Summary: That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.
Publications294 found, 100 shown here
- Pharmaceutical industry sponsorship and research outcome and quality: systematic reviewJoel Lexchin
School of Health Policy and Management, York University, Toronto, ON, Canada M3J 1P3
BMJ 326:1167-70. 2003....
- The price of innovation: new estimates of drug development costsJoseph A DiMasi
Tufts Center for the Study of Drug Development, Tufts University, 192 South Street, Suite 550, Boston, MA 02111, USA
J Health Econ 22:151-85. 2003..When compared to the results of an earlier study with a similar methodology, total capitalized costs were shown to have increased at an annual rate of 7.4% above general price inflation...
- How to improve R&D productivity: the pharmaceutical industry's grand challengeSteven M Paul
Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA
Nat Rev Drug Discov 9:203-14. 2010..We then propose specific strategies that could have the most substantial impact in improving R&D productivity...
- Evidence b(i)ased medicine--selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applicationsHans Melander
Medical Products Agency, Box 23, S 751 03 Uppsala, Sweden
BMJ 326:1171-3. 2003..To investigate the relative impact on publication bias caused by multiple publication, selective publication, and selective reporting in studies sponsored by pharmaceutical companies...
- Physicians and the pharmaceutical industry: is a gift ever just a gift?A Wazana
McGill University, Montreal, Quebec, Canada
JAMA 283:373-80. 2000....
- Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic reviewGeoffrey K Spurling
University of Queensland, Brisbane, Queensland, Australia
PLoS Med 7:e1000352. 2010..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...
- A survey of german physicians in private practice about contacts with pharmaceutical sales representativesKlaus Lieb
Klinik fur Psychiatrie und Psychotherapie, Universitätsmedizin Mainz, Mainz, Germany
Dtsch Arztebl Int 107:392-8. 2010..A further goal is to determine whether alternatives to current practices can be envisioned...
- Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than othersLisa Bero
Clinical Pharmacy and Health Policy, University of California, San Francisco, California, United States of America
PLoS Med 4:e184. 2007....
- Lessons from 60 years of pharmaceutical innovationBernard Munos
Lilly Corporate Center, Indianapolis, Indiana 46285, USA
Nat Rev Drug Discov 8:959-68. 2009..The implications of these findings and options to achieve sustainability for the pharmaceutical industry are discussed...
- Can the pharmaceutical industry reduce attrition rates?Ismail Kola
Basic Research at Merck Research Labs, 126 East Lincoln Avenue, Rahway, New Jersey 07075, USA
Nat Rev Drug Discov 3:711-5. 2004
- A national survey of physician-industry relationshipsEric G Campbell
Institute for Health Policy, Massachusetts General Hospital Partners Health Care System and Harvard Medical School, Boston, MA 02114, USA
N Engl J Med 356:1742-50. 2007..We surveyed physicians to collect information about their financial associations with industry and the factors that predict those associations...
- A social science perspective on gifts to physicians from industryJason Dana
Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, PA 15213, USA
JAMA 290:252-5. 2003
- Trial Registration at ClinicalTrials.gov between May and October 2005Deborah A Zarin
Lister Hill National Center for Biomedical Communications, National Library of Medicine, National Institutes of Health, Bethesda, MD 20894, USA
N Engl J Med 353:2779-87. 2005..gov database to describe patterns of trial registration before and after the implementation by journal editors of a new policy requiring registration as a prerequisite for publication...
- Pharmaceutical company funding and its consequences: a qualitative systematic reviewSergio Sismondo
Department of Philosophy, Queen s University, Kingston, Canada K7L 3N6
Contemp Clin Trials 29:109-13. 2008..It reviews two earlier results, and surveys the recent literature. Results are clear: Pharmaceutical company sponsorship is strongly associated with results that favor the sponsors' interests...
- Medical students' exposure to and attitudes about drug company interactions: a national surveyFrederick S Sierles
Department of Psychiatry and Behavioral Sciences, Rosalind Franklin University of Medicine and Science The Chicago Medical School, North Chicago, Ill 60064, USA
JAMA 294:1034-42. 2005..While exposure to and attitudes about drug company interactions among residents have been studied extensively, relatively little is known about relationships between drug companies and medical students...
- Conflict of interest in clinical practice guideline development: a systematic reviewSusan L Norris
Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, Oregon, United States of America
PLoS ONE 6:e25153. 2011..We performed a systematic review of the prevalence of COI and its effect on CPG recommendations...
- Trends in risks associated with new drug development: success rates for investigational drugsJ A DiMasi
Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts, USA
Clin Pharmacol Ther 87:272-7. 2010..The estimated transition probabilities were also higher for all clinical phases with respect to large molecules...
- Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort studyAndreas Lundh
The Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark
PLoS Med 7:e1000354. 2010..We investigated industry-supported trials' influence on journal impact factors and revenue...
- Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry?Sergio Sismondo
Queen s University, Kingston, Ontario, Canada
PLoS Med 4:e286. 2007
- Drug discovery: new models for industry-academic partnershipsCathy J Tralau-Stewart
Drug Discovery Centre and Business Development, Imperial College London SW7 2AZ, UK
Drug Discov Today 14:95-101. 2009..The introduction of an industry-like process and experienced management teams signals a revolution in discovery that benefits society by improving the value gained from publicly funded research...
- Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payersJakub Adamski
Ministry of Health, Warsaw, Poland
BMC Health Serv Res 10:153. 2010..There is though confusion surrounding the terminology as well as concerns with existing schemes...
- Influence of patients' requests for direct-to-consumer advertised antidepressants: a randomized controlled trialRichard L Kravitz
Center for Health Services Research in Primary Care, University of California, Davis, Sacramento, CA 95817, USA
JAMA 293:1995-2002. 2005..Critics charge that it leads to overprescribing, while proponents counter that it helps avert underuse of effective treatments, especially for conditions that are poorly recognized or stigmatized...
- Promoting transparency in pharmaceutical industry-sponsored researchJoseph S Ross
Section of General Internal Medicine, Yale University School of Medicine and Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, CT 06520 8093, USA
Am J Public Health 102:72-80. 2012..Minimizing marketing's impact on clinical trial research and strengthening the science will protect medical literature's integrity and the public's health...
- Evergreening, patent challenges, and effective market life in pharmaceuticalsC Scott Hemphill
Columbia Law School, Columbia University, New York, NY 10032, United States
J Health Econ 31:327-39. 2012..Overall, this evidence suggests that challenges serve to maintain, not reduce, the historical baseline of effective market life, thereby limiting the effectiveness of "evergreening" by branded firms...
- How pharmaceutical industry funding affects trial outcomes: causal structures and responsesSergio Sismondo
Queen s University, Philosophy, John Watson Hall, Kingston, Canada
Soc Sci Med 66:1909-14. 2008..Given these points, most proposed measures to respond to this bias are too piecemeal to be adequate...
- Industry sponsorship and research outcomeAndreas Lundh
The Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark
Cochrane Database Syst Rev 12:MR000033. 2012..This review is an update using more stringent methodology and also investigating sponsorship of device studies...
- Medical students' exposure to and attitudes about the pharmaceutical industry: a systematic reviewKirsten E Austad
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts, United States of America
PLoS Med 8:e1001037. 2011..Physicians' attitudes towards the industry can form early in their careers, but little is known about this key stage of development...
- Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic reviewAmy T Wang
Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA
BMJ 340:c1344. 2010..To explore a possible link between authors' financial conflicts of interest and their position on the association of rosiglitazone with increased risk of myocardial infarction in patients with diabetes...
- Do drug samples influence resident prescribing behavior? A randomized trialRichard F Adair
University of Minnesota, Minneapolis, Minn, USA
Am J Med 118:881-4. 2005..The purpose of the study was to determine whether access to drug samples influences resident prescribing decisions...
- 16S ribosomal DNA-based analysis of bacterial diversity in purified water used in pharmaceutical manufacturing processes by PCR and denaturing gradient gel electrophoresisMako Kawai
Quality Assurance Division, Biological Quality Assurance Section, Dainippon Pharmaceutical Co Ltd, Osaka 553 0001, Japan
Appl Environ Microbiol 68:699-704. 2002..and Stenotrophomonas sp., while the dominant bacterium was not closely related to previously characterized bacteria. These data suggest the importance of culture-independent methods of quality control for pharmaceutical water...
- Empirical uncertainty and moral contest: a qualitative analysis of the relationship between medical specialists and the pharmaceutical industry in AustraliaE Doran
Discipline of Clinical Pharmacology, School of Medical Practice and Population Health, University of Newcastle, New South Wales, Australia
Soc Sci Med 62:1510-9. 2006....
- Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemmaHans Georg Eichler
European Medicines Agency, Canary Wharf, London, UK
Nat Rev Drug Discov 7:818-26. 2008....
- Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaintsAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, Boston, Massachusetts, United States of America
PLoS Med 8:e1000431. 2011..However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing...
- Teaching appropriate interactions with pharmaceutical company representatives: the impact of an innovative workshop on student attitudesJames L Wofford
Department of Internal Medicine, Wake Forest University School of Medicine, Winston Salem, NC, USA
BMC Med Educ 5:5. 2005..We examined whether an innovative, mandatory workshop for third year medical students had immediate effects on knowledge and attitudes regarding interactions with PCRs...
- Economics of new oncology drug developmentJoseph A DiMasi
Tufts Center for the Study of Drug Development, Tufts University, Boston, MA 02111, USA
J Clin Oncol 25:209-16. 2007..Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development...
- Effect of exposure to small pharmaceutical promotional items on treatment preferencesDavid Grande
Department of Medicine and Leonard Davis Institute of Health Economics, University of Pennsylvania, 3641 Locust Walk, Philadelphia, PA 19104 6218, USA
Arch Intern Med 169:887-93. 2009..Our experiment measures whether exposure to these items results in more favorable attitudes toward marketed products and whether policies that restrict pharmaceutical marketing mitigate this effect...
- All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-givingDana Katz
University of Pennsylvania, USA
Am J Bioeth 3:39-46. 2003..Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated...
