Present DDT and lindane indoor concentrations after extensive use of wood preservatives in attics in the past; Aktuelle DDT- und Lindan-Konzentrationen in Wohnraeumen nach intensivem Holzschutzmitteleinsatz auf Dachboeden in der Vergangenheit

Energy Technology Data Exchange (ETDEWEB)

Rosskamp, E.; Horn, W.; Ullrich, D.; Seifert, B. [Umweltbundesamt, Berlin (Germany). Inst. fuer Wasser-, Boden- und Lufthygiene

1999-12-01

In the former German Democratic Republic (GDR) the wood preservative Hylotox 59, which contained DDT and lindane as biocides, was used indoors until 1988. It was the aim of this study to determine the concentration levels of DDT and lindane in the air of attics, newly converted attic apartments or apartments situated immediately under attics which had been treated with Hylotox 59. In some cases dust and wood samples were examined, too. This study shows that concentrations of DDT and lindane of up to 4600 and 930 ng/m{sup 3} can be found in air of treated attics even more than 20 years after the application of wood preservatives. However, the median concentrations in recently converted attic apartments and apartments below an attic were much lower, namely 20 and 40 ng/m{sup 3}, respectively, for DDT and 5 and 20 ng/m{sup 3}, respectively, for lindane. Only some apartments showed DDT and lindane concentrations above 100 ng/m{sup 3}. In these cases biocides had been used directly in the apartment or there was a possibility for an air exchange between the attic and the rooms. Exposure of dwellers to DDT and lindane occurs mainly by inhalation. In addition, infants and small children who usually play on the floor may be exposed by contact with and intake of house dust. The maximum DDT content of house dust observed in the apartments under study was 200 mg/kg, with a median of 20 mg/kg. The lindane content of house dust reached only 9 mg/kg. The calculated exposure of a small child to DDT and lindane in house dust is far below the allowable daily intake (ADI) recommended by FAO/WHO. (orig.) [German] Die Biozide DDT und Lindan wurden in der ehemaligen DDR bis 1988 als Wirkstoffe im Holzschutzmittel Hylotox 59 auf Dachboeden und z.T. auch in Innenraeumen eingesetzt. Ziel dieser Untersuchungen war es, die Biozidbelastung der Raumluft und die von einigen Staub- und Holzproben in vormals Hylotox-behandelten Dachboeden, in Wohnungen direkt unter solchen Dachboeden sowie in

Dual actions of lindane (γ-hexachlorocyclohexane) on calcium homeostasis and exocytosis in rat PC12 cells

International Nuclear Information System (INIS)

Heusinkveld, Harm J.; Thomas, Gareth O.; Lamot, Ischa; Berg, Martin van den; Kroese, Alfons B.A.; Westerink, Remco H.S.

2010-01-01

The persistent organochlorine pesticide lindane is still abundantly found in the environment and in human and animal tissue samples. Lindane induces a wide range of adverse health effects, which are at least partially mediated via the known inhibition of GABA A and glycine receptors. Additionally, lindane has been reported to increase the basal intracellular Ca 2+ concentration ([Ca 2+ ] i ). As Ca 2+ triggers many cellular processes, including cell death and vesicular neurotransmitter release (exocytosis), we investigated whether lindane affects exocytosis, Ca 2+ homeostasis, production of reactive oxygen species (ROS) and cytotoxicity in neuroendocrine PC12 cells. Amperometric recordings and [Ca 2+ ] i imaging experiments with fura-2 demonstrated that lindane (≥ 10 μM) rapidly increases basal exocytosis and basal [Ca 2+ ] i . Additional imaging and electrophysiological recordings revealed that this increase was largely due to a lindane-induced membrane depolarization and subsequent opening of N- and P/Q-type voltage-gated Ca 2+ channels (VGCC). On the other hand, lindane (≥ 3 μM) induced a concentration-dependent but non-specific inhibition of VGCCs, thereby limiting the lindane-induced increase in basal [Ca 2+ ] i and exocytosis. Importantly, the non-specific inhibition of VGCCs also reduced stimulation-evoked exocytosis and Ca 2+ influx. Though lindane exposure concentration-dependently increased ROS production, cell viability was not affected indicating that the used concentrations were not acute cytotoxic. These combined findings indicate that lindane has two, partly counteracting effects. Lindane causes membrane depolarization, thereby increasing basal [Ca 2+ ] i and exocytosis. In parallel, lindane inhibits VGCCs, thereby limiting the basal effects and reducing stimulation-evoked [Ca 2+ ] i and exocytosis. This study further underlines the need to consider presynaptic, non-receptor-mediated effects in human risk assessment.

Persistence and fate of soil applied 14C-lindane in a maize ecosystem

International Nuclear Information System (INIS)

Yeboah, P.O.; Montford, K.G.; Apoh, W.; Dodoo, S.

1997-01-01

14 C-lindane applied to soil surface in a maize ecosystem (one month after planting) was taken up by the plant. Within the first 25 days of treatment, 14 C-lindane or its metabolites were found within the entire plant with the greatest concentration in lower leaves (from the ground level); and a sharp build up of lindane concentration towards the tip of each leaf. Radioactivity and hence pesticide concentration was uniformly distributed in the plant with time; to the extent that measurable levels of 14 C-compounds were detected in the tussel cob and the grain. This indicated that soil applied lindane was available to the maize plant. The persistence of 14 C-lindane in soils of variable organic matter content was also studied. Evidence is presented to show that 14 C-lindane dissipated faster in soils of lower organic matter content. Levels of surface applied pesticides that became bound in the soil increased with time after application and also with increasing organic matter content. 14 C-activity was mainly associated with the top soil layer (0-30 mm). (author). 7 refs, 7 figs

Persistence of lindane in model cattle dips in sub-tropical climate of Delhi, India

International Nuclear Information System (INIS)

Singh, D.K.; Menon, P.; Agarwal, H.C.

1997-01-01

Persistence of lindane in model cattle dips under field conditions in the sub-tropical climate of Delhi was studied. In one set of experiments two model dips were utilized and filled with 200 L of water and treated with 2.37 MBq of 14 C-labelled and 4 g unlabelled lindane each. The radioactivity in water samples at zero time was estimated and considered to be 100 % (744 dpm/mL) which declined to 17.5 % (132 dpm/mL) 180 d after the treatment in Dip 1 (control dip). In the second dip 50 g of cowdung and soil were added 28 d after treatment and subsequently every time before sampling. The results in both the dips were similar indicating no effect of soil and cowdung on the persistence of lindane in the dips. The half life of lindane in water was 101 days. Lindane was extracted from water by hexane in the presence of methanol. The efficiency of this procedure was 99+ %. The main metabolises of lindane in water, identified by HPLC, were 1, 2, 4- trichlorobenzene, 1,3,5-trichlorobenzene and an unknown compound. In another experiment, 50 L of water was added to one dip which was treated with 2.90 MBq of 14 C-labelled and 1 g unlabelled lindane in 25 ml acetone. The cattle dip was recharged at monthly intervals with about 10 % of the initially applied lindane (290 kBq of 14 C labelled and 100 mg unlabelled lindane in 25 mL acetone). Soil and cow dung were added as in the first experiment. The concentration of lindane declined rapidly to 11.69 % (1.9 μg/mL, 425 dpm/mL) after the third recharge. The main metabolite was 1,2,4- trichlorobenzene which accounted for about 21 % after first and second recharge. The effect of pH ranging from 5 to 9 was also investigated. The dissipation appeared to be faster at pH 8 and comparatively slower at pH 6. (author)

Application of ligninolytic potentials of a white-rot fungus Ganoderma lucidum for degradation of lindane.

Science.gov (United States)

Kaur, Harsimran; Kapoor, Shammi; Kaur, Gaganjyot

2016-10-01

Lindane, a broad-spectrum organochlorine pesticide, has caused a widespread environmental contamination along with other pesticides due to wrong agricultural practices. The high efficiency, sustainability and eco-friendly nature of the bioremediation process provide an edge over traditional physico-chemical remediation for managing pesticide pollution. In the present study, lindane degradation was studied by using a white-rot fungus, Ganoderma lucidum GL-2 strain, grown on rice bran substrate for ligninolytic enzyme induction at 30 °C and pH 5.6 after incorporation of 4 and 40 ppm lindane in liquid as well as solid-state fermentation. The estimation of lindane residue was carried out by gas chromatography coupled to mass spectrometry (GC-MS) in the selected ion monitoring mode. In liquid-state fermentation, 100.13 U/ml laccase, 50.96 U/ml manganese peroxidase and 17.43 U/ml lignin peroxidase enzymes were obtained with a maximum of 75.50 % lindane degradation on the 28th day of incubation period, whereas under the solid-state fermentation system, 156.82 U/g laccase, 80.11 U/g manganese peroxidase and 18.61 U/g lignin peroxidase enzyme activities with 37.50 % lindane degradation were obtained. The lindane incorporation was inhibitory to the production of ligninolytic enzymes and its own degradation but was stimulatory for extracellular protein production. The dialysed crude enzyme extracts of ligninolytic enzymes were though efficient in lindane degradation during in vitro studies, but their efficiencies tend to decrease with an increase in the incubation period. Hence, lindane-degrading capabilities of G. lucidum GL-2 strain make it a potential candidate for managing lindane bioremediation at contaminated sites.

Elimination, distribution and metabolism of lindane (gamma Hexachloro cyclohexane) in male goat

International Nuclear Information System (INIS)

Elozargani, Gaafar A.; Elfahal, Rihab Ali

2001-01-01

Elimination, distribution in tissues and metabolic degradation of lindane insecticide (gamma hexachlorocyclohexane) were studied in male Nubian goat (Cappara aegagrus Hircus). The goat was dosed orally with 262.76 mg 14 C-lindane equivalent to one fourth of its lethal dose (LD50). Urine and faeces were collected for two weeks following the application date and the radioactivity was measured in order to determine the rate of the insecticide elimination from the animal body. Lindane elimination was found to be initially fairly rapid, principally via urine (19.6% of the applied dose was detected in urine and 3.1% in faeces). However, it was observed that total recovery of the insecticide via faeces and urine is low. After two weeks, the animal was sacrificed and samples of the brain, liver, kidneys, heart, lungs, legs muscles, and abdominal fat were collected. The percentage of the total radioactivity detected in all tissue sample was 0.29% of the applied radioactive Lindane. The fat contained 48.25% of this percentage, 29.78% was detected in the liver, 9.05% in the lungs and 8.72% in the heart. Smaller percentages were detected in the other tissues. Urine and faeces extracted, analysed and their contents of lindane metabolites were Identified using autoradiography. It was found that 23% of the labeled lindane detected in urine was extracted unchanged. A nonpolar compound possibly a trichlorophenol represented 26% of the radioactivity detected in urine, while 51% was represented in highly polar compound and conjugates

Persistence and effect of lindane (gamma HCH) in a maize field

International Nuclear Information System (INIS)

Bennaceur, M.; Ghezal, F.; Meguenni, H.; Hamadache, A.; Coste, C.M.

1997-01-01

The effects of lindane on the arthropod fauna and its persistence in soil and maize plants under field conditions were studied. Lindane significantly reduced the densities of collembola and spiders but had less significant effects on carabidae and formicidae. It decreased the damage caused by pest insects in maize plants but had no effect on the yield. Lindane dissipated rapidly from both plants and soil. The residues in harvested grains were 0.2 mg.kg -1 (year 1), 0.23 mg.kg -1 (year 2) and 0.05 mg.kg -1 (year 3) and below the recommended acceptable limit for grains. (author). 7 refs, 6 tabs

Biodegradation of lindane using a novel yeast strain, Rhodotorula sp. VITJzN03 isolated from agricultural soil.

Science.gov (United States)

Abdul Salam, Jaseetha; Lakshmi, V; Das, Devlina; Das, Nilanjana

2013-03-01

Lindane is a notorious organochlorine pesticide due to its high toxicity, persistence in the environment and its tendency to bioaccumulate. A yeast strain isolated from sorghum cultivation field was able to use lindane as carbon and energy source under aerobic conditions. With molecular techniques, it was identified and named as Rhodotorula strain VITJzN03. The effects of nutritional and environmental factors on yeast growth and the biodegradation of lindane was investigated. The maximum production of yeast biomass along with 100 % lindane mineralization was noted at an initial lindane concentration of 600 mg l(-1) within a period of 10 days. Lindane concentration above 600 mg l(-1) inhibited the growth of yeast in liquid medium. A positive relationship was noted between the release of chloride ions and the increase of yeast biomass as well as degradation of lindane. The calculated degradation rate and half life of lindane were found to be 0.416 day(-1) and 1.66 days, respectively. The analysis of the metabolites using GC-MS identified the formation of seven intermediates including γ-pentachlorocyclohexane(γ-PCCH), 1,3,4,6-tetrachloro-1,4-cyclohexadiene(1,4-TCCHdiene), 1,2,4-trichlorobenzene (1,2,4 TCB), 1,4-dichlorobenzene (1,4 DCB), chloro-cis-1,2-dihydroxycyclohexadiene (CDCHdiene), 3-chlorocatechol (3-CC) and maleylacetate (MA) derivatives indicating that lindane degradation follows successive dechlorination and oxido-reduction. Based on the results of the present study, the possible pathway for lindane degradation by Rhodotorula sp. VITJzN03 has been proposed. To the best of our knowledge, this is the first report on lindane degradation by yeast which can serve as a potential agent for in situ bioremediation of medium to high level lindane-contaminated sites.

Distribution of sup 14 C-lindane (γ-BHC) insecticide in a simulative mudflat microecosystem

International Nuclear Information System (INIS)

Nashriyah Mat; Burhanuddin Ahmad; Abdul Khalik Wood; Zaleha Hashim; Sabri Junoh; Zaharudin Ahmad

1997-01-01

Organochlorinated pesticide such as Lindane is very persistent in the marine environment. The distribution of sup 14 C-lindane in a simulative mudflat micro-ecosystem; in sea water, sediment and cockle (Anadara granosa) compartments was studied for a period of 10 weeks under aeration. Cockle bioconcentrated 2808.4 Bq/g tissue one day after exposure, which was gradually reduced to 1754.5 Bq/g tissue six days later. Lindane was probably slowly depurated by cockle following its migration to deeper-sediment layer within one week of exposure. Sediment absorption of sup 14 C-lindane was observed in the first and second weeks, reaching 595.4 Bq/g sediment at 15 days after exposure. A steady decline of its concentration was shown between 2-10 weeks of exposure to 216.7 Bq/g sediment possibly due to sediment desorption. The sup 14 C-lindane level in sea water was shown to steeply drop from 53.3 Bq/ml to 24.8 Bq/ml within 2 weeks exposure, followed by a steady decline to 0.47 Bq/ml between 2-10 weeks of exposure. The unaccounted radioactivity could have been lost in the form of volatilized lindane

Effect of fertilizer and irradiation sterilization on the degradation of lindane in soil

International Nuclear Information System (INIS)

Bennaceur, M.; Ghezal, F.

1992-10-01

The effect of fertilizer and sterelization using irradiation were studied on the fate of lindane degradation in two soils under laboratory conditions. Degradation of lindane is higher in organic matter rich soil. Half life of product is respectively about one week and one month for both rich soil and poor soil. Fertilizer used decreases PH of soils and irradiation dose of 1 mrad seems to be insufficient to sterilize completely the soils. Ammonium nitrate stimulates slightly the degradations of lindane in soil (not sterilized) after two months

Effect of commercial processing procedures on 14C-LINDANE residues in corn oil

International Nuclear Information System (INIS)

Soliman, S.M.

2006-01-01

At blooming, maize plants were sprayed twice, 23 days apart, at a dose of 22 mg equivalent to 5 μCi/ plant. At post harvest, maize seeds had a radioactivity corresponding to 0.36% of the applied dose. The insecticide residues in crude oil, cake and methanolic extract were amounted to 8 % and 60 % 5 % , respectively, of original residues inside the seeds.The 14 C-activity in the crude oil could be reduced by commercial processes locally used for refining. The refined oil had a residue level of about 0.7 ppm mainly in the form of unchanged lindane in addition to a number of chloro phenols as main metabolites. Refining of corn oil fortified with 14 C-lindane led to a high reduction of 14 C-lindane (88%). The refined oil contained a residue consisting lindane and its chloro phenols

Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

Science.gov (United States)

Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

2017-11-01

Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

Mechanism of action of the insecticides, lindane and fipronil, on glycine receptor chloride channels.

Science.gov (United States)

Islam, Robiul; Lynch, Joseph W

2012-04-01

Docking studies predict that the insecticides, lindane and fipronil, block GABA(A) receptors by binding to 6' pore-lining residues. However, this has never been tested at any Cys-loop receptor. The neurotoxic effects of these insecticides are also thought to be mediated by GABA(A) receptors, although a recent morphological study suggested glycine receptors mediated fipronil toxicity in zebrafish. Here we investigated whether human α1, α1β, α2 and α3 glycine receptors were sufficiently sensitive to block by either compound as to represent possible neurotoxicity targets. We also investigated the mechanisms by which lindane and fipronil inhibit α1 glycine receptors. Glycine receptors were recombinantly expressed in HEK293 cells and insecticide effects were studied using patch-clamp electrophysiology. Both compounds completely inhibited all tested glycine receptor subtypes with IC(50) values ranging from 0.2-2 µM, similar to their potencies at vertebrate GABA(A) receptors. Consistent with molecular docking predictions, both lindane and fipronil interacted with 6' threonine residues via hydrophobic interactions and hydrogen bonds. In contrast with predictions, we found no evidence for lindane interacting at the 2' level. We present evidence for fipronil binding in a non-blocking mode in the anaesthetic binding pocket, and for lindane as an excellent pharmacological tool for identifying the presence of β subunits in αβ heteromeric glycine receptors. This study implicates glycine receptors as novel vertebrate toxicity targets for fipronil and lindane. Furthermore, lindane interacted with pore-lining 6' threonine residues, whereas fipronil may have both pore and non-pore binding sites. © 2011 The Authors. British Journal of Pharmacology © 2011 The British Pharmacological Society.

Exposure levels, environmental fate modelling and human health risk assessment of lindane in Ghana

International Nuclear Information System (INIS)

Adu-Kumi, S.

2011-01-01

This thesis discusses an innovative approach of combining chemical trace analysis including the use of 13 C-labelled isotopes as internal and recovery standards) with multi-media modelling for assessing health risks of Lindane which is a persistent organic pollutant (POP) and a commercial formulated insecticide also known as Gamma-hexachlorocyclohexane (γ-HCH). Samples studied were background air, human breast milk, and edible fish (tilapia and catfish). The investigations focused on the exposure of the general population. For the first time levels and seasonal variation of Lindane, α-HCH and β-HCH in background air of Lake Bosumtwi, Kwabenya and East Legon in Ghana were studied with polyurethane foam based passive air samplers. Lindane (average concentration 53 pg m -3 ) was measured in all samples with (i) gas chromatography-mass spectrometer (GC-MS) and (ii) gas chromatography-mass spectrometer operated in electron ionization mode (GC-EI-MS). Agricultural application and revolatilisation from soils were main primary and secondary sources of HCH releases. Levels and variation of Lindane, α-HCH and β-HCH in pooled and individual human breast milk samples collected from lactating mothers countrywide were determined using a high-resolution gas chromatography interfaced with a high-resolution gas chromatography interfaced with a high-resolution mass spectrometer (HRGC-HRMS). This constitutes the first comprehensive nationwide human breast milk study of assessing risks of HCHs for the general population of Ghana. Mothers were selected from three major cities (Accra, Kumasi and Tamale) and three rural communities (Ada, Jachie/Pramso and Tolon) representing the Southern, Middle and Northern sectors respectively. The results of the study showed that the general population of Ghana is widely exposed to HCHs although the current levels are generally low; and also suggest that the usage pattern and exposure levels of Lindane vary among the various regions in Ghana. �

Simultaneous Removal of Lindane, Lead and Cadmium from Soils by Rhamnolipids Combined with Citric Acid

Science.gov (United States)

Long, Tao; Ying, Rongrong; Ye, Mao; Zhang, Shengtian; Li, Qun; Zhou, Yan; Lin, Yusuo

2015-01-01

This study investigated the performance of rhamnolipids-citric acid mixed agents in simultaneous desorption of lindane and heavy metals from soils. The capacity of the mixed agents to solubilize lindane, lead and cadmium in aqueous solution was also explored. The results showed that the presence of citric acid greatly enhanced the solubilization of lindane and cadmium by rhamnolipids. A combined effect of the mixed agents on lindane and heavy metals removal from soils was observed. The maximum desorption ratios for lindane, cadmium and lead were 85.4%, 76.4% and 28.1%, respectively, for the mixed agents containing 1% rhamnolipidsand 0.1 mol/L citric acid. The results also suggest that the removal efficiencies of lead and cadmium were strongly related to their speciations in soils, and metals in the exchangeable and carbonate forms were easier to be removed. Our study suggests that the combining use of rhamnolipids and citric acid is a promising alternative to simultaneously remove organochlorine pesticides and heavy metals from soils. PMID:26087302

Lindane blocks GABAA-mediated inhibition and modulates pyramidal cell excitability in the rat hippocampal slice.

Science.gov (United States)

Joy, R M; Walby, W F; Stark, L G; Albertson, T E

1995-01-01

An in vitro paired-pulse orthodromic stimulation technique was used to examine the effects of lindane on excitatory afferent terminals, CA1 pyramidal cells and recurrent collateral evoked inhibition in the rat hippocampal slice. This was done to establish simultaneous effects on a simple neural network and to develop procedures for more detailed analyses of the effects of lindane. Hippocampal slices 400 microns thick were perfused with oxygenated artificial cerebrospinal fluid. Electrodes were placed in the CA1 region to record extracellular population spike (PS) or excitatory postsynaptic potential (EPSP) responses to stimulation of Schaffer collateral/commissural (SC/C) fibers. Gamma-aminobutyric acid (GABA)-mediated recurrent inhibition was measured using a paired-pulse technique. Perfusion with lindane produced both time and dose dependent changes in a number of the responses measured. The most striking effect produced by lindane was the loss of GABAA-mediated recurrent collateral inhibition. This tended to occur rapidly, often before changes in EPSP or PS responses could be detected. With longer exposures to lindane, repetitive discharge of pyramidal cells developed resulting in multiple PSs to single stimuli. Lindane (50 microM) also completely reversed the effects of the injectable anesthetic, propofol, a compound known to potentiate GABAA-mediated inhibition via a direct action on the GABAA receptor-chloride channel complex. An analysis of input/output relationships at varying stimulus intensities showed that lindane increased EPSP and PS response amplitudes at any given stimulus intensity resulting in a leftward shift in the EPSP amplitude/stimulus intensity, PS amplitude/stimulus intensity and PS amplitude/EPSP amplitude relationships. This effect was most noticeable with low intensity stimuli and became progressively less so as stimulus intensities approached those yielding maximal responses. In addition lindane significantly increased paired pulse

Studies on fact of 14C-lindane in soil and chickpea plants under laboratory conditions

International Nuclear Information System (INIS)

Meguenni, H.

1997-01-01

The degradation of 14 C-lindane (γ-1,2,3,4,5,6 - hexachlorocyclohexane) was investigated under laboratory conditions. Chickpea plants and soil were treated with 14 C-lindane. The results indicated a decrease of lindane on the plant surface from 36.6% to 6.5% and a corresponding increase in extractable residues from within the plant from 12.5% to 34.5% during the 60 days of the trial. In the soil, extractable residues decreased from 47.4% to 31.2%. Bound residues in both plant and soil remained low throughout the trial. After 60 days, the chickpea plants took up 16.4% of the lindane applied to the soil. (author). 2 refs, 7 figs

Lindane contaminated soil bio stimulation with vegetable organic nitrogenated extracts: effects on soil biochemistry

International Nuclear Information System (INIS)

Garcia-Martinez, A. M.; Tejada, M.; Diaz, A. I.; Rodriguez-Morgado, B.; Bautista, J.; Parrado, J.

2009-01-01

1,2,3,4,5,6-Hexachlorocyclohexane (HCH) was one of the most extensively used organo chloride insecticides. Technical mixture of HCH consists of eight steric isomers but only the y-isomer, known as lindane, is insecticides and it is commercial. Despite the fact that most countries have prohibited the production and use of the toxic lindane (Voldner, et al, 1995), many contaminated soils remain because of the long persistence of lindane (MacRae et al, 1948) and, as a result, it cause environmental disease. (Author)

Remediation of soils polluted with lindane using surfactant-aided soil washing and electrochemical oxidation.

Science.gov (United States)

Muñoz-Morales, M; Braojos, M; Sáez, C; Cañizares, P; Rodrigo, M A

2017-10-05

In this work the complete treatment of soil spiked with lindane is studied using surfactant-aided soil-washing (SASW) to exhaust lindane from soil and electrolysis with diamond anodes to mineralize lindane from the soil washing fluid (SWF) waste. Results demonstrated that this technological approach is efficient and allow to remove this hazardous pollutant from soil. They also pointed out the significance of the ratio surfactant/soil in the efficiency of the SASW process and in the performance of the later electrolysis used to mineralize the pollutant. Larger values of this parameter lead to effluents that undergo a very efficient treatment which allows the depletion of lindane for applied charges lower than 15AhL -1 and the recovery of more than 70% of the surfactant for the regeneration of the SWF. Copyright © 2017 Elsevier B.V. All rights reserved.

Improving in vitro to in vivo extrapolation by incorporating toxicokinetic measurements: A case study of lindane-induced neurotoxicity

Energy Technology Data Exchange (ETDEWEB)

Croom, Edward L.; Shafer, Timothy J.; Evans, Marina V.; Mundy, William R.; Eklund, Chris R.; Johnstone, Andrew F.M.; Mack, Cina M.; Pegram, Rex A., E-mail: pegram.rex@epa.gov

2015-02-15

Approaches for extrapolating in vitro toxicity testing results for prediction of human in vivo outcomes are needed. The purpose of this case study was to employ in vitro toxicokinetics and PBPK modeling to perform in vitro to in vivo extrapolation (IVIVE) of lindane neurotoxicity. Lindane cell and media concentrations in vitro, together with in vitro concentration-response data for lindane effects on neuronal network firing rates, were compared to in vivo data and model simulations as an exercise in extrapolation for chemical-induced neurotoxicity in rodents and humans. Time- and concentration-dependent lindane dosimetry was determined in primary cultures of rat cortical neurons in vitro using “faux” (without electrodes) microelectrode arrays (MEAs). In vivo data were derived from literature values, and physiologically based pharmacokinetic (PBPK) modeling was used to extrapolate from rat to human. The previously determined EC{sub 50} for increased firing rates in primary cultures of cortical neurons was 0.6 μg/ml. Media and cell lindane concentrations at the EC{sub 50} were 0.4 μg/ml and 7.1 μg/ml, respectively, and cellular lindane accumulation was time- and concentration-dependent. Rat blood and brain lindane levels during seizures were 1.7–1.9 μg/ml and 5–11 μg/ml, respectively. Brain lindane levels associated with seizures in rats and those predicted for humans (average = 7 μg/ml) by PBPK modeling were very similar to in vitro concentrations detected in cortical cells at the EC{sub 50} dose. PBPK model predictions matched literature data and timing. These findings indicate that in vitro MEA results are predictive of in vivo responses to lindane and demonstrate a successful modeling approach for IVIVE of rat and human neurotoxicity. - Highlights: • In vitro to in vivo extrapolation for lindane neurotoxicity was performed. • Dosimetry of lindane in a micro-electrode array (MEA) test system was assessed. • Cell concentrations at the MEA EC

Responsiveness of cerebral and hepatic cytochrome P450s in rat offspring prenatally exposed to lindane

International Nuclear Information System (INIS)

Johri, Ashu; Yadav, Sanjay; Dhawan, Alok; Parmar, Devendra

2008-01-01

ABSTRACT: Prenatal exposure to low doses of lindane has been shown to affect the ontogeny of xenobiotic metabolizing cytochrome P450s (CYPs), involved in the metabolism and neurobehavioral toxicity of lindane. Attempts were made in the present study to investigate the responsiveness of CYPs in offspring prenatally exposed to lindane (0.25 mg/kg b. wt.; 1/350th of LD 50 ; p. o. to mother) when challenged with 3-methylcholanthrene (MC) or phenobarbital (PB), inducers of CYP1A and 2B families or a sub-convulsant dose of lindane (30 mg/kg b. wt., p. o.) later in life. Prenatal exposure to lindane was found to produce an increase in the mRNA and protein expression of CYP1A1, 1A2, 2B1, 2B2 isoforms in brain and liver of the offspring at postnatal day 50. The increased expression of the CYPs in the offspring suggests the sensitivity of the CYPs during postnatal development, possibly, to low levels of lindane, which may partition into mother's milk. A higher increase in expression of CYP1A and 2B isoenzymes and their catalytic activity was observed in animals pretreated prenatally with lindane and challenged with MC (30 mg/kg, i. p. x 5 days) or PB (80 mg/kg, i. p. x 5 days) when young at age (approx. 7 weeks) compared to animals exposed to MC or PB alone. Further, challenge of the control and prenatally exposed offspring with a single sub-convulsant dose of lindane resulted in an earlier onset and increased incidence of convulsions in the offspring prenatally exposed to lindane have demonstrated sensitivity of the CYPs in the prenatally exposed offspring. Our data assume significance as the subtle changes in the expression profiles of hepatic and cerebral CYPs in rat offspring during postnatal development could modify the adult response to a later exposure to xenobiotics

The effect of lindane on non-target fauna in a maize agro-ecosystem in Zambia

International Nuclear Information System (INIS)

Deedat, Y.D.; Chanda, S.; Chivundu, A.M.; Kalembe, G.; Mecha, C.D.

1997-01-01

The effect of lindane on non-target fauna in a maize agro-ecosystem was studied in Zambia in 1992 and 1993. While lindane was effective against the stalk borers, a target pest, it also affected other non-target fauna. Ants, spiders and springtails were significantly reduced. However the effect was only transient and lasted for approximately two months. Lindane appeared to have no real effect on aerial non-target fauna or on soil inhabiting microorganisms. (author). 8 refs, 6 tabs

Adverse effects of lindane in a maize agro-ecosystem in Uganda

International Nuclear Information System (INIS)

Tukarhirwa, E.M.; Tinzaara, W.; Kiremire, B.T.

1997-01-01

The impact of lindane, at commercial rates of application, on invertebrate fauna, soil microbial activity, earthworm populations, crop damage and yields in a maize agro-ecosystem was studied and compared with unsprayed control plots of maize using a pitfall trap, D-Vac suction, litter bag, the earthworm formalin expulsion and crop assessment methods. The findings of the study generally portrayed lindane as having very few effects on the maize agro-ecosystem. (author). 5 refs, 9 tabs

Persistence and distribution of [14C]-lindane residues in coffee plants

International Nuclear Information System (INIS)

Flores-Rueegg, E.; Mesquita, T.B.

1976-01-01

Studies on weathering, volatilization, absorption, translocation and accumulation of [ 14 C]-lindane (γ-1,2,3,4,5,6-hexachlorocyclohexane) in coffee (Coffeea arabica L. var. Bourbon) plants are reported. Ten days after topical application to the leaf surface the insecticide can be absorbed and translocated to different parts of the plant. It accumulates mainly in the roots and appears in other leaves. In these experiments, when plants are cultivated in nutrient solution, release of radiocarbon through roots could be detected, indicating exchange of labelled material between plant and surrounding media. When the insecticide is supplied to coffee plants through the roots immersed in nutrient solution containing [ 14 C]-lindane, the labelled material is absorbed and, after 24 hours, radioactive material can be detected in young leaves of the upper parts of the plant. Loss of [ 14 C]-lindane by volatilization, evaporation and co-distillation with water is apparently continuous and represents a significant proportion of that applied. (author)

Pharmacoligaclly Active: Clinical Trials and the Pharmaceuticals ...

African Journals Online (AJOL)

Multinational pharmaceutical companies ('pharmas') import and produce pharmaceuticals and also conduct clinical trials which are an important aspect of research and development (R&D). This may raise the question: Is South Africa a guinea pig for the pharmas? The Department of Trade and Industry National Industrial ...

Integrated survey on toxic effects of lindane on neotropical fish: Corydoras paleatus and Jenynsia multidentata

International Nuclear Information System (INIS)

Pesce, Silvia F.; Cazenave, Jimena; Monferran, Magdalena V.; Frede, Silvia; Wunderlin, Daniel A.

2008-01-01

We report the effect of lindane on fish experimentally exposed to lindane. Sublethal toxicity was assessed through (a) changes in histopathology; (b) the activity of GST in different organs; and (c) bioaccumulation in exposed fish. We present a survey on toxic effects of lindane at these three levels, proposing a sequence of dose-dependent effects. Physiological damage was reversible at lowest doses, but severe at the highest, including damage consistent with fibrosis in liver and karyolitic nucleus in brain of both studied species. Exposure of Jenynsia multidentata above 6 μg L -1 caused activation a GST in liver and gills, followed by inhibition at 75 μg L -1 . Interestingly, the bioaccumulation rate was suddenly increased when GST was inhibited. Corydoras paleatus exposed to 6.0 μg L -1 lindane did not present significant changes in GST activity; however, enzymatic inhibition was observed above 25 μg L -1 . The bioaccumulation rate in C. paleatus remained constant throughout the experiments. All in all, these results evidence that C. paleatus is more sensitive to lindane than J. multidentata. - We observed an inverse correlation between GST activity and bioaccumulation in exposed fish, showing a severe increase of bioaccumulation and damages upon inhibition of GST

Degradation of lindane by microorganisms. Evaluation of inhibitory effect on microbial activity using radiorespirometry

International Nuclear Information System (INIS)

Farghaly, M.; Zayed, S.M.A.D.; Soliman, S.M.

1997-01-01

The degradation of U- 14 C-lindane in two type of Egyptian soil was studied under laboratory conditions. The rate of mineralization of lindane was slow. Evolution of 14 CO 2 increased with time and amounted to 3.5-5.5% of the initial concentration within 90 days. At this period both soil types contained about 88% of the applied radiocarbon; 33-37% of the initial dose being bound to the soil. The methanol 14 C-extractables showed by TLC and HPLC analysis the presence of lindane as main product together with traces of minor metabolites. In addition, the effect of different rates of application of lindane on the respiratory activity of soil microorganisms was evaluated using U- 14 C-glucose as substrate. Concentrations up to 5 mgkg -1 caused a short term suppression of 14 CO 2 evolution. A dose of 10 mgkg -1 significantly inhibited soil respiration as determined by 14 Co 2 evolution for the 11 day period of the experiment. (author). 8 refs, 6 figs, 3 tabs

Regional changes in brain 2-14C-deoxyglucose uptake induced by convulsant and non-convulsant doses of lindane

International Nuclear Information System (INIS)

Sanfeliu, C.; Sola, C.; Camon, L.; Martinez, E.; Rodriguez-Farre, E.

1990-01-01

Lindane-induced dose- and time-related changes in regional 2-14C-deoxyglucose (2-DG) uptake were examined in 59 discrete rat brain structures using the 2-DG autoradiographic technique. At different times (0.5-144 hr) after administration of a seizure-inducing single dose of lindane (60 mg/kg), 2-DG uptake was significantly increased in 18 cortical and subcortical regions mainly related to the limbic system (e.g., Ammon's horn, dentate gyrus, septal nuclei, nucleus accumbens, olfactory cortex) and extrapyramidal and sensory-motor areas (e.g., cerebellar cortex, red nucleus, medial vestibular nucleus). There was also a significant increase in superior colliculus layer II. In addition, significant decreases occurred in a group of 6 regions (e.g., auditory and motor cortices). Non-convulsing animals treated with the same dose of lindane showed a regional pattern of 2-DG uptake less modified than the convulsant group. A non-convulsant single dose of lindane (30 mg/kg) also modified significantly the 2-DG uptake (0.5-24 hr) in some brain areas. Although the various single doses of lindane tested produced different altered patterns of brain 2-DG uptake, some structures showed a similar trend in their modification (e.g., superior colliculi and accumbens, raphe and red nuclei). Repeated non-convulsant doses of lindane produced defined and long-lasting significant elevations of 2-DG uptake in some subcortical structures. Considering the treated groups all together, 2-DG uptake increased significantly in 26 of the 59 regions examined but only decreased significantly in 9 of them during the course of lindane effects. This fact can be related to the stimulant action described for this neurotoxic agent. The observed pattern provides a descriptive approach to the functional alterations occurring in vivo during the course of lindane intoxication

Distribution of 14C-lindane in the rat after a single dose intraperitoneal and intravenous injection

International Nuclear Information System (INIS)

Lievremont, Maurice; Le Flohic, J.-F.; Pascaud, Marc

1981-01-01

14 C-Lindane retentions in rat tissues were studied until 24 hrs after a single dose pesticide administration. Each organ shows particular kinetics. Adipose tissue is the most active in pesticide fixation but the lungs retain momentarily a large fraction of Lindane after intravenous injection [fr

Maintenance of Clinical Expertise and Clinical Research by the Clinical Professors at Gifu Pharmaceutical University.

Science.gov (United States)

Tachi, Tomoya; Noguchi, Yoshihiro; Teramachi, Hitomi

2017-01-01

The clinical professors at Gifu Pharmaceutical University (GPU) provide pharmaceutical services at GPU Pharmacy, Gifu University Hospital, and Gifu Municipal Hospital to keep their clinical skills up-to-date; they also perform clinical research in collaboration with many clinical institutes. The Laboratory of Clinical Pharmacy is part of the Department of Pharmacy Practice and Science, to which the clinical professors belong, and is composed of three clinical professors (a professor, an associate professor, and an assistant professor). The professor administers the GPU Pharmacy as its director, while the associate professor and assistant professor provide pharmaceutical services to patients at Gifu Municipal Hospital, and also provide practical training for students in the GPU Pharmacy. Collectively, they have performed research on such topics as medication education for students, clinical communication education, and analysis of clinical big data. They have also conducted research in collaboration with clinical institutes, hospitals, and pharmacies. Here, we introduce the collaborative research between the Laboratory of Clinical Pharmacy and Gifu Municipal Hospital. These studies include "Risk factors contributing to urinary protein expression resulting from bevacizumab combination chemotherapy", "Hyponatremia and hypokalemia as risk factors for falls", "Economic evaluation of adjustments of levofloxacin dosage by dispensing pharmacists for patients with renal dysfunction", and "Effect of patient education upon discharge for use of a medication notebook on purchasing over-the-counter drugs and health foods". In this symposium, we would like to demonstrate one model of the association and collaborative research between these clinical professors and clinical institutes.

Persistence of lindane and endosulfan under field conditions in Zambia

International Nuclear Information System (INIS)

Mwangala, F.S.; Mundia, P.M.; Nondo, J.C.; Banda, R.; Mangoye, C.

1997-01-01

The persistence of lindane and endosulfan was studied under field conditions in Zambia in 1992 to 1994. Both pesticides dissipated rapidly under field conditions. About 29% and 73% of initial concentration was lost during the first 30 and 60 days after treatment, respectively in 1992. After 180 days, about 11% of the initial concentration was recovered from the soil. In 1993, 40% of initial residues were lost during the first 30 days. At 180 days after spraying, slightly more residues (25% of the initial values) were recovered at this time than in 1992. This indicated a change in the longer term behaviour of lindane in the soil since the calculated half-lives of lindane, covering the shorter term behaviour, were 55-80 days in 1992 and ∼ 17 days in 1993. In 1994, losses of α-Endosulfan and β-Endosulfan were 40% and 37% respectively during the initial 30 days after treatment. A further 25% of α-Endosulfan and 33% of β-Endosulfan were lost during the following 30 days. These data allow estimates of the half-lives of α- and β-Endosulfan (40 and 38 days) under the field conditions pertaining in Zambia at the time of the trials showing that this compound has only moderate persistence and unlikely to cause long term environmental problems. (author). 7 refs, 8 tabs

The effects of lindane and long-term potentiation (LTP) on pyramidal cell excitability in the rat hippocampal slice.

Science.gov (United States)

Albertson, T E; Walby, W F; Stark, L G; Joy, R M

1997-01-01

An in vitro orthodromic stimulation technique was used to examine the effects of lindane and long-term potentiation (LTP) inducing stimuli, alone or in combination, on the excitatory afferent terminal of CA1 pyramidal cells and on recurrent collateral evoked inhibition using the rat hippocampal slice model. Hippocampal slices of 400 microns thickness were perfused with oxygenated artificial cerebrospinal fluid. Stimulation of Schaffer collateral/commissural fibers produced extracellular excitatory postsynaptic potential (EPSP) and/or populations spike (PS) responses recorded from electrodes in the CA1 region. A paired-pulse technique was used to measure gamma-aminobutyric acid (GABAA)-mediated recurrent inhibition before and after treatments. After both lindane and LTP, larger PS amplitudes for a given stimulus intensity were seen. The resulting leftward shift in the curve of the PS amplitude versus stimulus intensity was larger after LTP than after 25 microM lindane. Both lindane and LTP treatments reduced PS thresholds and reduced or eliminated recurrent inhibition as measured by paired-pulse stimulation at the 15 msec interval. The reduction of recurrent inhibition after both treatments was more pronounced at lower stimulus intensities. When LTP stimuli were applied after lindane exposure a further large shift to the left was seen in the PS amplitude versus stimulus intensity curve. A smaller shift to the left was seen in the PS amplitude versus stimulus intensity curve only at the higher stimuli when lindane exposure occurred after LTP. Only at low stimulus intensities were further argumentations seen in PS amplitudes when the LTP stimuli was followed by a second LTP stimuli. Previous exposure to 25 microM lindane stimuli does not block the development of a further robust LTP in this in vitro model.

Effects of pH on the toxicity and uptake of [14C]lindane in the midge, Chironomus riparius

International Nuclear Information System (INIS)

Fisher, S.W.

1985-01-01

The toxicity of the insecticide, lindane, was measured in the midge, Chironomus riparius, at pH 4, 6, and 8 with the finding that lindane is significantly more toxic at pH 6 than at pH 4 and 8. The higher toxicity of lindane at pH 6 is a product of two factors. First the penetration of the compound into the midge is lower at pH 4 than at pH 6 and 8. Second, a greater percentage of total radioactivity is contributed by parent compound at pH 6

Lindane residues in cultivated cucumber and in the most consumed fish in Caspian Sea (Iran).

Science.gov (United States)

Shokrzadeh, M; Saeedi Saravi, S S; Zehtab Yazdi, Y

2009-09-01

In this study, the concentrations of lindane residues (organochlorine pesticides) were analyzed in samples of cultivated cucumbers (Cucumis sativus L.) and four species of most consumed fish (Sefid, Koli, Kilca and Kafal fish). Samples of cucumber were collected from five sites in Sari city (north, south, east, west and central areas) and samples of fish were caught using electric fishing from four major fishing centers (Chalous and Babolsar cities, Khazar Abad and Miankaleh regions) in Mazandaran province of Iran. Quantitative determination of the lindane content was performed by gas chromatography electron-capture detection (GC-ECD). The results showed that the concentration of lindane in cucumber samples and in the dorsal muscle of the selected fish were less than the Food and Agriculture Organization/World Health Organization (FAO/WHO) recommended intake.

Biodegradation of14 C-lindane by some soil fungi

International Nuclear Information System (INIS)

Attaby, H.S.H.; Adam, Y.M.

1991-01-01

In a culture medium incorporated with 14 C-labelled lindane, the 3 soil fungi helminthosporium sp., alternaria brassicola, and verticillium agaricinum were incubated for 10 days. Most of the recovered radioactivity was found to be maintained mainly in the medium of helminthosporium and alternaria but in case of verticillium the majority was associated with the mat. The 3 fungal species showed degradation capacity of 6.1, 5.1 and 3.2% of the total recovered radioactivity radioactivity as hydrolytic products. TLC chromatographic analysis of chloroform fractions revealed the presence of only unchanged lindane either in medium of mat. The aqueous fractions of the 3 fungal species, demonstrated three degraded products (unknown ι,π and tri) having Rf values of 0.40 - 0.47, 0.66 - 0.73, and 0.87 in addition to a polar compound (Rf = 0.07) with the major radioactivity. A certain percentage of radiocarbon 6.7, 5.7 and 30.3% of the mats of helminthosporium, alternria and verticillium, respectively.2 tab

Removal of lindane from an aqueous solution by using aminopropyl silica gel-immobilized calix[6]arene.

Science.gov (United States)

Tor, Ali; Aydin, Mehmet Emin; Aydin, Senar; Tabakci, Mustafa; Beduk, Fatma

2013-11-15

An aminopropyl silica gel-immobilized calix[6]arene (C[6]APS) has been used for the removal of lindane from an aqueous solution in batch sorption technique. The C[6]APS was synthesized with p-tert-butylcalix[6]arene hexacarboxylate derivative and aminopropyl silica gel in the presence of N,N'-diisopropyl carbodiimide coupling reagent. The sorption study was carried out as functions of solution pH, contact time, initial lindane concentration, C[6]APS dosage and ionic strength of solution. The matrix effect of natural water samples on the sorption efficiency of C[6]APS was also investigated. Maximum lindane removal was obtained at a wide pH range of 2-8 and sorption equilibrium was achieved in 2h. The isotherm analysis indicated that the sorption data can be represented by both Langmuir and Freundlich isotherm models. Increasing ionic strength of the solutions increased the sorption efficiency and matrix of natural water samples had no effect on the sorption of lindane. By using multilinear regression model, regression equation was also developed to explain the effects of the experimental variables. Copyright © 2013 Elsevier B.V. All rights reserved.

Participants' perception of pharmaceutical clinical research: a cross-sectional controlled study

Directory of Open Access Journals (Sweden)

González-Saldivar G

2016-04-01

Full Text Available Gerardo González-Saldivar,1 René Rodríguez-Gutiérrez,2 José Luis Viramontes-Madrid,3 Alejandro Salcido-Montenegro,2 Kevin Erick Gabriel Carlos-Reyna,2 Andrés Marcelo Treviño-Alvarez,2 Neri Alejandro Álvarez-Villalobos,4 José Gerardo González-González2 1Ophthalmology Department, 2Endocrinology Division, Hospital Universitario “Dr. José E. González”, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, 3Instituto Nacional de Salud Pública, Cuernavaca, Morelos, 4Medical Statistics Department, Hospital Universitario “Dr. José E. González”, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico Background: There is scarce scientific information assessing participants’ perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials.Methods: To assess the perception that 604 trial participants (cases and 604 nonparticipants (controls of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico.Results: Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4% than controls (50.7% perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%. We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants’ health is put at risk

Effects of some environmental parameters on catalase activity measured in the mussel (Mytilus galloprovincialis) exposed to lindane

Energy Technology Data Exchange (ETDEWEB)

Khessiba, Asma [Laboratoire de Bio-surveillance de l' Environnement, Unite d' Ecologie Cotiere, Faculte des Sciences de Bizerte, 7021, Zarzouna (Tunisia); Romeo, Michele [UMR INRA-UNSA 1112, ROSE - Reponse des Organismes aux Stress Environnementaux, Faculte des Sciences, BP 71, 06108, Nice Cedex 2 (France)]. E-mail: romeo@unice.fr; Aissa, Patricia [Laboratoire de Bio-surveillance de l' Environnement, Unite d' Ecologie Cotiere, Faculte des Sciences de Bizerte, 7021, Zarzouna (Tunisia)

2005-01-01

Mussels (Mytilus galloprovincialis), collected from the Bizerta lagoon, were acclimated for four days to various conditions of temperature, salinity, photoperiod and food supply and then exposed to lindane at a concentration of 40 {mu}g l{sup -1}. Catalase activity, which is a biomarker of exposure to an oxidative stress, was measured in the whole soft tissues of control and assay groups. In control mussels, high temperature, high salinity and light duration significantly increased catalase activity whereas this activity decreased when food, composed of freeze-dried, algae was available. When mussels were treated with lindane, catalase activities were higher than in controls. This increase was significant with temperature, salinity and light duration. The food supply did not change catalase activity, which was always higher compared to controls. Oxidative stress was shown in mussels exposed to lindane. The results highlight the need of considering abiotic parameters in biomonitoring studies, and especially when using catalase as a biomarker. - Oxidative stress in mussels exposed to lindane was also influenced by a number of abiotic parameters.

Effects of some environmental parameters on catalase activity measured in the mussel (Mytilus galloprovincialis) exposed to lindane

International Nuclear Information System (INIS)

Khessiba, Asma; Romeo, Michele; Aissa, Patricia

2005-01-01

Mussels (Mytilus galloprovincialis), collected from the Bizerta lagoon, were acclimated for four days to various conditions of temperature, salinity, photoperiod and food supply and then exposed to lindane at a concentration of 40 μg l -1 . Catalase activity, which is a biomarker of exposure to an oxidative stress, was measured in the whole soft tissues of control and assay groups. In control mussels, high temperature, high salinity and light duration significantly increased catalase activity whereas this activity decreased when food, composed of freeze-dried, algae was available. When mussels were treated with lindane, catalase activities were higher than in controls. This increase was significant with temperature, salinity and light duration. The food supply did not change catalase activity, which was always higher compared to controls. Oxidative stress was shown in mussels exposed to lindane. The results highlight the need of considering abiotic parameters in biomonitoring studies, and especially when using catalase as a biomarker. - Oxidative stress in mussels exposed to lindane was also influenced by a number of abiotic parameters

Effects of lindane on the photosynthetic apparatus of the cyanobacterium Anabaena: fluorescence induction studies and immunolocalization of ferredoxin-NADP+ reductase.

Science.gov (United States)

Bueno, Marta; Fillat, Maria F; Strasser, Reto J; Maldonado-Rodriguez, Ronald; Marina, Nerea; Smienk, Henry; Gómez-Moreno, Carlos; Barja, Francisco

2004-01-01

Cyanobacteria have the natural ability to degrade moderate amounts of organic pollutants. However, when pollutant concentration exceeds the level of tolerance, bleaching of the cells and death occur within 24 hours. Under stress conditions, cyanobacterial response includes the short-term adaptation of the photosynthetic apparatus to light quality, named state transitions. Moreover, prolonged stresses produce changes in the functional organization of phycobilisomes and in the core-complexes of both photosystems, which can result in large changes in the PS II fluorescence yield. The localization of ferredoxin-NADP+ reductase (FNR) at the ends of some peripheral rods of the cyanobacterial phycobilisomes, makes this protein a useful marker to check phycobilisome integrity. The goal of this work is to improve the knowledge of the mechanism of action of a very potent pesticide, lindane (gamma-hexaclorociclohexane), in the cyanobacterium Anabaena sp., which can be considered a potential candidate for bioremediation of pesticides. We have studied the effect of lindane on the photosynthetic apparatus of Anabaena using fluorescence induction studies. As ferredoxin-NADP+ reductase plays a key role in the response to oxidative stress in several systems, changes in synthesis, degradation and activity of FNR were analyzed. Immunolocalization of this enzyme was used as a marker of phycobilisome integrity. The knowledge of the changes caused by lindane in the photosynthetic apparatus is essential for rational further design of genetically-modified cyanobacteria with improved biorremediation abilities. Polyphasic chlorophyll a fluorescence rise measurements (OJIP) have been used to evaluate the vitality and stress adaptation of the nitrogen-fixing cyanobacterium Anabaena PCC 7119 in the presence of increasing concentrations of lindane. Effects of the pesticide on the ultrastructure have been investigated by electron microscopy, and FNR has been used as a marker of phycobilisome

A study of the stability of coumaphos, 14C-labelled lindane and 14C-labelled chlorpyrifos in model cattle dip

International Nuclear Information System (INIS)

Malek, M.A.; Rahman, M.M.; Amin, M.R.; Rahman, M.S.; Khatoon, J.

