk assessment protocol. Recent studies established gut microbiota as one of the key player in intercession of toxicity of drugs and synthetic chemicals. Hence, the need of the hour is to include the assessment for microbiota specifically gut microbiota in human toxicological risk assessment protocol. Herewith we are proposing a framework for assessment of gut microbiota upon exposure to drugs or chemicals.
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Preferred supplier contracts in post-patent prescription drug markets.
Blankart, Carl Rudolf; Stargardt, Tom
2016-02-22
In recent years, the expiration of patents for large drug classes has increased the importance of post-patent drug markets. However, previous research has focused solely on patent drug markets. In this study, the authors evaluate the influence of preferred supplier contracts, the German approach to tendering, in post-patent drug markets using a hierarchical market share attraction model. The authors find that preferred supplier contracts are a powerful strategic instrument for generic manufacturers in a highly competitive environment. They quantify the effects of signing a preferred supplier contract and show that brand-name manufacturers are vulnerable to tendering. Therefore, brand-name manufacturers should readjust their strategies and consider including preferred supplier contracts in their marketing mix. In addition, the authors employ a simulation to demonstrate that a first-mover advantage might be gained from signing a preferred supplier contract. Furthermore, their results can be used as a blueprint for decision makers in the pharmaceutical industry to assess the market share effects of different contracting strategies regarding preferred supplier contracts.
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On being a neurologist in industry.
Leppert, David; Glanzman, Robert
2013-03-01
Neurologists in the pharmaceutical industry have an attractive and rewarding career path that offers the chance to participate in large projects, contribute directly to clinical breakthroughs in drug development, and translate biomarker research into applied practice. This article describes the different and common features of corporate compared to academic environments, and highlights the key factors necessary for success in the business world. Integrity, communication skills, an open-minded attitude, and an ability to handle stress and manage complex organizational structures are prerequisites that enable physician-neuroscientists to pursue successful and exciting careers in the corporate environment. Copyright © 2013 American Neurological Association.
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Drugs@FDA: FDA Approved Drug Products
... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...
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Pharmaceutical cocrystals: the coming wave of new drug substances.
Brittain, Harry G
2013-02-01
Solid crystalline phases containing two cocrystallized components offer a new development pathway whereby one can potentially improve the physical characteristics (i.e., equilibrium solubility, dissolution rate, solid-state stability, etc.) of a drug substance that exhibits a profile that is less than desirable. In this commentary, the topic of pharmaceutical cocrystals will be briefly explored, and a short exposition of the solubility and dissolution rate advantages that have been realized in various systems will be provided. The Guidance for Industry document recently proposed by United States Food and Drug Administration will be outlined, and its requirements explained. Finally, the subset of pharmaceutical cocrystals that consist of a drug substance and a salt of that substance (termed a salt cocrystal) will be examined to illustrate this additional class of pharmaceutical cocrystals that may offer significant scientific and regulatory advantages. Copyright © 2012 Wiley Periodicals, Inc.
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Energy Technology Data Exchange (ETDEWEB)
Marvillet, Ch. [Ecole Centrale de Lyon, 69 - Ecully (France); Groupement pour la Recherche sur les Echangeurs Thermiques, GRETh (France)
2001-10-01
Refrigeration is used in most of the industrial domains: food industry (conservation of the organoleptic properties and sanitary quality of products, control of fermentation, of juice concentration and of the dehydration of products), transformation industries (plastic industry, rubber industry, mechanical industry (fretting, hardening and surface treatment of materials, dehumidification of compressed air), liquefaction and purification of industrial gases and hydrocarbons, processing of wastes (removal of VOCs, purification of liquid effluents etc..), civil engineering (consolidation of soils, cooling of big concrete structures), leisure (skating rink, artificial snow). (J.S.)