1997-01-01

The study was undertaken to evaluate the stability of coumaphos, 14 C-labelled lindane and chlorpyrifos insecticides/acaricides in a simulated cattle dipping vat. During the period of the study the pH of the suspension in vat increased due to addition of soil from the vacinity of cattle barn as well as due to standing in cement-concrete of the vat. The residual amounts of lindane and chiorpyrifos were estimated by counting the corresponding radioactivity in the suspension. Lindane dissipated rapidly and its half-life during the first phase was 4 d only. After standing for 3 weeks lindane residues were equivalent to 3.5% of the original amount in the suspension and 9.6% in the supernatent. Similarly, 97% of the original amount of lindane bad dissipated in the soil sediment at the end of 3 weeks, indicating that dissipation of lindane was primarily due to volatilization. Chlorpyrifos was more stable under the experimental conditions and its half life was calculated to be 22 d during the first phase of dissipation. After 3 weeks the concentration of chlorpyriphos in the suspension remained almost unchanged. However, in the supernatant its concentration increased to 115% of the initial amount. The concentration of soil-bound residues of chlopyrofos remained less than 5% of the total amount applied through out the period of study

75 FR 11551 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Science.gov (United States)

2010-03-11

...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive...

76 FR 38188 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Science.gov (United States)

2011-06-29

...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General..., 2011, the committee will discuss current strategies for FDA's Office of Pharmaceutical Science...

78 FR 58315 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Science.gov (United States)

2013-09-23

...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... continuous manufacturing for pharmaceutical products. Speakers from the Agency, academia, and industry will...

The release of lindane from contaminated building materials

OpenAIRE

Volchek, Konstantin; Thouin, Geneviève; Kuang, Wenxing; Li, Ken; Tezel, F. Handan; Brown, Carl E.

2014-01-01

The release of the organochlorine pesticide lindane (γ-hexachlorocyclohexane) from several types of contaminated building materials was studied to assess inhalation hazard and decontamination requirements in response to accidental and/or intentional spills. The materials included glass, polypropylene carpet, latex-painted drywall, ceramic tiles, vinyl floor tiles, and gypsum ceiling tiles. For each surface concentration, an equilibrium concentration was determined in the vapour phase of the s...

76 FR 38668 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Science.gov (United States)

2011-07-01

...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General.... In response to feedback during the April 13, 2010, Advisory Committee for Pharmaceutical Science and...

78 FR 58314 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Science.gov (United States)

2013-09-23

...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... session, the Office of Pharmaceutical Science and the Office of Compliance will discuss with the committee...

Residues of Lindane and Chlorpyrifos in firewood and woodsmoke

Science.gov (United States)

P.B. Bush; J.W. Taylor; Charles K. McMahon; D.G. Neary

1987-01-01

Abstract.Pine bark beetle insecticide treatment plots were established on the Ocala National Forest, in central Florida. Each plot consisted of five sand pine, pinus clausa (Chapm. Ex. Engelm) Vassey ex. Sarg., trees treated with either 0.5% lindane (benzene hexachloride) or 2% chlorpyrifos (O,O-diethyl O-(3,5,6-trichloro-2-pgridyl) phosphorothioate...

Enhanced biodegradation of lindane using oil-in-water bio-microemulsion stabilized by biosurfactant produced by a new yeast strain, Pseudozyma VITJzN01.

Science.gov (United States)

Abdul Salam, Jaseetha; Das, Nilanjana

2013-11-28

Organochlorine pesticide residues continue to remain as a major environmental threat worldwide. Lindane is an organochlorine pesticide widely used as an acaricide in medicine and agriculture. In the present study, a new lindane-degrading yeast strain, Pseudozyma VITJzN01, was identified as a copious producer of glycolipid biosurfactant. The glycolipid structure and type were elucidated by FTIR, NMR spectroscopy, and GC-MS analysis. The surface activity and stability of the glycolipid was analyzed. The glycolipids, characterized as mannosylerythritol lipids (MELs), exhibited excellent surface active properties and the surface tension of water was reduced to 29 mN/m. The glycolipid was stable over a wide range of pH, temperature, and salinity, showing a very low CMC of 25 mg/l. Bio-microemulsion of olive oil-in-water (O/W) was prepared using the purified biosurfactant without addition of any synthetic cosurfactants, for lindane solubilization and enhanced degradation assay in liquid and soil slurry. The O/W bio-microemulsions enhanced the solubility of lindane up to 40-folds. Degradation of lindane (700 mg/l) by VITJzN01 in liquid medium amended with bio-microemulsions was found to be enhanced by 36% in 2 days, compared with degradation in 12 days in the absence of bio-microemulsions. Lindane-spiked soil slurry incubated with bio-microemulsions also showed 20-40% enhanced degradation compared with the treatment with glycolipids or yeast alone. This is the first report on lindane degradation by Pseudozyma sp., and application of bio-microemulsions for enhanced lindane degradation. MEL-stabilized bio-microemulsions can serve as a potential tool for enhanced remediation of diverse lindanecontaminated environments.

Evaluation of hexachlorocyclohexane contamination from the last lindane production plant operating in India.

Science.gov (United States)

Jit, Simran; Dadhwal, Mandeep; Kumari, Hansi; Jindal, Swati; Kaur, Jasvinder; Lata, Pushp; Niharika, Neha; Lal, Devi; Garg, Nidhi; Gupta, Sanjay Kumar; Sharma, Pooja; Bala, Kiran; Singh, Ajaib; Vijgen, John; Weber, Roland; Lal, Rup

2011-05-01

α-Hexachlorocyclohexane (HCH), β-HCH, and lindane (γ-HCH) were listed as persistent organic pollutants by the Stockholm Convention in 2009 and hence must be phased out and their wastes/stockpiles eliminated. At the last operating lindane manufacturing unit, we conducted a preliminary evaluation of HCH contamination levels in soil and water samples collected around the production area and the vicinity of a major dumpsite to inform the design of processes for an appropriate implementation of the Convention. Soil and water samples on and around the production site and a major waste dumpsite were measured for HCH levels. All soil samples taken at the lindane production facility and dumpsite and in their vicinity were contaminated with an isomer pattern characteristic of HCH production waste. At the dumpsite surface samples contained up to 450 g kg(-1) Σ HCH suggesting that the waste HCH isomers were simply dumped at this location. Ground water in the vicinity and river water was found to be contaminated with 0.2 to 0.4 mg l(-1) of HCH waste isomers. The total quantity of deposited HCH wastes from the lindane production unit was estimated at between 36,000 and 54,000 t. The contamination levels in ground and river water suggest significant run-off from the dumped HCH wastes and contamination of drinking water resources. The extent of dumping urgently needs to be assessed regarding the risks to human and ecosystem health. A plan for securing the waste isomers needs to be developed and implemented together with a plan for their final elimination. As part of the assessment, any polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) generated during HCH recycling operations need to be monitored.

Bioconcentration of 14 C-Carbofuran and 14 C- Lindane in fresh water Tilapia Nilitica and the bioavailability of their residues to rats

International Nuclear Information System (INIS)

Aly, M.A.S.; Afifi, L.M.

1997-01-01

Tilapia Nilotica were exposed to 14 C- carbofuran (125 MUg/1) and 14 C - lindane (80 MUg/1) for 96 h. Uptake period followed by 8 days depuration period. The bioconcentration factor (BCF) for carbofuran reached 32.4 at 12 h and 82 for lindane at 48 h. The amount of 14 C-activity found in fish treated with 14 C - carbofuran after the uptake period showed the following descending order: viscera > remaining parts > gills > muscles. In case of 14 C - lindane treated fish the recovered amount followed the order; remaining parts> viscera > gills muscles. During the depuration period, carbofuran residues taken up by fish were eliminated in 2 phases, an initial rapid phase followed by a slower gradual one. However, the rate of elimination in case of lindane was much slower especially during the first 2 days. At the end of the depuration period (8 days), the muscles (edible portion) contained 10% and 58% of 14 C -activity in case of carbofuran and lindane treated groups, respectively. Both insecticides proved to be bioavailable when rats were fed treated fish. Of the administered dose, 44.1% and 53.0% were excreted in urine and feces case of 14 C-carbofuran while in case of 14 C - lindane it was 30.9% and 41.7% for urine and feces, respectively. 2 figs., 2 tabs

Lindane induces testicular apoptosis in adult Wistar rats through the involvement of Fas-FasL and mitochondria-dependent pathways

International Nuclear Information System (INIS)

Saradha, B.; Vaithinathan, S.; Mathur, P.P.

2009-01-01

Lindane, an organochlorine pesticide, is known to impair testicular functions and fertility. To elucidate the mechanism(s) underpinning the gonadal effects of lindane, we sought to investigate the levels of apoptosis-related proteins, namely cytochrome c, caspase-3 and-9, Fas and FasL in the testis of adult rats. Furthermore, the study aims to delineate whether nuclear factor kappa B (NF-κB) is involved in meditating the testicular effects of lindane. Animals were administered with a single dose of lindane (5 mg/kg body weight) and sacrificed at specific post-treatment intervals (0, 3, 6, 12, 24 and 72 h). Significant elevations in the levels of cytosolic cytochrome c with a parallel increase in pro-caspase-9 were observed as early as 6 h following exposure. Time-dependent elevations in the levels of Fas, FasL and caspase-3 were observed. Immunofluorescence studies revealed increased colocalization of Fas and caspase-3 in peritubular germ cells. FasL levels were increased in Sertoli and peritubular germ cells. The cytoplasmic levels of NF-κB p65 decreased from 3 h following exposure with a maximal decline at 12 and 24 h. Changes in the localization of NF-κB were observed with maximal nuclear translocation in germ cells at 12 and 24 h. Terminal deoxynucleotidyl transferase-mediated dUTP nickend-labeling (TUNEL) assay revealed a time-dependent increase in the number of apoptotic cells. Taken together, the data illustrate induction of testicular apoptosis in adult rats following exposure to a single dose of lindane. Early activation of NF-κB in contrast to late increase in Fas expression suggests a pro-apoptotic role of NF-κB in testicular response to lindane

The effect of water content on the persistence of 14C- lindane in Brazilian soils

International Nuclear Information System (INIS)

Hirata, R.; Mesquita, T.B.; Ruegg, E.F.

1985-01-01

The effect to the water content on the behaviour of 14 C-lindane was determined under laboratory conditions in two soil samples from the state of Parana, differing in organic matter and clay content. In Brunizem soil, richer in organic matter, the rate of degradation of 14 C-lindane, as measured by 14 CO 2 evolution, was twice under 3/3 field capacity and flooded condition as compared with 2/3 field capacity. The percentage of 14 CO 2 envolved from the Dark Red Latosol soil practically the same for the three levels of moisture content and about equal to the Brunizem soil at 2/3 field capacity. Although after 240 days of incubation with 14 C-lindane about 5% of the applied activity could be extracted from both soils, between 20 to 36% of the parent radiocarbon was yet bound to the soils. The degradation of 14 C-lindage into 14 CO 2 , the volatization of 14 C-lindage, and the radiocarbon probably lost as volatile metabolites were the main routes of dissipation of the insecticide from both soils. (Author) [pt

In vivo plasma concentration for lindane after 6 hour exposure in human skin

Data.gov (United States)

U.S. Environmental Protection Agency — Dataset is a time course description of lindane disappearance in blood plasma after dermal exposure in human volunteers. This dataset is associated with the...

Fate and distribution of lindane and endosulfan in maize and cowpea ecosystems respectively

International Nuclear Information System (INIS)

Yeboah, P.O.; Montford, K.G.; Klake, R.K.; Akpabli, C.K.

1997-01-01

A quantitative study is presented on linande and endosulfan residues in maize and cowpea ecosystems respectively. Both pesticides were found to dissipate very fast under the tropical Ghanaian conditions. The high rate of dissipation in leaves is attributed to the fact that the leaves were exposed to sunshine and wind leading to increased volatilisation. Endosulfan was found to dissipate faster from the cowpea ecosystem than lindane did in the maize ecosystem. The mean residue levels of lindane in maize grains were 0.02 μg g -1 ; whilst residue levels of endosulfan in cowpea seeds were 0.05 μg g -1 . These levels are lower than the maximum residue limits recognized as acceptable by the Codex Alimentarus Commission. (author). 11 refs, 7 tabs

Long-Term Collaboration Network Based on ClinicalTrials.gov Database in the Pharmaceutical Industry

Directory of Open Access Journals (Sweden)

Heyoung Yang

2018-01-01

Full Text Available Increasing costs, risks, and productivity problems in the pharmaceutical industry are important recent issues in the biomedical field. Open innovation is proposed as a solution to these issues. However, little statistical analysis related to collaboration in the pharmaceutical industry has been conducted so far. Meanwhile, not many cases have analyzed the clinical trials database, even though it is the information source with the widest coverage for the pharmaceutical industry. The purpose of this study is to test the clinical trials information as a probe for observing the status of the collaboration network and open innovation in the pharmaceutical industry. This study applied the social network analysis method to clinical trials data from 1980 to 2016 in ClinicalTrials.gov. Data were divided into four time periods—1980s, 1990s, 2000s, and 2010s—and the collaboration network was constructed for each time period. The characteristic of each network was investigated. The types of agencies participating in the clinical trials were classified as a university, national institute, company, or other, and the major players in the collaboration networks were identified. This study showed some phenomena related to the pharmaceutical industry that could provide clues to policymakers about open innovation. If follow-up studies were conducted, the utilization of the clinical trial database could be further expanded, which is expected to help open innovation in the pharmaceutical industry.

Fate and effects of 14C-lindane in an agricultural ecosystem

International Nuclear Information System (INIS)

Farghaly, M.; Zayed, S.M.A.D.; Soliman, S.M.; Nawito, M.; Desouky, H.M.

1997-01-01

The fate of 14 C-lindane was studied using a terrestrial field ecosystem that included plants, soil, beetles, earthworms and one type of common bird in Egypt (Asfur baladi). The study was conducted on a restricted field area that was cultivated with maize plants as the target crop and soybean plants as an alternate crop. The residue level in soybean seeds (3.20 μg g -1 ) was almost 10 times more than that in dry maize seeds (0.36 μg g -1 ). The concentration of 14 C-residues in beetles was 2.18 μg g -1 on day 60 after spraying 14 C-lindane, and decreased thereafter. The earthworms, on the other hand, showed a progressive increase in concentration of residues with time. Birds showed the highest concentration of residues in the brain, liver and heart and histological changes were observed in these tissues. (author). 8 refs, 8 figs, 7 tabs

75 FR 10488 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Science.gov (United States)

2010-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

76 FR 3912 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Science.gov (United States)

2011-01-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

78 FR 42966 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Science.gov (United States)

2013-07-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

77 FR 41790 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Science.gov (United States)

2012-07-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

77 FR 42746 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Science.gov (United States)

2012-07-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

77 FR 1696 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Science.gov (United States)

2012-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

75 FR 8368 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Science.gov (United States)

2010-02-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

Radiotracer studies on the degradation and dissipation of lindane under Malaysian environment. Part of a coordinated programme on the fate of persistent pesticides in the tropics, using radioisotopes

International Nuclear Information System (INIS)

Jamaluddin, M.D.

1983-11-01

A protocol was designed to provide information on rates of dissipation and degradation of lindane (γ-isomer of 1,2,3,4,5,6-hexachlorocyclohexane), a chemical used in Malaysia for pest control in rice paddies. The parameters studied included adsorption to three Malaysian soils, volatilization, degradation, dissipation through leaching and terminal residues in the grain. 14 C-labelled lindane was used after mixing with appropriate concentrations of the cold chemical. Standard nuclear techniques such as liquid scintillation counting and radiochromatography were applied. Adsorption of lindane to soil decreased in the order clay>sandy clay>loam>sandy loam. Volatilization of lindane was proportional to the chemical concentration and was more rapid in non-flooded and sterilized flooded soils. Under flooding conditions, microorganismal activities seem to play a dominant role in the disappearance, possibly degradation, of lindane. The half-life of lindane in non-sterilized flooded soil ranged from 10.5 to 34.5 days depending on the type of soil. The chemical residue in the grain was well below the maximum residue level. This is part of a project designed to provide data on the degradation and dissipation of lindane in the Malaysian environment in an attempt to pass a realistic judgement as to its persistence

Lindane and propuxur residues in the top soils of some cocoa ...

African Journals Online (AJOL)

Lindane and propoxur residues in some topsoil samples from five cocoa growing districts in the Central Region of Ghana have been determined. Ten soil samples were taken randomly at a depth of 0-10 cm from pre-selected farms in each district. Some physical and chemical properties of the soils were determined.

Big Pharma on the Farm: Students Are Exposed to Pharmaceutical Marketing More Often in Rural Clinics.

Science.gov (United States)

Evans, David V; Keys, Toby; Desnick, Laurel; A Andrilla, C Holly; Bienz, Danielle; Rosenblatt, Roger

2016-07-01

Pharmaceutical marketing techniques are effective in changing the behavior of health care providers in ways that deviate from evidence-based practices. To mitigate the influence of pharmaceutical marketing on learners, academic medical centers (AMCs) have adopted policies to limit student/industry interaction. Many clinical experiences occur outside of the AMC. The purpose of this study was to compare medical students' exposure to pharmaceutical marketing in off-campus rural and urban underserved clinical sites. The University of Washington School of Medicine Rural and Underserved Opportunities Program (RUOP) places rising second-year medical students in underserved clinical sites in five northwestern states. We surveyed RUOP students to evaluate their exposure to pharmaceutical marketing. Of 120 students, 86 (72%) completed surveys. Sixty-five (76%) did their RUOP rotation in rural areas. Students in rural locations were more likely to report exposure to pharmaceutical marketing. Distribution of free drug samples was reportedly three times higher in rural than urban sites (54% versus 15%). Doctors meeting with sales representatives were reported as four times higher in rural clinics (40% versus 10%). Students at rural sites reported exposure to pharmaceutical marketing more than those in urban settings. Rural medical educators should provide faculty development for community clinicians on the influences of pharmaceutical marketing on learners. Medical schools must review local clinic and institution-wide policies to limit pharmaceutical marketing exposure to learners in the rural learning environment.

The sea urchin Paracentrotus lividus immunological response to chemical pollution exposure: The case of lindane.

Science.gov (United States)

Stabili, Loredana; Pagliara, Patrizia

2015-09-01

In the marine environment organochlorine insecticides can be broadly detected in water, sediments, and biota. These pollutants may have major ecological consequences since they may affect marine organisms and endanger organismal growth, reproduction or survival. In this study we investigated the modification of some sea urchin immunological parameters in response to subchronic lindane (γ-HCH) exposure. Adult specimens of the sea urchin Paracentrotus lividus were exposed to two different concentrations (0.1 and 0.5 mg L(-1)) of lindane. After 24 and 48h of treatment, we examined the lindane influence on coelomocytes vitality and enumeration as well on some humoral parameters. Our results showed that the presence of the pesticide affected both cellular and humoral components of the immune system. In particular, P. lividus coelomocytes vitality did not change but a decrease of the total cell number and an increase of the red cells was recorded. Haemolytic and lysozyme-like activities as well as antibacterial activity on Vibrio alginolyticus of treated animals decreased. Sea urchin immunological competence modifications might represent a tool for monitoring disease susceptibility thus providing biological criteria for the implementation of water quality standards to protect marine organisms. Copyright © 2015 Elsevier Ltd. All rights reserved.

Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety.

Science.gov (United States)

de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

2018-01-01

Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical

About the sorption of C-14 labelled γ-hexachlorcyclohexane (lindane) in the ng/l-range at geogene adsorbers

International Nuclear Information System (INIS)

Wirth, H.

1985-01-01

In order to evaluate the environmental behaviour of chlorinated hydrocarbons more precisely, laboratory adsorption experiments under defined conditions taking lindane as a model were carried out. Adsorbents used were Elbe River suspended matter, quartz, kaolinite, illite, bentonite, Na-humate and peat. Organogenic substrates showed the highest adsorption rates. Adsorption was affected by several parameters such as salinity and temperature. High remobility of lindane was found in desorption experiments. These results can be transferred to natural aquatic systems since the concentration ranges used herein are equivalent to those found in the environment. (orig.) [de

Pre-Clinical Medical Students' Exposure to and Attitudes Toward Pharmaceutical Industry Marketing.

Science.gov (United States)

Fein, Eric H; Vermillion, Michelle L; Uijtdehaage, Sebastian H J

2007-12-01

Background - Recent studies have examined the exposures and attitudes of physicians and third- and fourth-year medical students toward pharmaceutical industry marketing, but fewer studies have addressed these topics among pre-clinical medical students. Thus, the purpose of this study was to assess pre-clinical students' level of exposure to the pharmaceutical industry and their attitudes toward marketing. Method - First and second-year medical students at UCLA completed a 40-item survey based on previous studies. Results - Over three quarters of pre-clinical students (78.5% or 226 of 288) responded to the survey. Exposure to pharmaceutical industry marketing started very early in medical school. Most second-year students (77%) had received gifts including drug samples after three semesters. Most felt that this would not affect their future prescribing behavior. Conclusions - These findings and findings from related studies, coupled with the students' desire to learn more about the issue, suggest that an early educational intervention addressing this topic may be warranted in American medical schools.

Clinical trial allocation in multinational pharmaceutical companies – a qualitative study on influential factors

DEFF Research Database (Denmark)

Dombernowsky, Tilde; Haedersdal, Merete; Lassen, Ulrik

2017-01-01

(1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting......Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were...... trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site-related qualities...

Application of ion chromatography in clinical studies and pharmaceutical industry.

Science.gov (United States)

Michalski, Rajmund

2014-01-01

Ion chromatography is a well-established regulatory method for analyzing anions and cations in environmental, food and many other samples. It offers an enormous range of possibilities for selecting stationary and mobile phases. Additionally, it usually helps to solve various separation problems, particularly when it is combined with different detection techniques. Ion chromatography can also be used to determine many ions and substances in clinical and pharmaceutical samples. It provides: availability of high capacity stationary phases and sensitive detectors; simple sample preparation; avoidance of hazardous chemicals; decreased sample volumes; flexible reaction options on a changing sample matrix to be analyzed; or the option to operate a fully-automated system. This paper provides a short review of the ion chromatography applications for determining different inorganic and organic substances in clinical and pharmaceutical samples.

Clinical trial allocation in multinational pharmaceutical companies - a qualitative study on influential factors.

Science.gov (United States)

Dombernowsky, Tilde; Haedersdal, Merete; Lassen, Ulrik; Thomsen, Simon F

2017-06-01

Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were (1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site-related qualities. The results suggest that headquarters and regional departments are key decision makers during country selection, whereas subsidiaries decide on site selection. Study participants argued that headquarters primarily value timely patient recruitment and quality of data when assessing subsidiaries. The site-related qualities most commonly emphasized during interviews were study population availability, timely patient recruitment, resources at the site, and site personnel's interest and commitment. Costs of running the trials were described as less important. Site personnel experience in conducting trials was described as valuable but not imperative. In conclusion, multinational pharmaceutical companies consider recruitment-related factors as crucial when allocating clinical trials. Quality of data and site personnel's interest and commitment are also essential, whereas costs seem less important. While valued, site personnel experience in conducting clinical trials is not imperative.

Sorption mechanisms of phenanthrene, lindane, and atrazine with various humic acid fractions from a single soil sample.

Science.gov (United States)

Wang, Xilong; Guo, Xiaoying; Yang, Yu; Tao, Shu; Xing, Baoshan

2011-03-15

The sorption behavior of organic compounds (phenanthrene, lindane, and atrazine) to sequentially extracted humic acids and humin from a peat soil was examined. The elemental composition, XPS and (13)C NMR data of sorbents combined with sorption isotherm data of the tested compounds show that nonspecific interactions govern sorption of phenanthrene and lindane by humic substances. Their sorption is dependent on surface and bulk alkyl carbon contents of the sorbents, rather than aromatic carbon. Sorption of atrazine by these sorbents, however, is regulated by polar interactions (e.g., hydrogen bonding). Carboxylic and phenolic moieties are key components for H-bonding formation. Thermal analysis reveals that sorption of apolar (i.e., phenanthrene and lindane) and polar (i.e., atrazine) compounds by humic substances exhibit dissimilar relationships with condensation and thermal stability of sorption domains, emphasizing the major influence of domain spatial arrangement on sorption of organic compounds with distinct polarity. Results of pH-dependent sorption indicate that reduction in sorption of atrazine by the tested sorbents is more evident than phenanthrene with increasing pH, supporting the dependence of organic compound sorption on its polarity and structure. This study highlights the different interaction mechanisms of apolar and polar organic compounds with humic substances.

Coming Soon to a Physician Near You: Medical Neoliberalism and Pharmaceutical Clinical Trials.

Science.gov (United States)

Fisher, Jill A

2007-01-01

This paper aims to expand standard conceptions of current ethical issues by discussing pharmaceutical clinical trials in terms of the broader political economy. Specifically, it explores one important characteristic of the political economy in the United States: the trend towards the neoliberalization of health care. First, it provides an overview of neoliberalism and its manifestations in the health care sector. Then, it applies this perspective to pharmaceutical drug development. The paper argues that federal regulation must attend to the context of clinical research to protect human subjects more fully.

Herbal remedy clinical trials in the media: a comparison with the coverage of conventional pharmaceuticals

Directory of Open Access Journals (Sweden)

Caulfield Timothy

2008-11-01

Full Text Available Abstract Background This study systematically compares newspaper coverage of clinical trials for herbal remedies, a popular type of complementary and alternative medicine, with clinical trials for pharmaceuticals using a comparative content analysis. This is a timely inquiry given the recognized importance of the popular press as a source of health information, the complex and significant role of complementary and alternative medicine in individual health-care decisions, and the trend toward evidence-based research for some complementary and alternative medical therapies. We searched PubMed for clinical trials, Lexis/Nexis for newspaper articles in the UK, US, Australia/New Zealand, and Factiva for Canadian newspaper articles from 1995 to 2005. We used a coding frame to analyze and compare 48 pharmaceutical and 57 herbal remedy clinical trials as well as 201 pharmaceutical and 352 herbal remedy newspaper articles. Results Herbal remedy clinical trials had similar Jadad scores to pharmaceutical trials but were significantly smaller and of shorter duration. The trials were mostly studies from Western countries and published in high-ranking journals. The majority of pharmaceutical (64% and herbal remedy (53% clinical trials had private sector funding involvement. A minority declared further author conflicts of interest. Newspaper coverage of herbal remedy clinical trials was more negative than for pharmaceutical trials; a result only partly explained by the greater proportion of herbal remedy clinical trials reporting negative results (P = 0.0201; χ2 = 7.8129; degrees of freedom = 2. Errors of omission were common in newspaper coverage, with little reporting of dose, sample size, location, and duration of the trial, methods, trial funding, and conflicts of interest. There was an under-reporting of risks, especially for herbal remedies. Conclusion Our finding of negative coverage of herbal remedy trials is contrary to the positive trends in most

REQUIREMENTS ON CLINICAL TRIALS FOR VETERINARY PHARMACEUTICAL PRODUCTS FOR FISH

Directory of Open Access Journals (Sweden)

Simona Sturzu

2016-12-01

Full Text Available Veterinary pharmaceutical products intended for use in fish should comply with all usual requirements regarding approval for marketing, according to the Order of the President of the National Sanitary Veterinary Agency and for Food Safety No.187/2007, with subsequent amendments and additions. According to the legislation the technical file should containe documentation of quality, safety of animals, consumer, user and environment and demonstration of efficacy and tolerance in the target species. This paper provides the important information on requirements for demonstration on efficacy of pharmaceutical products indended for use in fish. The principal aim of the efficacy data is to prove the therapeutic value of pharmaceutical products and to establish an optimal dose and period of dose administration. In efficacity clinical trial is needed, also, to take into account, the various conditions such as climatic aspects, disease situation, water temperature and salinity, because these may influence the outcome and veracity of the studies.

[Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

Science.gov (United States)

Nakajima, Toshifusa

2016-04-01

Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media.

Safety and clinical efficacy of some radiation-sterilized medical products and pharmaceuticals

International Nuclear Information System (INIS)

Kulkarni, R.D.; Gopal, N.G.S.

1975-01-01

Medical products and pharmaceuticals must conform to certain minimum physico-chemical microbiological and biological requirements. The biological requirements comprise principally testing for toxicity, safety, and pyrogens. Besides the above-mentioned criteria, there are two other important characteristics, viz. clinical efficacy and tolerance in animal and/or human beings. These latter requirements, expected from the final product released for general human use, are not carried out routinely. In the present-day pharmaceutical and medical technology, numerous mew products are appearing, many of them requiring radiation sterilization as they are not stable towards the other conventional methods of sterilization. While the post-irradiation physicochemical changes in a product may not be significant, the bio-availability or biological activity of the product may be affected to a more significant extent. Some evidence of this has recently been reported. Hence, it is desirable to carry out studies on safety as well as clinical efficacy on irradiated products. This paper describes some studies on plastic-based medical products, a pharmaceutical raw material, a typical infusion fluid such as normal saline, antibiotics and their ointments. (author)

Basic Pharmaceutical Sciences Examination as a Predictor of Student Performance during Clinical Training.

Science.gov (United States)

Fassett, William E.; Campbell, William H.

1984-01-01

A comparison of Basic Pharmaceutical Sciences Examination (BPSE) results with student performance evaluations in core clerkships, institutional and community externships, didactic and clinical courses, and related basic science coursework revealed the BPSE does not predict student performance during clinical instruction. (MSE)

Pharmaceutical product cross-contamination: industrial and clinical ...

African Journals Online (AJOL)

problems. Pharmaceutical product cross-contamination is a serious problem which has been detected as an obstacle ... In the pharmaceutical care of patients in developed countries, cross-contamination ..... neonatal intensive care units.

Current perceptions of the term Clinical Pharmacy and its relationship to Pharmaceutical Care: a survey of members of the European Society of Clinical Pharmacy.

Science.gov (United States)

Dreischulte, Tobias; Fernandez-Llimos, Fernando

2016-12-01

Background The definitions that are being used for the terms 'clinical pharmacy' and 'pharmaceutical care' seem to have a certain overlap. Responsibility for therapy outcomes seems to be especially linked to the latter term. Both terms need clarification before a proper definition of clinical pharmacy can be drafted. Objective To identify current disagreements regarding the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care' and to assess to which extent pharmacists with an interest in Clinical Pharmacy are willing to accept responsibility for drug therapy outcomes. Setting The membership of the European Society of Clinical Pharmacy. Methods A total of 1,285 individuals affiliated with the European Society of Clinical Pharmacy were invited by email to participate in an online survey asking participants to state whether certain professional activities, providers, settings, aims and general descriptors constituted (a) 'Clinical Pharmacy only', (b) 'Pharmaceutical Care only', (c) 'both' or (d) 'neither'. Further questions examined pharmacists' willingness to accept ethical or legal responsibility for drug therapy outcomes, under current and ideal working conditions. Main outcome measures Level of agreement with a number of statements. Results There was disagreement (responsibility under current/ideal working conditions were: safety (32.7%/64.3%), effectiveness (17.9%/49.2%), patient-centeredness (17.1%/46.2%), cost-effectiveness (20.3%/44.0%). Conclusions The survey identified key disagreements around the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care', which future discussions around a harmonised definition of 'Clinical Pharmacy' should aim to resolve. Further research is required to understand barriers and facilitators to pharmacists accepting responsibility for drug therapy outcomes.

Ties that bind: multiple relationships between clinical researchers and the pharmaceutical industry.

Science.gov (United States)

Henry, David; Doran, Evan; Kerridge, Ian; Hill, Suzanne; McNeill, Paul M; Day, Richard

2005-11-28

It is believed that pharmaceutical industry sponsorship of clinical research leads to the development of multiple ties between clinicians and the pharmaceutical industry. To quantify this relationship we conducted a survey of medical specialists listed in the Medical Directory of Australia in 2002 and 2003. A questionnaire was mailed that elicited information about all aspects of research relationships between clinicians and pharmaceutical companies. The odds of reporting multiple additional ties (financial and professional) with pharmaceutical companies by clinicians who had an active research relationship were compared with those who did not. All clinicians who returned a completed questionnaire about their research activities were included in the study. A questionnaire was mailed to 2120 medical specialists; 823 (39%) responded. Of these, 338 (41%) reported involvement in industry-sponsored research in the previous year. They were more likely than others to have been offered industry-sponsored items or activities valued at more than 500 AU dollars (>382 US dollars; odds ratio [OR], 3.5; 95% confidence interval [CI], 2.6-4.7) and support for attending international conferences (OR, 5.4; 95% CI, 3.9-7.4). The strongest associations were seen for acting as a paid consultant to industry (OR, 9.0; 95% CI, 3.9-20.4) and for membership on advisory boards (OR, 6.9; 95% CI, 5.1-9.6). There was a strong relationship between research collaboration and accumulation of industry ties. For 1 additional tie the OR was 2.2 (95% CI, 1.2-3.8) and rose to 6.3 (95% CI, 3.5-11.1) with 3 ties and 41.8 (95% CI, 14.5-143.4) with 6 or more ties. Medical specialists who have research relationships with the pharmaceutical industry are much more likely to have multiple additional ties than those who do not have research relationships. Institutional review should discourage clinical researchers from developing multiple ties.

Emissions of heavy metals and lindane into German river basins; Schwermetalleintraege in die Oberflaechengewaesser Deutschlands. Quantifizierung der Schwermetalleintraege aus Deutschland zur Umsetzung der Beschluesse der Internationalen Nordseeschutzkonferenz

Energy Technology Data Exchange (ETDEWEB)

Fuchs, S.; Scherer, U.; Hillenbrand, T.; Marscheider-Weidemann, F.; Behrendt, H.; Opitz, D.

2002-12-01

According to international agreements, encouraging all partners to diminish the emission of priority pollutants into North- and Baltic Sea significantly within a time period of 1985 to 2000, the aim of this project was to quantify the changes in the emission situation for both heavy metals and lindane within the mentioned period To reach this aim the total emissions of heavy metals (As, Cd, Cr, Cu, Hg, Ni, Pb, Zn) and the pesticide lindane ({gamma}-HCH) into German river systems were quantified for the periods of 1983-1985, 1993-1995 and 1999/2000. For the quantification of the emissions via point sources a nation-wide survey on heavy metal data of municipal wastewater treatment plants and industrial direct discharges was carried out. The input via diffuse pathways was calculated using an adapted version of the model MONERIS. This model accounts for the significant transport processes, and it includes a geographical information system (GIS) that provides digital maps as well as extensive statistical information. For a comparison of the calculated heavy metal emission with the measured heavy metal load at monitoring stations the losses of heavy metals due to retention processes within the river systems have to be considered. Therefore heavy metal retention was calculated according to the retention function given by Vink/Behrendt (2002). For the large river basins a good correspondence could be found between estimated and measured heavy metal loads in rivers. The total emission into the German river basins decreased for each metal during the period of 1985 to 2000. The reduction varies between 36 and 85% mainly caused by the decline of emissions via point sources. Today's emissions of heavy metals into river basins of Germany are dominated by the input via diffuse pathways. The most important diffuse pathways are paved urban areas (Cd, Cu, Hg, Pb, Zn), erosion (Pb, Cr) and groundwater (As, Ni). Since the application of the pesticide lindane is illegal today a

Dermal absorption of the insecticide lindane (1 delta, 2 delta, 3 beta, 4 delta, 5 delta, 6 beta-hexachlorocyclohexane) in rats and rhesus monkeys: Effect of anatomical site

International Nuclear Information System (INIS)

Moody, R.P.; Ritter, L.

1989-01-01

Dermal absorption of the insecticide lindane (1 delta, 2 delta, 3 beta, 4 delta, 5 delta, 6 beta-hexachlorocyclohexane) was determined in rats and rhesus monkeys. Lindane is in widespread use as a 1% cream or lotion scabicide formulation and as a 1% miticide shampoo for body lice control in humans. Results obtained following our in vivo dermal absorption procedure demonstrated that 18 +/- 4.1%, 34 +/- 5.2%, and 54 +/- 26.3% of the applied dose was absorbed following topical applications at a rate of 1.5 micrograms/cm2 (6.2 micrograms/100 microliters of acetone) of the 14C-labeled pesticide to 4.2-cm2 regions of the forearm (n = 8), forehead (n = 7), and palm (n = 4) of rhesus monkeys, respectively. Dose sites were washed with soapy water 24 h posttreatment. Comparative studies in rats (n = 5) dosed middorsally demonstrated 31 +/- 9.5% absorption. Statistical analysis of the 14C excretion kinetics demonstrated slower clearance of lindane from rats than monkey forearm, forehead, or palm. Intramuscular (im) injections of 14C-lindane gave 52 +/- 7.1% recovery in monkey (n = 8) and 64 +/- 5.9% in rats (n = 5), suggesting body storage of this lipophilic chemical

Analysis of Biological Interactions by Affinity Chromatography: Clinical and Pharmaceutical Applications.

Science.gov (United States)

Hage, David S

2017-06-01

The interactions between biochemical and chemical agents in the body are important in many clinical processes. Affinity chromatography and high-performance affinity chromatography (HPAC), in which a column contains an immobilized biologically related binding agent, are 2 methods that can be used to study these interactions. This review presents various approaches that can be used in affinity chromatography and HPAC to characterize the strength or rate of a biological interaction, the number and types of sites that are involved in this process, and the interactions between multiple solutes for the same binding agent. A number of applications for these methods are examined, with an emphasis on recent developments and high-performance affinity methods. These applications include the use of these techniques for fundamental studies of biological interactions, high-throughput screening of drugs, work with modified proteins, tools for personalized medicine, and studies of drug-drug competition for a common binding agent. The wide range of formats and detection methods that can be used with affinity chromatography and HPAC for examining biological interactions makes these tools attractive for various clinical and pharmaceutical applications. Future directions in the development of small-scale columns and the coupling of these methods with other techniques, such as mass spectrometry or other separation methods, should continue to increase the flexibility and ease with which these approaches can be used in work involving clinical or pharmaceutical samples. © 2016 American Association for Clinical Chemistry.

Solubilisation of a host molecule in a surfactant film: thermodynamic and structural approach in the case of lindane

International Nuclear Information System (INIS)

Testard, Fabienne

1996-01-01

In this research thesis, the author aimed at understanding the main aspects of solubilisation in the specific case of a pesticide, the lindane, which is a hydrophobic molecule, poorly soluble in water. She first proposes a review of some existing models of solubilisation, and presents the only existing predictive model for the prediction of solubilisation in water-ionic surfactant binary systems. She addresses these systems and tries to characterise disruptions induced by the presence of the solute for lindane-saturated solutions (study of phase diagrams, of structure for different surfactant concentrations and different temperatures). Then she focuses on a part of the ternary diagram which allows micro emulsions to be reached at the point of spontaneous null curvature. She reports the study (by neutron and X ray scattering at small angles) of structural information on the surfactant film in different aggregates of ternary solutions in presence of solute. She finally proposes a more chemical approach to solubilisation [fr

Lethal toxicity of Lindane on a teleost fish, Anguilla anguilla from Albufera Lake (Spain): hardness and temperature effects.

Science.gov (United States)

Ferrando, M D; Almar, M M; Andreu, E

1988-02-01

This paper reports the results of toxicity tests conducted using Anguilla anguilla under three different water temperature (15, 22 and 29 degrees C) and two hardness regimes (250 and greater than 600 ppm CaCO3). The 96-h LC50 increased in the experimental medium (p less than 0.05) by an order of magnitude from 0.32 to 0.45 mg/L between 15 and 29 degrees C. However in the natural medium it is similar (p greater than 0.05) (0.54 to 0.55 mg/L) for these same temperatures. The toxicity of Lindane on eels increased when the water hardness decreased. The 24, 48, 72 and 96-h LC50 for this fish in both media is less at 15 degrees C (96-h LC50 = 0.32 and 0.55 mg/L) than at 29 degrees C (96-h LC50 = 0.45 and 0.55 mg/L). These results suggest that the toxicity of Lindane presents a negative temperature coefficient.

Pharmaceutical advertising in emergency departments.

Science.gov (United States)

Marco, Catherine A

2004-04-01

Promotion of prescription drugs represents a growing source of pharmaceutical marketing expenditures. This study was undertaken to identify the frequency of items containing pharmaceutical advertising in clinical emergency departments (EDs). In this observational study, emergency physician on-site investigators quantified a variety of items containing pharmaceutical advertising present at specified representative times and days, in clinical EDs. Measurements were obtained by 65 on-site investigators, representing 22 states. Most EDs in this study were community EDs (87% community and 14% university or university affiliate), and most were in urban settings (50% urban, 38% suburban, and 13% rural). Investigators measured 42 items per ED (mean = 42; median = 31; interquartile range of 14-55) containing pharmaceutical advertising in the clinical area. The most commonly observed items included pens (mean 15 per ED; median 10), product brochures (mean 5; median 3), stethoscope labels (mean 4; median 2), drug samples (mean 3; median 0), books (mean 3.4), mugs (mean 2.4), and published literature (mean 3.1). EDs with a policy restricting pharmaceutical representatives in the ED had significantly fewer items containing pharmaceutical advertising (median 7.5; 95% CI = 0 to 27) than EDs without such a policy (median 35; 95% CI = 27 to 47, p = 0.005, nonparametric Wilcoxon two-sample test). There were no differences in quantities of pharmaceutical advertising for EDs in community compared with university settings (p = 0.5), rural compared with urban settings (p = 0.3), or annual ED volumes (p = 0.9). Numerous items containing pharmaceutical advertising are frequently observed in EDs. Policies restricting pharmaceutical representatives in the ED are associated with reduced pharmaceutical advertising.

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.

Science.gov (United States)

Newcombe, J P; Kerridge, I H

2007-01-01

Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

Exploration of the phycoremediation potential of Laminaria digitata towards diflubenzuron, lindane, copper and cadmium in a multitrophic pilot-scale experiment

DEFF Research Database (Denmark)

Anacleto, Patrícia; van den Heuvel, Freek H M; Oliveira, C

2017-01-01

The presence of contaminants in aquatic ecosystems can cause serious problems to the environment and marine organisms. This study aims to evaluate the phycoremediation capacity of macroalgae Laminaria digitata for pesticides (diflubenzuron and lindane) and toxic elements (cadmium and copper) in s...

Residues of lindane and endosulfan in water and fish samples from rivers, farms in Besease, Agogo and Akomadan in the Ashanti region of Ghana

International Nuclear Information System (INIS)

Osafo-Acquaah, S.; Frimpong, E.

1997-01-01

Pesticide residue analyses were performed on water and fish samples from River Oda in Besease, River Aframso in Nobewam near Kumasi, River Atwetwe in Akomadan, and River Kowire at Agogo. Residues of lindane and endosulfan were found in water and fish (Oreochromis niloticus, Tilapia zillii, Barbus trispulis, Heterobranchus sp., Tilapia busumana, Ophiocephalus obscura and Chana obscura) samples. The residues of lindane varied between the years and months in the year but were in the range of 0.3 - 15 ng L -1 (1993-94) and 8.7-32.0 ng L -1 (1995) for the water samples and 0.2-24 ng g -1 (1993-93) and 8.4-120.4 ng g -1 (1995) for the fish samples. Residues of endosulfan in the water and the fish samples were zero in 1993-1994 but, in 1995, were in the range of 6.4-35.2 ng L -1 for the water samples and 5.0-267.5 ng g -1 for the fish samples. In all cases the lindane and ensofulfan concentrations in the water were 10,000-20,000 times lower than known toxic concentration levels and therefore unlikely to cause fish toxicity problems. (author). 11 refs, 4 tabs

Publication Trend of Clinical Trials with Negative Results Funded by Pharmaceutical Industries for the 2007-2012 Period

Directory of Open Access Journals (Sweden)

Evert A. Jiménez-Cotes

2015-01-01

Full Text Available Abstract: Objective: To evaluate the results of clinical trials financed by the pharmaceutical industries during the period 2007-2012 in a general medical journal. Materials and methods: We performed an observational cross sectional study where originals clinical trials financed by the pharmaceutical industry published between 2007 and 2012 in the journal The New England Journal of Medicine (http://www.nejm.org were reviewed. Trend Chi2 test was used to evaluate the results of studies over the years. A database was created with different variables, identifying the number of publications and the period of greater publishing negatives studies, as well as the medical specialty and pharmaceutical industry funding. Results: 321 clinical trials were analyzed. The Odds Ratio was calculated for each year evaluated, finding a Chi2 of linear trend in negatives studies of 2.91 with value p 0.08 and positive studies of 1.16 with value p 0.28. It was found that in the period 2007-2009 123 studies were published, 40 % of which presented negative results; unlike the 2010-2012 period in which 198 clinical trials where published, 142 of them, showed positive results, OR 1.68, 95 % CI (1.02-2.78 value p 0.03. The highest figures of negative results were published in 2007: 44.7 %. Conclusions: A progressive decrease in the number of publications with annual general negative results has been observed. A statistically significant difference in the publication of negative studies per year was not found between the periods 2007-2012. The medical specialty that showed the largest number of total and negative publications in both periods was cardiology. The pharmaceutical industry that sponsored most total clinical trials with negative results in both periods did so through Merck, Glaxo SmithKline, and Sanofi-Aventis. 50% of neurology publications showed negative results.

A combination of ascorbic acid and α-tocopherol or a combination of Mg and Zn are both able to reduce the adverse effects of lindane-poisoning on rat brain and liver.

Science.gov (United States)

Hfaiedh, Najla; Murat, Jean-Claude; Elfeki, Abdelfettah

2012-10-01

The purpose of this study, carried out on male Wistar rats, was to evaluate the beneficial effects of supplementation with ascorbic acid (Vit C) and α-tocopherol (Vit E) or with Mg and Zn upon lindane-induced damages in liver and brain. Under our experimental conditions, lindane poisoning (5mg/kg body weight per day for 3 days) resulted in (1) an increased level of plasma glucose, cholesterol and triglycerides, (2) an increased activity of LDH, ALP, AST, ALT, (3) an oxidative stress in liver and brain as revealed by an increased level of lipids peroxidation (TBARS) and a decrease of glutathione-peroxidase, superoxide dismutase and catalase activities in liver and brain. In conclusion, both Vit C+E or Mg+Zn treatments display beneficial effects upon oxidative stress induced by lindane treatment in liver and brain. Copyright © 2012 Elsevier GmbH. All rights reserved.

Detection of 14C - lindane metabolites in coffee plants by thin-layer chromatography and autoradiography

International Nuclear Information System (INIS)

Mesquita, T.B.; Hirata, R.; Ruegg, E.F.

1986-01-01

Immersion of seedling from coffee plants in aquous solution of 14 C - lindane was done for 60 days. The insecticide was taken up the roots and translocated to the stems and leaves. However, chromatographic assays indicated that several metabolites were detected only in the roots. Two of them probably are chlorobenzenes and were visualized in chromatograms of extracts from non-acidic fractions. Seven other radioactive spots which are suspected to be chlorophenols, were found in the acidic fractions. (Author) [pt

Effects of lindane on a maize ecosystem at TPRI, Arusha, Tanzania

International Nuclear Information System (INIS)

Minja, E.M.; Makusi, R.; Tesha, F.

1997-01-01

The effects of the organochlorine insecticide, lindane, on target and non-target organisms was studied in field plots of maize at Arusha, Tanzania for 4 growing seasons. A single application of 1 kg.ha -1 caused leaf scorch to the crop but two applications of 0.5 kg.ha -1 at an interval of 2 weeks were tolerated. The insecticide reduced damage by the stem borers Busseola fusca and Sesamia calamistis in all seasons and maize yields were higher on the treated plots although the differences were not always significant (P>0.05). Collembola and sometimes ant and spider numbers were lower in treated plots early in the season but the differences did not persist. Differences in rates of decomposition of buried leaf litter were not significant. (author). 7 refs, 4 figs, 6 tabs

Does brand differentiate pharmaceuticals?

Science.gov (United States)

Bednarik, Josef

2005-12-01

Role of marketing in pharmaceutical industry is increasing and inspiration by successful brands known from consumer goods market influenced pharmaceutical companies enough to switch their attention to branding initiatives. Still there is little evidence that pharmaceutical brands represent anything more than product only. This study aims to explore the area of branding in pharmaceutical industry. Central hypothesis of the research has been that brand and its emotional content differentiate pharmaceuticals as well as rational data derived from clinical studies. It has been tested by extensive review of available literature as well as by primary research focused on drivers of physicians' attitudes towards products and their influence on prescribing behavior. The research has been conducted in the sample of psychiatrists in the Czech Republic. No evidence about pharmaceutical brand exceeding value of product has been found in reviewed literature. Nevertheless, the primary research conducted in the sample of Czech psychiatrists indicates that emotional brand in pharmaceutical industry exists and enables author to draw a model of Customer/product life cycle that describes likely impact of functional, emotional and self-expressive benefits throughout pharmaceutical product's market presence. Pharmaceutical brand is likely to develop differently than the same of consumer goods products--it seems to be built predominantly on long-term positive experience. Marketing role in this process should lie in finding relevant product position and building brand identity compliant with real product capabilities.

Pharmaceutical advertisements in medical journals received in a medical clinic: are we having "too much of a good thing"?

Science.gov (United States)

Lohiya, Sapna

2005-05-01

A convenience sample of all medical journals found in a medical clinic was reviewed for pharmaceutical advertisements. Ads were present in 25 (96%) of the 26 journals. Ad space varied from 0-34% (mean 12) in research, and 9-48% (mean: 36) in nonresearch journals. In 23 (88%) journals, individual ads consisted of more than one page. Colorful glossy insert-ads, of up to nine pages, were seen in 18 (69%) journals. Six (23%) journals contained more advertising than editorial pages. Many ads were longer than the longest article in that journal. Medical journals devote considerable space to pharmaceutical ads. Excessive pharmaceutical advertising may bias the journals' owners and readers and may be distracting and annoying.

Overexpression of cerebral and hepatic cytochrome P450s alters behavioral activity of rat offspring following prenatal exposure to lindane

Energy Technology Data Exchange (ETDEWEB)

Johri, Ashu; Yadav, Sanjay; Dhawan, Alok [Developmental Toxicology Division, Industrial Toxicology Research Centre, P. O. Box 80, M. G. Marg, Lucknow-226 001, U. P. (India); Parmar, Devendra [Developmental Toxicology Division, Industrial Toxicology Research Centre, P. O. Box 80, M. G. Marg, Lucknow-226 001, U. P. (India)

2007-12-15

Oral administration of different doses (0.0625, 0.125 or 0.25 mg/kg corresponding to 1/1400th, 1/700th or 1/350th of LD{sub 50}) of lindane to the pregnant Wistar rats from gestation days 5 to 21 were found to produce a dose-dependent increase in the activity of cytochrome P450 (CYP)-dependent 7-ethoxyresorufin-O-deethylase (EROD), 7-pentoxyresorufin-O-dealkylase (PROD) and N-nitrosodimethylamine demethylase (NDMA-d) in brain and liver of offspring postnatally at 3 weeks. The increase in the activity of CYP monooxygenases was found to be associated with the increase in the mRNA and protein expression of xenobiotic metabolizing CYP1A, 2B and 2E1 isoenzymes in the brain and liver of offspring. Dose-dependent alterations in the parameters of spontaneous locomotor activity in the offspring postnatally at 3 weeks have suggested that increase in CYP activity may possibly lead to the formation of metabolites to the levels that may be sufficient to alter the behavioral activity of the offspring. Interestingly, the inductive effect on cerebral and hepatic CYPs was found to persist postnatally up to 6 weeks in the offspring at the relatively higher doses (0.125 and 0.25 mg/kg) of lindane and up to 9 weeks at the highest dose (0.25 mg/kg), though the magnitude of induction was less than that observed at 3 weeks. Alterations in the parameters of spontaneous locomotor activity in the offspring postnatally at 6 and 9 weeks, though significant only in the offspring at 3 and 6-week of age, have further indicated that due to the reduced activity of the CYPs during the ontogeny, lindane and its metabolites may not be effectively cleared from the brain. The data suggest that low dose prenatal exposure to the pesticide has the potential to produce overexpression of xenobiotic metabolizing CYPs in brain and liver of the offspring which may account for the behavioral changes observed in the offspring.

Overexpression of cerebral and hepatic cytochrome P450s alters behavioral activity of rat offspring following prenatal exposure to lindane

International Nuclear Information System (INIS)

Johri, Ashu; Yadav, Sanjay; Dhawan, Alok; Parmar, Devendra

2007-01-01

Oral administration of different doses (0.0625, 0.125 or 0.25 mg/kg corresponding to 1/1400th, 1/700th or 1/350th of LD 50 ) of lindane to the pregnant Wistar rats from gestation days 5 to 21 were found to produce a dose-dependent increase in the activity of cytochrome P450 (CYP)-dependent 7-ethoxyresorufin-O-deethylase (EROD), 7-pentoxyresorufin-O-dealkylase (PROD) and N-nitrosodimethylamine demethylase (NDMA-d) in brain and liver of offspring postnatally at 3 weeks. The increase in the activity of CYP monooxygenases was found to be associated with the increase in the mRNA and protein expression of xenobiotic metabolizing CYP1A, 2B and 2E1 isoenzymes in the brain and liver of offspring. Dose-dependent alterations in the parameters of spontaneous locomotor activity in the offspring postnatally at 3 weeks have suggested that increase in CYP activity may possibly lead to the formation of metabolites to the levels that may be sufficient to alter the behavioral activity of the offspring. Interestingly, the inductive effect on cerebral and hepatic CYPs was found to persist postnatally up to 6 weeks in the offspring at the relatively higher doses (0.125 and 0.25 mg/kg) of lindane and up to 9 weeks at the highest dose (0.25 mg/kg), though the magnitude of induction was less than that observed at 3 weeks. Alterations in the parameters of spontaneous locomotor activity in the offspring postnatally at 6 and 9 weeks, though significant only in the offspring at 3 and 6-week of age, have further indicated that due to the reduced activity of the CYPs during the ontogeny, lindane and its metabolites may not be effectively cleared from the brain. The data suggest that low dose prenatal exposure to the pesticide has the potential to produce overexpression of xenobiotic metabolizing CYPs in brain and liver of the offspring which may account for the behavioral changes observed in the offspring

Radio-pharmaceuticals for human use: the legal framework and the clinical indications authorised in Spain

International Nuclear Information System (INIS)

Cortes-Blanco, A.; Esteban Gomez, J

2003-01-01

The inclusion of radio-pharmaceuticals in the health legislation represented a significant change because of the obligation, for the first time, to undergo a registration process to enable them to be marketed. It also served to regulate clinical investigation using these drugs, and the prior evaluation they must undergo in other to obtain official health clearance. (Author) 27 refs

Postgraduate Courses in Pharmaceutical Medicine in Italy

Directory of Open Access Journals (Sweden)

Domenico Criscuolo

2017-06-01

Full Text Available Italy has a significant tradition of excellence in the area of clinical trials (CTRs: important achievements in the clinical development of rifampicin and adriamycin, the two most famous drugs discovered in the research laboratories of two Italian pharmaceutical companies, paved the way to the establishment of a culture of clinical development, mainly in the areas of antimicrobials and oncology. Despite the fact that now the Italian market of pharmaceuticals is largely dominated by multinational companies with headquarters outside Italy, the contribution of Italian studies to the clinical development of new drugs is still significant. Indeed, it largely exceeds the percentage of Italian inhabitants versus the ones living in the remaining EU countries, as Italy has about 12% of EU population, but has a 17% share of the EU CTRs. Education in Pharmaceutical Medicine is now a must for all professionals interested to work either in pharma companies or in contract research organizations: several Italian universities are offering high quality courses, and in the last 10 years, more than 1,200 professionals received a postgraduate education in pharmaceutical medicine. This result places Italy on top of countries concerned about the professional education of people involved in drug development and will represent an asset for a larger involvement of Italian clinical sites in the global process of clinical research.

The role of cocrystals in pharmaceutical science.

Science.gov (United States)

Shan, Ning; Zaworotko, Michael J

2008-05-01

Pharmaceutical cocrystals, a subset of a long known but little-studied class of compounds, represent an emerging class of crystal forms in the context of pharmaceutical science. They are attractive to pharmaceutical scientists because they can significantly diversify the number of crystal forms that exist for a particular active pharmaceutical ingredient (API), and they can lead to improvements in physical properties of clinical relevance. In this article we address pharmaceutical cocrystals from the perspective of design (crystal engineering) and present a series of case studies that demonstrate how they can enhance the solubility, bioavailability, and/or stability of API crystal forms.

Pharmaceutical industry's barriers and preferences to conduct clinical drug trials in Finland: a qualitative study.

Science.gov (United States)

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.

The argument for pharmaceutical policy.

Science.gov (United States)

Traulsen, Janine Morgall; Almarsdóttir, Anna Birna

2005-02-01

Pharmaceutical policy is a global concern. It has become a hot political topic in most countries--developed as well as developing--and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it be understood, discussed and debated within the pharmacy profession and included in the curriculum of schools of pharmacy. This, the first article in a series, argues for the importance of the academic discipline of pharmaceutical policy analysis and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how pharmaceutical policy is made; pharmaceutical policy as a dynamic process; and the new public health as a global issue. The article ends with a short description of the remaining five articles in the series which will deal with important aspects of pharmaceutical policy. The topics include: economic pressures on health care systems; drug utilization from the clinical viewpoint (rational use of medicines); the impact of pharmaceutical policy on patients and the patient impact on pharmaceutical policy; the professional perspective; and finally the last article which deals with studying and evaluating pharmaceutical policy.

Current Status and Issues in Basic Pharmaceutical Education.

Science.gov (United States)

Yasuhara, Tomohisa

2017-01-01

Basic research in pharmaceutical sciences has a long and successful history. Researchers in this field have long given prime importance to the knowledge they have gained through their pharmaceutical education. The transition of pharmacy education to a 6-year course term has not only extended its duration but also placed more emphasis on practical clinical education. The School Education Act (in article 87, second paragraph) determines that "the term of the course, whose main purpose is to cultivate practical ability in clinical pharmacy, shall be six years" (excerpt). The 6-year pharmacy education is an exception to the general 4-year university term determined by the School Education Act. Therefore, the purpose of the 6-year course in pharmacy is clearly proscribed. This is true of the basic course in pharmaceutical education as well; hence, the basic course must be oriented toward developing "practical ability in clinical" education, too. The 6-year pharmacy course, starting from practice (Do), has evolved with the development of a syllabus that includes a model core curriculum (Plan). Furthermore, improvement in the course can be seen by the promoted development of faculty (Act). Now, evidence-based education research will be introduced (Check). This is how the Plan-Do-Check-Act cycle in pharmaceutical education is expected to work. Currently, pedagogy research in pharmacy education has just begun, so it is difficult to evaluate at this time whether basic pharmaceutical education does in fact contribute to enhancing the "practical clinical ability" component of pharmaceutical education.

Peranan Pharmaceutical Care dalam Meningkatkan Hasil Klinis dan Kualitas Hidup Pasien Penderita Diabetes Melitus

Directory of Open Access Journals (Sweden)

Muhamad Syaripuddin

2015-05-01

Full Text Available Pharmaceutical care is patient oriented pharmacy practice that required other healthcare to optimize drug therapy. In the management of diabetes mellitus indicators was established as a target in pharmaceutical care. The purpose of this paper is to evaluate pharmaceutical care program, in order to optimize clinical result and quality of life of the patient diabetes mellitus, and to identify indicators in pharmaceutical care program for patient diabetes mellitus as well. Research of the impact of pharmaceutical care program for diabetes mellitus patient have been done in other countries. The results showed that diabetes mellitus indicators in patients managed with pharmaceutical care program were better than those without that program applied. All patients with intervention of pharmaceutical care program can control clinical result such as blood glucose, blood presure, level of HbA1C, HDL, LDL and total cholesterol. The patient’s quality of life with intervention had improved compare to those without intervention. Indicators to evaluate pharmaceutical care program have changed from clinical indicators only to clinical plus quality of life indicators. Pharmaceutical care program was useful to improve clinical result and quality of life of diabetic patient. Quality of life indicators could be added to evaluate pharmaceutical care program. Pharmaceutical care program brings about positif impact for patient, provider, pharmacist and economic aspect as well.

International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

Science.gov (United States)

2010-01-21

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.

Multiscale mechanistic modeling in pharmaceutical research and development.

Science.gov (United States)

Kuepfer, Lars; Lippert, Jörg; Eissing, Thomas

2012-01-01

Discontinuation of drug development projects due to lack of efficacy or adverse events is one of the main cost drivers in pharmaceutical research and development (R&D). Investments have to be written-off and contribute to the total costs of a successful drug candidate receiving marketing authorization and allowing return on invest. A vital risk for pharmaceutical innovator companies is late stage clinical failure since costs for individual clinical trials may exceed the one billion Euro threshold. To guide investment decisions and to safeguard maximum medical benefit and safety for patients recruited in clinical trials, it is therefore essential to understand the clinical consequences of all information and data generated. The complexity of the physiological and pathophysiological processes and the sheer amount of information available overcharge the mental capacity of any human being and prevent a prediction of the success in clinical development. A rigorous integration of knowledge, assumption, and experimental data into computational models promises a significant improvement of the rationalization of decision making in pharmaceutical industry. We here give an overview of the current status of modeling and simulation in pharmaceutical R&D and outline the perspectives of more recent developments in mechanistic modeling. Specific modeling approaches for different biological scales ranging from intracellular processes to whole organism physiology are introduced and an example for integrative multiscale modeling of therapeutic efficiency in clinical oncology trials is showcased.

Pharmaceutical biotechnology: drug discovery and clinical applications

National Research Council Canada - National Science Library

Kayser, Oliver; Müller, Rainer H

2004-01-01

.... The biopharmaceutical industry has changed dramatically since the first recombinant ® protein (Humulin ) was approved for marketing in 1982. The range of resources required for the pharmaceutical industry has expanded from its traditional fields. Advances in the field of recombinant genetics allows scientists to routinely clone genes and create ge...

Formation and bio release of bound residues of [14 C]-lindane and [14 C]-parathion in two Brazilian soils

International Nuclear Information System (INIS)

Andrea, M.M. de.

1992-01-01

This work studied the extractable and bound residues formation of 14 C-lindane and 14 C-parathion immediately after application and after 3 months of interaction of the pesticides with the soils. Metabolism, bio release, and the possible bioavailability of bound residues were studied by employing bio meter flasks which allowed a relative comparison of the behaviour of the two different 14 C-pesticides, by a balance of the applied or present radiocarbon in the soils after the bio tests. (author)

Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries.

Science.gov (United States)

Tomlinson, Lindsay; Boone, Laura I; Ramaiah, Lila; Penraat, Kelley A; von Beust, Barbara R; Ameri, Mehrdad; Poitout-Belissent, Florence M; Weingand, Kurt; Workman, Heather C; Aulbach, Adam D; Meyer, Dennis J; Brown, Diane E; MacNeill, Amy L; Bolliger, Anne Provencher; Bounous, Denise I

2013-09-01

The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines) and published recommendations for best practices in veterinary toxicologic clinical pathology, particularly in the pharmaceutical and biotechnology industries, and to utilize the combined experience of ASVCP RAC to provide updated recommendations. Discussion points include (1) instrumentation, validation, and sample collection, (2) routine laboratory variables, (3) cytologic laboratory variables, (4) data interpretation and reporting (including peer review, reference intervals and statistics), and (5) roles and responsibilities of clinical pathologists and laboratory personnel. Revision and improvement of current practices should be in alignment with evolving regulatory guidance documents, new technology, and expanding understanding and utility of clinical pathology. These recommendations provide a contemporary guide for the refinement of veterinary toxicologic clinical pathology best practices. © 2013 American Society for Veterinary Clinical Pathology.

Integrating systems Approaches into Pharmaceutical Sciences

DEFF Research Database (Denmark)

Westerhoff, H.V.; Mosekilde, Erik; Noe, C. R.

2008-01-01

During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and BioSim, the major European Network of Excellence on Systems Biology, held a challenging conference on the use of mathematical models in the drug development process. More precisely, the purpose...... of the conference was to promote the ‘Integration of Systems Approaches into Pharmaceutical Sciences’ in view of optimising the development of new effective drugs. And a challenge this is, considering both the high attrition rates in the pharmaceutical industry and the failure of finding definitive drug solutions...... for many of the diseases that plague mankind today. The conference was co-sponsored by the American College of Clinical Pharmacology, the European Center for Pharmaceutical Medicine, and the Swiss Society of Pharmaceutical Sciences and, besides representatives from the European Regulatory Agencies and FDA...

Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36-month randomized controlled clinical trial.

Science.gov (United States)

Obreli-Neto, Paulo Roque; Marusic, Srecko; Guidoni, Camilo Molino; Baldoni, André de Oliveira; Renovato, Rogério Dias; Pilger, Diogo; Cuman, Roberto Kenji Nakamura; Pereira, Leonardo Régis Leira

2015-01-01

Most diabetic and hypertensive patients, principally the elderly, do not achieve adequate disease control and consume 5%-15% of annual health care budgets. Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension. To evaluate the economic cost and the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country. A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group (n = 100) and an intervention group (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultations). The intervention group received the usual care plus a pharmaceutical care intervention. The intervention and control groups were compared with regard to the direct costs of health services (i.e., general practitioner, specialist, nurse, and pharmacist appointments; emergency room visits; and drug therapy costs) and the ICER per QALY. These evaluations used the health system perspective. No statistically significant difference was found between the intervention and control groups in total direct health care costs ($281.97 ± $49.73 per patient vs. $212.28 ± $43.49 per patient, respectively; P = 0.089); pharmaceutical care added incremental costs of $69.60 (± $7.90) per patient. The ICER per QALY was $53.50 (95% CI = $51.60-$54.00; monetary amounts are given in U.S. dollars). Every clinical parameter evaluated improved for the pharmaceutical care group, whereas these clinical parameters remained unchanged in the usual care group. The difference in differences (DID) tests indicated that for each clinical parameter, the patients in the intervention group improved more from pre to post than the control group (P < 0.001). While pharmaceutical

High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey.

Science.gov (United States)

Kurihara, Chieko; Kusuoka, Hideo; Ono, Shunsuke; Kakee, Naoko; Saito, Kazuyuki; Takehara, Kenji; Tsujide, Kiyokazu; Nabeoka, Yuzo; Sakuhiro, Takuya; Aoki, Hiroshi; Morishita, Noriko; Suzuki, Chieko; Kachi, Shigeo; Kondo, Emiko; Komori, Yukiko; Isobe, Tetsu; Kageyama, Shigeru; Watanabe, Hiroshi

2014-01-01

International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported. Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan. With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation. Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country's compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data.

[E-commerce of pharmaceuticals].

Science.gov (United States)

Shani, Segev

2003-05-01

The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications.

[Written pharmaceutical advertising--still unreliable?].

Science.gov (United States)

Gladsø, Kristin Haugen; Garberg, Hedda Rosland; Spigset, Olav; Slørdal, Lars

2014-09-02

Marketing by the pharmaceutical industry affects doctors' prescribing habits. All pharmaceutical advertising received by nine doctors in two GP offices over a period of three months was collected. The advertising material was sorted by compound. For each compound, the advert with the highest number of references was selected. The cited references were obtained, and the claims in the adverts were assessed in terms of their consistency with the source data based on the provisions in the Norwegian regulations on pharmaceuticals. The references were also assessed with regard to the incidence of conflicts of interest among authors. The doctors received a total of 270 shipments of advertising for 46 different compounds. Altogether 95% of the 173 references cited in the 46 selected adverts could be obtained. The adverts contained a total of 156 claims. Of these, 56% were assessed as correct when compared to the source data and as having clinical relevance. Altogether 75% of the journal articles reported relevant conflicts of interest for the authors. About half the claims in the adverts were found to be correct and clinically relevant. These results concur with those from a methodologically identical study based on advertising material collected in 2004. The cited literature was of varying quality and often funded by the pharmaceutical companies. The findings indicate that the target group should be sceptical of this type of marketing.

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

Science.gov (United States)

Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

2017-12-05

To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track

Evidence of the clinical effectiveness of cognitive pharmaceutical services for aged patients.

Science.gov (United States)

Sáez-Benito, Loreto; Fernandez-Llimos, Fernando; Feletto, Eleonora; Gastelurrutia, Miguel Angel; Martinez-Martinez, Fernando; Benrimoj, Shalom I

2013-07-01

cognitive pharmaceutical services (CPSs) encompass a variety of pharmacists' interventions to optimise pharmacotherapy. The clinical effectiveness of CPSs for aged patients remains controversial. to analyse and describe the evidence of the clinical effectiveness of CPSs in aged patients by means of performing a systematic review of systematic reviews. using the recommended methodology by Cochrane, a search was undertaken for systematic reviews of the clinical effectiveness of CPSs in MEDLINE, EMBASE, DOAJ, SCIELO and COCHRANE LIBRARY. Reviews were assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) instrument. Quality of the evidence in the reviews was ranked using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. a total of 14 systematic reviews and one meta-analysis were analysed. The overall quality of the reviews was moderate. High and moderate strength of evidence was found for the positive effect of certain CPSs on reducing the number and improving the appropriateness of medicines. There was conflicting evidence of the effect on adherence. There was limited evidence of high and moderate strength on clinical outcomes. No positive evidence was found on mortality, hospitalisations, functional capacity and cognitive function. No systematic reviews reported the effect on the level of control of health problems. certain types of CPSs reduce the number of medicines and improve the appropriateness of prescriptions. Longer follow-up periods and/or the use of surrogate clinical variables measuring the short-term impact are required to demonstrate the effect on clinical outcomes.

[Bioequivalence studies of pharmaceutical preparations].

Science.gov (United States)

Vetchý, D; Frýbortová, K; Rabisková, M; Danecková, H

2007-01-01

Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs. The target of such study is to evaluate the therapeutic compatibility of tested drugs (pharmaceutical equivalents or pharmaceutical alternatives). The importance of bioequivalence studies is increasing also due to the large growth of the production and consumption of generic products. Generic products represent approximately 50 % of the whole consumption in many European countries and USA. The search output of bioequivalence study is together with the pharmaceutical quality data of medical product one of the main part of the registration file submitted to a national regulatory authorities. The registration of generic products does not demand complicated and expensive clinical study contrary to original product. The comparison of the original and the generic product via bioequivalence study is suggested as sufficient. The aim of this article is to provide to a medical public a summary about the types of bioequivalence studies, their range, rules of their practise and let them gain their own attitude to this question.

Present Conditions and Problems of Home Care Education in Pharmaceutical Education: Through the Activities of "the Working Group to Create Home Clinical Cases for Education".

Science.gov (United States)

Kobuke, Yuko

2017-01-01

In the pharmaceutical education model core curriculums revision, "basic qualities required as a pharmacist" are clearly shown, and "the method based on learning outcomes" has been adopted. One of the 10 qualities (No. 7) is "Practical ability of the health and medical care in the community". In the large item "F. Pharmaceutical clinical" of the model core curriculums, "participation in the home (visit) medical care and nursing care" is written in "participation in the health, medical care, and welfare of the community", and it is an important problem to offer opportunities of home medical care education at university. In our university, we launched a working group to create "home clinical cases for education" from the educational point of view to pharmacy students to learn home medical care, in collaboration with university faculty members and pharmacists, who are practitioners of home care. Through its working group activities, we would like to organize the present conditions and problems of home care education in pharmaceutical education and to examine the possibility of using "home clinical case studies" in home care education at university.

Automatic recognition of disorders, findings, pharmaceuticals and body structures from clinical text: an annotation and machine learning study.

Science.gov (United States)

Skeppstedt, Maria; Kvist, Maria; Nilsson, Gunnar H; Dalianis, Hercules

2014-06-01

Automatic recognition of clinical entities in the narrative text of health records is useful for constructing applications for documentation of patient care, as well as for secondary usage in the form of medical knowledge extraction. There are a number of named entity recognition studies on English clinical text, but less work has been carried out on clinical text in other languages. This study was performed on Swedish health records, and focused on four entities that are highly relevant for constructing a patient overview and for medical hypothesis generation, namely the entities: Disorder, Finding, Pharmaceutical Drug and Body Structure. The study had two aims: to explore how well named entity recognition methods previously applied to English clinical text perform on similar texts written in Swedish; and to evaluate whether it is meaningful to divide the more general category Medical Problem, which has been used in a number of previous studies, into the two more granular entities, Disorder and Finding. Clinical notes from a Swedish internal medicine emergency unit were annotated for the four selected entity categories, and the inter-annotator agreement between two pairs of annotators was measured, resulting in an average F-score of 0.79 for Disorder, 0.66 for Finding, 0.90 for Pharmaceutical Drug and 0.80 for Body Structure. A subset of the developed corpus was thereafter used for finding suitable features for training a conditional random fields model. Finally, a new model was trained on this subset, using the best features and settings, and its ability to generalise to held-out data was evaluated. This final model obtained an F-score of 0.81 for Disorder, 0.69 for Finding, 0.88 for Pharmaceutical Drug, 0.85 for Body Structure and 0.78 for the combined category Disorder+Finding. The obtained results, which are in line with or slightly lower than those for similar studies on English clinical text, many of them conducted using a larger training data set, show that

Deep pharma: psychiatry, anthropology, and pharmaceutical detox.

Science.gov (United States)

Oldani, Michael

2014-06-01

Psychiatric medication, or psychotropics, are increasingly prescribed for people of all ages by both psychiatry and primary care doctors for a multitude of mental health and/or behavioral disorders, creating a sharp rise in polypharmacy (i.e., multiple medications). This paper explores the clinical reality of modern psychotropy at the level of the prescribing doctor and clinical exchanges with patients. Part I, Geographies of High Prescribing, documents the types of factors (pharmaceutical-promotional, historical, cultural, etc.) that can shape specific psychotropic landscapes. Ethnographic attention is focused on high prescribing in Japan in the 1990s and more recently in the Upper Peninsula of Michigan, in the US. These examples help to identify factors that have converged over time to produce specific kinds of branded psychotropic profiles in specific locales. Part II, Pharmaceutical Detox, explores a new kind of clinical work being carried out by pharmaceutically conscious doctors, which reduces the number of medications being prescribed to patients while re-diagnosing their mental illnesses. A high-prescribing psychiatrist in southeast Wisconsin is highlighted to illustrate a kind of med-checking taking place at the level of individual patients. These various examples and cases call for a renewed emphasis by anthropology to critically examine the "total efficacies" of modern pharmaceuticals and to continue to disaggregate mental illness categories in the Boasian tradition. This type of detox will require a holistic approach, incorporating emergent fields such as neuroanthropology and other kinds of creative collaborations.

Novel methodology for pharmaceutical expenditure forecast.

Science.gov (United States)

Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the 'EU Pharmaceutical expenditure forecast'; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). 1) Identification of all pharmaceuticals going off-patent and new branded medicinal products over a 5-year forecasting period in seven European Union (EU) Member States. 2) Development of a model to estimate direct and indirect impacts (based on health policies and clinical experts) on savings of generics and biosimilars. Inputs were originator sales value, patent expiry date, time to launch after marketing authorization, price discount, penetration rate, time to peak sales, and impact on brand price. 3) Development of a model for new drugs, which estimated sales progression in a competitive environment. Clinical expected benefits as well as commercial potential were assessed for each product by clinical experts. Inputs were development phase, marketing authorization dates, orphan condition, market size, and competitors. 4) Separate analysis of the budget impact of products going off-patent and new drugs according to several perspectives, distribution chains, and outcomes. 5) Addressing uncertainty surrounding estimations via deterministic and probabilistic sensitivity analysis. This methodology has proven to be effective by 1) identifying the main parameters impacting the variations in pharmaceutical expenditure forecasting across countries: generics discounts and penetration, brand price after patent loss, reimbursement rate, the penetration of biosimilars and discount price, distribution chains, and the time

The Purpose and Scope of Pedagogy in Pharmaceutical Education.

Science.gov (United States)

Nakamura, Akihiro

2017-01-01

The WHO and International Pharmaceutical Federation (FIP) introduced the concept of the "seven-star pharmacist" in which a pharmacist is described as a caregiver, communicator, decision-maker, teacher, lifelong learner, leader and manager. In six-year pharmaceutical education programs, which have been provided in schools of pharmacy since 2006, 5th year students participate in on-site practice experiences in hospitals and community pharmacies. Thus, Japanese pharmacists also began to have a role in pharmaceutical education as teachers in clinical settings. Not only pharmacists in clinical settings, but also faculty members of pharmacy schools, had not previously been familiar with evidence-based education, and therefore they often teach in the way they were taught. Since research on teaching and learning has not been well developed in Japanese pharmaceutical education, both the model core curriculum for six-year programs and the subject benchmark statement for four-year programs are based on insufficient scientific evidence. We should promote the scholarship of teaching and learning, which promotes teaching as a scholarly endeavor and a worthy subject for research. In this review, I will summarize the needs and expectations for the establishment of pedagogy in pharmaceutical education.

Five un-easy pieces of pharmaceutical policy reform.

Science.gov (United States)

Rodwin, Marc A

2013-01-01

Improper dependencies slant policy over a drug's life span, biasing the development of new drugs, the testing and marketing approval for new drugs, and the monitoring of patient safety after drugs are marketed. This article examines five ways in which the public improperly depends on pharmaceutical firms that compromise the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials to test whether drugs are safe and effective; (3) to decide what clinical trial data to disclose to the public; (4) to monitor post marketing drug safety; (5) to supply product information to physicians and to finance continuing medical education and other professional activities. The article suggests options to overcome each of these dependencies. © 2013 American Society of Law, Medicine & Ethics, Inc.

The insecticide lindane. Identification of possible risks for human reproduction; L'insetticida lindano. Identificazione dei rischi possibili per la riproduzione umana

Energy Technology Data Exchange (ETDEWEB)

Traina, M E; Urbani, E [Istituto Superiore di Sanita' , Lab. di Igiene Ambientale, Rome (Italy); Rescia, M; Mantovani, A [Istituto Superiore di Sanita' , Lab. di Tossicologia Comparata e Ecotossicologia, Rome (Italy)

2001-07-01

A growing international concern exists about the potential harm to human reproduction caused by pollutants able to interfere with the endocrine system. Particular interest is addressed to organochlorine pesticides persisting in the environment and organisms; such compounds are extensively studied for their adverse effects on reproductive functions and development of laboratory animals. The insecticide lindane (the {gamma}-isomer of hexachlorocyclohexane), widely used before the 80s, has yet to be adequately evaluated as regards the possible reproductive risk. The present report contains a critical revision of the available scientific literature about lindane effects on the male and female reproductive system, pregnancy and development. Besides, the possible higher exposure periods to this pesticide (years 60s-70s) have been determined through the analysis of the lindane products consumed and the evaluation of the active ingredient levels in the environment and in the tissues and biological fluids, with particular regard to Italy. The present review aims at supporting further toxicological and epidemiological studies to assess the possible reproductive risk posed by environmental and professional exposure to chlorinated insecticides. [Italian] L'ipotesi che l'esposizione a sostanze inquinanti in grado di alterare l'equilibrio del sistema endocrino possa avere effetti sulla riproduzione umana e sullo sviluppo e' attualmente oggetto d'interesse nella comunita' scientifica. Particoalre attenzione e' stata indirizzata ai pesticidi organoclorurati a lunga persistenza nell'ambiente e negli organismi, per i quali esistono numerose evidenze di effetti nocivi per la riproduzione, negli studi di tossicologia sperimentale. L'insetticida lindano (l'isomero-{gamma} dell'esaclorocicloesano), largamente utilizzato prima degli anni '80, non e' stato fino ad oggi adeguatamente valutato per un possibile rischio riproduttivo a lungo termine. In questa rassegna e' stata pertanto

Gateway to the Future. Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories.

Science.gov (United States)

Education Development Center, Inc., Newton, MA.

The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceutical companies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…

Adsorption and desorption characteristics of lindane, carbofuran and methyl parathion on various Indian soils

Energy Technology Data Exchange (ETDEWEB)

Rama Krishna, K. [Department of Civil Engineering, Indian Institute of Technology Madras, Chennai 600036 (India)], E-mail: ramakrishnaiitm@gmail.com; Philip, Ligy [Department of Civil Engineering, Indian Institute of Technology Madras, Chennai 600036 (India)], E-mail: ligy@iitm.ac.in

2008-12-30

Adsorption and desorption characteristics of three insecticides on four Indian soils were studied. Insecticides used were representative of organochlorine, organophosphate, and carbomate groups. The order of adsorption of pesticides on soils was: lindane > methyl parathion > carbofuran. Compost soil had shown the maximum adsorption capacity. The order of adsorption capacity of various soils were: compost soil > clayey soil > red soil > sandy soil. Adsorption isotherms were better fitted to Freundlich model and K{sub f} values increased with increase in organic matter content of the soils. Thermodynamic parameters indicated favorable adsorption of all the three pesticides in four different soils. Adsorption was exothermic in nature. Distilled water desorbed 30-60% of adsorbed pesticides whereas; organic solvents were able to affect 50-80% of sorbed pesticides. Clay content and organic matter played a significant role in pesticide adsorption and desorption processes. Hysteresis effect was observed in red, clayey and compost soils. Hysteresis effect increased with increase in organic matter and clay content of the soils.

Adsorption and desorption characteristics of lindane, carbofuran and methyl parathion on various Indian soils

International Nuclear Information System (INIS)

Rama Krishna, K.; Philip, Ligy

2008-01-01

Adsorption and desorption characteristics of three insecticides on four Indian soils were studied. Insecticides used were representative of organochlorine, organophosphate, and carbomate groups. The order of adsorption of pesticides on soils was: lindane > methyl parathion > carbofuran. Compost soil had shown the maximum adsorption capacity. The order of adsorption capacity of various soils were: compost soil > clayey soil > red soil > sandy soil. Adsorption isotherms were better fitted to Freundlich model and K f values increased with increase in organic matter content of the soils. Thermodynamic parameters indicated favorable adsorption of all the three pesticides in four different soils. Adsorption was exothermic in nature. Distilled water desorbed 30-60% of adsorbed pesticides whereas; organic solvents were able to affect 50-80% of sorbed pesticides. Clay content and organic matter played a significant role in pesticide adsorption and desorption processes. Hysteresis effect was observed in red, clayey and compost soils. Hysteresis effect increased with increase in organic matter and clay content of the soils

Occurrence of pharmaceuticals in Taiwan's surface waters: impact of waste streams from hospitals and pharmaceutical production facilities.

Science.gov (United States)

Lin, Angela Yu-Chen; Tsai, Yu-Ting

2009-06-01

We investigated the occurrence and distribution of pharmaceuticals (including antibiotics, estrogens, non-steroidal anti-inflammatory drugs (NSAIDs), beta-blockers, and lipid regulators) in three rivers and in the waste streams of six hospitals and four pharmaceutical production facilities in Taiwan. The most frequently detected pharmaceuticals were acetaminophen, erythromycin-H(2)O, sulfamethoxazole, and gemfibrozil. NSAIDs were the next most-often detected compounds, with a detection frequency >60%. The other analytes were not detected or were seen in only a few samples at trace concentrations. The present study demonstrates a significant discharge of human medications from hospital and drug production facilities into surface waters in the Taipei district. The high concentrations of pharmaceuticals found in the Sindian and Dahan rivers demonstrate the alarming degree to which they have been impacted by urban drainage (waste effluents from hospitals, households, and pharmaceutical production facilities). The ubiquitous occurrence at extremely high concentrations of acetaminophen and erythromycin-H(2)O in both rivers (up to 15.7 and 75.5 microg/L) and in wastewater from hospitals and pharmaceutical production facilities (up to 417.5 and 7.84 microg/L) was unique. This finding, in combination with acetaminophen's status as the drug most often prescribed by Taiwan's dominant clinical institute, suggests the potential use of acetaminophen as a molecular indicator of contamination of Taiwan's aqueous environments with untreated urban drainage.

Degradation of 14C-Lindane(gamma-hexachlorocyclohexane) in Corn and Soya Bean Seedlings

International Nuclear Information System (INIS)

Afifi, M.L.

2003-01-01

The degradation of lindane (gamma-hexachlorocyclohexane,(gamma-HCH) by corn and soya bean seedlings has been studied. Following root application, anumber of metabolic products were identified utilizing Gas-liquid chromatography and GLC-mass spectrometry. In corn seedlings, these metabolites proved to be m-dichlorobenzene;1,2,4-trichlorobenzene; 1,2,4,5-tetrachlorobenzene; 2,4,5-and 2,3,5-trichlorophenols and gamma-pentachlorocyclohex-1-ene as compared with the standards. In soya bean seedlings, however, while 1,2,3,4-tetrachlorobenzene and 2,3,5-trichlorophenol were missing, 1,2,3-trichlorobenzene and 2,4,6-trichlorophenol were produced. Of the total chlorinated compounds found in hexane extracts, these metabolic products accounted for 30-35%. The amount of trichlorophenols which contributed to 38% and 16% of the metabolic output in corn and peas respectively, provided futher evidence that the degrading pathways in monocots might differ from these in dicots. The results also show that in both plant tissues dechlorination generally took place and represented adominant intermediary detoxification process

Using containerless methods to develop amorphous pharmaceuticals.

Science.gov (United States)

Weber, J K R; Benmore, C J; Suthar, K J; Tamalonis, A J; Alderman, O L G; Sendelbach, S; Kondev, V; Yarger, J; Rey, C A; Byrn, S R

2017-01-01

Many pipeline drugs have low solubility in their crystalline state and require compounding in special dosage forms to increase bioavailability for oral administration. The use of amorphous formulations increases solubility and uptake of active pharmaceutical ingredients. These forms are rapidly gaining commercial importance for both pre-clinical and clinical use. Synthesis of amorphous drugs was performed using an acoustic levitation containerless processing method and spray drying. The structure of the products was investigated using in-situ high energy X-ray diffraction. Selected solvents for processing drugs were investigated using acoustic levitation. The stability of amorphous samples was measured using X-ray diffraction. Samples processed using both spray drying and containerless synthesis were compared. We review methods for making amorphous pharmaceuticals and present data on materials made by containerless processing and spray drying. It was shown that containerless processing using acoustic levitation can be used to make phase-pure forms of drugs that are known to be difficult to amorphize. The stability and structure of the materials was investigated in the context of developing and making clinically useful formulations. Amorphous compounds are emerging as an important component of drug development and for the oral delivery of drugs with low solubility. Containerless techniques can be used to efficiently synthesize small quantities of pure amorphous forms that are potentially useful in pre-clinical trials and for use in the optimization of clinical products. Developing new pharmaceutical products is an essential enterprise to improve patient outcomes. The development and application of amorphous pharmaceuticals to increase absorption is rapidly gaining importance and it provides opportunities for breakthrough research on new drugs. There is an urgent need to solve problems associated with making formulations that are both stable and that provide high

[Coordination between pharmaceutical services for integrated pharmacotherapy: the case of Catalonia].

Science.gov (United States)

Costa, Karen Sarmento; Goldbaum, Moisés; Guayta-Escolies, Rafel; Modamio, Pilar; Mariño, Eduardo Luis; Tolsá, José Luis Segú

2017-08-01

Pharmaceutical policies have been considered strategies to contribute to the guarantee of care coordination and clinical integration. This study sought to describe the pharmaceutical services developed at different levels of care in the health network in Catalonia, as well as to identify and analyze the mechanisms and instruments that act as facilitators and/or barriers to the coordination of pharmacotherapy. This is a descriptive study of 12 cases of hospital pharmacy services, primary care and community pharmacies. Advances related to the perception, formalization and clinical and assistance coordination of the pharmaceutical services were identified. However, weaknesses and potential improvements in coordination were observed. The conclusion drawn was that the different tools and instruments implemented appear to facilitate a greater possibility of integration between pharmaceutical services and the latter with the health services network to contribute to integrated pharmacotherapy.

The insecticide lindane. Identification of possible risks for human reproduction; L'insetticida lindano. Identificazione dei rischi possibili per la riproduzione umana

Energy Technology Data Exchange (ETDEWEB)

Traina, M.E.; Urbani, E. [Istituto Superiore di Sanita' , Lab. di Igiene Ambientale, Rome (Italy); Rescia, M.; Mantovani, A. [Istituto Superiore di Sanita' , Lab. di Tossicologia Comparata e Ecotossicologia, Rome (Italy)

2001-07-01

A growing international concern exists about the potential harm to human reproduction caused by pollutants able to interfere with the endocrine system. Particular interest is addressed to organochlorine pesticides persisting in the environment and organisms; such compounds are extensively studied for their adverse effects on reproductive functions and development of laboratory animals. The insecticide lindane (the {gamma}-isomer of hexachlorocyclohexane), widely used before the 80s, has yet to be adequately evaluated as regards the possible reproductive risk. The present report contains a critical revision of the available scientific literature about lindane effects on the male and female reproductive system, pregnancy and development. Besides, the possible higher exposure periods to this pesticide (years 60s-70s) have been determined through the analysis of the lindane products consumed and the evaluation of the active ingredient levels in the environment and in the tissues and biological fluids, with particular regard to Italy. The present review aims at supporting further toxicological and epidemiological studies to assess the possible reproductive risk posed by environmental and professional exposure to chlorinated insecticides. [Italian] L'ipotesi che l'esposizione a sostanze inquinanti in grado di alterare l'equilibrio del sistema endocrino possa avere effetti sulla riproduzione umana e sullo sviluppo e' attualmente oggetto d'interesse nella comunita' scientifica. Particoalre attenzione e' stata indirizzata ai pesticidi organoclorurati a lunga persistenza nell'ambiente e negli organismi, per i quali esistono numerose evidenze di effetti nocivi per la riproduzione, negli studi di tossicologia sperimentale. L'insetticida lindano (l'isomero-{gamma} dell'esaclorocicloesano), largamente utilizzato prima degli anni '80, non e' stato fino ad oggi adeguatamente valutato per un possibile rischio

[Attractiveness of France for international clinical research: 8th survey conducted by Leem (French association for pharmaceutical companies)].

Science.gov (United States)

Galaup, Ariane; Barthélémy, Philippe; Pouletty-Lefebvre, Brigitte; Béhier, Jehan-Michel; Zetlaoui, Jean; Borel, Thomas

2018-04-18

The Leem (French association of pharmaceutical companies) has conducted the eighth survey on attractiveness of France for clinical research. It serves to measure France's global competitiveness for international clinical trials and assess its strengths and areas of excellence. It also highlights the potential for progress and emerging trends at a time when the regulatory environment in France and Europe is undergoing change. This survey has been updated every two years since 2002 using the same methodology. It assesses the current status of research undertaken in France by the pharmaceutical industry between January 1st 2014 and December 31st 2015. Thirty companies (62% of the French market) have participated in this 8th survey which involved 3474 centers (versus 2860 in 2014) and 16,622 patients (versus 14,634 in 2014) enrolled in France across 586 clinical trials (versus 613 in 2014). This survey shows a reduction in the number of phase I and phase II trials. It also confirms that the studies conducted in France are primarily concerned with oncology (45%). Despite improvements across hospital contracts times (due to the adoption of the sole agreement) and performance indicators in trials (such as the number of patients enrolled by center), trial setup times in France are still overly lengthy (with stable times by French authorities). Ensuring that clinical research remains a priority issue for country is crucial for patients because of rapid access to innovation but also for the vitality of the French economy. Constructive dialogue with stakeholders on the subject of clinical research is essential to enhance the attractiveness of France and to improve the continuum between research, innovation and care. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

The Pharmaceutical Industry Beamline of Pharmaceutical Consortium for Protein Structure Analysis

International Nuclear Information System (INIS)

Nishijima, Kazumi; Katsuya, Yoshio

2002-01-01

The Pharmaceutical Industry Beamline was constructed by the Pharmaceutical Consortium for Protein Structure Analysis which was established in April 2001. The consortium is composed of 22 pharmaceutical companies affiliating with the Japan Pharmaceutical Manufacturers Association. The beamline is the first exclusive on that is owned by pharmaceutical enterprises at SPring-8. The specification and equipments of the Pharmaceutical Industry Beamline is almost same as that of RIKEN Structural Genomics Beamline I and II. (author)

The sublethal effects of the organochlorines dieldrin and lindane on growth and reproduction of Eudrilus eugeniae and Eisenia fetida (Oligochaeta

Directory of Open Access Journals (Sweden)

Editorial Office

1994-07-01

Full Text Available Experimental exposure of the earthworm species Eudrilus eugeniae to organochlorines showed that dieldrin causes damage to sperm ultrastructure when viewed electronmicroscopically. Worms containing concentrations of 7,27 mg/kg dieldrin and higher showed more than 10% sperm damage. Exposure of Eisenia fetida to sublethal concentrations of lindane did not result in sperm damage but demonstrated an increase in growth and reproductive activity. It is argued that quantification of sperm damage and correlation with pesticide concentration could provide a useful tool for evaluating environmental quality. Furthermore, the effects of sublethal concentrations of pesticides that manifest themselves in increased growth and reproductive activity could affect ecological balances.

Impact of pharmaceutical cocrystals: the effects on drug pharmacokinetics.

Science.gov (United States)

Shan, Ning; Perry, Miranda L; Weyna, David R; Zaworotko, Michael J

2014-09-01

Pharmaceutical cocrystallization has emerged in the past decade as a new strategy to enhance the clinical performance of orally administered drugs. A pharmaceutical cocrystal is a multi-component crystalline material in which the active pharmaceutical ingredient is in a stoichiometric ratio with a second compound that is generally a solid under ambient conditions. The resulting cocrystal exhibits different solid-state thermodynamics, leading to changes in physicochemical properties that offer the potential to significantly modify drug pharmacokinetics. The impact of cocrystallization upon drug pharmacokinetics has not yet been well delineated. Herein, we compile previously published data to address two salient questions: what effect does cocrystallization impart upon physicochemical properties of a drug substance and to what degree can those effects impact its pharmacokinetics. Cocrystals can impact various aspects of drug pharmacokinetics, including, but not limited to, drug absorption. The diversity of solid forms offered through cocrystallization can facilitate drastic changes in solubility and pharmacokinetics. Therefore, it is unsurprising that cocrystal screening is now a routine step in early-stage drug development. With the increasing recognition of pharmaceutical cocrystals from clinical, regulatory and legal perspectives, the systematic commercialization of cocrystal containing drug products is just a matter of time.

Sex, gender, and pharmaceutical politics: From drug development to marketing.

Science.gov (United States)

Fisher, Jill A; Ronald, Lorna M

2010-08-01

Biological sex differences and sociocultural gender norms affect the provision of health care products and services, but there has been little explicit analysis of the impact of sex differences and gender norms on the regulation of pharmaceutical development and marketing. This article provides an overview of the regulation of pharmaceuticals and examines the ways that regulatory agencies account for sex and gender in their review of scientific data and marketing materials. The primary focus is on the US context, but information is also included about regulatory models in Europe, Canada, and Japan for comparative purposes. Specific examples show how sex differences and gender norms influence scientific and policy decisions about pharmaceuticals. The United States and Canada were found to be the only countries that have explicit requirements to include women in clinical trials and to perform sex-based subgroup analysis on study results. The potential influence of politics on regulatory decisions may have led to an uneven application of standards, as seen through the examples of mifepristone (for abortion) and sildenafil citrate (for erectile dysfunction). Three detailed case studies illustrate the importance of considering sex and gender in pharmaceutical development and marketing: Phase I clinical trials; human papillomavirus quadrivalent vaccine; and tegaserod, a drug for irritable bowel syndrome. Sex and gender play important roles in pharmaceutical regulation, from the design of clinical trials and the approval of new drugs to advertising and postmarketing surveillance. However, regulatory agencies pay insufficient attention to both biological sex differences and sociocultural gender norms. This disregard perpetuates inequalities by ignoring drug safety problems that predominate in women and by allowing misleading drug marketing that reinforces gender stereotypes. Recommendations have been made to improve the regulation of pharmaceuticals in regard to sex and

The use of atomic spectroscopy in the pharmaceutical industry for the determination of trace elements in pharmaceuticals.

Science.gov (United States)

Lewen, Nancy

2011-06-25

The subject of the analysis of various elements, including metals and metalloids, in the pharmaceutical industry has seen increasing importance in the last 10-15 years, as modern analytical instrumentation has afforded analysts with the opportunity to provide element-specific, accurate and meaningful information related to pharmaceutical products. Armed with toxicological data, compendial and regulatory agencies have revisited traditional approaches to the testing of pharmaceuticals for metals and metalloids, and analysts have begun to employ the techniques of atomic spectroscopy, such as flame- and graphite furnace atomic absorption spectroscopy (FAAS, Flame AA or FAA and GFAAS), inductively coupled plasma-atomic emission spectroscopy (ICP-AES) and inductively coupled plasma-mass spectrometry (ICP-MS), to meet their analytical needs. Newer techniques, such as laser-induced breakdown spectroscopy (LIBS) and Laser Ablation ICP-MS (LAICP-MS) are also beginning to see wider applications in the analysis of elements in the pharmaceutical industry.This article will provide a perspective regarding the various applications of atomic spectroscopy in the analysis of metals and metalloids in drug products, active pharmaceutical ingredients (API's), raw materials and intermediates. The application of atomic spectroscopy in the analysis of metals and metalloids in clinical samples, nutraceutical, metabolism and pharmacokinetic samples will not be addressed in this work. Copyright © 2010 Elsevier B.V. All rights reserved.

Introducing Pharmaceutical Care to Primary Care in Iceland—An Action Research Study

Directory of Open Access Journals (Sweden)

Anna Bryndis Blondal

2017-04-01

Full Text Available Even though pharmaceutical care is not a new concept in pharmacy, its introduction and development has proved to be challenging. In Iceland, general practitioners are not familiar with pharmaceutical care and additionally no such service is offered in pharmacies or primary care settings. Introducing pharmaceutical care in primary care in Iceland is making great efforts to follow other countries, which are bringing the pharmacist more into patient care. General practitioners are key stakeholders in this endeavor. The aim of this study was to introduce pharmacist-led pharmaceutical care into primary care clinics in Iceland in collaboration with general practitioners by presenting different setting structures. Action research provided the framework for this research. Data was collected from pharmaceutical care interventions, whereby the pharmaceutical care practitioner ensures that each of a patient’s medications is assessed to determine if it is appropriate, effective, safe, and that the patient can take medicine as expected. Sources of data included pharmaceutical care notes on patients, researcher’s notes, meetings, and interviews with general practitioners over the period of the study. The study ran from September 2013 to October 2015. Three separate semi-structured in-depth interviews were conducted with five general practitioners from one primary health care clinic in Iceland at different time points throughout the study. Pharmaceutical care was provided to elderly patients (n = 125 before and between general practitioners’ interviews. The study setting was a primary care clinic in the Reykjavik area and the patients’ homes. Results showed that the GPs’ knowledge about pharmacist competencies as healthcare providers and their potential in patient care increased. GPs would now like to have access to a pharmacist on a daily basis. Direct contact between the pharmacist and GPs is better when working in the same physical space

Pharmaceutical care in smoking cessation.

Science.gov (United States)

Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando

2015-01-01

As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre-post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation.

Basic pharmaceutical technology

OpenAIRE

Angelovska, Bistra; Drakalska, Elena

2017-01-01

The lecture deals with basics of pharmaceutical technology as applied discipline of pharmaceutical science, whose main subject of study is formulation and manufacture of drugs. In a broad sense, pharmaceutical technology is science of formulation, preparation, stabilization and determination of the quality of medicines prepared in the pharmacy or in pharmaceutical industry

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...

Capitated chronic disease management programs: a new market for pharmaceutical companies.

Science.gov (United States)

Cave, D G

1995-01-01

With corporatism of the medical care delivery system, the pharmaceutical industry is searching for new ways to market prescription drug product lines. A new strategy focuses on developing chronic disease management programs. In doing so, pharmaceutical companies work with clinical leaders of HMOs or large physician groups on disease management guidelines to reduce practice pattern variations and improve the quality of patient care. In addition, pharmaceutical companies capitate payment to physicians treating chronic disease patients to give them financial incentives to comply with the disease management guidelines.

Soil persistence, plant and non-target insect uptake of endosulfan and lindane applied to soya bean and maize in field trials in Zimbabwe

International Nuclear Information System (INIS)

Zaranyika, M.F.; Mugari, P.

1997-01-01

The persistence of lindane and endosulfan in the soil, uptake by, and distribution in plants, and effects on and absorption by non-target insects, following application of the insecticides for the control of maize pests and soya bean respectively were determined under Zimbabwean weather conditions. No large scale effects on the non-target insects were observed though some small effects on the populations of semiloopers and orthoptera in the endosulfan treated soya bean plot were noted. Concentrations of the insecticides in spiders declined during the trial though those in grasshoppers and crickets appeared to increase. Concentrations of both insecticides in soil fell rapidly during the first 7 weeks after application but, after that, the rates of loss were much slower possibly owing to the drier conditions prevailing during this later period, reducing both physicochemical and microbial loss processes. Initial concentrations of both insecticides in all the vegetative parts of plants examined after spray application declined systematically to low levels during the 10 weeks of observations, probably owing to both metabolism within the plants and to crop volume dilution effects and will have declined to even lower levels by harvest time. Surprisingly, low concentrations of lindane and endosulfan were found in the harvested maize and soya bean seeds. At early stages after application, there were also traces of both insecticides in the vegetative parts of the plants from the untreated, control plots probably arising from uptake of soil residues from the previous year and/or spray drift but these became undetectable at later stages of growth. (author). 31 refs, 7 tabs

DEGRADATION BY PULSED CORONA DISCHARGES: STUDY ON THE POSSIBLE CHEMICAL DEGRADATION PATHWAY FOR DICLOFENAC

OpenAIRE

TORRES-GODOY, CYNTHIA

2012-01-01

The remo val of hazardous organic pollutants such as polychlorinated biphenyls (PCB's), polycyclic aromatic hydrocarbons (benzopyrene, dibenzoanthracene), pesticides (DDT, lindane), and pharmaceutical products ( diclofenac, ibuprofen, carbamazepine) from waste water is a growing concem in environmental science and technology. Therefore, innovative methods for water remediation in removing contaminants from waste sites need to be examined. This work explores the use of Pulsed Corona Disc...

[Medication adverse events: Impact of pharmaceutical consultations during the hospitalization of patients].

Science.gov (United States)

Santucci, R; Levêque, D; Herbrecht, R; Fischbach, M; Gérout, A C; Untereiner, C; Bouayad-Agha, K; Couturier, F

2014-11-01

The medication iatrogenic events are responsible for nearly one iatrogenic event in five. The main purpose of this prospective multicenter study is to determine the effect of pharmaceutical consultations on the occurrence of medication adverse events during hospitalization (MAE). The other objectives are to study the impact of age, of the number of medications and pharmaceutical consultations on the risk of MAE. The pharmaceutical consultation is associated to a complete reassessment done by both a physician and a pharmacist for the home medication, the hospital treatment (3days after admission), the treatment during chemotherapy, and/or, the treatment when the patient goes back home. All MAE are subject to an advice for the patient, additional clinical-biological monitoring and/or prescription changes. Among the 318 patients, 217 (68%) had 1 or more clinically important MAE (89% drug-drug interaction, 8% dosing error, 2% indication error, 1% risk behavior). The patients have had 1121 pharmaceutical consultations (3.2±1.4/patient). Thus, the pharmaceutical consultations divided by 2.34 the risk of MAE (unadjusted incidence ratio, P≤0.05). Each consultation decreased by 24% the risk of MAE. Moreover, adding one medication increases from 14 to 30% as a risk of MAE on the population. Pharmaceutical consultations during the hospital stay could reduce significantly the number of medication adverse effects. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Pharmaceutical counseling: Between evidence-based medicine and profits.