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Abraham, John; Davis, Courtney
2005-09-01
By going beyond individual case studies and solely quantitative surveys, this paper systematically examines why there were over twice as many new prescription drugs withdrawn from the market on grounds of safety in the UK as there were in the US between 1971 and 1992. Drawing on interviews with regulators, industry scientists and others involved, and on regulatory data never before accessed outside governments and companies, five key hypotheses which might explain this difference in drug safety withdrawals are analysed. These are: (1) simply because the UK approved more new drugs than the US; (2) because of an industrial corporate strategy to seek approval of 'less safe' drugs in the UK earlier; (3) because British regulators were more vigilant at spotting post-marketing safety problems than their US counterparts; (4) because the slowness of the US in approving new drugs enabled regulators there to learn from, and avoid, safety problems that had already emerged in the UK or European market; and (5) because more stringent regulation in the US meant that they approved fewer unsafe drugs on to the market in the first place. It is concluded that the main explanation for fewer drug safety withdrawals in the US is that the regulatory agency there applied more stringent pre-market review and/or standards, which took longer than UK regulatory checks, but prevented unsafe drugs marketed in the UK from entering the US market. Contrary to the claims frequently made by the pharmaceutical industry and regulatory agencies on both sides of the Atlantic, these results imply that it is likely that acceleration of regulatory review times in the US and the UK since the early 1990s is compromising drug safety.
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2012-10-01
... bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. This draft... infection caused by bacterial pathogens that show resistance to most antibacterial drugs on in vitro...
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[Occupational digestive diseases in chemical industry workers of West Siberia].
Pomytkina, T E; Pershin, A N
2010-01-01
The high incidence of chronic digestive diseases is recorded in chemical industry workers exposed to the isolated action of noxious substances. The aim of the investigation was to make a hygienic assessment of the risk for occupational digestive diseases in chemical industry workers exposed to a combination of noxious drugs. The working conditions and the prevalence of digestive diseases were studied in 4120 workers engaged in chemical and auxiliary processes. Under the isolated action of noxious substances, the workers had an average of 35% increase in the incidence of digestive diseases than unexposed ones (p 4.0-11.1 and 3.5-10.7 times higher, respectively (p < 0.05) than in the unexposed subjects.
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Chen, Dengyue; Sirkar, Kamalesh K; Jin, Chi; Singh, Dhananjay; Pfeffer, Robert
2017-01-01
Membrane technologies are of increasing importance in a variety of separation and purification applications involving liquid phases and gaseous mixtures. Although the most widely used applications at this time are in water treatment including desalination, there are many applications in chemical, food, healthcare, paper and petrochemical industries. This brief review is concerned with existing and emerging applications of various membrane technologies in the pharmaceutical and biopharmaceutical industry. The goal of this review article is to identify important membrane processes and techniques which are being used or proposed to be used in the pharmaceutical and biopharmaceutical operations. How novel membrane processes can be useful for delivery of crystalline/particulate drugs is also of interest. Membrane separation technologies are extensively used in downstream processes for bio-pharmaceutical separation and purification operations via microfiltration, ultrafiltration and diafiltration. Also the new technique of membrane chromatography allows efficient purification of monoclonal antibodies. Membrane filtration techniques of reverse osmosis and nanofiltration are being combined with bioreactors and advanced oxidation processes to treat wastewaters from pharmaceutical plants. Nanofiltration with organic solvent-stable membranes can implement solvent exchange and catalyst recovery during organic solvent-based drug synthesis of pharmaceutical compounds/intermediates. Membranes in the form of hollow fibers can be conveniently used to implement crystallization of pharmaceutical compounds. The novel crystallization methods of solid hollow fiber cooling crystallizer (SHFCC) and porous hollow fiber anti-solvent crystallization (PHFAC) are being developed to provide efficient methods for continuous production of polymer-coated drug crystals in the area of drug delivery. This brief review provides a general introduction to various applications of membrane technologies in
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Medical students' exposure to and attitudes about the pharmaceutical industry: a systematic review.