Science.gov (United States)

Egorova, S N; Akhmetova, T

2015-01-01

pharmaceutical counseling standards: Article 1.1 "Code of Ethics of the pharmaceutical worker of Russia" states: "The main task of the professional activity of the pharmaceutical worker - protection of human health", Article 1.3 states that a pharmaceutical worker must take professional decisions solely in the interests of a patient [1]. However, the pharmacy is a trade organization, thus as a retailer the pharmacy is directly interested in making profits and increasing sales of pharmaceutical products, including non-prescription medicines. Moreover, while the clinical medicine is monitored for unjustified prescribing and measures are being taken to prevent polypharmacy, for a pharmacist the growing sales of over-the-counter drugs, active promotion of dietary supplements, homeopathic medicines, medical devices, and, consequently, an increase of financial indicators (particularly "average purchase size") - all are characteristics of success [2].Rational use of over-the-counter medicines requires introduction of pharmaceutical counseling standards (pharmaceutical care) according to symptoms - major reasons to visit a pharmacy as part of responsible self-medication (cold, sore throat, headache, diarrhea, etc.). Standards of pharmaceutical counseling should be objective, reliable and up-to-date and contain recommendations for the rational use of over-the-counter drugs as well as indications requiring treatment to the doctor. Standardization of pharmaceutical counseling in terms of Evidence-based Pharmacy would enhance the efficiency, safety and cost-effectiveness of over-the-counter medicines.Currently, the lack of clinical component in the higher pharmaceutical education and the lack of approved standards of pharmaceutical counseling lead to the introduction of cross-selling technologies (which are broadly applied in other areas of trade, for example, the offer of a boot-polish during the sale of shoes) to the pharmaceutical practice [2, 3]. However, drugs belong to a special group

Pharmaceutical care in smoking cessation

Directory of Open Access Journals (Sweden)

Marín Armero A

2015-01-01

Full Text Available Alicia Marín Armero,1 Miguel A Calleja Hernandez,2 Sabina Perez-Vicente,3 Fernando Martinez-Martinez4 1Community Pharmacy, Murcia, Spain; 2Hospital Pharmacy, University Hospital Virgen de las Nieves, Granada, Spain; 3Result Evaluation Unit, Institute of Biomedicine, Sevilla, Spain; 4Research Unit in Pharmaceutical Care, University of Granada, Granada, Spain Abstract: As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients’ access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre–post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy’s smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. Keywords: community pharmacy, health campaign, tobacco cessation, nicotine replacement therapy

ETHICAL ASPECTS OF THE COOPERATION BETWEEN PHYSICIAN AND PHARMACEUTICAL INDUSTRY

Directory of Open Access Journals (Sweden)

Jože Drinovec

2001-09-01

Full Text Available Background. It is not possible to isolated ethical aspects and norms in the work of physician from the professional and scientific ones. The physician will not act contrary to ethical principles if he will work for the interests of the patient and in accordance with scientific knowledge.Present situation and possible solutions. Every physician, especially if working in university institution is co-operating with pharmaceutical industry, at least he is makes the prescriptions and chooses one drug of the possible ones. There are also other aspects of co-operation: clinical trials, writing expertise and lectures at scientific meetings, sponsored by pharmaceutical industry. There are guidelines and codex in Western countries for more than ten years, which regulate the relation between physician and pharmaceutical industry. The most important ones are those from World Health Organisation, European Federation of Pharmaceutical Industries’ Associations’, and International Federation of Pharmaceutical Manufacturers Associations’. Scientific independence of lecturers and writers is tried to be achieved by disclosure of relevant financial relation with pharmaceutical corporation in advance.Conclusions. Physician working with pharmaceutical industry has o follow the guidelines of international professional associations. He/she has to be independent relaying only upon scientific and professional principles seeing primary the benefit of the patient.

Pharmaceutical cocrystals: along the path to improved medicines.

Science.gov (United States)

Duggirala, Naga K; Perry, Miranda L; Almarsson, Örn; Zaworotko, Michael J

2016-01-14

Cocrystals, a long known but understudied class of crystalline solids, have attracted interest from crystal engineers and pharmaceutical scientists in the past decade and are now an integral part of the preformulation stage of drug development. This is largely because cocrystals that contain a drug molecule, pharmaceutical cocrystals, can modify physicochemical properties without the need for covalent modification of the drug molecule. This review presents a brief history of cocrystals before addressing recent advances in design, discovery and development of pharmaceutical cocrystals that have occurred since an earlier review published in 2004. We address four aspects of cocrystals: nomenclature; design using hydrogen-bonded supramolecular synthons; methods of discovery and synthesis; development of pharmaceutical cocrystals as drug products. Cocrystals can be classified into molecular cocrystals (MCCs) that contain only neutral components (coformers) and ionic cocrystals (ICCs), which are comprised of at least one ionic coformer that is a salt. That cocrystals, especially ICCs, offer much greater diversity in terms of composition and properties than single component crystal forms and are amenable to design makes them of continuing interest. Seven recent case studies that illustrate how pharmaceutical cocrystals can improve physicochemical properties and clinical performance of drug substances, including a recently approved drug product based upon an ICC, are presented.

Normas para la publicación de investigaciones clínicas patrocinadas por la industria farmacéutica Publication standards for clinical research sponsored by the pharmaceutical industry

Directory of Open Access Journals (Sweden)

2003-07-01

Full Text Available The role played by the private sector, in particular the pharmaceutical industry, in funding research has been growing at an accelerated pace in recent decades. So much so, in fact, that the private sector has become the primary funding source of clinical trials in some countries. As a result, pharmaceutical companies exercise ever-growing control over not only the design of clinical trials but also the publication of their results. The conflicts of interest involved in this kind of situation can lead to ethical breaches (for example, suppression or distortion of results or the intimidation of investigators, and it is crucial to take concrete steps to guard against such breaches. This is exactly what a Working Group made up of members of the pharmaceutical industry itself has done, preparing a series of guidelines for that industry in order to promote good publication practices. These guidelines, which were just recently published in English, represent an important step in efforts to achieve greater transparency and accountability in the presentation of results of research funded by manufacturers of pharmaceutical products. Although the guidelines, now translated into Spanish in this piece, are subject to future revisions, they are a valuable starting point for further discussion of a problem that deserves the urgent attention of the scientific community.

EU pharmaceutical expenditure forecast.

Science.gov (United States)

Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States' pharmaceutical budgets. This model took into account population ageing, as well as current and future country-specific pricing, reimbursement, and market access policies (the project was performed for the European Commission; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). In order to have a representative heterogeneity of EU Member States, the following countries were selected for the analysis: France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. A forecasting period of 5 years (2012-2016) was chosen to assess the net pharmaceutical budget impact. A model for generics and biosimilars was developed for each country. The model estimated a separate and combined effect of the direct and indirect impacts of the patent cliff. A second model, estimating the sales development and the risk of development failure, was developed for new drugs. New drugs were reviewed individually to assess their clinical potential and translate it into commercial potential. The forecast was carried out according to three perspectives (healthcare public payer, society, and manufacturer), and several types of distribution chains (retail, hospital, and combined retail and hospital). Probabilistic and deterministic sensitivity analyses were carried out. According to the model, all countries experienced drug budget reductions except Poland (+€41 million). Savings were expected to be the highest in the United Kingdom (-€9,367 million), France (-€5,589 million), and, far behind them

Systematic review: treatment pattern and clinical effectiveness and safety of pharmaceutical therapies for Crohn’s disease in Europe

Directory of Open Access Journals (Sweden)

Lelli F

2016-10-01

Full Text Available Filippo Lelli,1 Solomon Nuhoho,2 Xin Ying Lee,3 Weiwei Xu4 1EMEA Hemar, Janssen, Milan, Italy; 2Health Economics, Market Access and Reimbursement, Johnson & Johnson Middle East FZ LLC, Dubai, United Arab Emirates; 3EMEA Hemar, Janssen, Birkerød, Denmark; 4Pharmerit International, Rotterdam, the Netherlands Background: Although many clinical trials have been conducted in treatments of Crohn’s ­disease (CD, whether the trial results were representative of daily practice needs to be supported by studies conducted in real-world settings. Aim: This study aims to identify how CD is treated and what are the clinical effectiveness and safety of the pharmaceutical therapies of CD in real-world settings. Methods: A systematic literature review was conducted based on Medline®, Embase®, and Cochrane. All publications were assessed for title/abstract and full-text according to a predefined study protocol. Data were extracted and reported.Results: A total of 1,998 publications were identified. Fifty studies including six publications reporting treatment pattern and 44 studies reporting clinical effectiveness and safety of pharmaceutical therapies in CD management in Europe were included. 5-Aminosalicylic acid and corticosteroids were reported to be used among 14%–74% of CD patients. Immunomodulators were used by 14%–25% and 29%–31% of CD patients as an initial and follow-up treatment, respectively. Biological therapies were used by 25%–33% of CD patients. A trend toward an increasing use of immunomodulators and biological therapies in Europe has been reported in recent years. Approximately 50% of patients achieved remission on immunomodulator or biologic treatment, although a relapse rate of up to 23% has been reported.Conclusion: There is a trend of treatment shift to immunomodulators and biologics in CD management. Clinical effectiveness of immunomodulators and biologics has been demonstrated, though with a lack of sustainability of the

Data Sharing in the Pharmaceutical Enterprise: The Genie's Out of the Bottle.

Science.gov (United States)

Beninger, Paul; Connelly, James; Natarajan, Chandrasekhar

2017-09-01

This Commentary shows that the present emphasis on the sharing of data from clinical trials can be extended to the entire pharmaceutical enterprise. The authors constructed a Data Sharing Dashboard that shows the relationship between all of the life-cycle domains of the pharmaceutical enterprise from discovery to obsolescence and the domain-bridging disciplines, such as target credentialing, structure-activity relationships, and exposure-effect relationships. The published literature encompassing the pharmaceutical enterprise is expansive, covering the major domains of discovery, translation, clinical development, and post-marketing outcomes research, all of which have even larger, though generally inaccessible, troves of legacy data bases. Notable exceptions include the fields of genomics and bioinformatics. We have the opportunity to broaden the present momentum of interest in data sharing to the entire pharmaceutical enterprise, beginning with discovery and extending into health technology assessment and post-patent expiry generic use with the plan of integrating new levels and disciplines of knowledge and with the ultimate goal of improving the care of our patients. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Impact of a pharmaceutical care program on clinical evolution and antiretroviral treatment adherence: a 5-year study

Directory of Open Access Journals (Sweden)

Hernández Arroyo MJ

2013-08-01

Full Text Available María Jesús Hernández Arroyo,1 Salvador Enrique Cabrera Figueroa,2 Rosa Sepúlveda Correa,3 María de la Paz Valverde Merino,1 Alicia Iglesias Gómez,4 Alfonso Domínguez-Gil Hurlé5 On behalf of the Tormes Team 1Pharmacy Service, University Hospital of Salamanca, Salamanca, Spain; 2Pharmacy Institute, University Austral of Chile, Valdivia, Chile; 3Department of Statistics, University of Salamanca, Salamanca, Spain; 4Infectious Disease Service, University Hospital of Salamanca, Salamanca, Spain; 5Department of Pharmacy and Pharmaceutical Technology, University of Salamanca, Salamanca, Spain Background: Antiretroviral treatments (ART form the basis of adequate clinical control in human immunodeficiency virus-infected patients, and adherence plays a primary role in the grade and duration of the antiviral response. The objectives of this study are: (1 to determine the impact of the implementation of a pharmaceutical care program on improvement of ART adherence and on the immunovirological response of the patients; and (2 to detect possible correlations between different adherence evaluation measurements. Methods: A 60-month long retrospective study was conducted. Adherence measures used were: therapeutic drug monitoring, a simplified medication adherence questionnaire, and antiretroviral dispensation records (DR. The number of interviews and interventions related to adherence made for each patient in yearly periods was related to the changes in the adherence variable (measured with DR in these same yearly periods. The dates when the laboratory tests were drawn were grouped according to proximity with the study assessment periods (February–May, 2005–2010. Results: A total of 528 patients were included in the study. A significant relationship was observed between the simplified medication adherence questionnaire and DR over the 60-month study period (P < 0.01. Improvement was observed in the mean adherence level (P < 0.001, and there was a

[Pharmaceutical chemistry of drug-initiated photosensitivity].

Science.gov (United States)

Rácz, Ákos; Tóth, Lívia

2015-01-01

The photosensitivity originated from drugs is a common problem in medical and pharmaceutical practice. It is of prominent importance in drug development and in regulatory issues. The photosensitizer effect of drug substances is determined by their chemical structures, and it mainly originates from aromatic chromophore systems and photo-dissociable bonds forming free radicals. The photodegradation may happen in many different types of chemical reaction pathways. Our aim is to demonstrate in this review the interrelations between structure and photodegradation. We show examples for the different reaction types, with drugs from different pharmacologic therapeutic classes. The in vivo chemical reactivity of photodegradates of pharmaceutical substances, the in vitro methods of investigation for testing photoreactivity and phototoxicity, and briefly the clinical tests for photosensitivity disorders are also discussed.

Medical students' exposure to pharmaceutical industry marketing: a survey at one U.S. medical school.

Science.gov (United States)

Bellin, Melena; McCarthy, Susan; Drevlow, Laurel; Pierach, Claus

2004-11-01

While much is known about the interactions between the pharmaceutical industry and physicians, very little is known about pharmaceutical marketing directed toward medical students. This study sought to characterize the extent and forms of medical students' exposure to pharmaceutical industry marketing. In 2001-02, an anonymous, 17-item questionnaire was distributed to 165 preclinical and 116 clinical students at the University of Minnesota Medical School-Twin Cities. The main outcome measures were the number and forms of exposures to pharmaceutical industry marketing reported by medical students and whether students had discussed these exposures with teachers or advisors. Preclinical and clinical students were compared using chi(2) analysis (p marketing. Seventy-six (71.7%) clinical students compared to 38 (33.3%) preclinical students recalled over 20 exposures (p textbook (p marketing with an instructor or advisor; 59 (55.7%) clinical students as compared to 87 (80.6%) preclinical students recalled no such discussion (p marketing during their early years of training. Given existing evidence that such exposure influences physicians' practice and prescribing patterns, the authors propose that medical school curricula include formal instruction to prepare students to critically assess these contacts.

Value of pharmaceuticals: ensuring the future of research and development.

Science.gov (United States)

Serajuddin, Hamida K; Serajuddin, Abu T M

2006-01-01

the expiration of initial patents has the potential to promote innovation, provide for more thorough clinical studies, reduce prices, and share know-how. In addition, some of the issues related to the so-called aggressive pharmaceutical marketing practices would be resolved.

Legal and ethical obligations to conduct a clinical drug trial in Australia as an investigator initiated and sponsored study for an overseas pharmaceutical company.

Science.gov (United States)

Beran, Roy G

2004-01-01

Most multi-centre trials are both financed and sponsored by the pharmaceutical company involved. What follows will map the path adopted for an investigator initiated and sponsored study for a new indication of an established medication. The chief investigators of a company-sponsored, investigator-initiated, multi-centre, placebo-controlled study of an established medication, Pharmaceutical Benefit Scheme (PBS) listed for treatment of one condition but trialled in the management of another condition (trial of off-label use), were approached to submit a protocol to repeat the type of study with a different compound. The new study would test a different agent, also PBS listed, for the same condition as in the initial study and with the same off-licence application. The company would finance the study, provide the medication and matched placebo but only review the investigator-initiated protocol which would be sponsored by the principal investigator. This required the investigator to implement the trial, as would normally be done by the pharmaceutical company, yet also act as its principal investigator. The principal investigator, with colleagues and a Clinical Research Organisation (CRO), developed a protocol, adapted for the new agent, and submitted it for approval. Upon acceptance a contract was negotiated with the pharmaceutical company which had to overcome jurisdictional conflicts between common law and civil law legal systems. A CRO was contracted to undertake administrative functions which dictated special contractual agreements to overcome possible conflicts of interest for a sponsor/investigator to protect patient interests. There was need to find indemnification insurance with jurisdictional problems, co-investigators, ethics committee approvals and finance management as just some of the difficulties encountered. The paper will outline how these obstacles were overcome and how ethical and legal issues were respected through compromise. The ethical and legal

Between pharmaceutical patents and European patients: is a compromise still possible?

Science.gov (United States)

Garattini, Livio; Padula, Anna

2017-10-01

Pharmaceutical regulation has always attempted to balance the public health objective to make safe and effective drugs available for patients while providing commercial incentives through patents. Here we discuss whether it is still possible to find a balance between the incentives on the supply side and the regulatory framework on the demand side. Areas covered: The current regulatory framework on pharmaceutical exclusivity has been harshly criticized by many experts, arguing about whether it is still fit for public purposes and needs. Here we envisage a different scenario without 'revolutionizing' the whole present system. The main radical change should concern the present management of pharmaceutical patents by introducing a specific agency dedicated to them. Secondly, specific pharmaceutical patents could be restricted to compounds for one (or more) declared indication(s). Thirdly, pharmaceutical patents should be kept only for compounds that start a first clinical trial within five years from the granting date. Expert opinion: We think it is time to reconsider the regulation of pharmaceutical patents in the light of their relevance in terms of public health. New models of enhancing research investments are required for long-term sustainability of public pharmaceutical expenditure and the EU can still play a leading role.

Market Size and Innovation: Effects of Medicare Part D on Pharmaceutical Research and Development.

Science.gov (United States)

Blume-Kohout, Margaret E; Sood, Neeraj

2013-01-01

Recent evidence suggests that Medicare Part D increased prescription drug use among seniors, and increased pharmaceutical firms' revenues from sales. Previous studies also indicate that increases in market size induce pharmaceutical innovation. This paper assesses the impact of the Medicare Part D legislation on pharmaceutical research and development (R&D), using time-series data on the number of drugs entering preclinical and clinical development by therapeutic class and phase. We find that the passage and implementation of Medicare Part D is associated with significant increases in pharmaceutical R&D for therapeutic classes with higher Medicare market share.

Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to U.S. wastewaters

Science.gov (United States)

Scott, Tia-Marie; Phillips, Patrick J.; Kolpin, Dana W.; Colella, Kaitlyn M.; Furlong, Edward T.; Foreman, William T.; Gray, James L.

2018-01-01

Discharges from pharmaceutical manufacturing facilities (PMFs) previously have been identified as important sources of pharmaceuticals to the environment. Yet few studies are available to establish the influence of PMFs on the pharmaceutical source contribution to wastewater treatment plants (WWTPs) and waterways at the national scale. Consequently, a national network of 13 WWTPs receiving PMF discharges, six WWTPs with no PMF input, and one WWTP that transitioned through a PMF closure were selected from across the United States to assess the influence of PMF inputs on pharmaceutical loading to WWTPs. Effluent samples were analyzed for 120 pharmaceuticals and pharmaceutical degradates. Of these, 33 pharmaceuticals had concentrations substantially higher in PMF-influenced effluent (maximum 555,000 ng/L) compared to effluent from control sites (maximum 175 ng/L). Concentrations in WWTP receiving PMF input are variable, as discharges from PMFs are episodic, indicating that production activities can vary substantially over relatively short (several months) periods and have the potential to rapidly transition to other pharmaceutical products. Results show that PMFs are an important, national-scale source of pharmaceuticals to the environment.

Current Status of Regulatory Science Education in Faculties of Pharmaceutical Science in Japan.

Science.gov (United States)

Tohkin, Masahiro

2017-01-01

I introduce the current pharmaceutical education system in Japan, focusing on regulatory science. University schools or faculties of pharmaceutical science in Japan offer two courses: a six-year course for pharmacists and a four-year course for scientists and technicians. Students in the six-year pharmaceutical course receive training in hospitals and pharmacies during their fifth year, and those in the four-year life science course start research activities during their third year. The current model core curriculum for pharmaceutical education requires them to "explain the necessity and significance of regulatory science" as a specific behavior object. This means that pharmacists should understand the significance of "regulatory science", which will lead to the proper use of pharmaceuticals in clinical practice. Most regulatory science laboratories are in the university schools or faculties of pharmaceutical sciences; however, there are too few to conduct regulatory science education. There are many problems in regulatory science education, and I hope that those problems will be resolved not only by university-based regulatory science researchers but also by those from the pharmaceutical industry and regulatory authorities.

Content analysis of oncology-related pharmaceutical advertising in a peer-reviewed medical journal.

Science.gov (United States)

Yonemori, Kan; Hirakawa, Akihiro; Ando, Masashi; Hirata, Taizo; Yunokawa, Mayu; Shimizu, Chikako; Tamura, Kenji; Fujiwara, Yasuhiro

2012-01-01

The oncology market represents one of the largest pharmaceutical markets in any medical field, and printed advertising in medical journals is an important channel by which pharmaceutical companies communicate with healthcare professionals. The aim of the present study was to analyze the volume and content of and trends and changes in oncology-related advertising intended for healthcare professionals in a peer-reviewed medical journal. Information that could be included in advertisements to promote drug development and improve treatment strategies for cancer patients is discussed on the basis of the results of the analysis. Overall, 6,720 advertisements covering 13,039 pages in a leading oncology medical journal published (by the American Society of Clinical Oncology) between January 2005 and December 2009 were analyzed. The advertisements targeting pharmaceuticals and clinical trials, in particular, were reviewed. A total of 6,720 advertisements covering 13,039 pages were included in the analysis. For the years 2005-2009, the percentages of total journal pages dedicated to advertising were 24.0%, 45.7%, 49.8%, 46.8%, and 49.8%, respectively. Package insert information and efficacy and safety explanations appeared in more than 80% of advertisements intended for pharmaceutical promotion. From 2005 to 2009, the overall quantity of drug advertisements decreased by approximately 13%, whereas advertisements calling for the enrollment of patients into registration trials increased by approximately 11%. Throughout the study period, oncology-related pharmaceutical advertisements occupied a considerable number of pages relative to other journal content. The proportion of advertisements on ongoing clinical trials increased progressively throughout the study period.

Pharmaceutical management in ProCare Health Limited.

Science.gov (United States)

Malcolm, L; Barry, M; MacLean, I

2001-06-22

To review pharmaceutical budget holding and management in ProCare Health Limited by; describing budget holding strategies implemented in 1995/6, identifying prescribing savings achieved, analysing variation in prescribing behaviour and comparing the findings with experience elsewhere. With 340 members, ProCare is one of the largest and most progressive of New Zealand's independent practitioner associations (IPAs). Data were obtained for the three years 1994 to 1996 to determine pharmaceutical expenditure against budget and against national trends, by member and general medical services (GMS) consultations. ProCare has established a classical, quality focussed pharmaceutical management strategy. Savings against the agreed budget was 9.5% comparing 1996 with 1995 but 5.7% compared, with national trends. Wide variation in per capita and per consultation costs was not reduced and was entirely explained by prescribing volumes not drug prices. The most important finding is that general practitioners (GPs), working collaboratively, can establish a strategy of clinical and corporate governance which may be exerting a wide ranging influence over clinical behaviour. Although there may be doubts about the actual levels of saving these appeared to be well in excess of the financial investment in the strategy. Greater savings appear possible with a focus on addressing the large and apparently inappropriate per capita prescribing volume variation between practices. Understanding and successfully addressing this variation will be one of the key issues facing the implementation of the government's primary health care strategy.

[Pharmaceutical logistic in turnover of pharmaceutical products of Azerbaijan].

Science.gov (United States)

Dzhalilova, K I

2009-11-01

Development of pharmaceutical logistic system model promotes optimal strategy for pharmaceutical functioning. The goal of such systems is organization of pharmaceutical product's turnover in required quantity and assortment, at preset time and place, at a highest possible degree of consumption readiness with minimal expenses and qualitative service. Organization of the optimal turnover chain in the region is offered to start from approximate classification of medicaments by logistic characteristics. Supplier selection was performed by evaluation of timeliness of delivery, quality of delivered products (according to the minimum acceptable level of quality) and time-keeping of time spending for orders delivery.

Challenges in Translational Development of Pharmaceutical Cocrystals.

Science.gov (United States)

Kale, Dnyaneshwar P; Zode, Sandeep S; Bansal, Arvind K

2017-02-01

The last 2 decades have witnessed increased research in the area of cocrystals resulting in deeper scientific understanding, increase in intellectual property landscape, and evolution in the regulatory environment. Pharmaceutical cocrystals have received significant attention as a new solid form on account of their ability to modulate poor physicochemical properties of drug molecules. However, pharmaceutical development of cocrystals could be challenging, thus limiting their translation into viable drug products. In the present commentary, the role of cocrystals in the modulation of material properties and challenges involved in the pharmaceutical development of cocrystals have been discussed. The major hurdles encountered in the development of cocrystals such as safety of coformers, unpredictable performance during dissolution and solubility in different media, difficulties in establishing in vitro-in vivo correlation, and polymorphism have been extensively discussed. The influence of selecting appropriate formulation and process design on these challenges has been discussed. Finally, a brief outline of cocrystals that are undergoing clinical development has also been presented. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Optimization of the pharmaceutical care system for diabetes patients using modern pharmaceutical informatics methodology

Directory of Open Access Journals (Sweden)

Андрій Ігорович Бойко

2016-04-01

Full Text Available Aim. Implementation of pharmaceutical informatics methods in the system of pharmaceutical care for diabetes patients in Ukraine.Methods. System method was used for the analysis of status and reforming the pharmaceutical care for patients with diabetes; program-oriented management at informatization project realization; pharmaceutical informatics in the creation of computer pharmaceutical knowledge bases; methods of data synthesis and summarizing.Results. System analysis of the basic directions of reforming the pharmaceutical care for patients with diabetes in Ukraine was carried out. Ways of it’s of optimization were processed: establishment of specialized pharmacies with implementation of modern information technologies and special postgraduate education for pharmacists. Structure and information providing of computer knowledge base “Pharmaceutical care for patients with diabetes” was substantiated.Conclusion. Based on the regional project “Informatization of prescription antidiabetic drugs circulation in Ukraine” realization, the necessity of establishment of specialized pharmacies providing pharmaceutical care for patients with diabetes was substantiated. Ways for optimization of postgraduate education for pharmacists of the specialized pharmacies by implementation of special thematic improvement cycles were proceed. Computer knowledge base as an effective tool for optimization of pharmaceutical care for patients with diabetes was realized

THz spectroscopy: An emerging technology for pharmaceutical development and pharmaceutical Process Analytical Technology (PAT) applications

Science.gov (United States)

Wu, Huiquan; Khan, Mansoor

2012-08-01

As an emerging technology, THz spectroscopy has gained increasing attention in the pharmaceutical area during the last decade. This attention is due to the fact that (1) it provides a promising alternative approach for in-depth understanding of both intermolecular interaction among pharmaceutical molecules and pharmaceutical product quality attributes; (2) it provides a promising alternative approach for enhanced process understanding of certain pharmaceutical manufacturing processes; and (3) the FDA pharmaceutical quality initiatives, most noticeably, the Process Analytical Technology (PAT) initiative. In this work, the current status and progress made so far on using THz spectroscopy for pharmaceutical development and pharmaceutical PAT applications are reviewed. In the spirit of demonstrating the utility of first principles modeling approach for addressing model validation challenge and reducing unnecessary model validation "burden" for facilitating THz pharmaceutical PAT applications, two scientific case studies based on published THz spectroscopy measurement results are created and discussed. Furthermore, other technical challenges and opportunities associated with adapting THz spectroscopy as a pharmaceutical PAT tool are highlighted.

A review: Fentanyl and non-pharmaceutical fentanyls.

Science.gov (United States)

Suzuki, Joji; El-Haddad, Saria

2017-02-01

Fentanyl and non-pharmaceutical fentanyls (NPFs) have been responsible for numerous outbreaks of overdoses all over the United States since the 1970s. However, there has been a growing concern in recent years that NPFs are contributing to an alarming rise in the number of opioid-related overdoses. The authors conducted a narrative review of the published and grey literature on fentanyl and NPFs in PubMed, Google Scholar, and Google using the following search terms: "fentanyl", "non-pharmaceutical fentanyl", "fentanyl analogs", "fentanyl laced heroin" and "fentanyl overdose". References from relevant publications and grey literature were also reviewed to identify additional citations for inclusion. The article reviews the emergence and misuse of fentanyl and NPFs, their clinical pharmacology, and the clinical management and prevention of fentanyl-related overdoses. Fentanyl and NPFs may be contributing to the recent rise in overdose deaths in the United States. There is an urgent need to educate clinicians, researchers, and patients about this public health threat. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

[Steps aimed at upgrading a pharmaceutical care sector: the case of surgery].

Science.gov (United States)

Guérin, A; Thibault, M; Nguyen, C; Lebel, D; Bussières, J-F

2014-07-01

While the concept of clinical pharmacy was developed in the 1960s, clinical programs are characterized by their great variety and disparity when it comes to the presence of pharmacists in healthcare sectors. This article aims to describe a method in which pharmaceutical care sectors in healthcare facilities can be upgraded. This is a descriptive study supporting the upgrade of pharmaceutical care practiced in the surgery sector of a 500-bed mother-child university hospital center, the CHU Sainte-Justine. The pharmacy department employs more than 70 healthcare professionals. The study involved these proposed upgrading steps: firstly, a review of the literature; secondly, a description of the profile of the sector; thirdly, a description of the upgrading of pharmacist practice in surgery. A total of 137 articles were compiled, seven of which were selected to evaluate the impact and eight a description of the pharmacist's role in surgery. The authors did not identify any particular pharmaceutical activity based on very good quality data (A). However, there were five based on good quality data (B) and seven that lacked adequate proof (C, D) in relation to the practice of surgery. Nevertheless, a number of other authors described the development of the pharmacist's clinical role in surgery. There are few data on the impact of pharmacists in surgery. This descriptive study proposes a number of steps aimed at upgrading pharmaceutical care within a Quebec university hospital center. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Exposure of medical students to pharmaceutical marketing in primary care settings: frequent and influential.

Science.gov (United States)

Sarikaya, Ozlem; Civaner, Murat; Vatansever, Kevser

2009-12-01

It is known that interaction between pharmaceutical companies and medical professionals may lead to corruption of professional values, irrational use of medicine, and negative effects on the patient-physician relationship. Medical students frequently interact with pharmaceutical company representatives and increasingly accept their gifts. Considering the move toward early clinical encounters and community-based education, which expose students early to pharmaceutical representatives, the influence of those gifts is becoming a matter of concern. This study examines the frequency and influence of student exposure to drug marketing in primary care settings, as well as student perceptions of physician-pharmaceutical company relationships. This was a two-phase study consisting of qualitative research followed by a cross-sectional survey. Clinical experience logbooks of 280 second-year students in one school were analysed, and the themes that emerged were used to develop a survey that was administered to 308 third-year students from two medical schools. Survey results showed a 91.2% exposure to any type of marketing, and 56.8% of students were exposed to all classes of marketing methods studied. Deliberate targeting of students by pharmaceutical representatives, in particular, was correlated with being less sensitive to the negative effects of and having positive opinions about interactions with pharmaceutical companies. The vast majority of students are exposed to drug marketing in primary care settings, and may become more vulnerable to that strategy. Considering that medical students are vulnerable and are targeted deliberately by pharmaceutical companies, interventions aimed at developing skills in the rational use of medicines and in strategies for coping with drug marketing should be devised.

Evaluation of P-Listed Pharmaceutical Residues in Empty Pharmaceutical Containers

Science.gov (United States)

Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have stru...

Perceived needs of pharmaceutical care services among healthcare professionals in South Korea: a qualitative study.

Science.gov (United States)

Lee, Iyn-Hyang; Rhie, Sandy Jeong; Je, Nam Kyung; Rhew, Ki Yon; Ji, Eunhee; Oh, Jung Mi; Lee, Euni; Yoon, Jeong-Hyun

2016-10-01

Purpose To explore the need for pharmaceutical care services, key features of desirable pharmacy services, and perceived barriers for advancing the services in hospital environments with doctors and nurses who are key co-workers of the interdisciplinary team care services.Methods Semi-structured, in-depth interviews with eighteen doctors and fifteen nurses employing purposive and snowballing sampling strategies were conducted in ten hospitals in South Korea. Results The level of pharmaceutical care was varied across regions or institutions in South Korea. The concept of pharmaceutical care was insufficiently defined, and tended to be limited to some parts of medication counseling. Through pharmaceutical care services, doctors desired to acquire comprehensive drug information from and to share clinical responsibilities with pharmacists. Nurses wished to lower their burdens of medication counseling services from their daily practices. Doctors and nurses asked for pharmacists providing essential and carefully selected medication information to their patients in a patient-centered manner. The listed barriers to pharmaceutical care included the lack of appropriate systems for reward, insufficient accessibility to patient records by pharmacists, ambiguous role descriptions of pharmacist, and absence of effective communication among professionals. Conclusion A successful pharmaceutical care service model should allow efficient exchange of information among healthcare professionals to build inter-professional trust and to provide a continuity of care both in terms of time and setting. As prerequisites of such system, it was warranted to develop clinical evidence and an appropriate reward system for pharmaceutical care services.

Informed consent: Enforcing pharmaceutical companies' obligations abroad.

Science.gov (United States)

Lee, Stacey B

2010-06-15

The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections.

[Development of clinical trial education program for pharmaceutical science students through small group discussion and role-playing using protocol].

Science.gov (United States)

Imakyure, Osamu; Shuto, Hideki; Nishikawa, Fumi; Hagiwara, Yoshifuka; Inoue, Sachiko; Koyanagi, Taeko; Hirakawa, Masaaki; Kataoka, Yasufumi

2010-08-01

The acquirement of basic knowledge of clinical trials and professional attitude in their practices is a general instructional objective in the Model Core Curriculum for Pharmaceutical Education. Unfortunately, the previous program of clinical trial education was not effective in the acquirement of a professional attitude in their practices. Then, we developed the new clinical trial education program using protocol through small group discussion (SGD) and roll-playing. Our program consists of 7 steps of practical training. In step 1, the students find some problems after presentation of the protocol including case and prescription. In step 2, they analyse the extracted problems and share the information obtained in SGD. In steps 3 and 5, five clinical case scenarios are presented to the students and they discuss which case is suitable for entry to the clinical trial or which case corresponds to the discontinuance criteria in the present designed protocol. In steps 4 and 6, the roll-playing is performed by teachers and students as doctors and clinical research coordinators (CRC) respectively. Further, we conducted a trial practice based on this program for the students. In the student's self-evaluation into five grades, the average score of the skill acquisition level in each step was 3.8-4.7 grade. Our clinical trial education program could be effective in educating the candidates for CRC or clinical pharmacists.

Content analysis of oncology-related pharmaceutical advertising in a peer-reviewed medical journal.

Directory of Open Access Journals (Sweden)

Kan Yonemori

Full Text Available BACKGROUND: The oncology market represents one of the largest pharmaceutical markets in any medical field, and printed advertising in medical journals is an important channel by which pharmaceutical companies communicate with healthcare professionals. The aim of the present study was to analyze the volume and content of and trends and changes in oncology-related advertising intended for healthcare professionals in a peer-reviewed medical journal. Information that could be included in advertisements to promote drug development and improve treatment strategies for cancer patients is discussed on the basis of the results of the analysis. METHODS/PRINCIPAL FINDINGS: Overall, 6,720 advertisements covering 13,039 pages in a leading oncology medical journal published (by the American Society of Clinical Oncology between January 2005 and December 2009 were analyzed. The advertisements targeting pharmaceuticals and clinical trials, in particular, were reviewed. A total of 6,720 advertisements covering 13,039 pages were included in the analysis. For the years 2005-2009, the percentages of total journal pages dedicated to advertising were 24.0%, 45.7%, 49.8%, 46.8%, and 49.8%, respectively. Package insert information and efficacy and safety explanations appeared in more than 80% of advertisements intended for pharmaceutical promotion. From 2005 to 2009, the overall quantity of drug advertisements decreased by approximately 13%, whereas advertisements calling for the enrollment of patients into registration trials increased by approximately 11%. CONCLUSION/SIGNIFICANCE: Throughout the study period, oncology-related pharmaceutical advertisements occupied a considerable number of pages relative to other journal content. The proportion of advertisements on ongoing clinical trials increased progressively throughout the study period.

Pharmaceutically treated anxiety but not depression prior to cancer diagnosis predicts the onset of cardiovascular disease among breast cancer survivors

DEFF Research Database (Denmark)

Schoormans, Dounya; van de Poll-Franse, Lonneke; Vissers, Pauline

2017-01-01

PURPOSE: To examine the associations between pharmaceutically treated anxiety and depression present in the year prior to breast cancer diagnosis and the risk of incident cardiovascular disease (CVD), while controlling for traditional cardiovascular risk factors and clinical characteristics...... adjustment for depression, traditional cardiovascular risk factors, and clinical characteristics......., anxiety, and depression. By multivariable Cox regression analysis, we examined the risk associated with pharmaceutically treated anxiety and depression for developing CVD after cancer diagnosis, adjusting for age, pharmaceutically treated hypertension, hypercholesterolemia, and diabetes mellitus...

Clinical trial methodology

National Research Council Canada - National Science Library

Peace, Karl E; Chen, Ding-Geng

2011-01-01

... in the pharmaceutical industry, Clinical trial methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research...

A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan

Directory of Open Access Journals (Sweden)

Tanimoto T

2015-03-01

Full Text Available Tetsuya Tanimoto Division of Social Communication System for Advanced Clinical Research, Institute of Medical Science, University of Tokyo, Tokyo, Japan Abstract: The universal health care system in Japan is facing a historical turning point as a result of the increasing fiscal burden, rapidly aging society, and a decreasing population. To understand the challenges and opportunities in the Japanese pharmaceutical market, which occupies one tenth of the global share, this review highlights several issues related to the benefit-risk assessment that is unique to the modern Japanese society: 1 regulatory system for new drug development; 2 health hazards related to pharmaceuticals (“Yakugai” in Japanese; 3 drug lag; 4 problems and controversies in the vaccination policy; and 5 clinical study misconduct. The regulatory process places a significant importance on Japanese data collection regardless of data accumulation from other countries. Because Yakugai has repeatedly caused tragedies and social disputes historically, the regulatory judgments generally tend to be more prudential when safety concerns are raised for new and emerging pharmaceuticals. Such a regulatory system has caused more than several years of approval delays compared to delays in other countries. The problem of drug lag still lingers on despite several regulatory system revisions, while the solution is incompatible with the elimination of Yakugai because the lag potentially reduces the risk of unpredictable adverse events. The Japanese vaccination policy has also received a lot of criticism, and needs improvements so that the decision-making process can be more transparent and scientifically based. Additionally, repeated clinical study misconduct damaged the reputation of Japanese clinical studies with unnecessary defrayment in health insurance; therefore, the medical community must change its inappropriate relationship with the industry. The problems surrounding pharmaceuticals

Combating corruption in the pharmaceutical arena.

Science.gov (United States)

Lexchin, Joel; Kohler, Jillian Clare; Gagnon, Marc André; Crombie, James; Thacker, Paul; Shnier, Adrienne

2018-03-15

Corruption in healthcare generally and specifically in the pharmaceutical arena has recently been highlighted in reports by Transparency International. This article focuses on four areas of corruption: legislative/regulatory, financial, ideological/ethical, and communications. The problems identified and the solutions considered focus on structural considerations affecting how pharmaceuticals are discovered, developed, distributed, and ultimately used in clinical settings. These include recourse to user fees in the regulatory sphere, application of intellectual property rights to medical contexts (patents and access to research data), commercial sponsorship of ghost writing and guest authors, linkage/delinkage of the funding of research and overall health objectives to/from drug pricing and sales, transparency of payments to healthcare professionals and institutions, and credible regulatory sanctions. In general, financial and other incentives for all actors in the system should be structured to align with desired social outcomes - and to minimise conflicts of interest among researchers and clinicians.

[Logistics in the pharmaceutical service].

Science.gov (United States)

Stanko, P; Fulmeková, M

2005-11-01

The conception of the field of pharmaceutical service defines pharmaceutical service as the basic part of pharmacy, the principal task of which is to provide pharmaceutical care as an inseparable part of providing health care. It represents a set of professional activities of the pharmacist oriented to securing human and veterinary pharmaceutical products and health care products and to optimising effective, safe and quality pharmacotherapy. Technically, pharmaceutical service is an applied discipline, as it makes use of knowledge gained in other pharmaceutical, medical, psychological, social, and economic sciences. Because of its interdisciplinary character it is necessary to extend the theory of pharmaceutical service in such a way so that it may reflect all aspects of its sphere of activity. One of the possibilities is to define the pharmacy premises as an independent functional unit which operates on the basis of valid legal standards in such a way that on the one hand it secures the provision of health (pharmaceutical) care, and on the other hand it maintains its cost-effectiveness. To keep the quality of care of the patient and the economic aspect in balance, it is necessary to define the term pharmaceutical logistics also under the conditions of Slovak (Czech) pharmacy as early satisfaction of the requirements of the patient (client) in the pharmacy premises, which means that the appropriate pharmaceutical product or health care product and the appropriate information must be at the right time in the required amount and required quality in the right place.

Pharmaceutical powder compaction technology

National Research Council Canada - National Science Library

Çelik, Metin

2011-01-01

"Revised to reflect modern pharmaceutical compacting techniques, this Second Edition guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel...

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

Science.gov (United States)

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

Tropical Journal of Pharmaceutical Research

African Journals Online (AJOL)

Journal Homepage Image. We seek to encourage pharmaceutical and allied research of tropical and international relevance and to foster multidisciplinary research and collaboration among scientists, the pharmaceutical industry and the healthcare professionals. We publish articles in pharmaceutical sciences and related ...

Does pharmaceutical advertising affect journal publication about dietary supplements?

Directory of Open Access Journals (Sweden)

Hood Kaylene L

2008-04-01

Full Text Available Abstract Background Advertising affects consumer and prescriber behaviors. The relationship between pharmaceutical advertising and journals' publication of articles regarding dietary supplements (DS is unknown. Methods We reviewed one year of the issues of 11 major medical journals for advertising and content about DS. Advertising was categorized as pharmaceutical versus other. Articles about DS were included if they discussed vitamins, minerals, herbs or similar products. Articles were classified as major (e.g., clinical trials, cohort studies, editorials and reviews or other (e.g., case reports, letters, news, and others. Articles' conclusions regarding safety and effectiveness were coded as negative (unsafe or ineffective or other (safe, effective, unstated, unclear or mixed. Results Journals' total pages per issue ranged from 56 to 217 while advertising pages ranged from 4 to 88; pharmaceutical advertisements (pharmads accounted for 1.5% to 76% of ad pages. Journals with the most pharmads published significantly fewer major articles about DS per issue than journals with the fewest pharmads (P Conclusion These data are consistent with the hypothesis that increased pharmaceutical advertising is associated with publishing fewer articles about DS and publishing more articles with conclusions that DS are unsafe. Additional research is needed to test alternative hypotheses for these findings in a larger sample of more diverse journals.

The Korean Pharmaceutical Industry and the Expansion of the General Pharmaceuticals Market in the 1950-1960s

Directory of Open Access Journals (Sweden)

Kyu-Hwan SIHN

2015-12-01

Full Text Available After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The

[The Korean Pharmaceutical Industry and the Expansion of the General Pharmaceuticals Market in the 1950-1960s].

Science.gov (United States)

Sihn, Kyu-Hwan

2015-12-01

After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA) marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The market for

Pharmaceutical Formulation Facilities as Sources of Opioids and Other Pharmaceuticals to Wastewater Treatment Plant Effluents

Science.gov (United States)

2010-01-01

Facilities involved in the manufacture of pharmaceutical products are an under-investigated source of pharmaceuticals to the environment. Between 2004 and 2009, 35 to 38 effluent samples were collected from each of three wastewater treatment plants (WWTPs) in New York and analyzed for seven pharmaceuticals including opioids and muscle relaxants. Two WWTPs (NY2 and NY3) receive substantial flows (>20% of plant flow) from pharmaceutical formulation facilities (PFF) and one (NY1) receives no PFF flow. Samples of effluents from 23 WWTPs across the United States were analyzed once for these pharmaceuticals as part of a national survey. Maximum pharmaceutical effluent concentrations for the national survey and NY1 effluent samples were generally effluent had median concentrations ranging from 3.4 to >400 μg/L. Maximum concentrations of oxycodone (1700 μg/L) and metaxalone (3800 μg/L) in samples from NY3 effluent exceeded 1000 μg/L. Three pharmaceuticals (butalbital, carisoprodol, and oxycodone) in samples of NY2 effluent had median concentrations ranging from 2 to 11 μg/L. These findings suggest that current manufacturing practices at these PFFs can result in pharmaceuticals concentrations from 10 to 1000 times higher than those typically found in WWTP effluents. PMID:20521847

Pharmaceutical care in community pharmacies: practice and research in Denmark

DEFF Research Database (Denmark)

Herborg, Hanne; Sørensen, Ellen Westh; Frøkjaer, Bente

2007-01-01

% offer inhalation counseling, a reimbursed service. Research in pharmacy practice is well established and conducted primarily at universities and at Pharmakon A/S, which is owned by the Danish Pharmaceutical Association. DISCUSSION: Extended services in clinical pharmacy are priorities for all Danish...

[Changes of medico-pharmaceutical profession and private practice from the late 19th century to the early 20th century: ebb and flow of western pharmacies and clinics attached to pharmacy].

Science.gov (United States)

Lee, Heung-Ki

2010-12-31

This article examined i) how traditional medico-pharmaceutical custom from the late 19th century influenced such changes, ii) how medical laws of Daehan Empire and early colonial period influenced the differentiation of medico-pharmaceutical profession, and iii) what the responses of medico-pharmaceutical professionals were like, and arrived at following conclusions. First, in late Chosun, there was a nationwide spread of pharmacies (medicine room, medicine store) as general medical institutions in charge of prescription and medication as well as diagnosis. Therefore, Koreans' perception of Western medicine was not very different from that of traditional pharmacy. Second, Western pharmacies were established by various entities including oriental doctors, Western doctors and drug manufacturers.Their business ranged from medical consultation, prescription, medication and drug manufacture. This was in a way the extension of traditional medico-pharmaceutical custom, which did not draw a sharp line between medical and pharmaceutical practices. Also, regulations on medical and pharmaceutical business of Daehan Empire did not distinguish oriental and Western medicine. Third, clinics attached to pharmacy began to emerge after 1908, as some Western pharmacies that had grown their business based on selling medicine began to hire doctors trained in Western medicine. This trend resulted from Government General's control over medico-pharmaceutical business that began in 1908, following a large-scale dismissal of army surgeons trained in medical schools in 1907. Fourth, as specialization increased within medico-pharmaceutical business following the colonial medical law in early 1910s, such comprehensive business practices as Western pharmacy disappeared and existing businesses were differentiated into dealers of medical ingredients, drug manufacturer, patent medicine businessmen and herbalists. And private practice gradually became the general trend by establishment of medical

Review of recent applications of flow injection spectrophotometry to pharmaceutical analysis

International Nuclear Information System (INIS)

Tzanavaras, Paraskevas D.; Themelis, Demetrius G.

2007-01-01

Pharmaceutical analysis is one of the most important fields in analytical chemistry. The discovery of new drugs and the on-going update of international regulations for the safety and efficacy of pharmaceutical formulations demand the continuous development of new analytical methods. Inevitably, automation plays an important role, especially when a lot of samples have to be analyzed in the minimum of time. The present study reviews the applications of flow injection (FI) spectrophotometry to the determination of active pharmaceutical ingredients (APIs) in their respective formulations. However, the topic covered in this study is important not only to pharmaceutical analytical scientists. The principles, figures of merit and 'chemistry' of the presented methods can be of interest to bio-analytical and clinical chemists as well for the analysis of biological samples, to environmental analysts that study the up-to-date demand of the determination of the fate of pharmaceuticals in the environment and even to toxicologists and forensic scientists. This review covers scientific contributions published later than 2000. A variety of FI procedures based on homogeneous (direct UV measurements, colour-forming reactions, metal-drug interactions) and heterogeneous (optical sensors and solid-phase reactors) systems are discussed. A third section covers on-line sample pretreatment (solid-phase extraction, liquid-liquid extraction, on-line digestion, etc.)

Identification of Standards for Pharmaceutical Care in Benin City

African Journals Online (AJOL)

The goal of this study is to identify practice standards that can be effectively ... Pharmaceutical care evolved from clinical ... The specific objectives ..... The pharmacist should regularly run reports on their patients to see if they are ... Each pharmacist shall procure a certain amount of hours of continuing education on topics to.

Pharmaceutical compounds in drinking water

Directory of Open Access Journals (Sweden)

Vikas Chander

2016-06-01

Full Text Available Pharmaceutical products and their wastes play a major role in the degradation of environment. These drugs have positive as well as negative consequences on different environmental components including biota in different ways. Many types of pharmaceutical substances have been detected with significant concentrations through various advanced instrumental techniques in surface water, subsurface water, ground water, domestic waste water, municipal waste water and industrial effluents. The central as well as state governments in India are providing supports by creating excise duty free zones to promote the pharmaceutical manufacturers for their production. As a result, pharmaceutical companies are producing different types of pharmaceutical products at large scale and also producing complex non-biodegradable toxic wastes byproducts and releasing untreated or partially treated wastes in the environment in absence of strong regulations. These waste pollutants are contaminating all types of drinking water sources. The present paper focuses on water quality pollution by pharmaceutical pollutants, their occurrences, nature, metabolites and their fate in the environment.

Supramolecular Pharmaceutical Sciences: A Novel Concept Combining Pharmaceutical Sciences and Supramolecular Chemistry with a Focus on Cyclodextrin-Based Supermolecules.

Science.gov (United States)

Higashi, Taishi; Iohara, Daisuke; Motoyama, Keiichi; Arima, Hidetoshi

2018-01-01

Supramolecular chemistry is an extremely useful and important domain for understanding pharmaceutical sciences because various physiological reactions and drug activities are based on supramolecular chemistry. However, it is not a major domain in the pharmaceutical field. In this review, we propose a new concept in pharmaceutical sciences termed "supramolecular pharmaceutical sciences," which combines pharmaceutical sciences and supramolecular chemistry. This concept could be useful for developing new ideas, methods, hypotheses, strategies, materials, and mechanisms in pharmaceutical sciences. Herein, we focus on cyclodextrin (CyD)-based supermolecules, because CyDs have been used not only as pharmaceutical excipients or active pharmaceutical ingredients but also as components of supermolecules.

[Hospital pharmaceutical practice in prison].

Science.gov (United States)

Harcouët, L

2010-09-01

Since 1994, hospital pharmaceutical teams have been in charge of pharmaceutical tasks in "unités de consultation et de soins ambulatoires" (UCSA), which are hospital consulting care units in French prisons. In 2008, pharmaceutical team in Parisian prisons received 6500 prescriptions and prepared 85,000 nominative bags containing drugs. Prisoners were 1.3% to receive treatments against HIV, 8.2% cardiovascular drugs, 7.2% opioid substitution treatments, and 52.9% psychoactive drugs, including 39.3% hypnotics, 40.5% anxiolytics, 11.3% antidepressants and 12.2% neuroleptics. In prison, the dichotomy between somatic and mental care is marked, attitudes of prisoners about their medicines are complex (important claims, embezzlement, etc.) and it is difficult for law defendants to maintain treatment confidentiality and to prepare prison outing in terms of health. To attenuate the heterogeneity of drug distribution systems in French prisons, we propose pharmaceutical analysis of prescriptions and nominative dispensation, computerization in UCSA in coordination with hospitals, a better contribution of prison medical and pharmaceutical staff in hospital "drug committees" and the redaction of pharmaceutical guidelines. Acting in concert with multidisciplinary medical staff in UCSA, pharmaceutical teams have to develop epidemiological studies to improve knowledge in prisoner's health and also prevention and health care in prison. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

Compliance revisited: pharmaceutical drug trials in the era of the contract research organization.

Science.gov (United States)

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.

An evaluation of the adequacy of pharmaceutical services for the ...

African Journals Online (AJOL)

Background: With the introduction of nurse-initiated and -managed antiretroviral therapy (NIMART), new challenges have emerged with regard to the prescribing and dispensing of ART by nurses. One of the key challenges is ensuring adequate pharmaceutical services at PHC clinics. Objective: The objective of the study ...

Pharmaceutical Sponsorship Bias Influences Thrombolytic Literature in Acute Ischemic Stroke

Directory of Open Access Journals (Sweden)

Ryan P Radecki

2011-05-01

Full Text Available Background: The efficacy of thrombolytic therapy for acute ischemic stroke remains controversial in Emergency Medicine and has not been fully endorsed by either the American College of Emergency Physicians or the American Academy of emergency medicine. A growing recognition exists of the influence of pharmaceutical sponsorship on the reported findings of published clinical trials. Sponsorship bias has been suggested as a potential criticism of the literature and guidelines favoring thrombolytic therapy. Objective: The objective of this study is to review the most influential literature regarding thrombolytic therapy for acute ischemic stroke and document the presence or absence of pharmaceutical sponsorship. Methods: A publication-citation analysis was performed to identify the most frequently cited articles pertaining to thrombolytic therapy for acute ischemic stroke. Identified articles were reviewed for disclosures of pharmaceutical funding. Results: Of the 20 most-cited articles pertaining to thrombolytic therapy for acute stroke, 17 (85% disclosed pharmaceutical sponsorship. These disclosures range from general sponsorship to direct employment of authors by pharmaceutical companies. Conclusion: An overwhelming predominance of the most influential literature regarding thrombolytic therapy for acute ischemic stroke is susceptible to sponsorship bias. This potential bias may provide a basis for physician concern regarding the efficacy and safety of thrombolytic therapy. Further, large, independent, placebo-controlled studies may be required to guide therapy and professional guidelines definitively for acute ischemic stroke. [West J Emerg Med. 2011;12(4:435–441.