Directory of Open Access Journals (Sweden)
Kirsten E Austad
2011-05-01
Full Text Available The relationship between health professionals and the pharmaceutical industry has become a source of controversy. Physicians' attitudes towards the industry can form early in their careers, but little is known about this key stage of development.We performed a systematic review reported according to PRISMA guidelines to determine the frequency and nature of medical students' exposure to the drug industry, as well as students' attitudes concerning pharmaceutical policy issues. We searched MEDLINE, EMBASE, Web of Science, and ERIC from the earliest available dates through May 2010, as well as bibliographies of selected studies. We sought original studies that reported quantitative or qualitative data about medical students' exposure to pharmaceutical marketing, their attitudes about marketing practices, relationships with industry, and related pharmaceutical policy issues. Studies were separated, where possible, into those that addressed preclinical versus clinical training, and were quality rated using a standard methodology. Thirty-two studies met inclusion criteria. We found that 40%-100% of medical students reported interacting with the pharmaceutical industry. A substantial proportion of students (13%-69% were reported as believing that gifts from industry influence prescribing. Eight studies reported a correlation between frequency of contact and favorable attitudes toward industry interactions. Students were more approving of gifts to physicians or medical students than to government officials. Certain attitudes appeared to change during medical school, though a time trend was not performed; for example, clinical students (53%-71% were more likely than preclinical students (29%-62% to report that promotional information helps educate about new drugs.Undergraduate medical education provides substantial contact with pharmaceutical marketing, and the extent of such contact is associated with positive attitudes about marketing and skepticism
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Shah, Vinod P; Amidon, Gordon L
2014-09-01
The Biopharmaceutics Classification System (BCS) has become widely accepted today in the academic, industrial, and regulatory world. While the initial application of the BCS was to regulatory science bioequivalence (BE) issues and related implications, it has come to be utilized widely by the pharmaceutical industry in drug discovery and development as well. This brief manuscript will relate the story of the BCS development. While much of the ground work for the BCS goes back to the pharmacokinetic and drug absorption research by Gordon Amidon (GLA) in the 1970s and 1980s, the realization of the need for a classification or categorization of drug and drug products for setting dissolution standards became apparent to GLA during his 1990-1991 sabbatical year at the FDA. Initiated at the invitation of the then CEDR director, Dr. Carl Peck, to become a visiting scientist at the FDA, the goal was to promote regulatory research at the FDA, in my case, in biopharmaceutics, and to develop a science-based system to simplify regulatory requirements.
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Drug discovery and development tomorrow -- changing the mindset.
Coleman, Robert A
2009-09-01
Today's drug discovery and development paradigm is not working, and something needs to be done about it. There is good reason to believe that a move away from reliance on animal surrogates for human subjects in the Pharma Industry's R&D programmes could provide an important step forward. However, no serious move will be made in that direction until there is some hard evidence that it will be rewarded with improved productivity outcomes. The Safer Medicines Trust are proposing that a study be undertaken, involving a range of drugs that have been approved for human use, but have subsequently proved to have limitations in terms of safety and/or efficacy. The aim is to determine the efficiency of a battery of human-based test methods to identify a compound's safety and efficacy profiles, and to compare this with that of the more traditional, largely animal-based methods that were employed in their original development. Should such an approach prove more reliable, the authorities will be faced with important decisions relating to the role of human biological test data in regulatory submissions, while the Pharma Industry will be faced with the key logistical issue of how to acquire the human biomaterials necessary to make possible the routine application of such test methods. 2009 FRAME.
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Adamo, Michael; Sun, Guoyong; Qiu, Difei; Valente, Joseph; Lan, Wenkui; Song, Hangtian; Bolgar, Mark; Katiyar, Amit; Krishnamurthy, Girija
2017-01-20
Antibody drug conjugates or ADCs are currently being evaluated for their effectiveness as targeted chemotherapeutic agents across the pharmaceutical industry. Due to the complexity arising from the choice of antibody, drug and linker; analytical methods for release and stability testing are required to provide a detailed understanding of both the antibody and the drug during manufacturing and storage. The ADC analyzed in this work consists of a tubulysin drug analogue that is randomly conjugated to lysine residues in a human IgG1 antibody. The drug is attached to the lysine residue through a peptidic, hydrolytically stable, cathepsin B cleavable linker. The random lysine conjugation produces a heterogeneous mixture of conjugated species with a variable drug-to-antibody ratio (DAR), therefore, the average amount of drug attached to the antibody is a critical parameter that needs to be monitored. In this work we have developed a universal method for determining DAR in ADCs that employ a cathepsin B cleavable linker. The ADC is first cleaved at the hinge region and then mildly reduced prior to treatment with the cathepsin B enzyme to release the drug from the antibody fragments. This pre-treatment allows the cathepsin B enzyme unrestricted access to the cleavage sites and ensures optimal conditions for the cathepsin B to cleave all the drug from the ADC molecule. The cleaved drug is then separated from the protein components by reversed phase high performance liquid chromatography (RP-HPLC) and quantitated using UV absorbance. This method affords superior cleavage efficiency to other methods that only employ a cathepsin digestion step as confirmed by mass spectrometry analysis. This method was shown to be accurate and precise for the quantitation of the DAR for two different random lysine conjugated ADC molecules. Copyright © 2016 Elsevier B.V. All rights reserved.
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Common errors of drug administration in infants: causes and avoidance.