Pharmaceutical cocrystals: an overview.

Science.gov (United States)

Qiao, Ning; Li, Mingzhong; Schlindwein, Walkiria; Malek, Nazneen; Davies, Angela; Trappitt, Gary

2011-10-31

Pharmaceutical cocrystals are emerging as a new class of solid drugs with improved physicochemical properties, which has attracted increased interests from both industrial and academic researchers. In this paper a brief and systematic overview of pharmaceutical cocrystals is provided, with particular focus on cocrystal design strategies, formation methods, physicochemical property studies, characterisation techniques, and recent theoretical developments in cocrystal screening and mechanisms of cocrystal formations. Examples of pharmaceutical cocrystals are also summarised in this paper. Copyright © 2011 Elsevier B.V. All rights reserved.

Pharmaceutical care in Brazil’s primary health care

Directory of Open Access Journals (Sweden)

Patricia Sodré Araújo

2017-11-01

Full Text Available ABSTRACT OBJECTIVE To characterize the activities of clinical nature developed by pharmacists in basic health units and their participation in educational activities aiming at health promotion. METHODS This article is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015, a cross-sectional and exploratory study, of evaluative nature, consisting of a survey of information in a representative sample of cities, stratified by the Brazilian regions that constitute domains of study, and a subsample of primary health care services. The interviewed pharmacists (n=285 were responsible for the delivery of medicines and were interviewed in person with the use of a script. The characterization of the activities of clinical nature was based on information from pharmacists who declared to perform them, and on participation in educational activities aiming at health promotion, according to information from all pharmacists. The results are presented in frequency and their 95% confidence intervals. RESULTS From the interviewed subjects, 21.3% said they perform activities of clinical nature. Of these, more than 80% considered them very important; the majority does not dispose of specific places to perform them, which hinders privacy and confidentiality in these activities. The main denominations were “pharmaceutical guidance” and “pharmaceutical care.” The registration of activities is mainly made in the users’ medical records, computerized system, and in a specific document filed at the pharmacy, impairing the circulation of information among professionals. Most pharmacists performed these activities mainly along with physicians and nurses; 24.7% rarely participated in meetings with the health team, and 19.7% have never participated. CONCLUSIONS Activities of clinical nature

[Feedback on the evaluation of clinical pharmacy activities developed in surgery].

Science.gov (United States)

Jarfaut, A; Clauzel-Montserrat, M; Vigouroux, D; Kehrli, P; Gaudias, J; Kempf, J-F; Levêque, D; Nivoix, Y; Gourieux, B

2015-03-01

Our current development strategy integrates clinical pharmacy activities prioritized in surgical services. Patients in these services are typically risk patients: transfers, multiple prescribers, frequent medication change, pharmacotherapeutic risk classes. Three clinical pharmacy activities (admission reconciliation, pharmaceutical analysis, participation doctors round) have been developed in orthopaedic surgery and neurosurgery. Pharmacists prospectively recorded data describing their activities: number of reconciliations and analyzed requirements and time required to achieve them. Data on pharmaceutical interventions were recorded on the basis ActIP®. The clinical significance of interventions was retrospectively rated by a team of two pharmacists and two physicians on the scale adapted Hatoum et al. Four thousand five hundred pharmaceutical analysis and 248 reconciliations were conducted. One hundred and fifty-six pharmaceutical interventions were issued. The average acceptance rate was 80%. A total of 5.8% of pharmaceutical interventions have been listed with a very significant clinical importance and 48.1% with at least significant clinical importance. The activities and documentation required pharmaceutical average daily time (senior pharmacist, resident and external pharmacist) about 6 hours. Other studies, including comparative and medico-economic, must be conducted to support these results. Nevertheless, the indicators obtained attend a better readability of the clinical importance of the activities performed by clinical pharmacists and this particularly in surgical services, both by prescribers and authorities. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Pharmaceutical applications of magnetic resonance imaging (MRI).

Science.gov (United States)

Richardson, J Craig; Bowtell, Richard W; Mäder, Karsten; Melia, Colin D

2005-06-15

Magnetic resonance imaging (MRI) is a powerful imaging modality that provides internal images of materials and living organisms on a microscopic and macroscopic scale. It is non-invasive and non-destructive, and one of very few techniques that can observe internal events inside undisturbed specimens in situ. It is versatile, as a wide range of NMR modalities can be accessed, and 2D and 3D imaging can be undertaken. Despite widespread use and major advances in clinical MRI, it has seen limited application in the pharmaceutical sciences. In vitro studies have focussed on drug release mechanisms in polymeric delivery systems, but isolated studies of bioadhesion, tablet properties, and extrusion and mixing processes illustrate the wider potential. Perhaps the greatest potential however, lies in investigations of pharmaceuticals in vivo, where pilot human and animal studies have demonstrated we can obtain unique insights into the behaviour of gastrointestinal, topical, colloidal, and targeted drug delivery systems.

A rapid, solid phase extraction (SPE technique for the extraction and gas chromatographic determination lindane pesticide residue in tissue and milk

Directory of Open Access Journals (Sweden)

Yuningsih

2006-03-01

Full Text Available Organochlorine pesticide contamination in feed can cause residue in animal product (tissue and milk, so its become a problem in food safety. Solid phase extraction (SPE has been carried out for determination organochlorine pesticide residues in food animal production. The technique was rapid, not costly and produce limited amount of hazardous-waste. Samples were homogenized with acetonitrile trough cartridge C18, eluted in fluorocyl column with 2% ether-petroleum or acetonitrile fortissue and milk samples respectively. The recoveries of tissue sample by addition lindane standard solution: 0.50 and 1.00 μg are 85.10 and 103.10% respectively, while that of milk with the addition of 0.50, 1.00 and 1.50 μg are 83.80, 88.69 and 91.24% respectively. Three replicates were carried out for every sample. According of validation criteria of FAO/IAEA the recovery for analysis of pesticide residues was 70-110%. Therefore, the method is applicable.

Qatar pharmacists' understanding, attitudes, practice and perceived barriers related to providing pharmaceutical care.

Science.gov (United States)

El Hajj, Maguy Saffouh; Al-Saeed, Hassna Sohil; Khaja, Maryam

2016-04-01

Pharmaceutical care (PC) is the philosophy of practice that includes identifying and resolving medication therapy problems to improve patient outcomes. The study objectives were to examine the extent of pharmaceutical care practice and the barriers to pharmaceutical care provision as perceived by Qatar pharmacists and to assess their level of understanding of pharmaceutical care and their attitudes about pharmaceutical care provision. Setting Qatar pharmacies. A cross sectional survey of all pharmacists in Qatar was made. Consenting pharmacists were given the option to complete the survey either online using an online software or as paper by fax or by hand. 1. Extent of pharmaceutical care practice in Qatar. 2. Barriers to pharmaceutical care provision in Qatar. 3. Qatar pharmacists' level of understanding of pharmaceutical care. 4. Qatar pharmacists' attitudes toward pharmaceutical care provision. Over 8 weeks, 274 surveys were collected (34 % response rate). More than 80 % of respondents had correct understanding of the aim of PC and of the pharmacist role in PC. However, only 47 % recognized the patient role in PC and only 35 % were aware of the differences between clinical pharmacy and PC. Yet, more than 80 % believed that they could be advocates when it comes to patients' medications and health matters. Concerning their practice, respondents reported spending little time on PC activities. Offering feedback to the physician about the patient progress was always or most of the time performed by 21 % of respondents. The top perceived barriers for PC provision included inconvenient access to patient medical information (78 %) and lack of staff and time (77 and 74 % respectively). Although PC is not incorporated into pharmacy practice, Qatar pharmacists showed positive attitudes toward PC provision. Further work should focus on improving their PC understanding and on overcoming all barriers.

Impacto clínico y económico de las intervenciones farmacéuticas Clinical and economic impact of pharmaceutical interventions

Directory of Open Access Journals (Sweden)

Gonzalo Rodríguez Torné

2011-03-01

.39 euros. The record of interventions is considered advantageous for the detection of priority problems and areas for action, in addition to being a useful tool to prove the cost-effectiveness of actions. Key words: Pharmaceutical intervention, clinical impact, economic impact.

Electrochemical biosensors in pharmaceutical analysis

OpenAIRE

Gil, Eric de Souza; Melo, Giselle Rodrigues de

2010-01-01

Given the increasing demand for practical and low-cost analytical techniques, biosensors have attracted attention for use in the quality analysis of drugs, medicines, and other analytes of interest in the pharmaceutical area. Biosensors allow quantification not only of the active component in pharmaceutical formulations, but also the analysis of degradation products and metabolites in biological fluids. Thus, this article presents a brief review of biosensor use in pharmaceutical analysis, fo...

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

APPROACHES TO IMPLEMENTATION OF AN INTEGRATED MANAGEMENT SYSTEM IN THE PHARMACEUTICAL INDUSTRY. GALENICAL PHARMACEUTICAL PRODUCTION

Directory of Open Access Journals (Sweden)

Ershova Elena Vladimirovna

2015-10-01

Full Text Available This article reviews the issues associated with development of an integrated quality management system and its implementation into a galenical pharmaceutical company. Recently, the Russian pharmaceutical industry has been developing extensively: pharmaceutical clusters are being formed, new and innovative technologies are being developed. For the enterprises producing galenical pharmaceutical products, which feature low prices and a high level of competition, development and implementation of management systems is a way to prove their competitiveness. The purpose of this article is to review the architecture and the key elements of integrated management systems for pharmaceutical enterprises, develop an integrated management system in terms of the upcoming revision of ISO 9001:2015, as well as to describe the benefits of implementation of such systems. The presented approach is the result of an educational project implemented within the framework of the MBA programme in "Master of Business Administration (MBA" in the Federal State Budgetary Educational Institution of Continuing Professional Education Pastukhov State Academy of Industrial Management.

The pharmaceutical corporation and the 'good work' of managing women's bodies.

Science.gov (United States)

Padamsee, Tasleem Juana

2011-04-01

Pharmaceutical companies are intricately intertwined with every aspect of contemporary medical reality, and they increasingly drive the social process of medicalization in order to establish and dominate markets for their drugs and devices. In addition to funding the majority of clinical research, organizing it to generate an evidence base that favors their innovations, and influencing the regulation of pharmaceutical drugs and devices, companies still spend substantial resources on direct attempts to shape the attitudes, dispositions, and prescribing behavior of physicians. This article sheds new light on our picture of the relationship between the pharmaceutical industry and physicians by examining a novel form of physician-directed communication produced by one prominent corporation. An interpretive, thematic analysis of ORGYN - the unique, full-length magazine published by the Organon Corporation between 1990 and 2003 - reveals two overarching messages it communicated to physicians during that period. First, it offered a compelling picture of the "good work" obstetricians and gynecologists do, which involves enabling women of reproductive age to control their fertility through contraception and infertility treatment, and providing symptom relief and preventive benefits to older women by increasing compliance with hormone therapy regimes. Second, it included pharmaceutical technology in every aspect of the doctor's work, portraying pharmaceutical corporations as the physician's "natural partner", and women patients as passive, disempowered objects of medical practice. Through these consistent messages, the print magazine ORGYN represented one important set of mechanisms by which a pharmaceutical corporation helped drive and sustain medicalization. The article ends with a consideration of the implications of ORGYN's messages for companies, doctors, women patients, and the study of medicalization. Copyright © 2011 Elsevier Ltd. All rights reserved.

Pharmaceuticals labelled with stable isotopes

International Nuclear Information System (INIS)

Krumbiegel, P.

1986-11-01

The relatively new field of pharmaceuticals labelled with stable isotopes is reviewed. Scientific, juridical, and ethical questions are discussed concerning the application of these pharmaceuticals in human medicine. 13 C, 15 N, and 2 H are the stable isotopes mainly utilized in metabolic function tests. Methodical contributions are given to the application of 2 H, 13 C, and 15 N pharmaceuticals showing new aspects and different states of development in the field under discussion. (author)

Construction of ethics in clinical research: clinical trials registration

Directory of Open Access Journals (Sweden)

C. A. Caramori

2007-01-01

Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

Applications of Polymers as Pharmaceutical Excipients in Solid Oral Dosage Forms.

Science.gov (United States)

Debotton, Nir; Dahan, Arik

2017-01-01

Over the last few decades, polymers have been extensively used as pharmaceutical excipients in drug delivery systems. Pharmaceutical polymers evolved from being simply used as gelatin shells comprising capsule to offering great formulation advantages including enabling controlled/slow release and specific targeting of drugs to the site(s) of action (the "magic bullets" concept), hence hold a significant clinical promise. Oral administration of solid dosage forms (e.g., tablets and capsules) is the most common and convenient route of drug administration. When formulating challenging molecules into solid oral dosage forms, polymeric pharmaceutical excipients permit masking undesired physicochemical properties of drugs and consequently, altering their pharmacokinetic profiles to improve the therapeutic effect. As a result, the number of synthetic and natural polymers available commercially as pharmaceutical excipients has increased dramatically, offering potential solutions to various difficulties. For instance, the different polymers may allow increased solubility, swellability, viscosity, biodegradability, advanced coatings, pH dependency, mucodhesion, and inhibition of crystallization. The aim of this article is to provide a wide angle prospect of the different uses of pharmaceutical polymers in solid oral dosage forms. The various types of polymeric excipients are presented, and their distinctive role in oral drug delivery is emphasized. The comprehensive know-how provided in this article may allow scientists to use these polymeric excipients rationally, to fully exploit their different features and potential influence on drug delivery, with the overall aim of making better drug products. © 2016 Wiley Periodicals, Inc.

Interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: a comprehensive review

Directory of Open Access Journals (Sweden)

Sonali S. Bharate

2010-09-01

Full Text Available Studies of active drug/excipient compatibility represent an important phase in the preformulation stage of the development of all dosage forms. The potential physical and chemical interactions between drugs and excipients can affect the chemical nature, the stability and bioavailability of drugs and, consequently, their therapeutic efficacy and safety. The present review covers the literature reports of interaction and incompatibilities of commonly used pharmaceutical excipients with different active pharmaceutical ingredients in solid dosage forms. Examples of active drug/excipient interactions, such as transacylation, the Maillard browning reaction, acid base reactions and physical changes are discussed for different active pharmaceutical ingredients belonging to different therapeutic categories viz antiviral, anti-inflammatory, antidiabetic, antihypertensive, anti-convulsant, antibiotic, bronchodialator, antimalarial, antiemetic, antiamoebic, antipsychotic, antidepressant, anticancer, anticoagulant and sedative/hypnotic drugs and vitamins. Once the solid-state reactions of a pharmaceutical system are understood, the necessary steps can be taken to avoid reactivity and improve the stability of drug substances and products.

Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization.

Science.gov (United States)

Grady, Haiyan; Elder, David; Webster, Gregory K; Mao, Yun; Lin, Yiqing; Flanagan, Talia; Mann, James; Blanchard, Andy; Cohen, Michael J; Lin, Judy; Kesisoglou, Filippos; Hermans, Andre; Abend, Andreas; Zhang, Limin; Curran, David

2018-01-01

This article intends to summarize the current views of the IQ Consortium Dissolution Working Group, which comprises various industry companies, on the roles of dissolution testing throughout pharmaceutical product development, registration, commercialization, and beyond. Over the past 3 decades, dissolution testing has evolved from a routine and straightforward test as a component of end-product release into a comprehensive set of tools that the developer can deploy at various stages of the product life cycle. The definitions of commonly used dissolution approaches, how they relate to one another and how they may be applied in modern drug development, and life cycle management is described in this article. Specifically, this article discusses the purpose, advantages, and limitations of quality control, biorelevant, and clinically relevant dissolution methods. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Pharmaceutical virtue.

Science.gov (United States)

Martin, Emily

2006-06-01

In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good.

[PICS: pharmaceutical inspection cooperation scheme].

Science.gov (United States)

Morénas, J

2009-01-01

The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry.

Recognizing misleading pharmaceutical marketing online.

Science.gov (United States)

De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

2014-01-01

In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. © 2014 American Academy of Psychiatry and the Law.

Introduction to Pharmaceutical Biotechnology, Volume 1; Basic techniques and concepts

Science.gov (United States)

Bhatia, Saurabh; Goli, Divakar

2018-05-01

Animal biotechnology is a broad field including polarities of fundamental and applied research, as well as DNA science, covering key topics of DNA studies and its recent applications. In Introduction to Pharmaceutical Biotechnology, DNA isolation procedures followed by molecular markers and screening methods of the genomic library are explained. Interesting areas like isolation, sequencing and synthesis of genes, with the broader coverage on synthesis of genes, are also described. The book begins with an introduction to biotechnology and its main branches, explaining both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It then moves on to historical development and scope of biotechnology with an overall review of early applications that scientists employed long before the field was defined.

Pharmaceutical care in Kuwait: hospital pharmacists' perspectives.

Science.gov (United States)

Katoue, Maram G; Awad, Abdelmoneim I; Schwinghammer, Terry L; Kombian, Samuel B

2014-12-01

Pharmaceutical care practice has been championed as the primary mission of the pharmacy profession, but its implementation has been suboptimal in many developing countries including Kuwait. Pharmacists must have sufficient knowledge, skills, and positive attitudes to practise pharmaceutical care, and barriers in the pharmacy practice model must be overcome before pharmaceutical care can be broadly implemented in a given healthcare system. To investigate hospital pharmacists' attitudes towards pharmaceutical care, perceptions of their preparedness to provide pharmaceutical care, and the barriers to its implementation in Kuwait. Six general hospitals, eight specialized hospitals and seven specialized health centers in Kuwait. A descriptive, cross-sectional survey was distributed to all pharmacists working in the governmental hospitals in Kuwait (385 pharmacists). Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (standard deviations) were calculated and compared using statistical package for social sciences, version 20. Statistical significance was accepted at a p value of Kuwait. Completed surveys were received from 250 (64.9%) of the 385 pharmacists. Pharmacists expressed overall positive attitudes towards pharmaceutical care. They felt well prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Pharmacists with more practice experience expressed significantly more positive attitudes towards pharmaceutical care (p = 0.001) and they felt better prepared to provide pharmaceutical care competencies (p Kuwait advocate implementation of pharmaceutical care while also appreciating the organizational, technical and professional barriers to its widespread adoption. Collaborative efforts between health authorities and educational institutions, and the integration of innovative approaches in

Impact of Practice-Based Instruction on Graduate Programs in the Pharmaceutical Sciences--A Response.

Science.gov (United States)

Gourley, Dick R.

1979-01-01

Issues concerning graduate programs in the pharmaceutical sciences are discussed, including: recent trends, recruitment, clinical instruction, doctoral programs, graduate faculty, master's programs, competition, supply and demand, and professional education of professionals. (SF)

The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research

NARCIS (Netherlands)

De Vos, FJ; De Decker, M; Dierckx, RA

Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice

Entrepreneurial patent management in pharmaceutical startups.

Science.gov (United States)

Holgersson, Marcus; Phan, Tai; Hedner, Thomas

2016-07-01

Startups fill an increasingly important role as innovators in the pharmaceutical industry, and patenting is typically central to their success. This article aims to explore patent management in pharmaceutical startups. The results show that startups need to deal with several challenges related to patenting and an 'entrepreneurial' approach to patent management is called for. Resource constraints, venture capital provision, exits and other conditions and events must be readily considered in the patent management process to build a successful pharmaceutical venture, something that could benefit the pharmaceutical industry as a whole. Copyright © 2016 Elsevier Ltd. All rights reserved.

Introduction: Institutional corruption and the pharmaceutical policy.

Science.gov (United States)

Rodwin, Marc A

2013-01-01

Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. © 2013 American Society of Law, Medicine & Ethics, Inc.

The Effectiveness of Pharmaceutical Marketing

NARCIS (Netherlands)

E.R. Kappe

2011-01-01

textabstractPharmaceutical marketing effectiveness comprises the measurement of marketing efforts of pharmaceutical firms towards doctors and patients. These firms spend billions of dollars yearly to promote their prescription drugs. This dissertation provides empirical analyses and methods to

Construction of ethics in clinical research: clinical trials registration

OpenAIRE

C. A. Caramori

2007-01-01

Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong c...

ANALYSIS OF SCIENTIFIC RESEARCHES IN PHARMACEUTICAL PROMOTION GLOBALLY: TOWARDS INTERNATIONALLY DEVELOPING PRACTICALLY-ORIENTED GUIDELINES FOR PHARMACEUTICAL COMPANIES

Directory of Open Access Journals (Sweden)

M. M. Bahlol

2016-01-01

Full Text Available Purpose. Pharmaceutical industry is transnational and globally important. Many pharmaceutical companies operate their business in multinational and international forms in different countries. Diverse researches from different countries indicated and confirmed marketing promotion importance in pharmaceutical field. Therefore, marketing promotion and its effects are a very important issue that should be globally investigated in real life and evidence context. We oriented our research according to these scientific and practical values.Methodology. We reviewed pharmaceutical marketing promotion researches from more than 25 different countries, e.g., USA, Canada, Italy, France, Russia, India, Egypt and Syria where we employed our knowledge of three widely spread languages, i.e., English, Russian and Arabic. Such language variation supports us with large and variable amount of scientific knowledge, deep understanding and ability of analysis. Some studies investigated average response to pharmaceutical marketing promotion and few studies took into consideration heterogeneity in their effects with respect to advertising medium or drug characteristics.Originality. We investigated empirical evidences of pharmaceutical marketing promotion that can be directed to either consumer or healthcare professionals.Findings. We extracted, gathered and associated information of pharmaceutical promotion globally which oriented us to several evidence and practical facts with regard to employing promotion tools in different definite situations pertinent to main directions; their welfare and health enhancing effects and adverse effects. Practical Implications- Consequently, we developed practically-oriented guidelines for companies concerning pharmaceutical promotion globally ate the end of this paper.

Marketing orientation in pharmaceutical industry

Directory of Open Access Journals (Sweden)

Prošić Danica

2006-01-01

Full Text Available Pharmaceutical companies are major stakeholders in the global health agenda Virtually all drugs used by patients in Europe reach markets through the promotion tactics of a small number of corporations with a tremendous impact on global health. The sector is both fast growing and highly profitable. Effective marketing strategies are a crucial ingredient in making sure pharmaceutical products and profits flow in a virtuous cycle. At first glance, the relationship between doctors and drug companies, as well as advertising practices for over-the-counter medication, appears tightly regulated. According to many consumer organizations, drug promotion in Europe today can be characterized as nice and friendly marketing. This refers to the creation of a false sense of trust that consumers associate with branded pharmaceutical products, as a result of pharmaceutical marketing efforts disguised as genuine corporate responsibility.

PARTICULARITIES OF MODERN PHARMACEUTICAL PROMOTION

Directory of Open Access Journals (Sweden)

Юрий Владимирович Тарасов

2014-02-01

Full Text Available Pharmaceutical products market is one of the most saturated consumers’ markets. Characteristic features of it are: high competition, fierce struggle for the customer, specific technologies of promotion. In conditions of globalization and increase in competition both in world pharmaceutical market and in the market of medicines and goods of medical purpose in Russia modern marketing techniques of promotion of the products to the end consumers are the key tools for strengthening market positions – both of producers of pharmaceutical goods and their suppliers, distributors, big whole-sale companies. Among main tools of promotion are: advertising, public relations, stimulation of sales on the market of medicines, personal sales, computer technologies. The article describes different technologies of promotion of medicines: indoor-advertising, hot lines, pharmaceutical exhibitions, packing. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-1

Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints

OpenAIRE

Kesselheim, Aaron S.; Mello, Michelle M.; Studdert, David M.

2011-01-01

Editors' Summary Background Before a pharmaceutical company can market a new prescription drug in the US, the drug has to go through a long approval process. After extensive studies in the laboratory and in animals, the pharmaceutical company must test the drug's safety and efficacy in a series of clinical trials in which groups of patients with specific diseases are given the drug according to strict protocols. The results of these trials are reviewed by Federal Drug Administration (FDA, the...

National transparency assessment of Kuwait's pharmaceutical sector.

Science.gov (United States)

Badawi, Dalia A; Alkhamis, Yousif; Qaddoumi, Mohammad; Behbehani, Kazem

2015-09-01

Corruption is one of several factors that may hinder the access to pharmaceuticals. Since Kuwait has the highest per-capita spending on pharmaceuticals in the region, we wanted to evaluate the level of transparency in its pharmaceutical sector using an established assessment tool adapted by the World Health Organization. Standardized questionnaires were conducted via semi-structured interviews with key informants to measure the level of transparency in eight functions of the public pharmaceutical sector. The scores for the degree of vulnerability to corruption reflected marginal to moderate venerability to corruption for most pharmaceutical sectors. The perceived strengths included availability of appropriate laws, the presence of clear standard operating procedures, and the use of an efficient registration/distribution system. Weaknesses included lack of conflict of interest guidelines and written terms of reference, absence of pharmacoeconomic studies, and inconsistencies in law enforcement. Findings reveal that few functions of Kuwait pharmaceutical sector remain fairly vulnerable to corruption. However, the willingness of Kuwait Ministry of Health to adopt the assessment study and the acknowledgement of the weaknesses of current processes of the pharmaceutical sector may assist to achieve a transparent pharmaceutical system in the near future. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Strategic Management of Innovations at Pharmaceutical Enterprises

Directory of Open Access Journals (Sweden)

Honcharova Svіtlana Yu.

2014-01-01

Full Text Available The article is devoted to theoretical and practical issues of the use of the concept of strategic management of innovations at pharmaceutical enterprises. It studies main barriers, which restrict development of Ukrainian pharmaceutical enterprises. It analyses the state and tendencies of development of innovation activity of pharmaceutical enterprises and studies foreign experience of innovation activity. It marks out specific features of strategic management of innovation development in pharmaceutical industry. It specifies the role and advantages of methods of strategic analysis in the system of management of a pharmaceutical enterprise. It considers the essence of “innovation development” and “innovation model of development” notions and analyses their organisational and legal provision. It justifies strategic tasks of the pharmaceutical filed to focus on in order to achieve a breakthrough when building an innovation model of economic development. The article proves that the most important factors that ensure growth of efficiency of pharmaceutical production are: wide application of the concept of strategic management and creation of innovations.

[Chinese medicine industry 4.0：advancing digital pharmaceutical manufacture toward intelligent pharmaceutical manufacture].

Science.gov (United States)

Cheng, Yi-Yu; Qu, Hai-Bin; Zhang, Bo-Li

2016-01-01

A perspective analysis on the technological innovation in pharmaceutical engineering of Chinese medicine unveils a vision on "Future Factory" of Chinese medicine industry in mind. The strategy as well as the technical roadmap of "Chinese medicine industry 4.0" is proposed, with the projection of related core technology system. It is clarified that the technical development path of Chinese medicine industry from digital manufacture to intelligent manufacture. On the basis of precisely defining technical terms such as process control, on-line detection and process quality monitoring for Chinese medicine manufacture, the technical concepts and characteristics of intelligent pharmaceutical manufacture as well as digital pharmaceutical manufacture are elaborated. Promoting wide applications of digital manufacturing technology of Chinese medicine is strongly recommended. Through completely informationized manufacturing processes and multi-discipline cluster innovation, intelligent manufacturing technology of Chinese medicine should be developed, which would provide a new driving force for Chinese medicine industry in technology upgrade, product quality enhancement and efficiency improvement. Copyright© by the Chinese Pharmaceutical Association.

Rheology in Pharmaceutical Sciences

DEFF Research Database (Denmark)

Aho, Johanna; Hvidt, Søren; Baldursdottir, Stefania

2016-01-01

Rheology is the science of flow and deformation of matter. Particularly gels and non-Newtonian fluids, which exhibit complex flow behavior, are frequently encountered in pharmaceutical engineering and manufacturing, or when dealing with various in vivo fluids. Therefore understanding rheology......, together with the common measurement techniques and their practical applications. Examples of the use of rheological techniques in the pharmaceutical field, as well as other closely related fields such as food and polymer science, are also given....... is important, and the ability to use rheological characterization tools is of great importance for any pharmaceutical scientist involved in the field. Flow can be generated by shear or extensional deformations, or a combination of both. This chapter introduces the basics of both shear and extensional rheology...

Pharmaceutical Public-Private Partnerships

DEFF Research Database (Denmark)

Bagley, Constance; Tvarnø, Christina D.

2014-01-01

This article provides a game theory and law-and-management analysis of for- profit pharmaceutical public-private partnerships, a complex type of legal arrangement in the highly regulated pharmaceutical industry. A pharmaceutical public-private partnership (PPPP) agreement is a legally binding...... and a practical perspective on how properly crafted PPPP arrangements can promote innovation more efficiently than traditional self-optimizing contracts. In particular, a properly framed binding contract, coupled with respect for positive incentives, can move the parties away from an inefficient prisoners...... systems to build and share innovation. When coupled with appropriate attention to the difficult task of coordinating the actions of interdependent actors, a PPPP arrangement can enhance the likelihood of successful commercialization of pharmacological discoveries by flipping the par- ties’ incentives...

Reconfiguring global pharmaceutical value networks through targeted technology interventions

OpenAIRE

Harrington, Tomas Seosamh; Phillips, MA; Srai, Jagjit Singh

2016-01-01

Targeting a series of advanced manufacturing technology (AMT) ‘interventions’ provides the potential for significant step changes across the pharmaceutical value chain, from early stage ‘system discovery’ and clinical trials, through to novel service supply models. This research explores future value network configurations which, when aligned with disruptive shifts in technology (process and digital), may enable alternative routes to medicines production and the delivery of additional value t...

United States private-sector physicians and pharmaceutical contract research: a qualitative study.

Science.gov (United States)

Fisher, Jill A; Kalbaugh, Corey A

2012-01-01

There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators' role in clinical investigation. Our objective was to study private-sector clinics involved in US pharmaceutical clinical trials to understand the contract research arrangements supporting drug development, and specifically how private-sector physicians engaged in contract research describe their professional identities. We conducted a qualitative study in 2003-2004 combining observation at 25 private-sector research organizations in the southwestern United States and 63 semi-structured interviews with physicians, research staff, and research participants at those clinics. We used grounded theory to analyze and interpret our data. The 11 private-sector physicians who participated in our study reported becoming principal investigators on industry clinical trials primarily because contract research provides an additional revenue stream. The physicians reported that they saw themselves as trial practitioners and as businesspeople rather than as scientists or researchers. Our findings suggest that in addition to having financial motivation to participate in contract research, these US private-sector physicians have a professional identity aligned with an industry-based approach to research ethics. The generalizability of these findings and whether they have changed in the intervening years should be addressed in future studies. Please see later in the article for the Editors' Summary.

United States private-sector physicians and pharmaceutical contract research: a qualitative study.

Directory of Open Access Journals (Sweden)

Jill A Fisher

Full Text Available There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators' role in clinical investigation. Our objective was to study private-sector clinics involved in US pharmaceutical clinical trials to understand the contract research arrangements supporting drug development, and specifically how private-sector physicians engaged in contract research describe their professional identities.We conducted a qualitative study in 2003-2004 combining observation at 25 private-sector research organizations in the southwestern United States and 63 semi-structured interviews with physicians, research staff, and research participants at those clinics. We used grounded theory to analyze and interpret our data. The 11 private-sector physicians who participated in our study reported becoming principal investigators on industry clinical trials primarily because contract research provides an additional revenue stream. The physicians reported that they saw themselves as trial practitioners and as businesspeople rather than as scientists or researchers.Our findings suggest that in addition to having financial motivation to participate in contract research, these US private-sector physicians have a professional identity aligned with an industry-based approach to research ethics. The generalizability of these findings and whether they have changed in the intervening years should be addressed in future studies. Please see later in the article for the Editors' Summary.

Conceptualizing Pharmaceutical Plants

DEFF Research Database (Denmark)

Larsen, Bent Dalgaard; Jensen, Klaes Ladeby; Gjøl, Mikkel

2006-01-01

In the conceptual design phase of pharmaceutical plants as much as 80%-90% of the total cost of a project is committed. It is therefore essential that the chosen concept is viable. In this design process configuration and 3D models can help validate the decisions made. Designing 3D models...... is a complex task and requires skilled users. We demonstrate that a simple 2D/3D configuration tool can support conceptualizing of pharmaceutical plants. Present paper reports on preliminary results from a full scale implementation project at a Danish engineering company....

PSE in Pharmaceutical Process Development

DEFF Research Database (Denmark)

Gernaey, Krist; Cervera Padrell, Albert Emili; Woodley, John

2011-01-01

The pharmaceutical industry is under growing pressure to increase efficiency, both in production and in process development. This paper will discuss the use of Process Systems Engineering (PSE) methods in pharmaceutical process development, and searches for answers to questions such as: Which PSE...

Contribution of hospital effluents to the load of pharmaceuticals in urban wastewaters: identification of ecologically relevant pharmaceuticals.

Science.gov (United States)

Santos, Lúcia H M L M; Gros, Meritxell; Rodriguez-Mozaz, Sara; Delerue-Matos, Cristina; Pena, Angelina; Barceló, Damià; Montenegro, M Conceição B S M

2013-09-01

The impact of effluent wastewaters from four different hospitals: a university (1456 beds), a general (350 beds), a pediatric (110 beds) and a maternity hospital (96 beds), which are conveyed to the same wastewater treatment plant (WWTP), was evaluated in the receiving urban wastewaters. The occurrence of 78 pharmaceuticals belonging to several therapeutic classes was assessed in hospital effluents and WWTP wastewaters (influent and effluent) as well as the contribution of each hospital in WWTP influent in terms of pharmaceutical load. Results indicate that pharmaceuticals are widespread pollutants in both hospital and urban wastewaters. The contribution of hospitals to the input of pharmaceuticals in urban wastewaters widely varies, according to their dimension. The estimated total mass loadings were 306 g d(-1) for the university hospital, 155 g d(-1) for the general one, 14 g d(-1) for the pediatric hospital and 1.5 g d(-1) for the maternity hospital, showing that the biggest hospitals have a greater contribution to the total mass load of pharmaceuticals. Furthermore, analysis of individual contributions of each therapeutic group showed that NSAIDs, analgesics and antibiotics are among the groups with the highest inputs. Removal efficiency can go from over 90% for pharmaceuticals like acetaminophen and ibuprofen to not removal for β-blockers and salbutamol. Total mass load of pharmaceuticals into receiving surface waters was estimated between 5 and 14 g/d/1000 inhabitants. Finally, the environmental risk posed by pharmaceuticals detected in hospital and WWTP effluents was assessed by means of hazard quotients toward different trophic levels (algae, daphnids and fish). Several pharmaceuticals present in the different matrices were identified as potentially hazardous to aquatic organisms, showing that especial attention should be paid to antibiotics such as ciprofloxacin, ofloxacin, sulfamethoxazole, azithromycin and clarithromycin, since their hazard quotients

Novel methodology for pharmaceutical expenditure forecast

OpenAIRE

Vataire, Anne-Lise; Cetinsoy, Laurent; Aball?a, Samuel; R?muzat, C?cile; Urbinati, Duccio; Kornfeld, ?sa; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

Background and objective: The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the ‘EU Pharmaceutical e...

Bioremediation Kinetics of Pharmaceutical Industrial Effluent

OpenAIRE

M. Šabić; M. Vuković Domanovac; Z. Findrik Blažević; E. Meštrović

2015-01-01

In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmente...

Vulnerabilities to misinformation in online pharmaceutical marketing.

Science.gov (United States)

De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

2013-05-01

Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users' vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain.

In silico toxicology for the pharmaceutical sciences

International Nuclear Information System (INIS)

Valerio, Luis G.

2009-01-01

The applied use of in silico technologies (a.k.a. computational toxicology, in silico toxicology, computer-assisted tox, e-tox, i-drug discovery, predictive ADME, etc.) for predicting preclinical toxicological endpoints, clinical adverse effects, and metabolism of pharmaceutical substances has become of high interest to the scientific community and the public. The increased accessibility of these technologies for scientists and recent regulations permitting their use for chemical risk assessment supports this notion. The scientific community is interested in the appropriate use of such technologies as a tool to enhance product development and safety of pharmaceuticals and other xenobiotics, while ensuring the reliability and accuracy of in silico approaches for the toxicological and pharmacological sciences. For pharmaceutical substances, this means active and impurity chemicals in the drug product may be screened using specialized software and databases designed to cover these substances through a chemical structure-based screening process and algorithm specific to a given software program. A major goal for use of these software programs is to enable industry scientists not only to enhance the discovery process but also to ensure the judicious use of in silico tools to support risk assessments of drug-induced toxicities and in safety evaluations. However, a great amount of applied research is still needed, and there are many limitations with these approaches which are described in this review. Currently, there is a wide range of endpoints available from predictive quantitative structure-activity relationship models driven by many different computational software programs and data sources, and this is only expected to grow. For example, there are models based on non-proprietary and/or proprietary information specific to assessing potential rodent carcinogenicity, in silico screens for ICH genetic toxicity assays, reproductive and developmental toxicity, theoretical

Pharmaceutical policies in European countries.

Science.gov (United States)

Barros, Pedro Pita

2010-01-01

Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers. To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies. Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a "silver bullet" to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).

[Me-too pharmaceuticals -- marketing-strategies of drug producers and drug purchasers. Example: non-ionic contrast media].

Science.gov (United States)

Wild, C; Puig, S

2004-11-01

In the context of increasing economic pressure upon on hospital budgets, it is inevitable that central and standardized purchasing of pharmaceuticals must be considered. It was the aim of this assessment to analyse the many different non-ionic contrast media/CM products on the actual "clinical relevance of the differences" in order to give advice for a more concerted purchasing of CM. The assessment was commissioned by a large scale Austrian hospital cooperation; it can be regarded as the beginning of a broad strategy against the many new, only rarely innovative, but nevertheless patent-protected pharmaceuticals. Eight different non-ionic contrast media - used in routine care - were compared for their physico-chemical characteristics: osmolality, nephrotoxicity, viscosity, hydrophilicity and electric charge. In a systematic review 193 publications were analysed. The examined CM show similar pharmacokinetic and -dynamic attributes, and no differences of clinical relevance. An optimisation of purchasing pharmaceuticals by standardisation of the range of products takes place in the context of common strategies of producers and buying agents in marketing-economies. The strategies of the pharmaceutical industry (patent protection of me-too drugs, high-price-policy, extensive marketing of up to 40 % of revenue) and the counter-strategies of the central hospital purchasers (market concentration, drug commissions, institutional measures to disentangle interests) are presented - exemplified by contrast media - in this article.

Nanocrystals Technology for Pharmaceutical Science.

Science.gov (United States)

Cheng, Zhongyao; Lian, Yumei; Kamal, Zul; Ma, Xin; Chen, Jianjun; Zhou, Xinbo; Su, Jing; Qiu, Mingfeng

2018-05-17

Nanocrystals technology is a promising method for improving the dissolution rate and enhancing the bioavailability of poorly soluble drugs. In recent years, it has been developing rapidly and applied to drug research and engineering. Nanocrystal drugs can be formulated into various dosage forms. This review mainly focused on the nanocrystals technology and its application in pharmaceutical science. Firstly, different preparation methods of nanocrystal technology and the characterization of nanocrystal drugs are briefly described. Secondly, the application of nanocrystals technology in pharmaceutical science is mainly discussed followed by the introduction of sustained release formulations. Then, the scaling up process, marketed nanocrystal drug products and regulatory aspects about nanodrugs are summarized. Finally, the specific challenges and opportunities of nanocrystals technology for pharmaceutical science are summarized and discussed. This review will provide a comprehensive guide for scientists and engineers in the field of pharmaceutical science and biochemical engineering. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

EU pharmaceutical expenditure forecast

OpenAIRE

Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

Background and Objectives: With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States’ ph...

Nanotechnology tools in pharmaceutical R&D

OpenAIRE

Challa S.S.R. Kumar

2010-01-01

Nanotechnology is a new approach to problem solving and can be considered as a collection of tools and ideas which can be applied in pharmaceutical industry. Application of nanotechnology tools in pharmaceutical R&D is likely to result in moving the industry from ‘blockbuster drug’ model to ‘personalized medicine’. There are compelling applications in pharmaceutical industry where inexpensive nanotechnology tools can be utilized. The review explores the possibility of categorizing various nan...

77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

Science.gov (United States)

2012-08-16

... include the following: (1) Are We There Yet?; (2) What FDA Expects in a Pharmaceutical Clinical Trial; (3) Medical Device Aspects of Clinical Research; (4) Adverse Event Reporting--Science, Regulation, Error, and...

Patent indicators: a window to pharmaceutical market success.

Science.gov (United States)

Guo, Yang; Hu, Yuanjia; Zheng, Mingli; Wang, Yitao

2013-07-01

Pharmaceutical success in the market is the best reward for pharmaceutical investors undergoing the lengthy, costly and risky process of pharmaceutical Research and Development (R&D). Drugs with high market revenues trigger fierce competition between pharmaceutical enterprises, as is demonstrated by the increasing Mergers & Acquisitions (M&A) cases focusing on seizing the best-selling products. On the other hand, patents, as the best shield for innovative drugs against generic drugs, become a powerful weapon for pharmaceutical enterprises to win the substantial returns generated by market exclusivity. Patents seem to be directly responsible for the commercial success of new medicines. In this context, it is of great significance to find out the empirical associations between pharmaceutical commercial success and patents. By comprehensively analysing 127 drugs marketed in the USA and their 621 American patents, this article identifies the evidence to link various patent indicators with pharmaceutical sales in actual market.

Environmental risk and toxicology of human and veterinary waste pharmaceutical exposure to wild aquatic host-parasite relationships.

Science.gov (United States)

Morley, Neil J

2009-03-01

Pollution of the aquatic environment by human and veterinary waste pharmaceuticals is an increasing area of concern but little is known about their ecotoxicological effects on wildlife. In particular the interactions between pharmaceuticals and natural stressors of aquatic communities remains to be elucidated. A common natural stressor of freshwater and marine organisms are protozoan and metazoan parasites, which can have significant effects on host physiology and population structure, especially under the influence of many traditional kinds of toxic pollutants. However, little is known about the effects of waste pharmaceuticals to host-parasite dynamics. In order to assess the risk waste pharmaceuticals pose to aquatic wildlife it has been suggested the use of toxicological data derived from mammals during the product development of pharmaceuticals may be useful for predicting toxic effects. An additional similar source of information is the extensive clinical studies undertaken with numerous classes of drugs against parasites of human and veterinary importance. These studies may form the basis of preliminary risk assessments to aquatic populations and their interactions with parasitic diseases in pharmaceutical-exposed habitats. The present article reviews the effects of the most common classes of pharmaceutical medicines to host-parasite relationships and assesses the risk they may pose to wild aquatic organisms. In addition the effects of pharmaceutical mixtures, the importance of sewage treatment, and the risk of developing resistant strains of parasites are also assessed. Copyright © 2008 Elsevier B.V. All rights reserved.

Ecotoxicological assessment of soils polluted with chemical waste from lindane production: Use of bacterial communities and earthworms as bioremediation tools.

Science.gov (United States)

Muñiz, Selene; Gonzalvo, Pilar; Valdehita, Ana; Molina-Molina, José Manuel; Navas, José María; Olea, Nicolás; Fernández-Cascán, Jesús; Navarro, Enrique

2017-11-01

An ecotoxicological survey of soils that were polluted with wastes from lindane (γ-HCH) production assessed the effects of organochlorine compounds on the metabolism of microbial communities and the toxicity of these compounds to a native earthworm (Allolobophora chlorotica). Furthermore, the bioremediation role of earthworms as facilitators of soil washing and the microbial degradation of these organic pollutants were also studied. Soil samples that presented the highest concentrations of ε-HCH, 2,4,6-trichlorophenol, pentachlorobenzene and γ-HCH were extremely toxic to earthworms in the short term, causing the death of almost half of the population. In addition, these soils inhibited the heterotrophic metabolic activity of the microbial community. These highly polluted samples also presented substances that were able to activate cellular detoxification mechanisms (measured as EROD and BFCOD activities), as well as compounds that were able to cause endocrine disruption. A few days of earthworm activity increased the extractability of HCH isomers (e.g., γ-HCH), facilitating the biodegradation of organochlorine compounds and reducing the intensity of endocrine disruption in soils that had low or medium contamination levels. Copyright © 2017 Elsevier Inc. All rights reserved.

Archives: Tropical Journal of Pharmaceutical Research

African Journals Online (AJOL)

Items 1 - 50 of 97 ... Archives: Tropical Journal of Pharmaceutical Research. Journal Home > Archives: Tropical Journal of Pharmaceutical Research. Log in or Register to get access to full text downloads.

Archives: Nigerian Journal of Pharmaceutical Research

African Journals Online (AJOL)

Items 1 - 9 of 9 ... Archives: Nigerian Journal of Pharmaceutical Research. Journal Home > Archives: Nigerian Journal of Pharmaceutical Research. Log in or Register to get access to full text downloads.

Attitudes and relationship between physicians and the pharmaceutical industry in a public general hospital in Lima, Peru.

Directory of Open Access Journals (Sweden)

Aldo De Ferrari

Full Text Available BACKGROUND: The interaction between physicians and the pharmaceutical industry influences physicians' attitudes and prescribing behavior. Although largely studied in the US, this topic has not been well studied in resource-poor settings, where a close relationship between physicians and industry still exists. OBJECTIVE: To describe physician interactions with and attitudes towards the pharmaceutical industry in a public general hospital in Lima, Peru. DESIGN: Descriptive, cross-sectional study through an anonymous, self-filled questionnaire distributed among faculty and trainee physicians of five different clinical departments working in a Peruvian public general hospital. A transcultural validation of an existing Spanish questionnaire was performed. Exposure to marketing activities, motivations to contact pharmaceutical representatives and attitudes towards industry were studied. Collected data was analyzed by degree of training, clinical department, gender and teaching status. Attitudes were measured on a four-point LIKERT scale. RESULTS: 155 physicians completed the survey, of which 148 were included in the study sample. 94.5% of attending physicians reported ongoing encounters with pharmaceutical representatives. The most common industry-related activities were receiving medical samples (91.2%, promotional material (87.8% and attending meetings in restaurants (81.8%. Respondents considered medical samples and continuing medical education the most ethically acceptable benefits. We found significant differences between attendings and residents, and teaching and non-teaching attendings. An association between the amount of encounters with pharmaceutical representatives, and attitudes towards industry and acceptance of medical samples was found. CONCLUSIONS: A close physician-industry relationship exists in the population under study. The contact is established mainly through pharmaceutical representatives. Medical samples are the most received

Pharmaceutical technology management--profitable business avenue.

Science.gov (United States)

Puthli, Shivanand P

2010-01-01

Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business.

Computer-assisted detection (CAD) methodology for early detection of response to pharmaceutical therapy in tuberculosis patients

Science.gov (United States)

Lieberman, Robert; Kwong, Heston; Liu, Brent; Huang, H. K.

2009-02-01

The chest x-ray radiological features of tuberculosis patients are well documented, and the radiological features that change in response to successful pharmaceutical therapy can be followed with longitudinal studies over time. The patients can also be classified as either responsive or resistant to pharmaceutical therapy based on clinical improvement. We have retrospectively collected time series chest x-ray images of 200 patients diagnosed with tuberculosis receiving the standard pharmaceutical treatment. Computer algorithms can be created to utilize image texture features to assess the temporal changes in the chest x-rays of the tuberculosis patients. This methodology provides a framework for a computer-assisted detection (CAD) system that may provide physicians with the ability to detect poor treatment response earlier in pharmaceutical therapy. Early detection allows physicians to respond with more timely treatment alternatives and improved outcomes. Such a system has the potential to increase treatment efficacy for millions of patients each year.

Pharmaceutical care education in Kuwait: pharmacy students’ perspectives

OpenAIRE

Katoue, Maram G.; Awad, Abdelmoneim I.; Schwinghammer, Terry L.; Kombian, Samuel B.

2014-01-01

Background: Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients’ quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective: To investigate pharmacy students’ attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance...

Vulnerabilities to misinformation in online pharmaceutical marketing

Science.gov (United States)

De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

2013-01-01

Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users’ vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain. PMID:23761527

Pharmaceutical costs of assisted reproduction in Spain.

Science.gov (United States)

Lorente, Maria-Reyes; Hernández, Juana; Antoñanzas, Fernando

2013-11-01

Assisted reproduction is one of the health services currently being considered for possible limitation or exclusion from the public health services portfolio in Spain. One of the main reasons claimed for this is the impact on the budget for pharmaceutical expenditure. The objective of this study was to assess the significance of the pharmaceutical costs of assisted reproduction in Spain. This study focused on medical practice in Spain, and is based on the opinions of experts in assisted reproduction and the results provided by professional societies' publications. The reference year is 2012 and the setting was secondary care. We have included all existing pharmaceutical modalities for assisted reproduction, as well as the most common drug for each modality. We have considered the pharmaceutical cost per cycle for artificial insemination, in vitro fertilisation with or without intracytoplasmic sperm injection (IVF_ICSI), and cryotransfer and donated fresh oocytes reception. In Spain, artificial insemination has a pharmaceutical cost per cycle of between €69.36 and €873.79. This amounts to an average cycle cost of €364.87 for partner's sperm and €327.10 for donor sperm. The pharmaceutical cost of IVF_ICSI ranges between €278.16 and €1,902.66, giving an average cost per cycle of €1,139.65. In the case of cryotransfer and donated fresh oocytes reception, the pharmaceutical cost per cycle is between €22.61 and €58.73, yielding an average cost of €40.67. The budgetary impact of pharmaceutical expenditure for assisted reproduction in Spain for the year 2012 was estimated at €98.7 million. In Spain, the total pharmaceutical cost of assisted reproduction is substantial. According to our results, we can say that about 29% of the total pharmaceutical expenditure for assisted reproduction techniques is funded by the National Health System and the rest represents 2.4% of the total annual out-of-pocket family expenditure on drugs.

Pharmaceutical studies on and clinical application of olanzapine suppositories prepared as a hospital preparation

OpenAIRE

Matsumoto, Kazuaki; Kimura, Satoru; Takahashi, Kenichi; Yokoyama, Yuta; Miyazawa, Masayuki; Kushibiki, Satoko; Katamachi, Morio; Kizu, Junko

2016-01-01

Background A new formulation of olanzapine available for terminally ill patients is needed. Rectal administration using suppositories is an alternative for patients for whom administration via the oral route is not feasible. In the present study, we prepared olanzapine suppositories, and confirmed using pharmaceutical tests. Furthermore, we demonstrated the efficacy and safety of olanzapine suppositories in terminally ill patients. Methods We prepared olanzapine suppositories using bases cons...

Pharmaceutical policy and the pharmacy profession

DEFF Research Database (Denmark)

Traulsen, Janine Marie; Almarsdóttir, Anna Birna

2005-01-01

In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy and indu......In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy...... and industrial policy. In order to analyse and understand pharmaceutical policy, it is important to know how policymakers view pharmacy and pharmacists. The authors look at the issues that arise when policy regulates pharmacy as a business, and what this means for the profession. The perspective of pharmacy...... in managerialism, and how the division of labour with other health professionals such as physicians and pharmacy assistants is affecting the pharmacy profession's position in the labour market. Next the authors look at ways in which the pharmacy profession has affected policy. Pharmacists have been instrumental...

A Pharmaceutical Bioethics Consultation Service: Six-Year Descriptive Characteristics and Results of a Feedback Survey.

Science.gov (United States)

Van Campen, Luann E; Allen, Albert J; Watson, Susan B; Therasse, Donald G

2015-04-03

Background : Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods : Data on the descriptive characteristics of bioethics consultations were collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results : Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions : Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service

Nonconsensual clinical trials: a foreseeable risk of offshoring under global corporatism.

Science.gov (United States)

Spielman, Bethany

2015-03-01

This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be presented as health care in a unique form of outsourcing from the host country to pharmaceutical corporations. Bioethicists' assessments of the risks and potential benefits of offshore corporate pharmaceutical trials should therefore systematically include not only the hoped for benefits and the risks of the experimental drug but also the risk that subjects will not have consented, as well as the broader international consequences of nonconsensual experimentation.

Amelioration of Gamma-hexachlorocyclohexane (Lindane induced renal toxicity by Camellia sinensis in Wistar rats

Directory of Open Access Journals (Sweden)

W. L. N. V. Vara Prasad

2016-11-01

Full Text Available Aim: A study to assess the toxic effects of gamma-hexachlorocyclohexane (γ-HCH (lindane and ameliorative effects of Camellia sinensis on renal system has been carried out in male Wistar rats. Materials and Methods: Four groups of rats with 18 each were maintained under standard laboratory hygienic conditions and provided feed and water ad libitum. γ-HCH was gavaged at 20 mg/kg b.wt. using olive oil as vehicle to Groups II. C. sinensis at 100 mg/kg b.wt. was administered orally in distilled water to Group IV in addition to γ-HCH 20 mg/kg b.wt. up to 45 days to study ameliorative effects. Groups I and III were treated with distilled water and C. sinensis (100 mg/kg b.wt., respectively. Six rats from each group were sacrificed at fortnight intervals. Serum was collected for creatinine estimation. The kidney tissues were collected in chilled phosphate buffer saline for antioxidant profile and in also 10% buffered formalin for histopathological studies. Results: γ-HCH treatment significantly increased serum creatinine and significantly reduced the renal antioxidative enzymes catalase, superoxide dismutase, and glutathione peroxidase. Grossly, severe congestion was noticed in the kidneys. Microscopically, kidney revealed glomerular congestion, atrophy, intertubular hemorrhages, degenerative changes in tubular epithelium with vacuolated cytoplasm, desquamation of epithelium and urinary cast formation. A significant reduction in serum creatinine levels, significant improvement in renal antioxidant enzyme activities and near to normal histological appearance of kidneys in Group IV indicated that the green tea ameliorated the effects of γ-HCH, on renal toxicity. Conclusion: This study suggested that C. sinensis extract combined with γ-HCH could enhance antioxidant/detoxification system which consequently reduced the oxidative stress thus potentially reducing γ-HCH toxicity and tissue damage.

Pharmaceuticals: pharmaceutical cost controls--2005. End of Year Issue Brief.

Science.gov (United States)

Seay, Melicia; Varma, Priya

2005-12-31

The enactment of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) gave states the option of offering pharmaceutical benefits within their Medicaid programs. But the law placed restrictions on states' flexibility to control what prescriptions they would cover and required the states to reimburse outpatient prescription drugs from manufacturers that signed rebate agreements with the U.S. Department of Health and Human Services. Forty-nine states--Arizona is excluded, based on its program structure--and the District of Columbia currently offer prescription drug coverage under the Medicaid Drug Rebate Program. During the past four years, states all over the country have been plagued with revenue shortfalls in their state Medicaid budgets. While the fiscal situation improved for most states in the 2004 legislative session, many states still face budget pressures in 2005. Compounding existing budget pressures are threats from the Bush Administration to shift increased costs of the Medicaid program on to the states. All things considered, the economic pressure of funding Medicaid is at the top of legislative agendas in 2005. As in previous years, states are attempting to reduce costs to their Medicaid programs by seeking savings in their pharmaceutical programs. Prescription drug costs are highly attributed as a contributing factor to the fiscal climate of state Medicaid programs. Currently, prescription drug spending outpaces that of every other category of health care and drug prices are rising faster than inflation. In response, states are instituting a variety of pharmaceutical cost control measures such as creating preferred drug lists (PDLs), negotiating supplemental rebates, forming bulk purchasing pools, promoting generic drug substitution and implementing price controls. As prescription drug cost containment tools have gained acceptance and momentum, they continue to be controversial. This issue brief explores the debate, history, methodology, utilization

Pharmaceutical care education in Kuwait: pharmacy students' perspectives.

Science.gov (United States)

Katoue, Maram G; Awad, Abdelmoneim I; Schwinghammer, Terry L; Kombian, Samuel B

2014-07-01

Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients' quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. To investigate pharmacy students' attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. A descriptive, cross-sectional survey of pharmacy students (n=126) was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD) were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%), lack of pharmacist time (83.3%), organizational obstacles (82.6%), and pharmacists' physical separation from patient care areas (82.6%). Pharmacy students' attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University understand and advocate implementation of pharmaceutical care while also

Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

OpenAIRE

Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

2016-01-01

Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employe...

[Pharmaceutical research progress of rhynchophylla based on chemical stability].

Science.gov (United States)

Hao, Bo; Yang, Xiu-Juan; Feng, Yi; Hong, Yan-Long

2014-12-01

Rhynchophylla is a Chinese herb commonly used in clinical practice. It's also the primary herb of some famous Chinese herbal compound such as Tianma Gouteng decoction, and Lingyang Gouteng decoction. According the record from many previous materia medica literatures, rhynchophylla should be added later during decoction. Pharmaceutical research showed that rhynchophylla alkaloids were not stable. Which has resulted in many problems in the research and its application. For example, there was not a quantitative determination method in "Chinese Pharmacopoeia" of past and present versions, which seriously impacted its quality control and product application. Firstly, records from previous materia medica literatures and "Chinese Pharmacopoeia" were systematically sorted based on the chemical stability of rhynchophylla. Secondly, pharmaceutical research including chemical compositions and their stability, pharmacological effects, extraction process and quality analysis, was reviewed after reference of literatures published at home and abroad in recent decades. Positive reference and evidence for further research and development of rhynchophylla will be provided in the article.

Biocatalytic Synthesis of Chiral Pharmaceutical Intermediates

Directory of Open Access Journals (Sweden)

Ramesh N. Patel

2004-01-01

Full Text Available The production of single enantiomers of drug intermediates has become increasingly important in the pharmaceutical industry. Chiral intermediates and fine chemicals are in high demand from both the pharmaceutical and agrochemical industries for the preparation of bulk drug substances and agricultural products. The enormous potential of microorganisms and enzymes for the transformation of synthetic chemicals with high chemo-, regio- and enantioselectivities has been demonstrated. In this article, biocatalytic processes are described for the synthesis of chiral pharmaceutical intermediates.

Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

Directory of Open Access Journals (Sweden)

Dipak Dilip Gadade

2016-12-01

Full Text Available Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development.

Science.gov (United States)

Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

2016-12-01

Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

Pharmaceutical lobbying in Brazil: a missing topic in the public health research agenda.

Science.gov (United States)

Paumgartten, Francisco José Roma

2016-12-22

In the US, where registration of lobbyists is mandatory, the pharmaceutical industry and private health-care providers spend huge amounts of money seeking to influence health policies and government decisions. In Brazil, where lobbying lacks transparency, there is virtually no data on drug industry expenditure to persuade legislators and government officials of their viewpoints and to influence decision-making according to commercial interests. Since 1990, however, the Associação da Indústria Farmacêutica de Pesquisa (Interfarma - Pharmaceutical Research Industry Association), Brazilian counterpart of the Pharmaceutical Research and Manufacturers of America (PhRMA), main lobbying organization of the US pharmaceutical industry, has played a major role in the advocacy of interests of major drug companies. The main goals of Interfarma lobbying activities are: shortening the average time taken by the Brazilian regulatory agency (ANVISA) to approve marketing authorization for a new drug; making the criteria for incorporation of new drugs into SUS (Brazilian Unified Health System) more flexible and speeding up technology incorporation; changing the Country's ethical clearance system and the ethical requirements for clinical trials to meet the need of the innovative drug industry, and establishing a National Policy for Rare Diseases that allows a prompt incorporation of orphan drugs into SUS. Although lobbying affects community health and well-being, this topic is not in the public health research agenda. The impacts of pharmaceutical lobbying on health policies and health-care costs are of great importance for SUS and deserve to be investigated.

Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations

Directory of Open Access Journals (Sweden)

Guo JW

2014-10-01

Full Text Available Jiun-Wen Guo,1 Yu-Hsuan Lee,2 Hsiau-Wen Huang,3 Mei-Chyun Tzou,3 Ying-Jan Wang,2 Jui-Chen Tsai1,4 1Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Chung Kung University, Tainan, Taiwan; 2Department of Environmental and Occupational Health, College of Medicine, National Cheng Kung University, Tainan, Taiwan; 3Food and Drug Administration, Ministry of Health and Welfare, Taiwan; 4Center for Pharmaceutical Regulatory Science, National Cheng Kung University, Tainan, Taiwan Abstract: Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan’s regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may

An insight into the emerging role of regional medical advisor in the pharmaceutical industry

Directory of Open Access Journals (Sweden)

Sandeep Kumar Gupta

2013-01-01

Full Text Available The position of regional medical advisor (RMA is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving. The RMA is a field based position whose main mission is to foster collaborative relationships with the key opinion leaders (KOLs and to facilitate the exchange of unbiased scientific information between the medical community and the company. Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry′s increased focus on global operations including emerging markets. Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. The major objective of the RMA is to develop the professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact. The RMA can facilitate investigator-initiated clinical research proposals from approval until completion, presentation, and publication. It is possible for a RMA to have valuable access to KOLs through his expertise in the clinical research. The RMA can assist in the development, review, and follow-up of the clinical studies initiated within the relevant therapeutic area at the regional/local level. The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the International Conference of Harmonisation Good Clinical Practice (ICH GCP guidelines.

Pharmaceutical characterization of novel tenofovir liposomal formulations for enhanced oral drug delivery: in vitro pharmaceutics and Caco-2 permeability investigations

Directory of Open Access Journals (Sweden)

Spinks CB

2017-02-01

Full Text Available Crystal B Spinks,1 Ahmed S Zidan,2,3 Mansoor A Khan,4 Muhammad J Habib,1 Patrick J Faustino2 1Department of Pharmaceutical Sciences, School of Pharmacy, Howard University, Washington, DC, 2Division of Product Quality Research, Office of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD, USA; 3Faculty of Pharmacy, Zagazig University, Zagazig, Egypt; 4Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, College Station, TX, USA Abstract: Tenofovir, currently marketed as the prodrug tenofovir disoproxil fumarate, is used clinically to treat patients with HIV/AIDS. The oral bioavailability of tenofovir is relatively low, limiting its clinical effectiveness. Encapsulation of tenofovir within modified long-circulating liposomes would deliver this hydrophilic anti-HIV drug to the reticuloendothelial system for better therapeutic efficacy. The objectives of the current study were to prepare and pharmaceutically characterize model liposomal tenofovir formulations in an attempt to improve their bioavailability. The entrapment process was performed using film hydration method, and the formulations were characterized in terms of encapsulation efficiency and Caco-2 permeability. An efficient reverse-phase high-performance liquid chromatography method was developed and validated for tenofovir quantitation in both in vitro liposomal formulations and Caco-2 permeability samples. Separation was achieved isocratically on a Waters Symmetry C8 column using 10 mM Na2PO4/acetonitrile pH 7.4 (95:5 v/v. The flow rate was 1 mL/min with a 12 min elution time. Injection volume was 10 µL with ultraviolet detection at 270 nm. The method was validated according to United States Pharmacopeial Convention category I requirements. The obtained result showed that tenofovir encapsulation within the prepared liposomes was dependent on the employed amount of the positive charge-imparting agent. The obtained results indicated that

Organic Colouring Agents in the Pharmaceutical Industry

Directory of Open Access Journals (Sweden)

Šuleková M.

2017-09-01

Full Text Available Food dyes are largely used in the process of manufacturing pharmaceutical products. The aim of such a procedure is not only to increase the attractiveness of products, but also to help patients distinguish between pharmaceuticals. Various dyes, especially organic colouring agents, may in some cases have a negative impact on the human body. They are incorporated into pharmaceutical products including tablets, hard gelatine capsules or soft gelatine capsules, lozenges, syrups, etc. This article provides an overview of the most widely used colouring agents in pharmaceuticals, their characteristics and the EU legislation which regulates their use.

Fate and bioavailability of ¹⁴C-pyrene and ¹⁴C-lindane in sterile natural and artificial soils and the influence of aging.

Science.gov (United States)

Smídová, Klára; Hofman, Jakub; Ite, Aniefiok E; Semple, Kirk T

2012-12-01

Soil organic matter is used to extrapolate the toxicity and bioavailability of organic pollutants between different soils. However, it has been shown that other factors such as microbial activity are crucial. The aim of this study was to investigate if sterilization can reduce differences in the fate and bioavailability of organic pollutants between different soils. Three natural soils with increasing total organic carbon (TOC) content were collected and three artificial soils were prepared to obtain similar TOCs. Soils were sterilized and spiked with (14)C-pyrene and (14)C-lindane. Total (14)C radioactivity, HPCD extractability, and bioaccumulation in Eisenia fetida were measured over 56 days. When compared to non-sterile soils, differences between the natural and artificial soils and the influence of soil-contaminant contact time were generally reduced in the sterile soils (especially with middle TOC). The results indicate the possibility of using sterile soils as "the worst case scenario" in soil ecotoxicity studies. Copyright © 2012 Elsevier Ltd. All rights reserved.

Non clinical research at CENTIS supporting biotechnological and pharmaceutical industry

International Nuclear Information System (INIS)

Hernandez Gonzalez, Ignacio

2012-01-01

Drugs production is a highly demanding industry because the rigor of legislations and guidelines. Standards are applied to manufacturing facilities and also to research and development stage. Our national biotechnological industry is developing and producing important medications for diseases like cancer, some of them in the national and international market. Isotopes Centre is an institution supporting such development by means of a work platform to carry out researches in the field of pharmacokinetic and biodistribution in experimental models. Accumulated experience allows us to contribute to research and development of different kind of molecules as pharmaceuticals, specially the biotechnological ones. We are evolving in direction to new technologies and methodologies more suitable to current standards. Radiolabeling is still a convenient choice considering present and new imaging technologies to investigate distribution and kinetic in living subjects. With the techniques we have and the ones to incorporate in a near future, new and more demanding investigations will be affordable. (author)

Patrick Couvreur: inspiring pharmaceutical innovation.

Science.gov (United States)

Stanwix, Hannah

2014-05-01

Patrick Couvreur speaks to Hannah Stanwix, Managing Comissioning Editor: Professor Patrick Couvreur received his pharmacy degree from the Université Catholique de Louvain (Louvain-la-Neuve, Belgium) in 1972. He holds a PhD in pharmaceutical technology from the same university and completed a postdoctoral fellowship at the Eidgenössische Technische Hochschule (Zürich, Switzerland). Since 1984, Professor Couvreur has been Full Professor of Pharmacy at the Paris-Sud University (Paris, France) and was holder of the Chair of Innovation Technologique at the prestigious Collège de France (Paris, France). He has published more than 450 peer-reviewed articles and has an H-index of 73, with over 19,000 citations. Professor Coureur has been recognized by numerous national and international awards, including the 2004 Pharmaceutical Sciences World Congress Award, the prestigious Host Madsen Medal, the Prix Galien, the European Pharmaceutical Scientist Award 2011 from the European Federation of Pharmaceutical Sciences, the Médaille de l'Innovation from the Centre National de la Recherche Scientifique, and recently the European Inventor Award 2013 from the European Patent Office.

The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school.

Science.gov (United States)

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.

Pharmaceutical R&D performance by firm size: approval success rates and economic returns.

Science.gov (United States)

DiMasi, Joseph A

2014-01-01

The R&D productivity of pharmaceutical firms has become an increasingly significant concern of industry, regulators, and policymakers. To address an important aspect of R&D performance, public and private data sources were used to estimate clinical phase transition and clinical approval probabilities for the pipelines of the 50 largest pharmaceutical firms (by sales) by 3 firms size groups (top 10 firms, top 11-20 firms, and top 21-50 firms). For self-originated compounds, the clinical approval success rates were 14.3%, 16.4%, and 18.4% for top 10 firms, top 11-20 firms, and top 21-50 firms, respectively. The results showing higher success rates for smaller firms were largely driven by outcomes for the small-molecule drugs. Adjustments for the relatively small differences in therapeutic class distributions across the firm size groups showed that the success rate for small-molecule self-originated drugs was 6% below average for top 10 firms and 17% above average for top 21-50 firms. Although success rates for small firms were higher, this advantage was offset to some degree by lower returns on approved drugs, suggesting different strategic objectives with regard to risk and reward by firm size.

Coordinated research project on radiation sterilization and decontamination of pharmaceuticals and pharmaceutical raw materials. CRP report

International Nuclear Information System (INIS)

2005-01-01

Radiation processing is a very convenient tool for imparting desirable effects in materials and it has been an area of enormous interest in the last few decades. Radiation processing of synthetic and natural polymers for improving their characteristics is largely used in laboratory and industrial scale. Radiation sterilization is a well developed and established technology for many products. It is especially useful for the treatment of pharmaceuticals due to flexibility of radiation processing to be carried out at any desired temperature, sterilizability of mixed products in kits, offering simultaneous sterilization and modification of polymer based formulations. The success of radiation technology for processing of synthetic and natural polymers and treatment of pharmaceuticals has been based, to a large extent, on empirical knowledge. But now, the applications of natural polymers are being sought in knowledge-demanding areas such as pharmacy and biotechnology. Reliable analytical methods are being developed for controlling of degradation effects of radiation on polymers. Procedures and chemical formulations are being investigated enhancing or preventing degradation effects depending on the desired application of the process. The Coordinated Research Project (CRP) on the use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials has been completed in 2002. The overall objective of the CRP was to coordinate the research and development programmes carried out in different countries in use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutic raw materials. It has been concluded that in addition to well known advantages of radiation sterilization being a well developed and established technology requiring the control of only one parameter, dose, to achieve sterilization; it is especially useful for the treatment of pharmaceuticals due to flexibility of radiation

Coordinated research project on radiation sterilization and decontamination of pharmaceuticals and pharmaceutical raw materials. CRP report

Energy Technology Data Exchange (ETDEWEB)

NONE

2005-07-01

Radiation processing is a very convenient tool for imparting desirable effects in materials and it has been an area of enormous interest in the last few decades. Radiation processing of synthetic and natural polymers for improving their characteristics is largely used in laboratory and industrial scale. Radiation sterilization is a well developed and established technology for many products. It is especially useful for the treatment of pharmaceuticals due to flexibility of radiation processing to be carried out at any desired temperature, sterilizability of mixed products in kits, offering simultaneous sterilization and modification of polymer based formulations. The success of radiation technology for processing of synthetic and natural polymers and treatment of pharmaceuticals has been based, to a large extent, on empirical knowledge. But now, the applications of natural polymers are being sought in knowledge-demanding areas such as pharmacy and biotechnology. Reliable analytical methods are being developed for controlling of degradation effects of radiation on polymers. Procedures and chemical formulations are being investigated enhancing or preventing degradation effects depending on the desired application of the process. The Coordinated Research Project (CRP) on the use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials has been completed in 2002. The overall objective of the CRP was to coordinate the research and development programmes carried out in different countries in use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutic raw materials. It has been concluded that in addition to well known advantages of radiation sterilization being a well developed and established technology requiring the control of only one parameter, dose, to achieve sterilization; it is especially useful for the treatment of pharmaceuticals due to flexibility of radiation

FORMATION AND FURTHER DEVELOPMENT OF MODERN PROMOTION OF PHARMACEUTICAL PRODUCTS

Directory of Open Access Journals (Sweden)

Юрий Владимирович Тарасов

2014-02-01

Full Text Available The articles addresses key notions and elements of marketing of pharmaceutical companies. Key stages and particularities of formation of pharmaceutical marketing are considered. It is proved that in general pharmaceutical market is developing under general marketing rules, however while developing strategy of promotion of pharmaceutical products specific features of the industry must be taken into consideration. The authors describes specific features of modern pharmaceutical market, which must be considered while developing policy of promotion of pharmaceutical products.The analysis is made of modern state of Russian pharmaceutical industry, its place in world pharmaceutical market. It is found that development of pharmaceutical market is directly influenced by the reform of pharmaceutical industry initiated by the Government of our country in 2008. Characteristic of current stage of market development is more strict conditions in marketing sphere and promotion of drugs. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-2

Pharmaceutical care education in Kuwait: pharmacy students’ perspectives

Directory of Open Access Journals (Sweden)

Katoue MG

2014-09-01

Full Text Available Background: Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients’ quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective: To investigate pharmacy students’ attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. Methods: A descriptive, cross-sectional survey of pharmacy students (n=126 was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. Results: The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%, lack of pharmacist time (83.3%, organizational obstacles (82.6%, and pharmacists’ physical separation from patient care areas (82.6%. Conclusion: Pharmacy students’ attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University

Analysis of diacetylmorphine, caffeine, and degradation products after volatilization of pharmaceutical heroin for inhalation

NARCIS (Netherlands)

Klous, Marjolein G.; Lee, WeiChing; Hillebrand, Michel J. X.; van den Brink, Wim; van Ree, Jan M.; Beijnen, Jos H.

2006-01-01

Pharmaceutical smokable heroin was developed for a clinical trial on medical co-prescription of heroin and methadone. This product, consisting of 75% w/w diacetylmorphine base and 25% w/w caffeine anhydrate, was intended for use via "chasing the dragon", that is, inhalation after volatilization.

Supply Chain Management in Zhendong Pharmaceutical Company

OpenAIRE

Li, Yan

2011-01-01

Medicines are special commodity related to people’s lives and health, therefore, pharmaceutical distribution is an industry affecting the national economy and the people's livelihood. With health care reform, changeable pharmaceutical policy and fiercely increasing competition in the medical industry, pharmaceutical distribution companies should improve their level of logistics operations and reduce overall logistics management costs in order to gain a leading position in the competition. In ...

[Fourcroy and pharmaceutical journals].

Science.gov (United States)

Bonnemain, Bruno

2011-04-01

Cadet de Gassicourt wrote a brief Eloge of Fourcroy in January 1810 as he died in December of 1809. Fourcroy had a major role concerning the new ideas on the place of pharmacy at the beginning of the 19th century. Fourcroy has had a key influence for the start of several pharmaceutical journals that wanted to emphasize the link between the new chemistry and pharmacy. None of these journals created with him will survive and one has to wait for 1909 to see the creation, without Fourcroy, of a new pharmaceutical journal, the "Journal de Pharmacie" that will become "Journal de Pharmacie et des Sciences accessoires", then "Journal de Pharmacie et de Chimie", before taking the name of"Annales Pharmaceutiques Françaises", the present official journal of the French Academy of Pharmacy. In spite of the essential role of Fourcroy at the start of pharmaceutical journals, Cadet did not even mention it in his Eloge of 1810.

Synthesis and applications of radiolabelled drugs in pharmaceutical development

International Nuclear Information System (INIS)

Landvatter, S.W.; Heys, J.R.; Garner, K.T.; Mack, J.F.; Senderoff, S.G.; Shu, A.Y.; Villani, A.J.; Saunders, D.

1994-01-01

Radiolabelled drugs play a vital role in the development of new pharmaceuticals including application in drug discovery, pre-clinical development and clinical development. The synthesis of these pharmaceuticals in tritium or carbon-14 labelled form poses many challenges for the synthetic organic chemist. The actual choice of synthetic route must take into account the small scale, limited choice and high cost of labelled precursors, and the positioning of the label into a metabolically stable position. There are, however, a number of synthetic strategies available for overcoming these constraints. Although in some C-14 syntheses the requisite labelled raw material can be purchased and the existing synthesis adapted for labelling, frequently the synthetic challenge is the synthesis of a structurally simple, yet commercially unavailable, labelled precursor (e.g., γ-butyrolactone-[2- 14 C], cyclohexanone-[ 3 H], CuCN-[ 14 C], 2-furancarboxaldehyde-[ 14 C]). Another useful strategy in C-14 synthesis is the conversion of an advanced intermediate, or perhaps the unlabelled product itself, into a precursor which can then be reconverted into the labelled version of the intermediate. Occasionally, a new total synthesis must be developed. In addition to these strategies, tritium labelling can uniquely take advantage of exchange labelling techniques, synthesis and reduction of unsaturated precursors, or tritium-halogen replacement reactions. Examples of these strategies and use of the labelled products are discussed

NMR imaging and pharmaceutical sciences

International Nuclear Information System (INIS)

Beall, P.T.; Good, W.R.

1986-01-01

Described is the technique of NMR-imaging in diagnostic medicine. Proton and phosphorus NMR in diagnosis of abnormal tissue pathology. Discussed is the value of NMR to the pharmaceutical sciences. NMR may play an important role in monitoring the response of tissues to drugs, determining the localization of drugs, performing real time pharmacokinetics and testing the use of NMR contrast pharmaceuticals

Bioremediation Kinetics of Pharmaceutical Industrial Effluent

Directory of Open Access Journals (Sweden)

M. Šabić

2015-05-01

Full Text Available In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmented activated sludge with isolated mixed bacterial culture. The experiments were conducted in a batch reactor in submerged conditions, at initial concentration of organic matter in pharmaceutical wastewater, expressed as COD, 5.01 g dm–3 and different initial concentrations of activated sludge, which ranged from 1.16 to 3.54 g dm–3. During the experiments, the COD, pH, concentrations of dissolved oxygen and biomass were monitored. Microscopic analyses were performed to monitor the quality of activated sludge. Before starting with the bioremediation in the batch reactor, toxicity of the pharmaceutical wastewater was determined by toxicity test using bacteria Vibrio fischeri. The obtained results showed that the effective concentration of the pharmaceutical wastewater was EC50 = 17 % and toxicity impact index was TII50 = 5.9, meaning that the untreated pharmaceutical industrial effluent must not be discharged into the environment before treatment. The results of the pharmaceutical wastewater bioremediation process in the batch reactor are presented in Table 1. The ratio γXv ⁄ γX maintained high values throughout all experiments and ranged from 0.90 and 0.95, suggesting that the concentrations of biomass remained unchanged during the experiments. The important kinetic parameters required for performance of the biological removal process, namely μmax, Ks, Ki, Y and kd were calculated from batch experiments (Table 2. Figs. 1 and 2 show the experimental

Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

Energy Technology Data Exchange (ETDEWEB)

Razem, D; Katusin-Razem, B [Institut Rudjer Boskovic, Zagreb (Yugoslavia); Starcevic, M; Galekovic, B [PLIVA Pharmaceutical Works, Zagreb (Yugoslavia)

1990-01-01

The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author).

Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

International Nuclear Information System (INIS)

Razem, D.; Katusin-Razem, B.; Starcevic, M.; Galekovic, B.

1990-01-01

The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author)

Horizon Scanning for Pharmaceuticals

DEFF Research Database (Denmark)

Lepage-Nefkens, Isabelle; Douw, Karla; Mantjes, GertJan

for a joint horizon scanning system (HSS).  We propose to create a central “horizon scanning unit” to perform the joint HS activities (a newly established unit, an existing HS unit, or a third party commissioned and financed by the collaborating countries). The unit will be responsible for the identification...... and filtration of new and emerging pharmaceutical products. It will maintain and update the HS database, organise company pipeline meetings, and disseminate the HSS’s outputs.  The HS unit works closely together with the designated national HS experts in each collaborating country. The national HS experts...... will collect country-specific information, liaise between the central HS unit and country-specific clinical and other experts, coordinate the national prioritization process (to select products for early assessment), and communicate the output of the HSS to national decision makers.  The outputs of the joint...

Nurse practitioners' perceptions and participation in pharmaceutical marketing.

Science.gov (United States)

Crigger, Nancy; Barnes, Kristen; Junko, Autumn; Rahal, Sarah; Sheek, Casey

2009-03-01

This paper reports on a study conducted to describe family nurse practitioners' perceptions towards and participation in pharmaceutical marketing and to explore the relationships among related variables. The pharmaceutical industry's intense global marketing strategies have resulted in widespread concern in healthcare professionals and professional groups, sectors of the public in many countries, and in the World Health Organization. Research on healthcare providers' participation in pharmaceutical marketing indicates that these relationships are conflicts of interests and compromise healthcare providers' prescribing practices and trust. Nursing, as a discipline, appears to be slow to address the impact of pharmaceutical marketing on nursing practice. Questionnaires about perceptions and participation in pharmaceutical marketing were completed by a random sample of 84 licensed family nurse practitioners in the United States of America in 2007. Family nurse practitioners viewed pharmaceutical company marketing uncritically as educational and beneficial. They also perceived other providers but not themselves as influenced by pharmaceutical marketing. The findings supported those found in previous research with nurses and physicians. Lack of education, participation in marketing and psychological and social responses may impede family nurse practitioners' ability to respond critically and appropriately to marketing strategies and the conflict of interest it creates.

Pharmaceutical drug detailing in primary care: extent and methods

DEFF Research Database (Denmark)

Schramm, Jesper

The dimension and methods of pharmaceutical marketing towards 47 danish general practitioners is described. Conclusions: Pharmaceutical drug detailing possesses a huge potential to influence the prescription pattern of GP's.......The dimension and methods of pharmaceutical marketing towards 47 danish general practitioners is described. Conclusions: Pharmaceutical drug detailing possesses a huge potential to influence the prescription pattern of GP's....

Doctors and pharmaceutical industry.

Science.gov (United States)

Beran, Roy G

2009-09-01

The pharmaceutical industry is seen as seducing doctors by providing expensive gifts, subsidising travel and underwriting practice expenses in return for those doctors prescribing products that otherwise they would not use. This paints doctors in a very negative light; suggests doctors are available to the highest bidder; implies doctors do not adequately act as independent agents; and that doctors are driven more by self-interest than by patient needs. Similar practices, in other industries, are accepted as normal business behaviour but it is automatically assumed to be improper if the pharmaceutical industry supports doctors. Should the pharmaceutical industry withdraw educational grants then there would be: fewer scientific meetings; reduced attendance at conferences; limited post graduate education; and a depreciated level of maintenance of professional standards. To suggest that doctors prescribe inappropriately in return for largesse maligns their integrity but where there is no scientific reason to choose between different treatments then there can be little argument against selecting the product manufactured by a company that has invested in the doctor and the question arises as to whether this represents bad medicine? This paper will examine what constitutes non-professional conduct in response to inducements by the pharmaceutical industry. It will review: conflict of interest; relationships between doctors and pharma and the consequences for patients; and the need for critical appraisal before automatically decrying this relationship while accepting that there remain those who do not practice ethical medicine.

Pharmaceutical companies and healthcare providers: Going beyond the gift - An explorative review.

Science.gov (United States)

Latten, Tom; Westra, Daan; Angeli, Federica; Paulus, Aggie; Struss, Marleen; Ruwaard, Dirk

2018-01-01

Interactions between pharmaceutical companies and healthcare providers are increasingly scrutinized by academics, professionals, media, and politicians. Most empirical studies and professional guidelines focus on unilateral donor-recipient types of interaction and overlook, or fail to distinguish between, more reciprocal types of interaction. However, the degree of goal alignment and potential for value creation differs in these two types of interactions. Failing to differentiate between these two forms of interaction between pharmaceutical companies and healthcare providers could thus lead to biased conclusions regarding their desirability. This study reviews the empirical literature regarding the effects of bilateral forms of interactions between pharmaceutical companies and healthcare providers in order to explore their effects. We searched two medical databases (i.e. PubMed and Cochrane Library) and one business database (i.e. EBSCO) for empirical, peer-reviewed articles concerning any type of bilateral interaction between pharmaceutical companies and healthcare providers. We included quantitative articles which were written in English and published between January 1st, 2000 and October 31st, 2016, and where the title or abstract included a combination of synonyms of the following keywords: pharmaceutical companies, healthcare providers, interaction, and effects. Our search results yielded 10 studies which were included in our analysis. These studies focused on either research-oriented interaction or on education-oriented interaction. The included studies reported various outcomes of interaction such as prescribing behavior, ethical dilemmas, and research output. Regardless of the type of interaction, the studies either reported no significant effects or ambivalent outcomes such as affected clinical practice or ethical issues. The effects of bilateral interactions reported in the literature are similar to those reported in studies concerning unilateral

The Impact of Biotechnology on Pharmaceutics.

Science.gov (United States)

Block, Lawrence H.

1990-01-01

The emergence of bioactive peptides and proteins as new drug species poses formidable problems for the pharmaceutical scientist. Implications for revision or change in undergraduate and graduate pharmaceutics curricula derive from the biopharmaceutical, pharmacokinetic, and physiochemical aspects of the new drug species, which differ from…

Comparative studies on drug binding to the purified and pharmaceutical-grade human serum albumins: Bridging between basic research and clinical applications of albumin.

Science.gov (United States)

Ashrafi-Kooshk, Mohammad Reza; Ebrahimi, Farangis; Ranjbar, Samira; Ghobadi, Sirous; Moradi, Nastaran; Khodarahmi, Reza

2015-09-01

Human serum albumin (HSA), the most abundant protein in blood plasma, is a monomeric multidomain protein that possesses an extraordinary capacity for binding, so that serves as a circulating depot for endogenous and exogenous compounds. During the heat sterilization process, the structure of pharmaceutical-grade HSA may change and some of its activities may be lost. In this study, to provide deeper insight on this issue, we investigated drug-binding and some physicochemical properties of purified albumin (PA) and pharmaceutical-grade albumin (PGA) using two known drugs (indomethacin and ibuprofen). PGA displayed significantly lower drug binding capacity compared to PA. Analysis of the quenching and thermodynamic parameters indicated that intermolecular interactions between the drugs and the proteins are different from each other. Surface hydrophobicity as well as the stability of PGA decreased compared to PA, also surface hydrophobicity of PA and PGA increased upon drugs binding. Also, kinetic analysis of pseudo-esterase activities indicated that Km and Vmax parameters for PGA enzymatic activity are more and less than those of PA, respectively. This in vitro study demonstrates that the specific drug binding of PGA is significantly reduced. Such studies can act as connecting bridge between basic research discoveries and clinical applications. Copyright © 2015 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

[The aspects of pricing policy in Azerbaijan pharmaceutical sector].

Science.gov (United States)

Dzhalilova, K I; Alieva, K Ia

2012-01-01

The effect of macro-, middle- and microeconomic factors on price formation in Azerbaijan pharmaceutical market has been studied. Worldwide pharmaceutical leaders have the goals to become leader on the pharmaceutical market of Azerbaijan and maximize their market share. Non-leaders pharmaceutical companies use different strategies of price formation: prime cost plus markup, or price formation on the base of current prices. It was revealed that domestic pharmaceutical market has high demand elasticity. Future market development is related to stimulation of product development, and hard penetration to the market through realization of price formation strategy. Non-state pharmaceutical organizations to achieve the purpose of survive in conditions of high competition should take in to account the factor perceptions of assortment by customers.

Uptake and depuration of pharmaceuticals in aquatic invertebrates

International Nuclear Information System (INIS)

Meredith-Williams, Melanie; Carter, Laura J.; Fussell, Richard; Raffaelli, David; Ashauer, Roman; Boxall, Alistair B.A.

2012-01-01

The uptake and depuration of a range of pharmaceuticals in the freshwater shrimp (Gammarus pulex) and the water boatman (Notonecta glauca) was studied. For one compound, studies were also done using the freshwater snail Planobarius corneus. In G. pulex, bioconcentration factors (BCFs) ranged from 4.6 to 185,900 and increased in the order moclobemide < 5-fluoruracil < carbamazepine < diazepam < carvedilol < fluoxetine. In N. glauca BCFs ranged from 0.1 to 1.6 and increased in the order 5-fluorouracil < carbamazepine < moclobemide < diazepam < fluoxetine < carvedilol. For P. corneus, the BCF for carvedilol was 57.3. The differences in degree of uptake across the three organisms may be due to differences in mode of respiration, behaviour and the pH of the test system. BCFs of the pharmaceuticals for each organism were correlated to the pH-corrected liposome–water partition coefficient of the pharmaceuticals. - Highlights: ► One of the first studies exploring the uptake of pharmaceuticals into aquatic invertebrates. ► Data presented on uptake, depuration rates and bioconcentration for a range of pharmaceuticals. ► Uptake is correlated with the pH-corrected liposome–water partition coefficient. ► Findings can be used to better predict impacts of pharmaceuticals on the aquatic environment. - The factors affecting the degree of uptake of pharmaceuticals into aquatic invertebrates were studied. The results indicate that species traits such as respiration and behaviour of the organisms and pH-corrected liposome–water partition coefficients are important factors in determining pharmaceutical uptake.

Pharmaceutical and Medicine Manufacturing Sector (NAICS 3254)

Science.gov (United States)

Find environmental regulatory and compliance information for the pharmaceutical manufacturing sector, including essential uses of CFCs, NESHAP for pharmaceutical production, effluent guidelines for wastewater and management of hazardous waste.

A model of the prescription-pharmaceutical sales process

Directory of Open Access Journals (Sweden)

Michael Stros

2018-06-01

Full Text Available The purpose of this paper is to determine the factors in marketing most relevant to achieving pharmaceutical sales success and their interrelations, as well as providing a prescription-pharmaceuticals sales process model. This will enable scholars to obtain a better understanding of the marketing process for prescription pharmaceuticals, as well as enabling marketers to apply more efficient marketing approaches. The study uses a unique data set, combining primary data and secondary data from the Swiss prescription-pharmaceuticals market. The data is analysed using a multiple-regression based model. A multi-level data structure is found, suggesting that factors concerning the specific brand and also the pharmaceutical substance itself are relevant to sales success. It is revealed that the factors most relevant to sales success are: order of market entry, perceived product-quality, average price, and marketing expenditures, leading to practical recommendations for scholars and marketing professionals. The study focuses only on the Swiss prescription-pharmaceuticals market, investigating five medical drug classes. The assumption is made that these results can be generalised to similar markets and drug classes. The study develops a conceptual prescription-pharmaceuticals sales-process model; offers practical guidelines and a good basis for further scholarly research are provided; and identifies several research gaps by giving proposals for future research.

Toward a Regional Research Agenda on Pharmaceutical ...

International Development Research Centre (IDRC) Digital Library (Canada)

African policymakers are pushing for local pharmaceutical manufacturing as a ... Africa Development Community Pharmaceutical Business Plan (2007-2013) and ... IDRC congratulates first cohort of Women in Climate Change Science Fellows.

Editorial Nano structures for Medicine and Pharmaceuticals

International Nuclear Information System (INIS)

Xing-Jie, L.; Kumar, A.; Donglu, S.; Daxiang, C.

2012-01-01

The rapid developments in nano structured materials and nano technology will have profound impact in many areas of biomedical applications including delivery of drugs and biomolecules, tissue engineering, detection of bio markers, cancer diagnosis, cancer therapy, and imaging. This field is expanding quickly, and a lot of work is ongoing in the design, characterization, synthesis, and application of materials, for controlling shape and size at nanometer scale to develop highly advanced materials for biomedical application and even to design better pharmaceutical products. In recent years, novel nano structure with multi functionalities has been focused on the use of nano structures toward solving problems of biology and medicine. The main scope of this special issue is to demonstrate the latest achievement of nano technology and its application in nano medicine particularly in new approaches for drug delivery such as targeted drug delivery system, nano structure for drug storage, nano materials for tissue engineering, medical diagnosis and treatment, and generation of new kinds of materials from biological sources. Therefore, many critical issues in nano structured materials, particularly their applications in biomedicine, must be addressed before clinical applications. This special issue devotes several review and research articles encompassing various aspects of nano materials for medicine and pharmaceuticals.

Concept of the Ural pharmaceutical cluster formation

Directory of Open Access Journals (Sweden)

Aleksandr Petrovich Petrov

2011-06-01

Full Text Available This paper substantiates the necessity of cluster organization of the pharmaceutical industry in the region. The estimation of the state and prospects of development of such structures in the domestic economy is given. Sverdlovsk region was chosen as the object of study on the possibility of forming a pharmaceutical cluster. Objective prerequisites for the organization of a cluster of pharmaceutical production in Sverdlovsk region are considered, among these were distinguished: capacious and fast-growing market for pharmaceutical products, availability of potential development of the pharmaceutical industry in the territory and the key success factors for enterprises - potential participants of the cluster. Indicated key success factors are: presence of a creative team and close interaction between business and government, high level of cooperation among the enterprises of the cluster and commercialization of products, implementation of research and development expenditures etc. Thus, it was substantiated that in there all references and resources for the formation of a pharmaceutical cluster. The concept of formation and development of the Ural pharmaceutical cluster was elaborated. Inside the concept, the goals, objectives, processing, product and organizational priorities for cluster formation are identified. Architecture of this structure with a justification of its members and certain forms of interaction between them is proposed. The stages of formation and development of the Ural pharmaceutical cluster on the basis of a ten-year settlement period for the full range of activities for this project are substantiated. At each stage, a set of key objectives and results of the cluster was defined. The choice of phases was carried out on the basis of investment programs of cluster's enterprises strategic position on the mastering of markets and infrastructure development. An assessment of socio-economic efficiency of the Ural pharmaceutical

Modelling of drying processes of pharmaceutical granules. Pharmaceutical Sciences for the Future of Medicines

DEFF Research Database (Denmark)

Mortier, S.T.F.C.; Vedantam, S.; De Beer, T.

Tablets are conventionally produced via consecutive batch process steps. Recent introduction of continuous process equipment is gaining industrial importance in pharmaceutics. Transition to continuous production requires improved understanding of all operations, necessitating the development...... of mechanistic models of multi‐phase systems which in the end allow process control. This contribution focuses on continuous fluidized bed drying of pharmaceutical wet granules. A stepwise approach is used in model development, starting with the drying behaviour of single granules. Experiments to determine...

Quality Systems Implementation in the Pharmaceutical Industry

African Journals Online (AJOL)

Nafiisah

quality standards imposed on local pharmaceutical manufacturers. Keywords: Quality/ .... GMP is concerned with both production and quality control. It is aimed ... in the European pharmaceutical industry in designing their quality systems:.

Pharmaceutical Education in Japan--Past, Present--, and Human Social Pharmacy Education in the Near Future.

Science.gov (United States)

Okuda, Jun

2015-01-01

In this paper, the foundation of the 74 Japanese pharmacy schools was reviewed. From the early Meiji era until the beginning World War II, 21 schools including Tokyo University were established. After the war, the new four-year university system was introduced from America, and the above 21 schools became universities and 25 universities were newly founded. In 2006, clinical pharmacy was introduced from America, and the six-year undergraduate system began. This system was divided into 2 groups, 1) 6 year system of clinical pharmacy plus 4 years doctor course and 2) 4 years system of pharmaceutical sciences and a master degree lasting 2 years plus a 3 year doctor course. These two systems started in 2006. The students of clinical pharmacy course must take the 22 weeks of clerkships in a community pharmacy and hospital pharmacy. The graduates (8,446) in 2015 March took the National License Examination for pharmacist, and the pass rate was 72.65%. The entrance into pharmacy school is not easy; however, the passing of the National License Examination is more difficult. The aim of pharmacy education should be to foster pharmacists with a deeper understanding of society and with richer humanity for the patient. To achieve this, what needs to be included in the curriculum are the subjects of the human social pharmacy, such as philosophy of pharmacy, ethics, religions, history of pharmacy, pharmaceutical affairs law, economics, management, and social pharmacy. The inclusion of such subjects needs to be implemented in the near future. Of course, the study of pharmaceutical sciences is a life-long endeavor.

PHARMACEUTICAL COMPANIES BETWEEN CRISIS AND COMPETITIVENESS - SECTORAL DIAGNOSIS

Directory of Open Access Journals (Sweden)

Mihaela\tBÎRSAN

2015-06-01

Full Text Available The evolution of the pharmaceutical industry was a positive constant with the indicators of industrial production even in years of crisis. Although the economic crisis in Romania decreased average growth rate of pharmaceutical companies, market value is expected to increase. The explanation comes from the fact that in order to boost productivity, pharmaceutical companies are turning to emerging countries with aging populations such as open new markets for future development. Add to this the recent health policies implemented by newly industrialized countries that are aimed at ensuring increased access to care. Analysts see the field phenomenon called "Farma-merger" a good chance for European pharmaceutical companies oriented to developing countries where drug sales should record a double-digit annual growth until 2017. In Erste Group reports stated that the impact of the crisis on the pharmaceutical industry should be limited markets for EU only their economic slowdown. This will be possible because the external indebtedness of pharmaceutical companies in the EU remains at a minimum, they are able to finance their investment plans without tapping financial markets, are not adversely affected by the current limited availability of credit resources. Therefore major pharmaceutical companies in the EU will remain a solid investment on the long term, the negative developments are limited due to high resistance to the crisis their business model segment "generic". The consequence of these developments is reflected in the recognition for the first time, the pharmaceutical sector as a strategic sector for the Romanian economy. In the context of public debate launching the National Strategy for Competitiveness 2014-2020, Generic Medicines Industry Association of Romania (APMGR local pharmaceutical industry reminds the Government proposals on correcting the current fiscal and operational regulatory framework, to allow unlocking investments in facilities

Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer.

Science.gov (United States)

Anyakora, Chimezie; Ekwunife, Obinna; Alozie, Faith; Esuga, Mopa; Ukwuru, Jonathan; Onya, Steve; Nwokike, Jude

2017-09-18

Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. The cost benefit of improving the quality of Chi Pharmaceuticals Limited's facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0-5.5). Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.

The role of the pharmaceutical animal health industry in post-marketing surveillance of resistance.

Science.gov (United States)

Lens, S

1993-06-01

The pharmaceutical animal health industry must be committed to the total life cycle of products, i.e. during both the pre- and post-marketing period. Support of antibacterial agents during the postmarketing period is not restricted to maintaining a well-established distribution and promotion system. Care has to be taken continuously to maintain and/or improve the quality, safety (for user, target animal and environment) and clinical efficacy. The pharmaceutical industry contributes to this by: 1. Introducing antibacterials in different animal species for the most effective disease condition only and by ensuring the veterinary profession is informed about relevant findings on: a. the mechanism of action; b. pharmacodynamic properties; c. pharmacokinetic properties (plasma, target tissue); d. clinical efficacy data and in vitro sensitivity data; e. valid species-specific MIC breakpoints; f. precise dose and treatment regime. 2. Updating on a regular basis on: a. new findings on the mechanism of action (in vitro and in vivo); b. the optimal use program in the light of changes in animal husbandry, farm management and epidemiology on national and international level; c. adjustment of species-specific MIC breakpoints when necessary. 3. Providing continuous information in collaboration with animal health laboratories about: a. clinical field surveillance for efficacy (national, international); b. in vitro sensitivity/resistance surveillance (national, international); c. use of in vitro data to support prediction of in vivo efficacy. Surveillance of resistance, in vitro, is therefore part of a package of information needed on a routine basis by the pharmaceutical industry to allow the best possible use of antibacterials and to minimize induction of resistance.(ABSTRACT TRUNCATED AT 250 WORDS)

A new e-beam application in the pharmaceutical industry

International Nuclear Information System (INIS)

Sadat, Theo; Malcolm, Fiona

2005-01-01

The paper presents a new electron beam application in the pharmaceutical industry: an in-line self-shielded atropic transfer system using electron beam for surface decontamination of products entering a pharmaceutical filling line. The unit was developed by Linac Technologies in response to the specifications of a multi-national pharmaceutical company, to solve the risk of microbial contamination entering a filling line housed inside an isolator. In order to fit the sterilization unit inside the pharmaceutical plant, a 'miniature' low-energy (200 keV) electron beam accelerator and e-beam tunnel were designed, all conforming to the pharmaceutical good manufacturing practice (GMP) regulations. Process validation using biological indicators is described, with reference to the regulations governing the pharmaceutical industry. Other industrial applications of a small-sized self-shielded electron beam sterilization unit are mentioned

Methods for handling uncertainty within pharmaceutical funding decisions

Science.gov (United States)

Stevenson, Matt; Tappenden, Paul; Squires, Hazel

2014-01-01

This article provides a position statement regarding decision making under uncertainty within the economic evaluation of pharmaceuticals, with a particular focus upon the National Institute for Health and Clinical Excellence context within England and Wales. This area is of importance as funding agencies have a finite budget from which to purchase a selection of competing health care interventions. The objective function generally used is that of maximising societal health with an explicit acknowledgement that there will be opportunity costs associated with purchasing a particular intervention. Three components of uncertainty are discussed within a pharmaceutical funding perspective: methodological uncertainty, parameter uncertainty and structural uncertainty, alongside a discussion of challenges that are particularly pertinent to health economic evaluation. The discipline has focused primarily on handling methodological and parameter uncertainty and a clear reference case has been developed for consistency across evaluations. However, uncertainties still remain. Less attention has been given to methods for handling structural uncertainty. The lack of adequate methods to explicitly incorporate this aspect of model development may result in the true uncertainty surrounding health care investment decisions being underestimated. Research in this area is ongoing as we review.

Pharmaceutical regulation in 15 European countries review.

Science.gov (United States)

Panteli, Dimitra; Arickx, Francis; Cleemput, Irina; Dedet, Guillaume; Eckhardt, Helen; Fogarty, Emer; Gerkens, Sophie; Henschke, Cornelia; Hislop, Jennifer; Jommi, Claudio; Kaitelidou, Daphne; Kawalec, Pawel; Keskimaki, Ilmo; Kroneman, Madelon; Lopez Bastida, Julio; Pita Barros, Pedro; Ramsberg, Joakim; Schneider, Peter; Spillane, Susan; Vogler, Sabine; Vuorenkoski, Lauri; Wallach Kildemoes, Helle; Wouters, Olivier; Busse, Reinhard

2016-10-01

In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. With the aim of guiding the health policy discourse towards questions that are important to actual and potential patients, this study investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution and resulting price levels in a sample of 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical care, albeit with varying configurations and rigour. This variation also influences the extent of publicly financed pharmaceutical costs. Overall, observed differences in pharmaceutical expenditure should be interpreted in conjunction with the differing volume and composition of consumption and price levels, as well as dispensation practices and their impact on measurement of pharmaceutical costs. No definitive evidence has yet been produced on the effects of different cost-containment measures on patient outcomes. Depending on the foremost policy concerns in each country, different levers will have to be used to enable the delivery of appropriate care at affordable prices. World Health Organization 2016 (acting as the host organization for, and secretariat of, the European Observatory on Health Systems and Policies).

Pharmacist-perceived barriers to pharmaceutical care of chronic and end-stage kidney disease patients in Saudi Arabia

Directory of Open Access Journals (Sweden)

Amal K Suleiman

2016-01-01

Conclusion: The contribution of pharmacists in CKD and ESRD will continue to grow as their clinical knowledge improves. Saudi pharmacists believe that the pharmaceutical care is an essential component of managing CKD and ESRD patients.

[Clinical pharmacy and surgery: Review].

Science.gov (United States)

Jarfaut, A; Nivoix, Y; Vigouroux, D; Kehrli, P; Gaudias, J; Kempf, J-F; Levêque, D; Gourieux, B

2014-05-01

Clinical pharmacy has been developed and evaluated in various medical hospital activities. Reviews conducted in this area reported a higher value of this discipline. In surgical services, evenly adverse drug events may occur, so clinical pharmacy activities must also help to optimize the management of drug's patient. The objectives of this literature review is to determine the profile of clinical pharmacy activities developed in surgical services and identify indicators. The research was conducted on Pubmed(®) database with the following keywords (2000-2013), "surgery", "pharmacy", "pharmacist", "pharmaceutical care", "impact" and limited to French or English papers. Studies dealing on simultaneously medical and surgical areas were excluded. Twenty-one papers were selected. The most frequently developed clinical pharmacy activities were history and therapeutic drug monitoring (antibiotics or anticoagulants). Two types of indicators were identified: activity indicators with the number of pharmaceutical interventions, their description and clinical signification, the acceptance rate and workload. Impact indicators were mostly clinical and economic impacts. The development of clinical pharmacy related to surgical patients is documented and appears to have, as for medical patients, a clinical and economical value. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Cleaner production at pharmaceutical industry: first steps assessment

Directory of Open Access Journals (Sweden)

Edilaine Conceição Rezende

2015-12-01

Full Text Available The Cleaner Production (CP is an environmental management system effective to comply the environmental obligations and promote sustainable development of enterprises. In this study, the implementing possibilities of CP practices were evaluated to pharmaceutical industry, through prior identification procedures for Pharmaceutical Manufacturing Practices. The study was conducted in a scientific and health care institution, which produces pharmaceutical drugs and makes assistance for public health. The production process was evaluated and made a survey of the main points of waste and sewage generations in each stage, in order to diagnose the measures of CP established and propose new actions. Thus, by using this tool, it was possible to demonstrate the reduction of environmental impacts associated with pharmaceutical production. The Pharmaceutical Manufacturing Practices also contributed to the implementation of measures CP, preserving the final product quality, and generating environmental and economic benefits.