Anderson, B J; Ellis, J F
1999-01-01
Drug administration errors are common in infants. Although the infant population has a high exposure to drugs, there are few data concerning pharmacokinetics or pharmacodynamics, or the influence of paediatric diseases on these processes. Children remain therapeutic orphans. Formulations are often suitable only for adults; in addition, the lack of maturation of drug elimination processes, alteration of body composition and influence of size render the calculation of drug doses complex in infants. The commonest drug administration error in infants is one of dose, and the commonest hospital site for this error is the intensive care unit. Drug errors are a consequence of system error, and preventive strategies are possible through system analysis. The goal of a zero drug error rate should be aggressively sought, with systems in place that aim to eliminate the effects of inevitable human error. This involves review of the entire system from drug manufacture to drug administration. The nuclear industry, telecommunications and air traffic control services all practise error reduction policies with zero error as a clear goal, not by finding fault in the individual, but by identifying faults in the system and building into that system mechanisms for picking up faults before they occur. Such policies could be adapted to medicine using interventions both specific (the production of formulations which are for children only and clearly labelled, regular audit by pharmacists, legible prescriptions, standardised dose tables) and general (paediatric drug trials, education programmes, nonpunitive error reporting) to reduce the number of errors made in giving medication to infants.
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Menthol cigarettes and smoking initiation: a tobacco industry perspective
Klausner, Kim
2011-01-01
Objectives To determine what the tobacco industry knew about menthol cigarettes and the initiation of smoking. Methods Based on Food and Drug Administration staff-supplied research questions we used a snowball sampling strategy to search the Legacy Tobacco Documents Library (http://legacy.library.ucsf.edu) between February and April 2010. Of the approximately 11 million documents available in the LTDL, the iterative searches returned tens of thousands of results. Researchers reviewed 2634 doc...
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Microemulsion utility in pharmaceuticals: Implications for multi-drug delivery.
Callender, Shannon P; Mathews, Jessica A; Kobernyk, Katherine; Wettig, Shawn D
2017-06-30
Emulsion technology has been utilized extensively in the pharmaceutical industry. This article presents a comprehensive review of the literature on an important subcategory of emulsions, microemulsions. Microemulsions are optically transparent, thermodynamically stable colloidal systems, 10-100nm diameter, that form spontaneously upon mixing of oil, water and emulsifier. This review is the first to address advantages and disadvantages, as well as considerations and challenges in multi-drug delivery. For the period 1 January 2011-30 April 2016, 431 publications related to microemulsion drug delivery were identified and screened according to microemulsion, drug classification, and surfactant types. Results indicate the use of microemulsions predominantly in lipophilic drug delivery (79.4%) via oil-in-water microemulsions and non-ionic surfactants (90%) for oral or topical administration. Cancer is the disease state most targeted followed by inflammatory diseases, microbial infections and cardiovascular disease. Key generalizations from this analysis include: 1) microemulsion formulation is largely based on trial-and-error despite over 1200 publications related to microemulsion drug delivery since their discovery in 1943; 2) characterization using methods including interfacial tension, droplet size, electrical conductivity, turbidity and viscosity may provide additional information for greater predictability; 3) microemulsion drug delivery publications arise primarily from China (27%) and India (21%) suggesting additional research opportunities elsewhere. Copyright © 2017 Elsevier B.V. All rights reserved.
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McGivern, Jered V; Ebert, Allison D
2014-04-01
In order for the pharmaceutical industry to maintain a constant flow of novel drugs and therapeutics into the clinic, compounds must be thoroughly validated for safety and efficacy in multiple biological and biochemical systems. Pluripotent stem cells, because of their ability to develop into any cell type in the body and recapitulate human disease, may be an important cellular system to add to the drug development repertoire. This review will discuss some of the benefits of using pluripotent stem cells for drug discovery and safety studies as well as some of the recent applications of stem cells in drug screening studies. We will also address some of the hurdles that need to be overcome in order to make stem cell-based approaches an efficient and effective tool in the quest to produce clinically successful drug compounds. Copyright © 2013 Elsevier B.V. All rights reserved.
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Smith, Meredith Y; Benattia, Isma
2016-09-01
Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point. Rising rates of per capita prescription drug use underscore the importance of having robust pharmacovigilance systems in place to detect and assess adverse drug reactions (ADRs). At the same time, the practice of pharmacovigilance is being transformed by a host of recent regulatory guidances and related initiatives which emphasize the importance of the patient's perspective in drug safety. Collectively, these initiatives impact the full range of activities that fall within the remit of pharmacovigilance, including ADR reporting, signal detection and evaluation, risk management, medication error assessment, benefit-risk assessment and risk communication. Examples include the fact that manufacturing authorization holders are now expected to monitor all digital sources under their control for potential reports of ADRs, and the emergence of new methods for collecting, analysing and reporting patient-generated ADR reports for signal detection and evaluation purposes. A drug safety department's ability to transition successfully into a more patient-centric organization will depend on three defining attributes: (1) a patient-centered culture; (2) deployment of a framework to guide patient engagement activities; and (3) demonstrated proficiency in patient-centered competencies, including patient engagement, risk communication and patient preference assessment. Whether, and to what extent, drug safety departments embrace the new patient-centric imperative, and the methods and
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Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics
Directory of Open Access Journals (Sweden)
Ryan D. Rykhus
2017-12-01
Full Text Available Over the past two decades, the biopharmaceutical industry has seen unprecedented expansion and innovation in concert with significant technological advancements. While the industry has experienced marked growth, the regulatory system in the United States still operates at a capacity much lower than the influx of new drug and biologic candidates. As a result, it has become standard for months or even years of waiting for commercial approval by the U.S. Food and Drug Administration. These regulatory delays have generated a system that stifles growth and innovation due to the exorbitant costs associated with awaiting approval from the nation’s sole regulatory agency. The recent re-emergence of diseases that impact pediatric demographics represents one particularly acute reason for developing a regulatory system that facilitates a more efficient commercial review process. Herein, we present a range of initiatives that could represent early steps toward alleviating the delays in approving life-saving therapeutics.
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Oral formulation strategies to improve solubility of poorly water-soluble drugs.
Singh, Abhishek; Worku, Zelalem Ayenew; Van den Mooter, Guy
2011-10-01
In the past two decades, there has been a spiraling increase in the complexity and specificity of drug-receptor targets. It is possible to design drugs for these diverse targets with advances in combinatorial chemistry and high throughput screening. Unfortunately, but not entirely unexpectedly, these advances have been accompanied by an increase in the structural complexity and a decrease in the solubility of the active pharmaceutical ingredient. Therefore, the importance of formulation strategies to improve the solubility of poorly water-soluble drugs is inevitable, thus making it crucial to understand and explore the recent trends. Drug delivery systems (DDS), such as solid dispersions, soluble complexes, self-emulsifying drug delivery systems (SEDDS), nanocrystals and mesoporous inorganic carriers, are discussed briefly in this review, along with examples of marketed products. This article provides the reader with a concise overview of currently relevant formulation strategies and proposes anticipated future trends. Today, the pharmaceutical industry has at its disposal a series of reliable and scalable formulation strategies for poorly soluble drugs. However, due to a lack of understanding of the basic physical chemistry behind these strategies, formulation development is still driven by trial and error.
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Pharmacogenetics in diverse ethnic populations--implications for drug discovery and development.
McCarthy, Linda C; Davies, Kirstie J; Campbell, David A
2002-07-01
It is widely acknowledged that the vast quantities of data now publicly available as a result of the human genome initiative have the potential to revolutionize the pharmaceutical industry. More tangibly to the drug development business, the dawn of the pharmacogenetics era has the potential to impact not only the discovery of new medicines but also the safety and efficacy of pharmaceutical agents. Coincident with these scientific advances is the emergence of new markets for pharmaceutical agents. Japan, which represents the world's second biggest market, is a good example. With the ICH E5 agreement in 1998 and a rapid change in the drug registration process in Japan, there are increasing opportunities to improve access to more medicines in all parts of the world. However, it is increasingly clear that significant genetic variation still exists between populations, with a host of data on interethnic variation in drug metabolizing enzyme and drug transporter activity. Evidence suggesting that this genetic variation may play an important role in defining some of the interethnic variation in drug response to currently marketed compounds is reviewed here, and future possibilities of using such information to better streamline the drug development process are discussed.
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Controlling type I error rate for fast track drug development programmes.