The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961-1990).

Science.gov (United States)

Erices, Rainer; Frewer, Andreas; Gumz, Antje

2018-01-01

After the building of the Berlin Wall in the 1960s, a number of international pharmaceutical manufacturers from the West had their drugs tested in Eastern Germany (GDR). So far, the extensive collection of documents on the subject stored in the archives of the GDR State Security Service (Stasi, MfS) has not been systematically analysed. Until now, the role of the Stasi with respect to the surveillance of the trials has been unclear. A keyword search within the database of the Stasi files was conducted. All available files were screened in order to identify institutions, companies and personnel involved in the clinical trials. On this basis, further files were requested. A total of 259 files were available for analysis. Relevant data was derived from 160 of these files. A contextualised approach was applied, which critically explored the origin, content, and impact of the data. In addition, an approach guided by the central steps of document analysis was applied. At least 400 clinical trials were conducted during the GDR period. The exact number remains speculative. According to references found in the Stasi files, it might have been considerably higher. Initially, the main goal of the trials was for the GDR authorities to decide whether to import certain Western drugs. By 1983, this intention had changed. Now, the primary aim of the trials was the procurement of foreign currency. The Stasi feared that the pharmaceutical companies could have a significant influence on GDR Health System. Stasi spies were holding positions in the responsible medical committees, universities, and hospitals. Constant surveillance by the Stasi served the purpose of monitoring any contact between people from the West and the East. Unknowingly, representatives of Western companies were surveilled by the Stasi. The studied documents also point to the fact that a number of clinical trials conducted during the GDR period did not comply with GDR regulations, and were therefore deemed illegal

Pharmaceutical services and health promotion: how far have we gone and how are we faring? Scientific output in pharmaceutical studies

Directory of Open Access Journals (Sweden)

Carina Akemi Nakamura

2014-12-01

Full Text Available The objective of this study was to investigate the scientific output on health promotion within the pharmaceutical field and its relation with the development of pharmaceutical services within health systems. A comprehensive review of published scientific articles from the Medline and Lilacs databases was carried out. The review comprised articles published until December 2011, and used combinations of the terms 'health promotion' or 'health education' and 'pharmacy', 'pharmacist' or 'pharmaceutical'. The articles were selected according to inclusion and exclusion criteria. A total of 170 full texts and 87 indexed abstracts were analyzed, evidencing that most described actions of health promotion in community pharmacies and other services. Following the Ottawa Charter, most of the studies dealt with new guidance of the service and the supply of pharmaceutical information and services. It was concluded that there is a lack of theoretical background on health promotion in the pharmaceutical field to sustain the professional education and practice required by the health system and the population.

East and Central African Journal of Pharmaceutical Sciences An ...

African Journals Online (AJOL)

An Approach to Effective Disinfection of Salon Items [clippers, combs and scissors]. O.S. OLONITOLA'*, P.F. OLURINOLA~ ... 2~epartment of Pharmaceutics and Pharmaceutical Microbiology, Faculty of Pharmaceutical. Sciences, Ahmadu Bello ... antimicrobial products with increased value over those currently available.

Pharmaceutical policy and the lay public

DEFF Research Database (Denmark)

Traulsen, Janine Marie; Almarsdóttir, Anna Birna

2005-01-01

Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient organisati......Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient...... organisations, industry and, most recently, the media. Although the overall aim of health and pharmaceutical policy is to address the needs of all citizens, there are only a few, well organised groups who are actually consulted and involved in the policymaking process, often with the support of the industry....... The reasons for this lack of citizen involvement in health and pharmaceutical policymaking are many, for example: there is no consensus about what public involvement means; there is a predominance of special interest groups with narrow, specific agendas; not all decision makers welcome lay participation...

Incorporating Natural Products, Pharmaceutical Drugs, Self-Care and Digital/Mobile Health Technologies into Molecular-Behavioral Combination Therapies for Chronic Diseases

Science.gov (United States)

Bulaj, Grzegorz; Ahern, Margaret M.; Kuhn, Alexis; Judkins, Zachary S.; Bowen, Randy C.; Chen, Yizhe

2016-01-01

Merging pharmaceutical and digital (mobile health, mHealth) ingredients to create new therapies for chronic diseases offers unique opportunities for natural products such as omega-3 polyunsaturated fatty acids (n-3 PUFA), curcumin, resveratrol, theanine, or α-lipoic acid. These compounds, when combined with pharmaceutical drugs, show improved efficacy and safety in preclinical and clinical studies of epilepsy, neuropathic pain, osteoarthritis, depression, schizophrenia, diabetes and cancer. Their additional clinical benefits include reducing levels of TNFα and other inflammatory cytokines. We describe how pleiotropic natural products can be developed as bioactive incentives within the network pharmacology together with pharmaceutical drugs and self-care interventions. Since approximately 50% of chronically-ill patients do not take pharmaceutical drugs as prescribed, psychobehavioral incentives may appeal to patients at risk for medication non-adherence. For epilepsy, the incentive-based network therapy comprises anticonvulsant drugs, antiseizure natural products (n-3 PUFA, curcumin or/and resveratrol) coupled with disease-specific behavioral interventions delivered by mobile medical apps. The add-on combination of antiseizure natural products and mHealth supports patient empowerment and intrinsic motivation by having a choice in self-care behaviors. The incentivized therapies offer opportunities: (1) to improve clinical efficacy and safety of existing drugs, (2) to catalyze patient-centered, disease self-management and behavior-changing habits, also improving health-related quality-of-life after reaching remission, and (3) merging copyrighted mHealth software with natural products, thus establishing an intellectual property protection of medical treatments comprising the natural products existing in public domain and currently promoted as dietary supplements. Taken together, clinical research on synergies between existing drugs and pleiotropic natural products

Effects of Repeated Intraperitoneal Injection of Pharmaceutical-grade and Nonpharmaceutical-grade Corn Oil in Female C57BL/6J Mice.

Science.gov (United States)

Hubbard, Jennifer S; Chen, Patty H; Boyd, Kelli L

2017-11-01

Due to potential adverse effects on animal wellbeing, the use of nonpharmaceutical-grade substances in animal research must be scientifically justified in cases where a pharmaceutical-grade version of the substance exists. This requirement applies to all substances, including vehicles used to solubilize experimental drugs. To date, no studies have evaluated the direct effect of the pharmaceutical classification of a compound on animal wellbeing. In this study, we evaluated intraperitoneal administration of pharmaceutical-grade corn oil, nonpharmaceutical-grade corn oil, and saline in female C57BL/6J mice. Compounds were administered every 48 h for a total of 4 injections. Mice were evaluated clinically by using body weight, body condition score, visual assessment score, CBC, and serum chemistries. Animals were euthanized at 24 h and 14 d after the final injection. Inflammation of the peritoneal wall and mesenteric fat was assessed microscopically by using a semiquantitative scoring system. Saline-dosed groups had lower pathology scores at both time points. At day 21, pharmaceutical-grade corn oil had a significantly higher pathology score compared with nonpharmaceutical-grade corn oil. No other significant differences between the corn oil groups were observed. The use of nonpharmaceutical grade corn oil did not result in adverse clinical consequences and is presumed safe to use for intraperitoneal injection in mice. Differences in inflammation between the 2 groups suggest that the use of either pharmaceutical-grade or nonpharmaceutical-grade corn oil should be consistent within a study.

Pharmaceutical care in the Netherlands. History, definition and projects

NARCIS (Netherlands)

van Mil, J.W F

1996-01-01

The evolving concept of Pharmaceutical Care knows different interpretations in a different countries. In the Netherlands community pharmacists already perform several functions which may be part of the Pharmaceutical Care concept. The Dutch concept of Pharmaceutical care is tested in the TOM and

Pharmaceutical new product development: the increasing role of in-licensing.

Science.gov (United States)

Edwards, Nancy V

2008-12-01

Many pharmaceutical companies are facing a pipeline gap because of the increasing economic burden and uncertainty associated with internal research and development programs designed to develop new pharmaceutical products. To fill this pipeline gap, pharmaceutical companies are increasingly relying on in-licensing opportunities. New business development identifies new pharmaceuticals that satisfy unmet needs and are a good strategic fit for the company, completes valuation models and forecasts, evaluates the ability of the company to develop and launch products, and pursues in-licensing agreements for pharmaceuticals that cannot be developed internally on a timely basis. These agreements involve the transfer of access rights for patents, trademarks, or similar intellectual property from an outside company in exchange for payments. Despite the risks, in-licensing is increasingly becoming the preferred method for pharmaceutical companies with pipeline gaps to bring new pharmaceuticals to the clinician.

Care ideologies reflected in 4 conceptions of pharmaceutical care.

Science.gov (United States)

Björkman, Ingeborg K; Bernsten, Cecilia B; Sanner, Margareta A

2008-12-01

Different ways to practice pharmaceutical care have been developed. One expression of this fact is the existence of many different classification systems to document drug-related problems (DRPs). Evidence suggests that classification systems have different characteristics and that these characteristics reflect different conceptions of pharmaceutical care. To increase the understanding of conceptions of pharmaceutical care, underlying values and beliefs (ideologies) can be explored. To explore various conceptions of pharmaceutical care to identify the care ideologies on which these conceptions are based. Representatives of 4 selected conceptions of pharmaceutical care were interviewed in face-to-face meetings. During the interviews, 4 basic questions were asked. Three were focused on pharmaceutical care and 1 on DRPs. Interview transcripts were analyzed by an inductive method inspired by grounded theory. The conceptions studied were Strand, Granada-II, PCNE v5.0, and Apoteket. In Strand, patients are given a more active role in the pharmaceutical care process, as compared to Granada-II, PCNE v5.0, and Apoteket. Pharmacists in all the conceptions of pharmaceutical care assume they have special knowledge that patients benefit from. However, they use their knowledge in different ways in the various pharmaceutical care conceptions. In Strand, individual goals of drug therapy are established together with the patient, whereas in Granada-II, PCNE, and Apoteket goals are not explicitly discussed. The identified differences correspond to different care ideologies. The pharmaceutical care conceptions are based on different care ideologies. The ideology is expressed in how therapy goals are set and patient needs defined. Strand is based on a patient-centered ideology; patient therapy goals and needs are defined by the patient together with the practitioners. Granada-II, PCNE, and Apoteket are based on an evidence-based medicine approach; patient therapy goals and needs are

Discovery of innovative therapeutics: today's realities and tomorrow's vision. 1. Criticisms faced by the pharmaceutical industry.

Science.gov (United States)

Abou-Gharbia, Magid; Childers, Wayne E

2013-07-25

The pharmaceutical industry is facing enormous challenges, including reduced efficiency, declining innovation, key patent expirations, fierce price competition from generics, high regulatory hurdles, and a tarnished image. There is a clear need for change in the paradigms designed to address these challenges. Pharma has responded by embarking on a range of initiatives. However, along the way the industry has accrued critics whose accusations have tainted its reputation. The first part of this two-part series will discuss the criticisms that have been leveled at the pharmaceutical industry and summarize the supporting data for and against these criticisms. The second installment will focus on the current challenges facing the pharmaceutical industry and Pharma's responses to address these challenges. It will describe the industry's changing perspective and new business models for coping with the recent loss of talent and declining clinical pipelines as well as present some examples of recent drug discovery successes.

Availability and Perceived Value of Masters of Business Administration Degree Programs in Pharmaceutical Marketing and Management

Science.gov (United States)

Clauson, Kevin A.; Latif, David A.

2012-01-01

Objectives. To examine pharmacist-targeted master of business administration (MBA) degree programs and investigate pharmacists’ perceptions regarding them. Methods. Specialized MBA programs in pharmaceutical marketing and management offered at US colleges and schools of pharmacy were identified in the literature and compared. Pharmacists’ perceptions of MBA programs were evaluated through a survey of clinical preceptors affiliated with a school of pharmacy. Results. Seven US universities that offer an MBA program in pharmaceutical marketing and management were identified. Thirty-three percent of the 57 pharmacist preceptors who responded to the survey reported plans to pursue an MBA degree program. Respondents preferred MBA programs related to healthcare or pharmacy (66%) over general MBA programs (33%). Conclusion. An MBA in pharmaceutical marketing and management could provide pharmacists with advanced knowledge of the operational and strategic business aspects of pharmacy practice and give pharmacy graduates an advantage in an increasingly competitive job market. PMID:22611273

Availability and perceived value of masters of business administration degree programs in pharmaceutical marketing and management.

Science.gov (United States)

Alkhateeb, Fadi M; Clauson, Kevin A; Latif, David A

2012-05-10

To examine pharmacist-targeted master of business administration (MBA) degree programs and investigate pharmacists' perceptions regarding them. Specialized MBA programs in pharmaceutical marketing and management offered at US colleges and schools of pharmacy were identified in the literature and compared. Pharmacists' perceptions of MBA programs were evaluated through a survey of clinical preceptors affiliated with a school of pharmacy. Seven US universities that offer an MBA program in pharmaceutical marketing and management were identified. Thirty-three percent of the 57 pharmacist preceptors who responded to the survey reported plans to pursue an MBA degree program. Respondents preferred MBA programs related to healthcare or pharmacy (66%) over general MBA programs (33%). An MBA in pharmaceutical marketing and management could provide pharmacists with advanced knowledge of the operational and strategic business aspects of pharmacy practice and give pharmacy graduates an advantage in an increasingly competitive job market.

Cell-Based Veterinary Pharmaceuticals - Basic Legal Parameters Set by the Veterinary Pharmaceutical Law and the Genetic Engineering Law of the European Union.

Science.gov (United States)

Faltus, Timo; Brehm, Walter

2016-01-01

Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States.

Supercritical fluid technology: concepts and pharmaceutical applications.

Science.gov (United States)

Deshpande, Praful Balavant; Kumar, G Aravind; Kumar, Averineni Ranjith; Shavi, Gopal Venkatesh; Karthik, Arumugam; Reddy, Meka Sreenivasa; Udupa, Nayanabhirama

2011-01-01

In light of environmental apprehension, supercritical fluid technology (SFT) exhibits excellent opportunities to accomplish key objectives in the drug delivery sector. Supercritical fluid extraction using carbon dioxide (CO(2)) has been recognized as a green technology. It is a clean and versatile solvent with gas-like diffusivity and liquid-like density in the supercritical phase, which has provided an excellent alternative to the use of chemical solvents. The present commentary provides an overview of different techniques using supercritical fluids and their future opportunity for the drug delivery industry. Some of the emerging applications of SFT in pharmaceuticals, such as particle design, drug solubilization, inclusion complex, polymer impregnation, polymorphism, drug extraction process, and analysis, are also covered in this review. The data collection methods are based on the recent literature related to drug delivery systems using SFT platforms. SFT has become a much more versatile and environmentally attractive technology that can handle a variety of complicated problems in pharmaceuticals. This cutting-edge technology is growing predominantly to surrogate conventional unit operations in relevance to the pharmaceutical production process. Supercritical fluid technology has recently drawn attention in the field of pharmaceuticals. It is a distinct conception that utilizes the solvent properties of supercritical fluids above their critical temperature and pressure, where they exhibit both liquid-like and gas-like properties, which can enable many pharmaceutical applications. For example, the liquid-like properties provide benefits in extraction processes of organic solvents or impurities, drug solubilization, and polymer plasticization, and the gas-like features facilitate mass transfer processes. It has become a much more versatile and environmentally attractive technology that can handle a variety of complicated problems in pharmaceuticals. This review is

A strategy to improve skills in pharmaceutical supply management in East Africa: the regional technical resource collaboration for pharmaceutical management

Directory of Open Access Journals (Sweden)

Minzi Omary

2008-12-01

Full Text Available Abstract Background International initiatives such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, the President's Emergency Plan for AIDS Relief and the President's Malaria Initiative have significantly increased availability and access to medicines in some parts of the developing world. Despite this, however, skills remain limited on quantifying needs for medications and ordering, receiving and storing medications appropriately; recording medications inventories accurately; distributing medications for use appropriately; and advising patients on how to use medications appropriately. The Regional Technical Resource Collaboration for Pharmaceutical Management (RTRC has been established to help address the problem of skills shortage in pharmaceutical management in East Africa. Methods The initiative brings together academic institutions from four East African countries to participate in skills-building activities in pharmaceutical supply management. The initiative targeted the institutions' ability to conduct assessments of pharmaceutical supply management systems and to develop and implement effective skills-building programmes for pharmaceutical supply chain management. Results Over a two-year period, the RTRC succeeded in conducting assessments of pharmaceutical supply management systems and practices in Kenya, Rwanda, Tanzania and Uganda. In 2006, the RTRC participated in a materials-development workshop in Kampala, Uganda, and contributed to the development of comprehensive HIV/AIDS pharmaceutical management training materials; these materials are now widely available in all four countries. In Tanzania and Uganda the RTRC has been involved with the training of health care workers in HIV/AIDS pharmaceutical management. In Kenya, Tanzania and Uganda the RTRC has been conducting operations research to find solutions to their countries' skills-shortage problems. Some of the interventions tested include applying and evaluating the

Internet pharmaceutical sales: attributes, concerns, and future forecast.

Science.gov (United States)

Bruckel, Katy; Capozzoli, Ernest A

2003-01-01

Internet pharmaceutical sales continue to skyrocket as healthcare providers and consumers are increasingly relying on the efficiencies and convenience that is available via such transactions. Managed care companies, increasing demands to reduce healthcare inefficiencies while maximizing the quality of patient care is a significant contributing factor to the expanding utilization and success of online pharmaceutical sales. However, with the expansion of Internet pharmaceutical sales, healthcare providers, pharmacy benefit management and insurance companies, and consumers realize new opportunities and risks. This paper will review the attributes and concerns associated with online pharmaceutical sales, discussing current and pending legislation intended to more effectively manage these parameters.

Pharmaceutical companies and healthcare providers: Going beyond the gift – An explorative review

Science.gov (United States)

Westra, Daan; Angeli, Federica; Paulus, Aggie; Struss, Marleen; Ruwaard, Dirk

2018-01-01

Introduction Interactions between pharmaceutical companies and healthcare providers are increasingly scrutinized by academics, professionals, media, and politicians. Most empirical studies and professional guidelines focus on unilateral donor-recipient types of interaction and overlook, or fail to distinguish between, more reciprocal types of interaction. However, the degree of goal alignment and potential for value creation differs in these two types of interactions. Failing to differentiate between these two forms of interaction between pharmaceutical companies and healthcare providers could thus lead to biased conclusions regarding their desirability. This study reviews the empirical literature regarding the effects of bilateral forms of interactions between pharmaceutical companies and healthcare providers in order to explore their effects. Material and methods We searched two medical databases (i.e. PubMed and Cochrane Library) and one business database (i.e. EBSCO) for empirical, peer-reviewed articles concerning any type of bilateral interaction between pharmaceutical companies and healthcare providers. We included quantitative articles which were written in English and published between January 1st, 2000 and October 31st, 2016, and where the title or abstract included a combination of synonyms of the following keywords: pharmaceutical companies, healthcare providers, interaction, and effects. Results Our search results yielded 10 studies which were included in our analysis. These studies focused on either research-oriented interaction or on education-oriented interaction. The included studies reported various outcomes of interaction such as prescribing behavior, ethical dilemmas, and research output. Regardless of the type of interaction, the studies either reported no significant effects or ambivalent outcomes such as affected clinical practice or ethical issues. Discussion and conclusion The effects of bilateral interactions reported in the literature are

The ethics of the medical-pharmaceutical relationship.

Science.gov (United States)

Vashi, Neelam A; Latkowski, Jo-Ann M

2012-01-01

Physician interaction with the pharmaceutical industry raises many ethical concerns. This relationship is complex, owing to a pluralism of beliefs held by physicians, patients, and third parties. As a result, determining whether physicians fulfill their responsibilities to both the professional and public communities is an arduous endeavor. In an effort to clarify the situation and provide transparency to this complex relationship, medical and pharmaceutical organizations have enacted their own respective codes and guidelines. Even with adherence to these guidelines, questions remain regarding the codependent relationship that interweaves the pharmaceutical industry with the medical community. Owing to the ever-changing landscape enmeshing product development, scientific advancement, corporate realities and patient care, the proper choice for physicians is rarely obvious; however, to operate to the highest standards, those in the medical community must be candid about relations with the pharmaceutical industry and transparent in their financial interests. Further undertakings should focus not on the eradication of physician-pharmaceutical interaction, but instead on the education of physicians about industry marketing strategies and the delineation of boundaries of these interactions to benefit not the individual physician, but our patients. Copyright © 2012. Published by Elsevier Inc.

Synthetic biology advances for pharmaceutical production

OpenAIRE

Breitling, Rainer; Takano, Eriko

2015-01-01

Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems.

Pricing and Reimbursement in U.S. Pharmaceutical Markets

OpenAIRE

Newhouse, Joseph Paul; Berndt, Ernst R.

2010-01-01

In this survey chapter on pricing and reimbursement in U.S. pharmaceutical markets, we first provide background information on important federal legislation, institutional details regarding distribution channel logistics, definitions of alternative price measures, related historical developments, and reasons why price discrimination is highly prevalent among branded pharmaceuticals. We then present a theoretical framework for the pricing of branded pharmaceuticals, without and then in the pre...

Assessing the assessments: Pharmaceuticals in the environment

International Nuclear Information System (INIS)

Enick, O.V.; Moore, M.M.

2007-01-01

The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accurately reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development

42 CFR 416.48 - Condition for coverage-Pharmaceutical services.

Science.gov (United States)

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Condition for coverage-Pharmaceutical services. 416... Coverage § 416.48 Condition for coverage—Pharmaceutical services. The ASC must provide drugs and... direction of an individual designated responsible for pharmaceutical services. (a) Standard: Administration...

Pharmaceutical information systems and possible implementations of informed consent - developing an heuristic

DEFF Research Database (Denmark)

Ploug, Thomas; Holm, Søren

2012-01-01

Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1......) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Results and Conclusion Based on the analysis a heuristic...... is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system. The danger of routinisation of consent is identified. The Danish pharmaceutical information system raises...

[The pharmaceutical industry in the industrial chemical group: the National Union of Chemical-Pharmaceutical Laboratories (1919-1936)].

Science.gov (United States)

Nozal, Raúl Rodríquez

2011-01-01

The pharmaceutical industry associations, as it happened with other businesses, had a significant rise during the dictatorship of Primo de Rivera and II Republic. The 'Cámara Nacional de Industrias Químicas', in Barcelona, represented the national chemical industry to its ultimate assimilation by the 'Organización Sindical' in 1939. In this association, matters relating to pharmaceutical products -- which we will especially deal with in this work -- were managed by the 'Unión Nacional de Laboratorios Químico-Farmacéuticos', which defended the interests of pharmaceutical companies in the presence of government authorities, using the resources and mechanisms also managed by business pressure groups. The inclusion of industrial pharmacy in the Chemical lobby separated the pharmaceutical industry from traditional exercise and its corporate environment. this created ups and downs, conflicts of interests and finally, love and hate relationships with their colleagues of the pharmacy work placement and, of course, with the association that represented them: the 'Unión Farmacéutica Nacional'.

Case histories in pharmaceutical risk management.

Science.gov (United States)

McCormick, Cynthia G; Henningfield, Jack E; Haddox, J David; Varughese, Sajan; Lindholm, Anders; Rosen, Susan; Wissel, Janne; Waxman, Deborah; Carter, Lawrence P; Seeger, Vickie; Johnson, Rolley E

2009-12-01

The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Administration (FDA) since the mid 1990s. This paper provides four case histories of risk management and post-marketing surveillance programs utilized recently to address problems associated with possible abuse, dependence and diversion. The pharmaceutical sponsors of each of these drugs were invited to present their programs and followed a similar template for their summaries that are included in this article. The drugs and presenting companies were OxyContin, an analgesic marketed by Purdue Pharma L.P., Daytrana and Vyvanse, ADHD medications marketed by Shire Pharmaceuticals, Xyrem for narcolepsy marketed by Jazz Pharmaceuticals, and Subutex and Suboxone for opioid dependence marketed by Reckitt Benckiser Pharmaceuticals Inc. These case histories and subsequent discussions provide invaluable real-world examples and illustrate both the promise of risk management programs in providing a path to market and/or for keeping on the market drugs with serious potential risks. They also illustrate the limitations of such programs in actually controlling unintended consequences, as well as the challenge of finding the right balance of reducing risks without posing undue barriers to patient access. These experiences are highly relevant as the FDA increasingly requires pharmaceutical sponsors to develop and implement the more formalized and enforceable versions of the risk management term Risk Evaluation and Mitigation Strategies (REMS).

Cost-containment as part of pharmaceutical policy

DEFF Research Database (Denmark)

Almarsdóttir, Anna Birna; Traulsen, Janine Marie

2005-01-01

and profit controls; 2) reimbursement system charges; 3) other fiscal measures; 4) quality measures. Pharmaceuticals policy has suffered from the pervasive misunderstanding that drugs are like any other commodity; resulting in policy makers viewing pharmaceuticals expenditures without thinking about drugs...

Information sources and utilization patterns of pharmaceutical ...

African Journals Online (AJOL)

The study investigated the adequacy of pharmaceutical scientists' information environment in feeding their occupational activities. Data was collected through observation and through questionnaire administration to all the twenty-seven scientists in two large pharmaceutical companies in Lagos, Nigeria. Findings revealed ...

Pharmaceutical penetration of new drug and pharmaceutical market structure in Taiwan: hospital-level prescription of thiazolidinediones for diabetes.

Science.gov (United States)

Tsai, Yi-Wen; Wen, Yu-Wen; Huang, Weng-Foung; Kuo, Ken N; Chen, Pei-Fen; Shih, Hsin-Wei; Lee, Yue-Chune

2010-06-01

This study used Taiwan's National Health Insurance claim database (years 2000-2005) to examine how thiazolidinediones (TZD), a new class of drugs for diabetes, penetrated into Taiwan's hospitals, and its association with the concentration of all diabetes drugs at the hospital level. We collected 72 monthly summaries of diabetes prescriptions from all hospitals in Taiwan. Hospital-level pharmaceutical concentration was measured by penetration of TZD, defined as monthly market share of TZD in each hospital. Concentration of diabetes drugs was measured by Herfindahl-Hirschman indices. We found a negative association (coefficient = -0.3610) between TZD penetration and concentration of diabetes drug but a positive association between penetration of TZD and the volume of prescribed diabetes drugs (coefficient = 0.4088). In conclusion, hospital characteristics and volume of services determined the concentration of pharmaceuticals at the institution level, reflecting the heterogeneous competition between pharmaceutical companies within each hospital. Institution-level pharmaceutical concentration influences the adoption and penetration of new drugs.

Rational Use of Medicines in Relation to Pharmaceutical Supply ...

African Journals Online (AJOL)

Pharmaceutical management involves a set of practices aiming at ensuring timely availability and appropriate use of safe, effective and quality pharmaceuticals and services in any health care setting. Rational use of medicines is often associated with efficiency of pharmaceutical supply system that operates in the health ...

Monitoring and remediation technologies of organochlorine pesticides in drainage water

Directory of Open Access Journals (Sweden)

Ismail Ahmed

2015-03-01

Full Text Available This study was carried out to monitor the presence of organochlorine in drainage water in Kafr-El-Sheikh Governorate, Egypt. Furthermore, to evaluate the efficiencies of different remediation techniques (advanced oxidation processes [AOPs] and bioremediation for removing the most frequently detected compound (lindane in drainage water. The results showed the presence of several organochlorine pesticides in all sampling sites. Lindane was detected with high frequency relative to other detected organochlorine in drainage water. Nano photo-Fenton like reagent was the most effective treatment for lindane removal in drainage water. Bioremediation of lindane by effective microorganisms (EMs removed 100% of the lindane initial concentration. There is no remaining toxicity in lindane contaminated-water after remediation on treated rats relative to control with respect to histopathological changes in liver and kidney. Advanced oxidation processes especially with nanomaterials and bioremediation using effective microorganisms can be regarded as safe and effective remediation technologies of lindane in water.

Membrane Bioprocesses for Pharmaceutical Micropollutant Removal from Waters

Directory of Open Access Journals (Sweden)

Matthias de Cazes

2014-10-01

Full Text Available The purpose of this review work is to give an overview of the research reported on bioprocesses for the treatment of domestic or industrial wastewaters (WW containing pharmaceuticals. Conventional WW treatment technologies are not efficient enough to completely remove all pharmaceuticals from water. Indeed, these compounds are becoming an actual public health problem, because they are more and more present in underground and even in potable waters. Different types of bioprocesses are described in this work: from classical activated sludge systems, which allow the depletion of pharmaceuticals by bio-degradation and adsorption, to enzymatic reactions, which are more focused on the treatment of WW containing a relatively high content of pharmaceuticals and less organic carbon pollution than classical WW. Different aspects concerning the advantages of membrane bioreactors for pharmaceuticals removal are discussed, as well as the more recent studies on enzymatic membrane reactors to the depletion of these recalcitrant compounds.

Prioritizing veterinary pharmaceuticals for aquatic environment in Korea.

Science.gov (United States)

Kim, Younghee; Jung, Jinyong; Kim, Myunghyun; Park, Jeongim; Boxall, Alistair B A; Choi, Kyungho

2008-09-01

Pharmaceutical residues may have serious impacts on nontarget biological organisms in aquatic ecosystems, and have therefore precipitated numerous investigations worldwide. Many pharmaceutical compounds available on the market need to be prioritized based on their potential ecological and human health risks in order to develop sound management decisions. We prioritized veterinary pharmaceuticals in Korea by their usage, potential to enter the environment, and toxicological hazard. Twenty compounds were identified in the top priority class, most of which were antibiotics. Among these compounds, 8 were identified as deserving more immediate attention: amoxicillin, enramycin, fenbendazole, florfenicol, ivermectin, oxytetracycline, tylosin, and virginiamycin. A limitation of this study is that we initially screened veterinary pharmaceuticals by sales tonnage for veterinary use only. However, this is the first attempt to prioritize veterinary pharmaceuticals in Korea, and it provides important concepts for developing environmental risk management plans for such contaminants in aquatic systems. Copyright © 2008 Elsevier B.V. All rights reserved.

Ozonation for degradation of pharmaceutical in hospital wastewater

DEFF Research Database (Denmark)

Bester, Kai; Hansen, Kamilla S; Spiliotopoulou, Aikaterini

-pollutants (Antoniou et al., 2013). In the present work, ozonation of biological treated hospital wastewater spiked with pharmaceuticals were performed to determine the required ozone dose for 90 % removal of the investigated pharmaceuticals. Effluents with different DOC level were used to investigate the effect...... of DOC on the removal of the pharmaceuticals. Furthermore, the effect of pH on ozone decomposition was investigated in relevant pH range....

The behaviour of pharmaceuticals in anaerobic digester sludge

OpenAIRE

Campbell, Alison

2013-01-01

Pharmaceuticals are biologically active compounds that may be consumed in hundreds of tonnes per year, and which are excreted into municipal sewerage systems. Many pharmaceuticals persist during sewage treatment, and significant environmental risk has been linked to incomplete removal of pharmaceuticals. Evaluation of this risk is important and should be as representative as possible, taking into consideration all significant exposure routes and removal processes. Sludge treatment processes a...

Risk assessment of supply chain for pharmaceutical excipients with AHP-fuzzy comprehensive evaluation.

Science.gov (United States)

Li, Maozhong; Du, Yunai; Wang, Qiyue; Sun, Chunmeng; Ling, Xiang; Yu, Boyang; Tu, Jiasheng; Xiong, Yerong

2016-04-01

As the essential components in formulations, pharmaceutical excipients directly affect the safety, efficacy, and stability of drugs. Recently, safety incidents of pharmaceutical excipients posing seriously threats to the patients highlight the necessity of controlling the potential risks. Hence, it is indispensable for the industry to establish an effective risk assessment system of supply chain. In this study, an AHP-fuzzy comprehensive evaluation model was developed based on the analytic hierarchy process and fuzzy mathematical theory, which quantitatively assessed the risks of supply chain. Taking polysorbate 80 as the example for model analysis, it was concluded that polysorbate 80 for injection use is a high-risk ingredient in the supply chain compared to that for oral use to achieve safety application in clinic, thus measures should be taken to control and minimize those risks.

Occurrence, sources, and fate of pharmaceuticals in aquatic environment and soil

International Nuclear Information System (INIS)

Li, W.C.

2014-01-01

With the rapid economic development, a better living condition leads to longer life expectancy, which increased the total population, in particular the elderly group. It may result in increase in the demand of pharmaceuticals for people in domestic use or in hospital. Although most sewage treatment plants or waste water treatment plantsmet the regulatory requirement, there are still many pharmaceuticals removed incompletely and thus discharged to the environment. Therefore, the pharmaceuticals residue draws the public concern because they might cause adverse effects on the organism even human beings. Recently, many studies have published on the source and occurrence as well as the fate of pharmaceuticals all over the world. This paper summarized and reviewed the recent studies on the sources, occurrence, fate and the effects of the most common pharmaceuticals. Finally, it gave the suggestion and risk management for controlling the pharmaceuticals. - Highlights: • The sources of pharmaceutical residuals are studied. • Occurrence and fate of pharmaceutical in environment are studied. • Risk management and recommendation are provided on pharmaceutical pollution. - Concentration of pharmaceuticals in the natural environment is lower than in effluent of sewage treatment plants in which carbamazepine is found frequently in soil and water body

Synthetic biology advances for pharmaceutical production

Science.gov (United States)

Breitling, Rainer; Takano, Eriko

2015-01-01

Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems. PMID:25744872

Microbial Evaluation of Some Non-sterile Pharmaceutical ...

African Journals Online (AJOL)

Purpose: To determine the type and incidence of predominant microorganisms in certain non-sterile pharmaceuticals immediately after collection and one year later. Methods: All pharmaceutical samples were subjected to the following examinations: total bacterial count and presence of microbial pathogens, using ...

Review on Physicochemical, Chemical, and Biological Processes for Pharmaceutical Wastewater

Science.gov (United States)

Li, Zhenchen; Yang, Ping

2018-02-01

Due to the needs of human life and health, pharmaceutical industry has made great progress in recent years, but it has also brought about severe environmental problems. The presence of pharmaceuticals in natural waters which might pose potential harm to the ecosystems and humans raised increasing concern worldwide. Pharmaceuticals cannot be effectively removed by conventional wastewater treatment plants (WWTPs) owing to the complex composition, high concentration of organic contaminants, high salinity and biological toxicity of pharmaceutical wastewater. Therefore, the development of efficient methods is needed to improve the removal effect of pharmaceuticals. This review provides an overview on three types of treatment technologies including physicochemical, chemical and biological processes and their advantages and disadvantages respectively. In addition, the future perspectives of pharmaceutical wastewater treatment are given.

Pattern of Duplicate Presentations at National Hematology-Oncology Meetings: Influence of the Pharmaceutical Industry.

Science.gov (United States)

Ramchandren, Radhakrishnan; Schiffer, Charles A

2016-03-01

The major large US hematology-oncology meetings sponsored by the American Society of Hematology (ASH) and American Society of Clinical Oncology (ASCO) have specific guidelines in place discouraging submission of scientific information presented previously at other meetings. Nonetheless, duplicate submissions are frequent. The incidence and motivations for duplicate hematologic presentations and the influence of the pharmaceutical industry on this process have not been thoroughly analyzed. Therefore, were viewed four consecutive ASH and ASCO meetings to assess the frequency of duplicate abstract presentations. All abstracts presented at ASCO2010 in the area of malignant hematology were compared with abstracts from ASCO and ASH 2009 and ASH 2010, and funding sources were reviewed. More than half (54%) of all abstracts submitted to ASCO 2010 acknowledged pharmaceutical company support. Almost one third (31%) of ASCO 2010 abstracts were resubmitted in the 2-year time period, and it was notable that a high fraction (75%) of these duplicate abstracts had pharmaceutical industry sponsorship, compared with 42% of the abstracts that were submitted only once. Despite current guidelines prohibiting duplicate abstract presentation, a substantial proportion (31%) of abstracts at large international hematology-oncology meetings are duplicative, with potential negative consequences. In addition, a disproportionate percentage of the duplicate abstracts rely on pharmaceutical industry support (75%), suggesting that marketing strategies may be a motivation for some of these repetitive submissions.

From new molecules to leads for innovation : studies on the post-innovation learning cycle for pharmaceuticals

NARCIS (Netherlands)

Stolk, P.|info:eu-repo/dai/nl/28050585X

2008-01-01

The pharmaceutical arena is evolving constantly: new drugs enter the market while older ones are discontinued, clinical practice changes, health care budgets rise and fall, and public health needs are redefined. To assist in thinking about the usage environment of drugs in a comprehensive manner

Information flow in the pharmaceutical supply chain.

Science.gov (United States)

Yousefi, Nazila; Alibabaei, Ahmad

2015-01-01

Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead.

Pharmaceutical marketing research and the prescribing physician.

Science.gov (United States)

Greene, Jeremy A

2007-05-15

Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue.

Funding pharmaceutical innovation through direct tax credits.

Science.gov (United States)

Lybecker, Kristina M; Freeman, Robert A

2007-07-01

Rising pharmaceutical prices, increasing demand for more effective innovative drugs and growing public outrage have heightened criticism of the pharmaceutical industry. The public debate has focused on drug prices and access. As a consequence, the patent system is being reexamined as an efficient mechanism for encouraging pharmaceutical innovation and drug development. We propose an alternative to the existing patent system, instead rewarding the innovating firm with direct tax credits in exchange for marginal cost pricing. This concept is based on the fundamental assumption that innovation that benefits society at large may be financed publicly. As an industry which produces a social good characterized by high fixed costs, high information and regulatory costs, and relatively low marginal costs of production, pharmaceuticals are well-suited to such a mechanism. Under this proposal, drug prices fall, consumer surplus increases, access is enhanced, and the incentives to innovate are preserved.

Microbiological testing of pharmaceuticals and cosmetics in Egypt.

Science.gov (United States)

Zeitoun, Hend; Kassem, Mervat; Raafat, Dina; AbouShlieb, Hamida; Fanaki, Nourhan

2015-12-09

Microbial contamination of pharmaceuticals poses a great problem to the pharmaceutical manufacturing process, especially from a medical as well as an economic point of view. Depending upon the product and its intended use, the identification of isolates should not merely be limited to the United States Pharmacopeia (USP) indicator organisms. Eighty-five pre-used non-sterile pharmaceuticals collected from random consumers in Egypt were examined for the eventual presence of bacterial contaminants. Forty-one bacterial contaminants were isolated from 31 of the tested preparations. These isolates were subjected to biochemical identification by both conventional tests as well as API kits, which were sufficient for the accurate identification of only 11 out of the 41 bacterial contaminants (26.8%) to the species level. The remaining isolates were inconclusively identified or showed contradictory results after using both biochemical methods. Using molecular methods, 24 isolates (58.5%) were successfully identified to the species level. Moreover, polymerase chain reaction (PCR) assays were compared to standard biochemical methods in the detection of pharmacopoeial bacterial indicators in artificially-contaminated pharmaceutical samples. PCR-based methods proved to be superior regarding speed, cost-effectiveness and sensitivity. Therefore, pharmaceutical manufacturers would be advised to adopt PCR-based methods in the microbiological quality testing of pharmaceuticals in the future.

[Pharmaceutical product quality control and good manufacturing practices].

Science.gov (United States)

Hiyama, Yukio

2010-01-01

This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

Global risk of pharmaceutical contamination from highly populated developing countries.

Science.gov (United States)

Rehman, Muhammad Saif Ur; Rashid, Naim; Ashfaq, Muhammad; Saif, Ameena; Ahmad, Nasir; Han, Jong-In

2015-11-01

Global pharmaceutical industry has relocated from the west to Asian countries to ensure competitive advantage. This industrial relocation has posed serious threats to the environment. The present study was carried out to assess the possible pharmaceutical contamination in the environment of emerging pharmaceutical manufacturing countries (Bangladesh, China, India and Pakistan). Although these countries have made tremendous progress in the pharmaceutical sector but most of their industrial units discharge wastewater into domestic sewage network without any treatment. The application of untreated wastewater (industrial and domestic) and biosolids (sewage sludge and manure) in agriculture causes the contamination of surface water, soil, groundwater, and the entire food web with pharmaceutical compounds (PCs), their metabolites and transformed products (TPs), and multidrug resistant microbes. This pharmaceutical contamination in Asian countries poses global risks via product export and international traveling. Several prospective research hypotheses including the development of new analytical methods to monitor these PCs/TPs and their metabolites, highly resistant microbial strains, and mixture toxicity as a consequence of pharmaceutical contamination in these emerging pharmaceutical exporters have also been proposed based on the available literature. Copyright © 2013 Elsevier Ltd. All rights reserved.

Clinical Impact of a Pharmaceutical Care Programme Developed in a Family Health Unit: Results of a Pharmacist-Physician Collaboration in the Treatment of Hypertensive Patients

Directory of Open Access Journals (Sweden)

Mónica Condinho

2016-07-01

Full Text Available Introduction: The positive impact of pharmacist-physician collaborative care has been reported in the international literature, although examples of this impact are limited in Portugal. We aim to underline the clinical added value for hypertensive patients that results from pharmacist-physician collaborations. Methods: A community trial was conducted at a Portuguese family health unit for 19 months. The intervention group was randomly selected from the global records and members of the group received pharmaceutical care in addition to physician care. The comparison group received only physician care. Both groups were comparable at the beginning of the study. In the intervention group, we analysed the hypertensive patients to evaluate the impact of pharmacist-physician collaboration on the patients’ blood pressure levels. This evaluation was performed by comparing the obtained blood pressure levels with the levels at baseline and between the groups. Results: A total of 17 patients with hypertension were enrolled in the pharmaceutical care programme, 12 of whom were female. The mean age was 68.50±3.26 years and, on average, each patient consumed 6.06±0.93 medicinal products. Thirteen patients were uncontrolled. Compared with the baseline, the intervention group achieved mean reductions of 28.85±5.90 mmHg (p < 0.0005 and 11.23±2.75 mmHg (p < 0.005 in their systolic and diastolic blood pressure, respectively. Considering the comparison group, improvements of 18.63±6.44 mmHg (p = 0.011 in systolic blood pressure and 9.03±2.63 mmHg ( p < 0.005 in diastolic blood pressure were observed. Conclusion: Pharmacist-physician collaborative care adds clinical value to the typical physician care provided to hypertensive patients within the context of a Portuguese family health unit.

Microbiological testing of pharmaceuticals and cosmetics in Egypt

OpenAIRE

Zeitoun, Hend; Kassem, Mervat; Raafat, Dina; AbouShlieb, Hamida; Fanaki, Nourhan

2015-01-01

Background Microbial contamination of pharmaceuticals poses a great problem to the pharmaceutical manufacturing process, especially from a medical as well as an economic point of view. Depending upon the product and its intended use, the identification of isolates should not merely be limited to the United States Pharmacopeia (USP) indicator organisms. Results Eighty-five pre-used non-sterile pharmaceuticals collected from random consumers in Egypt were examined for the eventual presence of b...

FACTORS AFFECTING EMPLOYEE JOB SATISFACTION OF PHARMACEUTICAL SECTOR

OpenAIRE

Mosammod Mahamuda Parvin; M M Nurul Kabir

2011-01-01

The Pharmaceutical sector plays a vital role in underpinning the economic development of a country. This study attempts to evaluate job satisfaction of employees in different pharmaceutical companies. It focuses on the relative importance of job satisfaction factors and their impacts on the overall job satisfaction of employees. It also investigates the impacts of pharmaceutical type, work experience, age, and sex differences on the attitudes toward job Satisfaction. The result shows that sal...

Metrology in Pharmaceutical Industry - A Case Study

International Nuclear Information System (INIS)

Yuvamoto, Priscila D.; Fermam, Ricardo K. S.; Nascimento, Elizabeth S.

2016-01-01

Metrology is recognized by improving production process, increasing the productivity, giving more reliability to the measurements and consequently, it impacts in the economy of a country. Pharmaceutical area developed GMP (Good Manufacture Practice) requeriments, with no introduction of metrological concepts. However, due to Nanomedicines, it is expected this approach and the consequent positive results. The aim of this work is to verify the level of metrology implementation in a Brazilian pharmaceutical industry, using a case study. The purpose is a better mutual comprehension by both areas, acting together and governmental support to robustness of Brazilian pharmaceutical area. (paper)

Pharmaceuticals as indictors of sewage-influenced groundwater

Science.gov (United States)

Müller, Beate; Scheytt, Traugott; Asbrand, Martin; de Casas, Andrea Mross

2012-09-01

A set of human pharmaceuticals enables identification of groundwater that is influenced by sewage and provides information on the time of recharge. As the consumption rates of the investigated pharmaceuticals have changed over time, so too has the composition of the sewage. At the study area, south of Berlin (Germany), irrigation was performed as a method of wastewater clean-up at sewage irrigation farms until the early 1990s. Today, treated wastewater is discharged into the surface-water-stream Nuthegraben. Groundwater and surface-water samples were analyzed for the pharmaceutical substances clofibric acid, bezafibrate, diclofenac, carbamazepine and primidone, the main ions and organic carbon. The pharmaceutical substances were detected at concentrations up to microgram-per-liter level in groundwater and surface-water samples from the Nuthegraben Lowland area and from the former irrigation farms. Concentrations detected in groundwater are generally much lower than in surface water and there is significant variation in the distribution of pharmaceutical concentrations in groundwater. Groundwater influenced by the irrigation of sewage water shows higher primidone and clofibric-acid concentrations. Groundwater influenced by recent discharge of treated sewage water into the surface water shows high carbamazepine concentrations while concentrations of primidone and clofibric acid are low.

Tropical Journal of Pharmaceutical Research: About this journal

African Journals Online (AJOL)

Tropical Journal of Pharmaceutical Research: About this journal. Journal Home > Tropical Journal of Pharmaceutical Research: About this journal. Log in or Register to get access to full text downloads.

Nigerian Journal of Pharmaceutical Research: About this journal

African Journals Online (AJOL)

Nigerian Journal of Pharmaceutical Research: About this journal. Journal Home > Nigerian Journal of Pharmaceutical Research: About this journal. Log in or Register to get access to full text downloads.

Cell-Based Veterinary Pharmaceuticals – Basic Legal Parameters Set by the Veterinary Pharmaceutical Law and the Genetic Engineering Law of the European Union

Science.gov (United States)

Faltus, Timo; Brehm, Walter

2016-01-01

Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States. PMID:27965965

Methods for the comparative evaluation of pharmaceuticals

Directory of Open Access Journals (Sweden)

Busse, Reinhard

2005-11-01

preferred to surrogate parameters. Following the concept of community effectiveness, drug review institutions also explicitly favour RCT in a "natural" design, i.e. in daily routine and country specific care settings. The countries' requirements for pharmacoeconomic studies are similar despite some methodological inconsistencies, e.g. concerning cost calculation. Outcomes of clinical and pharmacoeconomic analyses are largely determined by the choice of comparator. Selecting an appropriate comparative treatment is therefore crucial. In theory, the best or most cost effective therapy is regarded as appropriate comparator for clinical and economic studies. Pragmatically however, institutions accept that the drug is compared to the treatment of daily routine or to the least expensive therapy. If a pharmaceutical offers several approved indications, in some countries all of them are assessed. Others only evaluate a drug's main indication. Canada is the only country which also considers a medicine's off-label use. It is well known that clinical trials and pharmacoeconomic studies directly comparing a drug with adequate competitors are lacking - in quantitative as well as in qualitative terms. This is specifically the case before or shortly after marketing authorisation. Yet there is the need to support reimbursement or pricing decisions by scientific evidence. In this situation review bodies are often forced to rely on observational studies or on other internally less valid data (including expert and consensus opinions. As a second option they use statistical approaches like indirect adjusted comparisons (in Australia and the United Kingdom and, commonly, economic modelling. However, there is consensus that results provided by these techniques need to be verified by valid head-to-head comparisons as soon as possible.ConclusionsIn the majority of countries reimbursement and pricing decisions are based on systematic and evidence-based evaluation comparing a drug's clinical and

Methods for the comparative evaluation of pharmaceuticals.

Science.gov (United States)

Zentner, Annette; Velasco-Garrido, Marcial; Busse, Reinhard

2005-11-15

of community effectiveness, drug review institutions also explicitly favour RCT in a "natural" design, i.e. in daily routine and country specific care settings. The countries' requirements for pharmacoeconomic studies are similar despite some methodological inconsistencies, e.g. concerning cost calculation. Outcomes of clinical and pharmacoeconomic analyses are largely determined by the choice of comparator. Selecting an appropriate comparative treatment is therefore crucial. In theory, the best or most cost effective therapy is regarded as appropriate comparator for clinical and economic studies. Pragmatically however, institutions accept that the drug is compared to the treatment of daily routine or to the least expensive therapy. If a pharmaceutical offers several approved indications, in some countries all of them are assessed. Others only evaluate a drug's main indication. Canada is the only country which also considers a medicine's off-label use. It is well known that clinical trials and pharmacoeconomic studies directly comparing a drug with adequate competitors are lacking - in quantitative as well as in qualitative terms. This is specifically the case before or shortly after marketing authorisation. Yet there is the need to support reimbursement or pricing decisions by scientific evidence. In this situation review bodies are often forced to rely on observational studies or on other internally less valid data (including expert and consensus opinions). As a second option they use statistical approaches like indirect adjusted comparisons (in Australia and the United Kingdom) and, commonly, economic modelling. However, there is consensus that results provided by these techniques need to be verified by valid head-to-head comparisons as soon as possible. In the majority of countries reimbursement and pricing decisions are based on systematic and evidence-based evaluation comparing a drug's clinical and economic characteristics to daily treatment routine. However

[Benefits and usability of a pharmaceutical record in medical practice. A survey of hospital doctors and pharmacists (MATRIX study)].

Science.gov (United States)

Schuers, M; Timsit, M; Gillibert, A; Fred, A; Griffon, N; Bénichou, J; Darmoni, S J; Staccini, P

2016-09-01

To evaluate the impact of the pharmaceutical patient record use in emergency, geriatric and anaesthesia and intensive care departments, an experimentation was launched in 2013 in 55 hospitals. The purpose of the study was to assess the opinions of physicians and pharmacists about the benefits and usability of the patient pharmaceutical record. An e-mailed self-administered questionnaire was sent to all the pharmacists, anaesthesiologists, geriatricians and emergency physicians of the 55 hospitals involved in the patient pharmaceutical record experimentation. The questionnaire assessed the usability of the patient pharmaceutical record using the "System Usability Scale", as well as its use, its benefits and limitations perceived in clinical practice, and overall user satisfaction. Questionnaires were collected from November 2014 to January 2015. Ninety-six questionnaires were collected, from 47 hospitals, representing 86% of the hospitals involved in the experimentation. The patient pharmaceutical record was effectively operational in 36 hospitals. Data from 73 questionnaires filled by physicians and pharmacists with potential experience with the patient pharmaceutical record were used for evaluation. Forty-two respondents were pharmacists (57%) and 31 were physicians (43%), including 13 geriatricians, 11 emergency physicians and 7 anaesthesiologists. Patient pharmaceutical record overall usability score was 62.5 out of 100. It did not vary with the profession or seniority of the respondent. It was positively correlated with the frequency of use. More than half of respondents reported that they never or uncommonly used the patient pharmaceutical record. The length of access to data period was considered as insufficient. Main obstacles to more utilization of the patient pharmaceutical record were the lack of information about the dosage of dispensed drugs, the low number of patients in possession of their health card and the low number of patients with an activated

Pharmaceutical crystallography: is there a devil in the details?

DEFF Research Database (Denmark)

Bond, A. D.

2012-01-01

Modern instruments for small-molecule crystallography continue to become more sophisticated and more automated. This technical progress provides a basis for frontier research in chemical and pharmaceutical crystallography, but it also encourages analytical crystallographers to become more...... are presented for pharmaceutical compounds, and the potential importance of the "details" in pharmaceutical crystallography is discussed....