Shih, Weichung J; Ouyang, Peter; Quan, Hui; Lin, Yong; Michiels, Bart; Bijnens, Luc
2003-03-15
The U.S. Food and Drug Administration (FDA) Modernization Act of 1997 has a Section (No. 112) entitled 'Expediting Study and Approval of Fast Track Drugs' (the Act). In 1998, the FDA issued a 'Guidance for Industry: the Fast Track Drug Development Programs' (the FTDD programmes) to meet the requirement of the Act. The purpose of FTDD programmes is to 'facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs'. Since then many health products have reached patients who suffered from AIDS, cancer, osteoporosis, and many other diseases, sooner by utilizing the Fast Track Act and the FTDD programmes. In the meantime several scientific issues have also surfaced when following the FTDD programmes. In this paper we will discuss the concept of two kinds of type I errors, namely, the 'conditional approval' and the 'final approval' type I errors, and propose statistical methods for controlling them in a new drug submission process. Copyright 2003 John Wiley & Sons, Ltd.
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International Nuclear Information System (INIS)
Anon.
1997-01-01
The transportation component of the petroleum service industry was the focus of this conference. The human factors that play a role in oilfield trucking accidents were discussed. The industry has set standards and has taken the initiative to establish training programs in which basic criteria for transporting dangerous goods will be met. The principal themes addressed by the conference included an overall approach to industry compliance, new technologies, minimum safety requirements, forming partnerships with the Workers' Compensation Board, drug and alcohol policies and testing, oilfield driver training program, and risk management of human capital
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Nonimaging detectors in drug development and approval.
Wagner, H N
2001-07-01
Regulatory applications for imaging biomarkers will expand in proportion to the validation of specific parameters as they apply to individual questions in the management of disease. This validation is likely to be applicable only to a particular class of drug or a single mechanism of action. Awareness among the world's regulatory authorities of the potential for these emerging technologies is high, but so is the cost to the sponsor (including the logistics of including images in a dossier), and therefore the pharmaceutical industry must evaluate carefully the potential benefit of each technology for its drug development programs, just as the authorities must consider carefully the extent to which the method is valid for the use to which the applicant has put it. For well-characterized tracer systems, it may be possible to design inexpensive cameras that make rapid assessments.
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Do we have the training? The ethics of workplace drug testing and the GP.
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.
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Identifying problematic drugs based on the characteristics of their targets.
Lopes, Tiago J S; Shoemaker, Jason E; Matsuoka, Yukiko; Kawaoka, Yoshihiro; Kitano, Hiroaki
2015-01-01
Identifying promising compounds during the early stages of drug development is a major challenge for both academia and the pharmaceutical industry. The difficulties are even more pronounced when we consider multi-target pharmacology, where the compounds often target more than one protein, or multiple compounds are used together. Here, we address this problem by using machine learning and network analysis to process sequence and interaction data from human proteins to identify promising compounds. We used this strategy to identify properties that make certain proteins more likely to cause harmful effects when targeted; such proteins usually have domains commonly found throughout the human proteome. Additionally, since currently marketed drugs hit multiple targets simultaneously, we combined the information from individual proteins to devise a score that quantifies the likelihood of a compound being harmful to humans. This approach enabled us to distinguish between approved and problematic drugs with an accuracy of 60-70%. Moreover, our approach can be applied as soon as candidate drugs are available, as demonstrated with predictions for more than 5000 experimental drugs. These resources are available at http://sourceforge.net/projects/psin/.
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Identifying problematic drugs based on the characteristics of their targets
Directory of Open Access Journals (Sweden)
Tiago Jose eDa Silva Lopes
2015-09-01
Full Text Available Identifying promising compounds during the early stages of drug development is a major challenge for both academia and the pharmaceutical industry. The difficulties are even more pronounced when we consider multi-target pharmacology, where the compounds often target more than one protein, or multiple compounds are used together. Here, we address this problem by using machine learning and network analysis to process sequence and interaction data from human proteins to identify promising compounds. We used this strategy to identify properties that make certain proteins more likely to cause harmful effects when targeted; such proteins usually have domains commonly found throughout the human proteome. Additionally, since currently marketed drugs hit multiple targets simultaneously, we combined the information from individual proteins to devise a score that quantifies the likelihood of a compound being harmful to humans. This approach enabled us to distinguish between approved and problematic drugs with an accuracy of 60%¬–70%. Moreover, our approach can be applied as soon as candidate drugs are available, as demonstrated with predictions for more than 5000 experimental drugs. These resources are available at http://sourceforge.net/projects/psin/.
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ASTM and ASME-BPE Standards--Complying with the Needs of the Pharmaceutical Industry.