Effects of soil properties on the uptake of pharmaceuticals into earthworms

International Nuclear Information System (INIS)

Carter, Laura J.; Ryan, Jim J.; Boxall, Alistair B.A.

2016-01-01

Pharmaceuticals can enter the soil environment when animal slurries and sewage sludge are applied to land as a fertiliser or during irrigation with contaminated water. These pharmaceuticals may then be taken up by soil organisms possibly resulting in toxic effects and/or exposure of organisms higher up the food chain. This study investigated the influence of soil properties on the uptake and depuration of pharmaceuticals (carbamazepine, diclofenac, fluoxetine and orlistat) in the earthworm Eisenia fetida. The uptake and accumulation of pharmaceuticals into E. fetida changed depending on soil type. Orlistat exhibited the highest pore water based bioconcentration factors (BCFs) and displayed the largest differences between soil types with BCFs ranging between 30.5 and 115.9. For carbamazepine, diclofenac and fluoxetine BCFs ranged between 1.1 and 1.6, 7.0 and 69.6 and 14.1 and 20.4 respectively. Additional analysis demonstrated that in certain treatments the presence of these chemicals in the soil matrices changed the soil pH over time, with a statistically significant pH difference to control samples. The internal pH of E. fetida also changed as a result of incubation in pharmaceutically spiked soil, in comparison to the control earthworms. These results demonstrate that a combination of soil properties and pharmaceutical physico-chemical properties are important in terms of predicting pharmaceutical uptake in terrestrial systems and that pharmaceuticals can modify soil and internal earthworm chemistry which may hold wider implications for risk assessment. - Highlights: • Uptake of pharmaceuticals into earthworms is influenced by soil parameters. • Presence of pharmaceuticals in the terrestrial environment influences soil pH. • Uptake of pharmaceuticals by earthworms changes internal earthworm pH. - The uptake of pharmaceuticals into soil invertebrates is dependent on the complex interplay between pharmaceutical physico-chemical properties and soil

Pharmaceutical care: the PCNE definition 2013.

Science.gov (United States)

Allemann, Samuel S; van Mil, J W Foppe; Botermann, Lea; Berger, Karin; Griese, Nina; Hersberger, Kurt E

2014-06-01

Twenty-three years after Hepler and Strand published their well-known definition of Pharmaceutical Care (PhC), confusion remains about what the term includes and how to differentiate it from other terms. The board of the Pharmaceutical Care Network Europe (PCNE) felt the need to redefine PhC and to answer the question: "What is Pharmaceutical Care in 2013". The aims of this paper were to review existing definitions of PhC and to describe the process of developing a redefined definition. A literature search was conducted in the MEDLINE database (1964-January 2013). Keywords included "Pharmaceutical Care", "Medication (Therapy) Management", "Medicine Management", and "Pharmacist Care" in the title or abstract together with the term "defin*". To ease comparison between definitions, we developed a standardised syntax to paraphrase the definitions. During a dedicated meeting, a moderated discussion about the definition of PhC was organised. The initial literature search produced 186 hits, with eight unique PhC definitions. Hand searching identified a further 11 unique definitions. These 19 definitions were paraphrased using the standardised syntax (provider, recipient, subject, outcome, activities). Fourteen members of PCNE and 10 additional experts attended the moderated discussion. Working groups of increasing size developed intermediate definitions, which had similarities and differences to those retrieved in the literature search. At the end of the session, participants reached a consensus on a "PCNE definition of Pharmaceutical Care" reading: "Pharmaceutical Care is the pharmacist's contribution to the care of individuals in order to optimize medicines use and improve health outcomes". It was possible to paraphrase definitions of PhC using a standardised syntax focusing on the provider, recipient, subject, outcomes, and activities included in PhC practice. During a one-day workshop, experts in PhC research agreed on a definition, intended to be applicable for the

Mergers and innovation in the pharmaceutical industry.

Science.gov (United States)

Comanor, William S; Scherer, F M

2013-01-01

Conflicting trends confound the pharmaceutical industry. The productivity of pharmaceutical innovation has declined in recent years. At the same time, the cohort of large companies who are the leading engines of pharmaceutical R&D has become increasingly concentrated. The concurrent presence of these trends is not sufficient to determine causation. In response to lagging innovation prospects, some companies have sought refuge in mergers and acquisitions to disguise their dwindling prospects or gain R&D synergies. On the other hand, the increased concentration brought on by recent mergers may have contributed to the declining rate of innovation. In this paper, we consider the second of these causal relationships: the likely impact of the recent merger wave among the largest pharmaceutical companies on the rate of innovation. In other words, have recent mergers, which may have been taken in response to lagging innovation, represented a self-defeating strategy that only made industry outcomes worse? Copyright © 2012 Elsevier B.V. All rights reserved.

Financing pharmaceuticals in transition economies.

Science.gov (United States)

Kanavos, P

1999-06-01

This paper (a) provides a methodological taxonomy of pricing, financing, reimbursement, and cost containment methodologies for pharmaceuticals; (b) analyzes complex agency relationships and the health versus industrial policy tradeoff; (c) pinpoints financing measures to balance safety and effectiveness of medicines and their affordability by publicly funded systems in transition; and (d) highlights viable options for policy-makers for the financing of pharmaceuticals in transition. Three categories of measures and their implications for pharmaceutical policy cost containing are analyzed: supply-side measures, targeting manufacturers, proxy demand-side measures, targeting physicians and pharmacists, and demand-side measures, targeting patients. In pursuing supply side measures, we explore free pricing for pharmaceuticals, direct price controls, cost-plus and cost pricing, average pricing and international price comparisons, profit control, reference pricing, the introduction of a fourth hurdle, positive and negative lists, and other price control measures. The analysis of proxy-demand measures includes budgets for physicians, generic policies, practice guidelines, monitoring the authorizing behavior of physicians, and disease management schemes. Demand-side measures explore the effectiveness of patient co-payments, the impact of allowing products over-the-counter and health promotion programs. Global policies should operate simultaneously on the supply, the proxy demand, and the demand-side. Policy-making needs to have a continuous long-term planning. The importation of policies into transition economy may require extensive and expensive adaptation, and/or lead to sub-optimal policy outcomes.

New perspectives for visual characterization of pharmaceutical solids

DEFF Research Database (Denmark)

Laitinen, Niklas; Antikainen, Osmo; Rantanen, Jukka

2004-01-01

The utilization of descriptive image information in pharmaceutical powder technology is rather limited. Consequently, the development of this discipline is a challenge within physical characterization of pharmaceutical solids. The aim of this study was to develop and evaluate an inventive visual...... in particle size analysis also enabling the evaluation of the further product quality in the end of the granulation process. The idea of characterization of bulk surface images opens new perspectives for characterization of pharmaceutical solids....

Assessing the Factors Associated With Iran's Intra-Industry Trade in Pharmaceuticals.

Science.gov (United States)

Yusefzadeh, Hassan; Hadian, Mohammad; Abolghasem Gorji, Hassan; Ghaderi, Hossein

2015-03-30

Pharmaceutical industry is a sensitive and profitable industry. If this industry wants to survive, it should be able to compete well in international markets. So, study of Iran's intra-industry trade (IIT) in pharmaceuticals is essential in order to identify competitiveness potential of country and boost export capability in the global arena. This study assessed the factors associated with Iran's intra-industry trade in pharmaceuticals with the rest of the world during the 2001-2012 periods using seasonal time series data at the four-digit SITC level. The data was collected from Iran's pharmaceutical Statistics, World Bank and International Trade Center. Finally, we discussed a number of important policy recommendations to increase Iran's IIT in pharmaceuticals. The findings indicated that economies of scale, market structure and degree of economic development had a significantly positive impact on Iran's intra-industry trade in pharmaceuticals and tariff trade barriers were negatively related to IIT. Product differentiation and technological advancement didn't have the expected signs. In addition, we found that Iran's IIT in pharmaceuticals have shown an increasing trend during the study period. Thus, the composition of Iran trade in pharmaceuticals has changed from inter-industry trade to intra-industry trade. In order to get more prepared for integration into the global economy, the development of Iran's IIT in pharmaceuticals should be given priority. Therefore, paying attention to IIT could have an important role in serving pharmaceutical companies in relation to pharmaceutical trade.

Effectiveness of the Dader Method for Pharmaceutical Care on Patients with Bipolar I Disorder: Results from the EMDADER-TAB Study.

Science.gov (United States)

Salazar-Ospina, Andrea; Amariles, Pedro; Hincapié-García, Jaime A; González-Avendaño, Sebastián; Benjumea, Dora M; Faus, Maria José; Rodriguez, Luis F

2017-01-01

Bipolar I disorder (BD-I) is a chronic illness characterized by relapses alternating with periods of remission. Pharmacists can contribute to improved health outcomes in these patients through pharmaceutical care in association with a multidisciplinary health team; however, more evidence derived from randomized controlled trials (RCTs) is needed to demonstrate the effect of pharmaceutical care on patients with BD-I. To assess the effectiveness of a pharmaceutical intervention using the Dader Method on patients with BD-I, measured by the decrease in the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits from baseline through 1 year of follow-up. This study is based on the EMDADER-TAB trial, which was an RCT designed to compare pharmaceutical care with the usual care given to outpatients with BD-I in a psychiatric clinic. The main outcome was the use of health care services, using Kaplan-Meier methods and Cox regression. The trial protocol was registered in ClinicalTrials.gov (Identifier NCT01750255). 92 patients were included in the EMDADER-TAB study: 43 pharmaceutical care patients (intervention group) and 49 usual care patients (control group). At baseline, no significant differences in demographic and clinical characteristics were found across the 2 groups. After 1 year of follow-up, the risk of hospitalizations and emergencies was higher for the control group than for the intervention group (HR = 9.03, P = 0.042; HR = 3.38, P = 0.034, respectively); however, the risk of unscheduled outpatient visits was higher for the intervention group (HR = 4.18, P = 0.028). There was no "placebo" treatment, and patients in the control group might have produced positive outcomes and reduced the magnitude of differences compared with the intervention group. Compared with usual care, pharmaceutical care significantly reduced hospitalizations and emergency service consultations by outpatients with BD-I. This study received funding from

On radiation treatment of pharmaceutical products

International Nuclear Information System (INIS)

Zukov, V.; Mende, V.

1976-01-01

The progress made in the GDR over the past decade in the field of radiosterilization of products of the medical industry, has naturally raised the question of radiosterilization in pharmaceutics. However, because of the diversity and complicated nature of pharmaceutical products and, consequently, longer periods of time required for preliminary studies, their radiosterilization has not yet been applied on an industrial scale, in contrast to the situation in the medical industry. The studies carried out so far have been mainly concerned with ascertaining the permissibility and effectiveness of radiosterilization of individual products under particular conditions rather than with laying down a broad theoretical basis. Accordingly, the present paper does not describe results of special studies but presents a brief rewiev of some studies on radiation treatment of pharmaceutical products undertaken in the GDR. (author)

Pharmaceutical cocrystals, salts and polymorphs: Advanced characterization techniques.

Science.gov (United States)

Pindelska, Edyta; Sokal, Agnieszka; Kolodziejski, Waclaw

2017-08-01

The main goal of a novel drug development is to obtain it with optimal physiochemical, pharmaceutical and biological properties. Pharmaceutical companies and scientists modify active pharmaceutical ingredients (APIs), which often are cocrystals, salts or carefully selected polymorphs, to improve the properties of a parent drug. To find the best form of a drug, various advanced characterization methods should be used. In this review, we have described such analytical methods, dedicated to solid drug forms. Thus, diffraction, spectroscopic, thermal and also pharmaceutical characterization methods are discussed. They all are necessary to study a solid API in its intrinsic complexity from bulk down to the molecular level, gain information on its structure, properties, purity and possible transformations, and make the characterization efficient, comprehensive and complete. Furthermore, these methods can be used to monitor and investigate physical processes, involved in the drug development, in situ and in real time. The main aim of this paper is to gather information on the current advancements in the analytical methods and highlight their pharmaceutical relevance. Copyright © 2017 Elsevier B.V. All rights reserved.

Approaches to education of pharmaceutical biotechnology in faculties of pharmacy.

Science.gov (United States)

Calis, S; Oner, F; Kas, S; Hincal, A A

2001-06-01

Pharmaceutical biotechnology is developing rapidly both in academic institutions and in the biopharmaceutical industry. For this reason, FIP Special Interest Group of Pharmaceutical Biotechnology decided to develop a questionnaire concerning pharmaceutical biotechnology education. After preliminary studies were completed, questionnaires were sent to the leading scientists in academia and research directors or senior managers of various Pharmaceutical Biotechnology Companies in order to gather their views about how to create a satisfactory program. The objectives of this study were as follows: -To review all of the graduate and undergraduate courses which are presently available worldwide on pharmaceutical biotechnology in Faculties of Pharmacy. -To review all of the text books, references and scientific sources available worldwide in the area of pharmaceutical biotechnology. When replying to the questionnaires, the respondents were asked to consider the present status of pharmaceutical biotechnology education in academia and future learning needs in collaboration with the biotechnology industry. The data from various pharmacy faculties and biotechnology industry representatives from Asia, Europe and America were evaluated and the outcome of the survey showed that educational efforts in training qualified staff in the rapidly growing field of pharmaceutical biotechnology is promising. Part of the results of this questionnaire study have already been presented at the 57th International Congress of FIP Vancouver, Canada in 1997.

The pharmaceutical quality revolution

Directory of Open Access Journals (Sweden)

Jordi Botet

2016-01-01

Full Text Available Pharmaceutical products are patient-oriented. If they had a deficient quality they might put live at risk. Ensuring their quality is not, however, a straightforward task and this is why different approaches have been used along the way. This article analyzes them and shows how our present approach, if well implemented, is very effective in ensuring quality.Methods. This article analyzes the current pharmaceutical quality system as described by international guidances in the light of practical experience gathered by the author as an international GMP-consultant.Result. Nowadays we have come to understand that as quality is a global concept in terms of time and of requirements, it has to be assured in a global way too. This is why quality assurance is a permanent process that starts during the development of a product and goes on during its manufacturing life. Manufacturing should be performed within a pharmaceutical quality system which ensures GMP compliance. Decisions should be science and risk-based. Products and processes are monitored by means of critical variables.Conclusions. The approach followed in the 21st century for ensuring quality is very effective and allows for a progressive reduction of the level of quality risk. However, this quality system is either comprehensive or there is no quality

RFID in the pharmaceutical industry: addressing counterfeits with technology.

Science.gov (United States)

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.

influence of manufacturing practices on quality of pharmaceutical

African Journals Online (AJOL)

hi-tech

2004-06-01

Jun 1, 2004 ... PHARMACEUTICAL PRODUCTS MANUFACTURED IN KENYA. J. A. ORWA, L. K. ... Design: Cross-sectional study. ... of good manufacturing practices has been used in the production of each pharmaceutical product by ...

Radiation sterilization of pharmaceuticals and biomedical products

International Nuclear Information System (INIS)

Blackburn, R.; Iddon, B.; Moore, J.S.; Phillips, G.O.; Power, D.M.; Woodward, T.W.

1975-01-01

Sterilization of pharmaceuticals by radiation is accompanied by chemical degradation which must be eliminated or minimised if the method is to be successfully applied. In order to devise ways in which the pharmaceutical can be protected it is necessary to know the yield and nature of the decomposition products, the mechanisms by which degradation occurs, and the rate constants for the reactions involved. We have obtained such data for a variety of pharmaceutical compounds, viz. vitamin B12, benzyl penicillin, sulphonamides, indoles, heparin, alginates and phenylmercurics, both in the solid state and in aqueous solution. The scope and limitations of radiation sterilization are discussed in the light of these results. (author)

Decomposition of persistent pharmaceuticals in wastewater by ionizing radiation

International Nuclear Information System (INIS)

Kimura, Atsushi; Osawa, Misako; Taguchi, Mitsumasa

2012-01-01

Pharmaceuticals in wastewater were treated by the combined method of activated sludge and ionizing radiation in laboratory scale. Oseltamivir, aspirin, and ibuprofen at 5 μmol dm −3 in wastewater were decomposed by the activated sludge at reaction time for 4 h. Carbamazepine, ketoprofen, mefenamic acid, clofibric acid, and diclofenac were not biodegraded completely, but were eliminated by γ-ray irradiation at 2 kGy. The rate constants of the reactions of these pharmaceuticals with hydroxyl radicals were estimated by the competition reaction method to be 4.0–10×10 9 mol −1 dm 3 s −1 . Decompositions of the pharmaceuticals in wastewater by ionizing radiation were simulated by use of the rate constants and the amount of total organic carbon as parameters. Simulation curves of concentrations of these pharmaceuticals as a function of dose described the experimental data, and the required dose for the elimination of them in wastewater by ionizing radiation can be estimated by this simulation. - Highlights: ► We treat pharmaceuticals in wastewater by activated sludge and ionizing radiation. ► Activated sludge decreases the amounts of total organic carbons in wastewater. ► Pharmaceuticals were decomposed by γ-ray irradiation at 2 kGy. ► We construct simulation for treatment of pharmaceuticals by ionizing radiation.

The pharmaceutical sector inquiry: 'Hamlet' in a nutshell.

Science.gov (United States)

den Exter, André

2010-03-01

In July 2009, the European Commission (DG Competition) published a Communication on the pharmaceutical sector. This inquiry was launched because there were some indications that competition in the pharmaceutical market in the European Union might not be working well. The report examines the reasons for the observed delay. This article analyses the outcomes from a critical standpoint, arguing in favour of enhanced 'soft law' accountability mechanisms in the pharmaceutical sector, defending conditional patenting and the introduction of a Community patent.

Polymers in life sciences: Pharmaceutical and biomedical applications

Science.gov (United States)

Barba, Anna Angela; Dalmoro, Annalisa; d'Amore, Matteo; Lamberti, Gaetano; Cascone, Sara; Titomanlio, Giuseppe

2015-12-01

This paper deals with the work done by prof. Titomanlio and his group in the fields of pharmaceutical and biomedical applications of polymers. In particular, the main topics covered are: i) controlled drug release from pharmaceuticals based on hydrogel for oral delivery of drugs; ii) production and characterization of micro and nanoparticles based on stimuli-responsive polymers; iii) use of polymers for coronary stent gel-paving; iv) design and realization of novel methods (in-vitro and in-silico) to test polymer-based pharmaceuticals.

Valuing Trial Designs from a Pharmaceutical Perspective Using Value-Based Pricing.

Science.gov (United States)

Breeze, Penny; Brennan, Alan

2015-11-01

Our aim was to adapt the traditional framework for expected net benefit of sampling (ENBS) to be more compatible with drug development trials from the pharmaceutical perspective. We modify the traditional framework for conducting ENBS and assume that the price of the drug is conditional on the trial outcomes. We use a value-based pricing (VBP) criterion to determine price conditional on trial data using Bayesian updating of cost-effectiveness (CE) model parameters. We assume that there is a threshold price below which the company would not market the new intervention. We present a case study in which a phase III trial sample size and trial duration are varied. For each trial design, we sampled 10,000 trial outcomes and estimated VBP using a CE model. The expected commercial net benefit is calculated as the expected profits minus the trial costs. A clinical trial with shorter follow-up, and larger sample size, generated the greatest expected commercial net benefit. Increasing the duration of follow-up had a modest impact on profit forecasts. Expected net benefit of sampling can be adapted to value clinical trials in the pharmaceutical industry to optimise the expected commercial net benefit. However, the analyses can be very time consuming for complex CE models. © 2014 The Authors. Health Economics published by John Wiley & Sons Ltd.

[Share experiment: hospital mobile pharmaceutical teams, a proven concept!].

Science.gov (United States)

Lazaro, P; Sury-Lestage, S; Princet, I; Beuzit, K; Faucher-Grassin, J; Dupuis, A

2013-09-01

A few months ago, the pharmacy department of the University Hospital of Poitiers was located in the basement of the hospital; communicating with care units by fax, phone or messenger. Today, drugs and medical devices, are stored in a 3400m(2) logistic platform and most of the delivery activity is robotized. Control and validation of prescriptions and dispensing activities are done by the pharmaceutical teams directly in the care units. Quality indicators allow us to improve our services regularly. A great success and interesting prospects for clinical pharmacy. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Validation of a liquid chromatographic method for the pharmaceutical quality control of products containing elacridar

Directory of Open Access Journals (Sweden)

Emilia Sawicki

2016-08-01

Full Text Available Many anticancer drugs have an impaired bioavailability and poor brain penetration because they are substrates to drug efflux pumps such as P-glycoprotein and Breast Cancer Resistance Protein. Elacridar is a strong inhibitor of these two drug efflux pumps and therefore has great potential to improve oral absorption and brain penetration of many anticancer drugs. Currently, a clinical formulation of elacridar is unavailable and therefore the pharmaceutical development of a drug product is highly warranted. This also necessitates the availability of an analytical method for its quality control. A reverse-phase high-performance liquid chromatographic method with ultraviolet detection was developed for the pharmaceutical quality control of products containing elacridar as the active pharmaceutical ingredient. The analytical method was validated for linearity, accuracy, precision, selectivity, carry-over, stability of stock and reference solutions, stability of the final extract, stability-indicating capability and impurity testing. We found that elacridar is unstable in aqueous solutions that are exposed to light because a hydroxylation product of elacridar is formed. Therefore, sample solutions with elacridar must be protected from light.

Drivers of peak sales for pharmaceutical brands

NARCIS (Netherlands)

Fischer, Marc; Leeflang, Peter S. H.; Verhoef, Peter C.

2010-01-01

Peak sales are an important metric in the pharmaceutical industry. Specifically, managers are focused on the height-of-peak-sales and the time required achieving peak sales. We analyze how order of entry and quality affect the level of peak sales and the time-to-peak-sales of pharmaceutical brands.

An analysis of the warning letters issued by the FDA to pharmaceutical manufacturers regarding misleading health outcomes claims

Directory of Open Access Journals (Sweden)

Chatterjee S

2012-12-01

Full Text Available Objective: To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA to pharmaceutical manufacturers for promotional violations.Methods: Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-of-Life (QoL, and economic claims. Clinical claims included claims regarding unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims included unsubstantiated quality of life and/or health-related quality of life claims. Economic claims included any form of claim made on behalf of the pharmaceutical companies related to cost superiority of or cost savings from the drug compared to other drugs in the market.Results: In the 6-year study period, 65 warning letters were issued by FDA, which contained 144 clinical, three QoL, and one economic claim. On an average, 11 warning letters were issued per year. Omission of risk information was the most frequently violated claim (30.6% followed by unsubstantiated efficacy claims (18.6%. Warning letters were primarily directed to manufacturers of cardiovascular (14.6%, anti-microbial (14.6%, and CNS (12.5% drugs. Majority of the claims referenced in warning letters contained promotional materials directed to physicians (57%. Conclusion: The study found that misleading clinical outcome claims formed the majority of the promotional violations, and majority of the claims were directed to physicians. Since inadequate promotion of medications may lead to irrational prescribing, the study emphasizes the importance of disseminating reliable, credible, and scientific information to patients, and more importantly, physicians to protect public health.

[Pharmaceutical analysis and clinical efficacy of Kampo medicine, maoto, extract suppository against pediatric febrile symptoms].

Science.gov (United States)

Nishimura, Nobuhiro; Doi, Norio; Uemura, Tomochika; Taketani, Takeshi; Hayashi, George; Kasai, Takeshi; Kanai, Rie; Yamaguchi, Seiji; Iwamoto, Kikuo; Naora, Kohji

2009-06-01

A traditional Chinese herbal medicine, Kampo medicine, maoto, has been widely used in the treatment of febrile symptoms caused by viral infection. This herbal extract granule for oral use, however, is not well accepted by infants or young children due to its unpleasant taste and odor. Therefore, we prepared Kampo medicine, maoto, suppository and investigated the pharmaceutical and clinical efficacy of the suppository. Kampo medicine, maoto, granules were micro-pulverized and homogeneously dispersed into Hosco-H15 to prepare suppositories containing 0.25 to 1.0 g herbal extract by the conventional fusion method. Content of l-ephedrine, an index compound of Kampo medicine, maoto, in the extract granules and suppositories was determined by using a high performance liquid chromatographic method. Physicochemical experiments revealed that the suppository containing 0.5 g herbal extract had the most suitable melting point of 34 degrees C. Contents of l-ephedrine in the suppository were constant, 93-96% of those in the same amount of the extract granules in different three lots. Upper and lower portions of the suppository had the same content of l-ephedrine. The suppository maintained more than 95% of l-ephedrine content through 6 months at 4 degrees C, room temperature and 40 degrees C, although maldistribution of the extract constituent was observed after storage at 40 degrees C. The suppository was administered to 21 pediatric febrile patients at a dose of 1/3 to 2 full pieces depending on their body weight and physical status. Significant reduction (pchildren with viral febrile symptoms without any adverse effects.

Assessment of hospital pharmacists' clinical knowledge and ...

African Journals Online (AJOL)

Purpose: To evaluate hospital pharmacists' clinical knowledge and practical skill levels for pharmaceutical care. Methods: A quasi-experimental prospective longitudinal study design was used to evaluate the level of clinical skills with problem-based learning (PBL) sessions. Pharmacists' in three different government ...

Health risks of counterfeit pharmaceuticals.

Science.gov (United States)

ten Ham, Martijn

2003-01-01

Pharmaceutical products are not exempt from the practice of counterfeiting. In recent years, many reports have become available demonstrating the presence of fake medicines on the market. Several studies have demonstrated that they are quite often of bad quality. It is estimated that 5% of all world trade in branded goods is counterfeit, leading to huge financial losses for the pharmaceutical industry. But much more important, from a public health point of view, is that history has shown that such products may lead to a great health risk. The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product. The existence of counterfeit drugs has long been ignored both by the pharmaceutical industry and by drug regulatory authorities. At present initiatives are being taken, nationally and internationally, to curb counterfeiting. It is now realised that a strong regulatory agency is essential, but the initiatives can only be successful if all parties concerned actively co-operate.

Clinical effect of Fuzheng quyu therapy in patients undergoing ...

African Journals Online (AJOL)

Tropical Journal of Pharmaceutical Research January 2017; 16 (1): 219-224 ... cervical carcinoma surgery, thus suggesting its potential clinical applications. ..... surgery. However, further clinical investigations before it can be recommended for ...

Marketing concepts for pharmaceutical service development.

Science.gov (United States)

Grauer, D W

1981-02-01

Marketing concepts as a mechanism to help pharmacy develop, communicate, and sell future pharmaceutical services to consumers are discussed. Pharmacy as a profession must define itself broadly to take advantage of future growth opportunities. These growth opportunities will be realized from unmet health-care needs and changing consumer life style trends and values. New services must therefore be oriented toward consumers (i.e., patients, health professionals, and third-party agencies) to gain acceptance. Dispensing and drug-knowledge-distribution pharmaceutical services are reviewed by a product life cycle analysis of sales profits versus time. A marketing mix for new pharmaceutical services is developed consisting of service, price, distribution, and promotion strategies. Marketing can encompass those key elements necessary to meet the organizational goals of pharmacy and provide a systematic, disciplined approach for presenting a new service to consumers.

New opportunities for biocatalysis: making pharmaceutical processes greener

DEFF Research Database (Denmark)

Woodley, John

2008-01-01

The pharmaceutical industry requires synthetic routes to be environmentally compatible as well as to fulfill the demands of process economics and product specification and to continually reduce development times. Biocatalysis has the potential to deliver 'greener' chemical syntheses, and in this ......The pharmaceutical industry requires synthetic routes to be environmentally compatible as well as to fulfill the demands of process economics and product specification and to continually reduce development times. Biocatalysis has the potential to deliver 'greener' chemical syntheses...... of biocatalysis for making pharmaceutical processes greener....

Pharmaceutical care as a historical, normative-legal and social-economic category in the system of the population health and pharmaceutical care

Directory of Open Access Journals (Sweden)

G. L. Panfilova

2014-08-01

Full Text Available Aim. Terminological vagueness of the term «pharmaceutical care» in domestic legislative framework and scientific environment makes it impossible to introduce new forms and methods of providing pharmaceutical population in Ukraine effectively. In order to form the unified methodological approach to identify and order the use of the mentioned term, the results of organizational-economic studies in pharmacy and the existing legal framework have been analyzed. Methods and results. Using dialectical, historical, logical-semantic and other methods the basic stages in the development of pharmaceutical care have been established and definitions tree of the concept have been constructed. Conclusion. The results of these studies indicate the need for recognition and regulatory mapping integration (organizational and economic of the definition «pharmaceutical care» in domestic legislation and public health practice.

Adsorptive removal of selected pharmaceuticals by mesoporous silica SBA-15

International Nuclear Information System (INIS)

Bui, Tung Xuan; Choi, Heechul

2009-01-01

The removal of five selected pharmaceuticals, viz., carbamazepine, clofibric acid, diclofenac, ibuprofen, and ketoprofen was examined by batch sorption experiments onto a synthesized mesoporous silica SBA-15. SBA-15 was synthesized and characterized by X-ray diffraction (XRD), transmission electron microscopy (TEM), N 2 adsorption-desorption measurement, and point of zero charge (PZC) measurement. Pharmaceutical adsorption kinetics was rapid and occurred on a scale of minutes, following a pseudo-second-order rate expression. Adsorption isotherms were best fitted by the Freundlich isotherm model. High removal rates of individual pharmaceuticals were achieved in acidic media (pH 3-5) and reached 85.2% for carbamazepine, 88.3% for diclofenac, 93.0% for ibuprofen, 94.3% for ketoprofen, and 49.0% for clofibric acid at pH 3 but decreased with increase in pH. SBA-15 also showed high efficiency for removal of a mixture of 5 pharmaceuticals. Except for clofibric acid (35.6%), the removal of pharmaceuticals in the mixture ranged from 75.2 to 89.3%. Based on adsorption and desorption results, the mechanism of the selected pharmaceuticals was found to be a hydrophilic interaction, providing valuable information for further studies to design materials for the purpose. The results of this study suggest that mesoporous-silica-based materials are promising adsorbents for removing pharmaceuticals from not only surface water but also wastewater of pharmaceutical industrial manufactures.

Adsorptive removal of selected pharmaceuticals by mesoporous silica SBA-15

Energy Technology Data Exchange (ETDEWEB)

Bui, Tung Xuan, E-mail: bxtung@gist.ac.kr [Department of Environmental Science and Engineering, Gwangju Institute of Science and Technology (GIST), 261 Cheomdan-gwagiro, Buk-gu, Gwangju 500-712 (Korea, Republic of); Choi, Heechul, E-mail: hcchoi@gist.ac.kr [Department of Environmental Science and Engineering, Gwangju Institute of Science and Technology (GIST), 261 Cheomdan-gwagiro, Buk-gu, Gwangju 500-712 (Korea, Republic of)

2009-09-15

The removal of five selected pharmaceuticals, viz., carbamazepine, clofibric acid, diclofenac, ibuprofen, and ketoprofen was examined by batch sorption experiments onto a synthesized mesoporous silica SBA-15. SBA-15 was synthesized and characterized by X-ray diffraction (XRD), transmission electron microscopy (TEM), N{sub 2} adsorption-desorption measurement, and point of zero charge (PZC) measurement. Pharmaceutical adsorption kinetics was rapid and occurred on a scale of minutes, following a pseudo-second-order rate expression. Adsorption isotherms were best fitted by the Freundlich isotherm model. High removal rates of individual pharmaceuticals were achieved in acidic media (pH 3-5) and reached 85.2% for carbamazepine, 88.3% for diclofenac, 93.0% for ibuprofen, 94.3% for ketoprofen, and 49.0% for clofibric acid at pH 3 but decreased with increase in pH. SBA-15 also showed high efficiency for removal of a mixture of 5 pharmaceuticals. Except for clofibric acid (35.6%), the removal of pharmaceuticals in the mixture ranged from 75.2 to 89.3%. Based on adsorption and desorption results, the mechanism of the selected pharmaceuticals was found to be a hydrophilic interaction, providing valuable information for further studies to design materials for the purpose. The results of this study suggest that mesoporous-silica-based materials are promising adsorbents for removing pharmaceuticals from not only surface water but also wastewater of pharmaceutical industrial manufactures.

Pharmaceutical Care for hypertensive patients provided within the Family Health Strategy in Goiânia, Goiás, Brazil

Directory of Open Access Journals (Sweden)

Bárbara Posse Reis Martins

2013-09-01

Full Text Available The aim of Pharmaceutical Care programs is to improve patients' quality of life, and such programs are particularly effective in the case of chronic diseases such as hypertension. The objective of this longitudinal study was to analyze a Pharmaceutical Care model for hypertensive patients receiving care within the Family Health Strategy (FHS. All patients were being seen by an FHS team affiliated to a primary healthcare unit in Goiânia, Goiás, Brazil. Fourteen patients participated in the study, with each patient receiving six home visits during the Pharmaceutical Care. Overall, 142 drug-related problems were reported, the most common concerning the ineffectiveness of treatment (33.8%. A total of 135 pharmaceutical interventions were performed, 92.6% of which involved pharmacist-patient communication, with 48.8% of these interventions being implemented. Cardiovascular risk decreased in three patients and remained unchanged in nine. In hypertensive patients with diabetes, fasting glucose levels were reduced in six out of nine cases. The Pharmaceutical Care model proposed here was effective in detecting drug-related problems and in proposing interventions to resolve or prevent these problems. Consequently, this may have contributed towards improving clinical parameters, such as fasting glucose levels and cardiovascular risk in hypertensive patients receiving care within the FHS.

Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review.

Directory of Open Access Journals (Sweden)

Geoffrey K Spurling

2010-10-01

Full Text Available BACKGROUND: Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing. METHODS AND FINDINGS: We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise. Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008, International Pharmaceutical Abstracts (1970 to February 2008, Embase (1997 to February 2008, Current Contents (2001 to 2008, and Central (The Cochrane Library Issue 3, 2007 using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies and other sources (138 studies. Articles were then excluded because they did not fulfil inclusion criteria (179 or quality appraisal criteria (18, leaving 58 included studies with 87 distinct

Pharmaceutical Distribution Market Channels in Poland

Directory of Open Access Journals (Sweden)

Agnieszka Woś

2009-09-01

Full Text Available Distribution on the pharmaceutical market in Poland is interesting and the most difficult sphere to manage. Numerous varied and specialized companies operating on the market cause that the processes of choosing middlemen in distribution channels are very complex. The hereby article presents the role and location of the companies operating within distribution channels on the pharmaceutical market. It draws attention to the development of non-pharmacy and non-wholesale sales channels.

Methodologic quality and relevance of references in pharmaceutical advertisements in a Canadian medical journal.

Science.gov (United States)

Lexchin, J; Holbrook, A

1994-07-01

To evaluate the methodologic quality and relevance of references in pharmaceutical advertisements in the Canadian Medical Association Journal (CMAJ). Analytic study. All 114 references cited in the first 22 distinct pharmaceutical advertisements in volume 146 of CMAJ. Mean methodologic quality score (modified from the 6-point scale used to assess articles in the American College of Physicians' Journal Club) and mean relevance score (based on a new 5-point scale) for all references in each advertisement. Twenty of the 22 companies responded, sending 78 (90%) of the 87 references requested. The mean methodologic quality score was 58% (95% confidence limits [CL] 51% and 65%) and the mean relevance score 76% (95% CL 72% and 80%). The two mean scores were statistically lower than the acceptable score of 80% (p e., other than reports of clinical trials). Half of the advertisements had a methodologic quality score of less than 65%, but only five had a relevance score of less than 65%. Although the relevance of most of the references was within minimal acceptable limits, the methodologic quality was often unacceptable. Because advertisements are an important part of pharmaceutical marketing and education, we suggest that companies develop written standards for their advertisements and monitor their advertisements for adherence to these standards. We also suggest that the Pharmaceutical Advertising Advisory Board develop more stringent guidelines for advertising and that it enforce these guidelines in a consistent, rigorous fashion.

Knowledge and attitude of Iranian community pharmacists about the pharmaceutical care for epileptic females

International Nuclear Information System (INIS)

Sabzghabaee, A.M.; Zolfaghari, B.; Ebrahimabadi, M.H.

2012-01-01

This study was designed to evaluate the knowledge and attitude of a cohort of Iranian community pharmacists about the pharmaceutical care indexes and drug therapy in female epileptic patients. Methodology: This cross-sectional study was conducted in Iran (2011) and one hundred and twenty two community pharmacists were randomly selected using clustering method for sampling. A self-administered questionnaire which was originally made by a clinical pharmacy focus group was used. This questionnaire had 10 true/false questions for knowledge assessing (Spearman-Brown coefficient, 0.65) and 19 attitude statements (with Likert scale) about the intention of pharmacists for providing pharmaceutical care for epileptic females (Croanbach's alpha, 0.802). Face and content validity for both parts of the questionnaire were performed before the study. Results: There was a significant inverse relationship between pharmacists' knowledge on pharmaceutical care for epileptic females and the time elapsed from their graduation date. Considering the minimum passing score of 5, 85% of pharmacists did not have enough knowledge. The range of pharmacists' attitude scores was 35 to 64 and its mean was 46.09. Regarding the minimum passing score of 45, 63.3% of pharmacists had positive attitude to AEDs in epileptic females. Conclusion: It seems that the pharmaceutical care for epileptic females is a missing part of Pharmacy education. It is highly recommended to pay special attention to this topic in continuing education programs for Iranian pharmacists. (author)

Pharmaceutical cocrystals: walking the talk.

Science.gov (United States)

Bolla, Geetha; Nangia, Ashwini

2016-06-28

Pharmaceutical cocrystals belong to a sub-class of cocrystals wherein one of the components is a drug molecule (or an active pharmaceutical ingredient, API) and the second is a benign food or drug grade additive (generally regarded as safe, GRAS). The two components are hydrogen-bonded in a fixed stoichiometric ratio in the crystal lattice. In the past decade, pharmaceutical cocrystals have demonstrated significant promise in their ability to modify the physicochemical and pharmacokinetic properties of drug substances, such as the solubility and dissolution rate, bioavailability, particle morphology and size, tableting and compaction, melting point, physical form, biochemical and hydration stability, and permeability. In this feature review, we highlight some prominent examples of drug cocrystals which exhibit variable hardness/softness and elasticity/plasticity depending on coformer selection, improvement of solubility and permeability in the same cocrystal, increase of the melting point for solid formulation, enhanced color performance, photostability and hydration stability, and a longer half-life. Cocrystals of flavanoids and polyphenols can make improved pharmaceuticals and also extend to the larger class of nutraceuticals. The application of crystal engineering to assemble ternary cocrystals expands this field to drug-drug cocrystals which may be useful in multi-drug resistance, mitigating side effects of drugs, or attenuating/enhancing drug action synergistically by rational selection. The advent of new techniques for structural characterization beyond the standard X-ray diffraction will provide a better understanding of drug phases which are at the borderline of crystalline-amorphous nature and even newer opportunities in the future.

Temporal variation of pharmaceuticals in an urban and agriculturally influenced stream

International Nuclear Information System (INIS)

Veach, Allison M.; Bernot, Melody J.

2011-01-01

Pharmaceuticals have become ubiquitous in the aquatic environment. Previous studies consistently demonstrate the prevalence of pharmaceuticals in freshwater but we do not yet know how concentrations vary over time within a given system. Two sites in central Indiana with varying land use in the surrounding watershed (suburban and agricultural) were sampled monthly for pharmaceutical concentrations and stream physiochemical parameters. Sediment samples were also collected at each sampling event for measurement of δ 15 N natural abundance and sediment organic content. Across sites and sampling events, twelve pharmaceuticals were detected including acetaminophen, caffeine, carbamazepine, cotinine, N,N-diethyl-meta-toluamide (DEET), gemfibrozil, ibuprofen, sulfadimethoxine, sulfamethazine, sulfamethoxazole, triclosan, and trimethoprim. Sulfathiazole, lincomycin, and tylosin were not detected at either site at any time. The agriculturally-influenced site had comparable pharmaceutical concentrations to the urban-influenced site. In general, pharmaceutical concentrations increased during winter at both sites and decreased during spring and summer. Multiple regression analyses indicated that water column dissolved oxygen, the number of days since precipitation, and solar radiation influenced total pharmaceutical concentration in the urban-influenced site; whereas pH, chlorophyll a concentration, and total amount of rainfall in the previous 10 days influenced total pharmaceutical concentrations in the agriculturally-influenced site. Pharmaceutical concentrations were not correlated with sediment δ 15 N across or within sites. However, sediment in the urban-influenced site had higher mean δ 15 N signatures relative to sediment in the agriculturally-influenced site. These data indicate pharmaceuticals are persistent in aquatic ecosystems influenced by both agricultural and suburban activity. Pharmaceuticals are designed to have a physiological effect; therefore, it is

A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies.

Science.gov (United States)

Roggo, Yves; Chalus, Pascal; Maurer, Lene; Lema-Martinez, Carmen; Edmond, Aurélie; Jent, Nadine

2007-07-27

Near-infrared spectroscopy (NIRS) is a fast and non-destructive analytical method. Associated with chemometrics, it becomes a powerful tool for the pharmaceutical industry. Indeed, NIRS is suitable for analysis of solid, liquid and biotechnological pharmaceutical forms. Moreover, NIRS can be implemented during pharmaceutical development, in production for process monitoring or in quality control laboratories. This review focuses on chemometric techniques and pharmaceutical NIRS applications. The following topics are covered: qualitative analyses, quantitative methods and on-line applications. Theoretical and practical aspects are described with pharmaceutical examples of NIRS applications.

Recent trends and future of pharmaceutical packaging technology

Directory of Open Access Journals (Sweden)

Nityanand Zadbuke

2013-01-01

Full Text Available The pharmaceutical packaging market is constantly advancing and has experienced annual growth of at least five percent per annum in the past few years. The market is now reckoned to be worth over $20 billion a year. As with most other packaged goods, pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. Constant innovations in the pharmaceuticals themselves such as, blow fill seal (BFS vials, anti-counterfeit measures, plasma impulse chemical vapor deposition (PICVD coating technology, snap off ampoules, unit dose vials, two-in-one prefilled vial design, prefilled syringes and child-resistant packs have a direct impact on the packaging. The review details several of the recent pharmaceutical packaging trends that are impacting packaging industry, and offers some predictions for the future.

Recent trends and future of pharmaceutical packaging technology.

Science.gov (United States)

Zadbuke, Nityanand; Shahi, Sadhana; Gulecha, Bhushan; Padalkar, Abhay; Thube, Mahesh

2013-04-01

The pharmaceutical packaging market is constantly advancing and has experienced annual growth of at least five percent per annum in the past few years. The market is now reckoned to be worth over $20 billion a year. As with most other packaged goods, pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. Constant innovations in the pharmaceuticals themselves such as, blow fill seal (BFS) vials, anti-counterfeit measures, plasma impulse chemical vapor deposition (PICVD) coating technology, snap off ampoules, unit dose vials, two-in-one prefilled vial design, prefilled syringes and child-resistant packs have a direct impact on the packaging. The review details several of the recent pharmaceutical packaging trends that are impacting packaging industry, and offers some predictions for the future.

Impacts of international sanctions on Iranian pharmaceutical market.

Science.gov (United States)

Cheraghali, Abdol Majid

2013-07-31

Iran in recent decade faced several regional and international sanctions in foreign trade, financial and banking services. Iran national pharmaceutical industry has always played a major role in providing medicines to the Iranian patients. However, following the sanctions it has faced profound difficulties for importing of both finished products and pharmaceutical raw materials. Although medicines are exempted from sanctions, due to restriction on money transaction and proper insurance Iranian pharmaceutical companies have to pay cash in advance for imports of medicines and raw materials or to secure offshore funds at very high risks. Current situation in Iran pharmaceutical market confirms that the sanctions against Iran are affecting ordinary citizens and national health sector which resulted to reduction of availability of lifesaving medicines in the local market and has caused increasing pain and suffering for Iranian patients.

Recent trends and future of pharmaceutical packaging technology

Science.gov (United States)

Zadbuke, Nityanand; Shahi, Sadhana; Gulecha, Bhushan; Padalkar, Abhay; Thube, Mahesh

2013-01-01

The pharmaceutical packaging market is constantly advancing and has experienced annual growth of at least five percent per annum in the past few years. The market is now reckoned to be worth over $20 billion a year. As with most other packaged goods, pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. Constant innovations in the pharmaceuticals themselves such as, blow fill seal (BFS) vials, anti-counterfeit measures, plasma impulse chemical vapor deposition (PICVD) coating technology, snap off ampoules, unit dose vials, two-in-one prefilled vial design, prefilled syringes and child-resistant packs have a direct impact on the packaging. The review details several of the recent pharmaceutical packaging trends that are impacting packaging industry, and offers some predictions for the future. PMID:23833515

Attitudes and beliefs regarding direct-to-consumer advertising of pharmaceutical drugs: an exploratory comparison of physicians and pharmaceutical sales representatives.

Science.gov (United States)

Schulz, Steven A; Broekemier, Gregory M; Burkink, Tim J

2014-01-01

Even with many changes in regulation in recent years, direct-to-consumer advertising (DTCA) of pharmaceutical drugs remains a complicated and contentious issue. Many in our society argue for increased legislation of DTCA while others believe that DTCA serves a useful purpose and should not be overregulated. This study was designed to compare attitudes and beliefs regarding DTCA held by two key stakeholder groups, physicians and pharmaceutical sales representatives. A questionnaire was created, pretested, and administered to 30 physicians and 30 pharmaceutical sales representatives to investigate these issues. Significant differences between these two groups were found and implications for DTCA are discussed.

Returns to scientific publications for pharmaceutical products in the United States.

Science.gov (United States)

Slejko, Julia F; Basu, Anirban; Sullivan, Sean D

2018-02-01

Drug-specific clinical and health economic and outcomes research (HEOR) publications have amassed, but their effect on drug sales is largely unknown. We estimated the impact of publications on pharmaceutical sales in 3 markets (statins, rheumatoid arthritis, and asthma drugs) with varying generic competition. An event-study approach with fixed effects and difference-in-fixed-effects modeling was used to estimate the causal effects of drug-specific publications on subsequent quarter's drug-specific sales and volume. High-impact clinical and HEOR publications have significant positive effects on sales (mediated through price) and volume in the statin market (high generic competition). High-impact clinical publications have a significant positive effect on sales (mediated through volume) in low-generic competition market (asthma). The effects of publications in the rheumatoid arthritis market (no generic competition) on sales were null. Manufacturers' investment in clinical and HEOR publications needs to be strategic and should be anticipated and complemented by public investments in such studies. Copyright © 2017 John Wiley & Sons, Ltd.

Value Frameworks in Oncology: Comparative Analysis and Implications to the Pharmaceutical Industry.

Science.gov (United States)

Slomiany, Mark; Madhavan, Priya; Kuehn, Michael; Richardson, Sasha

2017-07-01

As the cost of oncology care continues to rise, composite value models that variably capture the diverse concerns of patients, physicians, payers, policymakers, and the pharmaceutical industry have begun to take shape. To review the capabilities and limitations of 5 of the most notable value frameworks in oncology that have emerged in recent years and to compare their relative value and application among the intended stakeholders. We compared the methodology of the American Society of Clinical Oncology (ASCO) Value Framework (version 2.0), the National Comprehensive Cancer Network Evidence Blocks, Memorial Sloan Kettering Cancer Center DrugAbacus, the Institute for Clinical and Economic Review Value Assessment Framework, and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale, using a side-by-side comparative approach in terms of the input, scoring methodology, and output of each framework. In addition, we gleaned stakeholder insights about these frameworks and their potential real-world applications through dialogues with physicians and payers, as well as through secondary research and an aggregate analysis of previously published survey results. The analysis identified several framework-specific themes in their respective focus on clinical trial elements, breadth of evidence, evidence weighting, scoring methodology, and value to stakeholders. Our dialogues with physicians and our aggregate analysis of previous surveys revealed a varying level of awareness of, and use of, each of the value frameworks in clinical practice. For example, although the ASCO Value Framework appears nascent in clinical practice, physicians believe that the frameworks will be more useful in practice in the future as they become more established and as their outputs are more widely accepted. Along with patients and payers, who bear the burden of treatment costs, physicians and policymakers have waded into the discussion of defining value in oncology care, as well

Pharmaceuticals as Groundwater Tracers - Applications and Limitations

Science.gov (United States)

Scheytt, T. J.; Mersmann, P.; Heberer, T.

2003-12-01

Pharmaceutically active substances and metabolites are found at concentrations up to the microgram/L-level in groundwater samples from the Berlin (Germany) area and from several other places world wide. Among the compounds detected in groundwater are clofibric acid, propyphenazone, diclofenac, ibuprofen, and carbamazepine. Clofibric acid, the active metabolite of clofibrate and etofibrate (blood lipid regulators) is detected in groundwater at maximum concentrations of 7300 ng/L. Among the most important input paths of drugs are excretion and disposal into the sewage system. Groundwater contamination is likely to be due to leaky sewage systems, influent streams, bank filtration, and irrigation with effluent water from sewage treatment plants. There are no known natural sources of the above mentioned pharmaceuticals. The use of pharmaceuticals as tracers may include: (a) Quantification of infiltration from underground septic tanks (b) Detection of leaky sewage systems / leaky sewage pipes (c) Estimation of the effectiveness of sewage treatment plants (d) Identification of transport pathways of other organic compounds (e) Quantification of surface water / groundwater interaction (f) Characterization of the biodegradation potential. The use of pharmaceuticals as tracers is limited by variations in input. These variations depend on the amount of drugs prescribed and used in the study area, the social structure of the community, the amount of hospital discharge, and temporal concentration variations. Furthermore, the analysis of trace amounts of pharmaceuticals is sophisticated and expensive and may therefore limit the applicability of pharmaceuticals as tracers. Finally, the transport and degradation behavior of pharmaceuticals is not fully understood. Preliminary experiments in the laboratory were conducted using sediment material and groundwater from the Berlin area to evaluate the transport and sorption behavior of selected drugs. Results of the column experiments

Ethical dilemma of mandated contraception in pharmaceutical research at catholic medical institutions.

Science.gov (United States)

Casey, Murray Joseph; O'Brien, Richard; Rendell, Marc; Salzman, Todd

2012-01-01

The Catholic Church proscribes methods of birth control other than sexual abstinence. Although the U.S. Food and Drug Administration (FDA) recognizes abstinence as an acceptable method of birth control in research studies, some pharmaceutical companies mandate the use of artificial contraceptive techniques to avoid pregnancy as a condition for participation in their studies. These requirements are unacceptable at Catholic health care institutions, leading to conflicts among institutional review boards, clinical investigators, and sponsors. Subjects may feel coerced by such mandates to adopt contraceptive techniques inconsistent with their personal situation and beliefs; women committed to celibacy or who engage exclusively in non-heterosexual activities are negatively impacted. We propose principles to insure informed consent to safeguard the rights of research subjects at Catholic institutions while mitigating this ethical conflict. At the same time, our proposal respects the interests of pharmaceutical research agencies and Catholic moral precepts, and fully abides by regulatory guidance.

Why regulatory indifference towards pharmaceutical pollution of the ...

African Journals Online (AJOL)

Unlike other environmental contaminants, pharmaceutical pollutants are not yet regulated globally, simply because acute risk assessments show insignificant human health hazard. But the pitfalls of pharmaceutical pollutants extend beyond acute effects to delayed effects from bioaccumulation, amplified effects from ...

Pharmaceutical supply chain risks: a systematic review

Science.gov (United States)

2013-01-01

Introduction Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. Objective In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Methods Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Results Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. Conclusion It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies. PMID:24355166

'Linkage' pharmaceutical evergreening in Canada and Australia

Science.gov (United States)

Faunce, Thomas A; Lexchin, Joel

2007-01-01

'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines. PMID:17543113

Pharmaceutical supply chain risks: a systematic review.

Science.gov (United States)

Jaberidoost, Mona; Nikfar, Shekoufeh; Abdollahiasl, Akbar; Dinarvand, Rassoul

2013-12-19

Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies.

Anticancer drug discovery and pharmaceutical chemistry: a history.