Huitt, William M
2011-01-01
Designing and building a pharmaceutical facility requires the owner, engineer of record, and constructor to be knowledgeable with regard to the industry codes and standards that apply to this effort. Up until 1997 there were no industry standards directed at the needs and requirements of the pharmaceutical industry. Prior to that time it was a patchwork effort at resourcing and adopting nonpharmaceutical-related codes and standards and then modifying them in order to meet the more stringent requirements of the Food and Drug Administration (FDA). In 1997 the American Society of Mechanical Engineers (ASME) published the first Bioprocessing Equipment (BPE) Standard. Through harmonization efforts this relatively new standard has brought together, scrutinized, and refined industry accepted methodologies together with FDA compliance requirements, and has established an American National Standard that provides a comprehensive set of standards that are integral to the pharmaceutical industry. This article describes various American National Standards, including those developed and published by the American Society for Testing and Materials (ASTM), and how they apply to the pharmaceutical industry. It goes on to discuss the harmonization effort that takes place between the various standards developers in an attempt to prevent conflicts and omissions between the many standards. Also included are examples of tables and figures taken from the ASME-BPE Standard. These examples provide the reader with insight to the relevant content of the ASME-BPE Standard. Designing and building a pharmaceutical facility requires the owner, engineer of record, and constructor to be knowledgeable with regard to the industry codes and standards that apply to this effort. Up until 1997 there were no industry standards directed at the needs and requirements of the pharmaceutical industry. Prior to that time it was a patchwork effort at resourcing and adopting nonpharmaceutical-related codes and
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2013-11-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability AGENCY... guidance, FDA recommended an in vivo fasting BE study with pharmacokinetic endpoints and in vitro studies...
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Realizing drug repositioning by adapting a recommendation system to handle the process.
Ozsoy, Makbule Guclin; Özyer, Tansel; Polat, Faruk; Alhajj, Reda
2018-04-12
Drug repositioning is the process of identifying new targets for known drugs. It can be used to overcome problems associated with traditional drug discovery by adapting existing drugs to treat new discovered diseases. Thus, it may reduce associated risk, cost and time required to identify and verify new drugs. Nowadays, drug repositioning has received more attention from industry and academia. To tackle this problem, researchers have applied many different computational methods and have used various features of drugs and diseases. In this study, we contribute to the ongoing research efforts by combining multiple features, namely chemical structures, protein interactions and side-effects to predict new indications of target drugs. To achieve our target, we realize drug repositioning as a recommendation process and this leads to a new perspective in tackling the problem. The utilized recommendation method is based on Pareto dominance and collaborative filtering. It can also integrate multiple data-sources and multiple features. For the computation part, we applied several settings and we compared their performance. Evaluation results show that the proposed method can achieve more concentrated predictions with high precision, where nearly half of the predictions are true. Compared to other state of the art methods described in the literature, the proposed method is better at making right predictions by having higher precision. The reported results demonstrate the applicability and effectiveness of recommendation methods for drug repositioning.
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Dynamic competition in pharmaceuticals. Patent expiry, generic penetration, and industry structure.
Magazzini, Laura; Pammolli, Fabio; Riccaboni, Massimo
2004-06-01
This paper investigates patterns of industrial dynamics and competition in the pharmaceutical industry, with particular reference to the consequences of patent expiry in different countries. We focus on the competition at the level of single chemical entities, distinguishing between original brands and generic products. Quarterly data, spanning from July 1987 to December 1998, on sales of pharmaceutical products in four countries (USA, UK, Germany, and France) constitute the basis of our analysis. All the products containing major molecules whose patent expiration date lies between 1986 and 1996 are included in our sample. We show how diffusion of generics is linked to the characteristics of the market and investigate how price dynamics of original products are affected by generic competition. Our empirical investigation shows that the dynamics of drug prices and the competition by generic drugs vary significantly across countries. This heterogeneity notwithstanding, a clear distinction seems to emerge. On the one hand, systems that rely on market-based competition in pharmaceuticals promote a clear distinction between firms that act as innovators and firms that act as imitators after patent expiry. Here, original products enjoy premium prices and exclusivity profits under patent protection, and face fierce price competition after patent expiry. On the other hand, in systems that rely on administered prices, penetration by generic drugs tends to be rather limited. Its descriptive and preliminary nature notwithstanding, our analysis seems to have relevant implications at different levels of generality, especially for Europe.