- Prescribers and pharmaceutical representatives: why are we still meeting?Melissa A Fischer
University of Massachusetts Medical School, 55 Lake Ave N, Worcester, MA 01655, USA
J Gen Intern Med 24:795-801. 2009..This work has primarily been with physicians and physician-trainees. Questions remain regarding why prescribers continue to meet with pharmaceutical representatives (PRs)...
- Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?Bodil Als-Nielsen
The Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark
JAMA 290:921-8. 2003..Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions...
- New developments in managing physician-industry relationshipsDavid J Rothman
Center on Medicine as a Profession, Columbia College of Physicians and Surgeons, 630 W 168th St, New York, NY 10032, USA
JAMA 300:1067-9. 2008
- Direct-to-consumer advertising under the radar: the need for realistic drugs policy in AustraliaF J MacKenzie
Centre for Values, Ethics and the Law in Medicine, University of Sydney, Sydney, New South Wales, Australia
Intern Med J 37:224-8. 2007..The prohibition is further threatened by recent international trade agreements. These factors make DTCA-PM inevitable and legislative and professional bodies need to acknowledge this to create a more effective health-care policy...
- Can literature analysis identify innovation drivers in drug discovery?Pankaj Agarwal
Computational Biology Department, GlaxoSmithKline Pharmaceuticals, 709 Swedeland Road, PO Box 1539, King of Prussia, Pennsylvania 19406, USA
Nat Rev Drug Discov 8:865-78. 2009....
- Nurses' reported influence on the prescription and use of medicationA Jutel
Otago Polytechnic, Dunedin 9054, New Zealand
Int Nurs Rev 57:92-7. 2010..To identify the activities senior nurses report undertaking that may influence the prescription and use of medicines...
- Quality of pharmaceutical advertising and gender bias in medical journals (1998-2008): a review of the scientific literatureBelén Cambronero Saiz
Communication and Social Psychology Department, University of Alicante, San Vicente del Raspeig Alicante, Spain
Gac Sanit 26:469-76. 2012..To review the scientific literature on pharmaceutical advertising aimed at health professionals in order to determine whether gender bias has decreased and the quality of information in pharmaceutical advertising has improved over time...
- Doctors and drug companies--scrutinizing influential relationshipsEric G Campbell
Massachusetts General Hospital and Harvard Medical School, Boston, USA
N Engl J Med 357:1796-7. 2007
- The effect of educational gifts from pharmaceutical firms on medical students' recall of company names or productsW S Sandberg
Department of Medicine, University of Chicago, Illinois 60637, USA
Acad Med 72:916-8. 1997..To assess the influence of pharmaceutical advertising (in the form of books) directed at medical students and also to examine students' attitudes toward pharmaceutical representatives after interacting with them...
- The influence of the 'organizational factor' on compound quality in drug discoveryPaul D Leeson
AstraZeneca R and D Charnwood, Bakewell Road, Loughborough, Leicestershire LE11 5RH, UK
Nat Rev Drug Discov 10:749-65. 2011..On the basis of our analysis, we conclude that a substantial sector of the pharmaceutical industry has not modified its drug design practices and is still producing compounds with suboptimal physicochemical profiles...
- Effect of restricting contact between pharmaceutical company representatives and internal medicine residents on posttraining attitudes and behaviorB B McCormick
Mount Sinai Hospital, 600 University Ave, Room 427, Toronto, Ontario, Canada M5G 1X5
JAMA 286:1994-9. 2001..CONCLUSIONS: Policies restricting PCR access to internal medicine trainees and the amount of contact during residency appear to affect future attitudes and behavior of physicians...
- Models for financing the regulation of pharmaceutical promotionJoel Lexchin
School of Health Policy and Management, York University, 4700 Keele St, Toronto, ON M3J 1P3, Canada
Global Health 8:24. 2012..However, it involves an initial outlay of money that is currently not being spent and many national governments, in both rich and poor countries, are unwilling to incur extra costs...
- Influence of commercial information on prescription quantity in primary careFrancisco Caamano
Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Spain
Eur J Public Health 12:187-91. 2002..The objective of this study is to identify the effect of the perceived quality stated in commercial information, its uses, and how physicians perceive the influence it has on prescription amounts...
- Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribingDeborah Korenstein
Department of Medicine, Mount Sinai School of Medicine, New York, New York, United States of America
PLoS ONE 6:e23336. 2011..Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing...
- Reporting of conflicts of interest in meta-analyses of trials of pharmacological treatmentsMichelle Roseman
Department of Psychiatry, McGill University, Montreal, Quebec, Canada
JAMA 305:1008-17. 2011..Authors of meta-analyses, however, are not required to report COIs disclosed in original reports of included RCTs...
- Vulnerability of health to market forcesMayer Brezis
Center for Bioethics, Brigham and Women s Hospital and Harvard Medical School, Boston, MA, USA
Med Care 49:232-9. 2011..This article reviews adverse influences of for-profit enterprises on health care and public health, and examines significance for public policy...
- Those who have the gold make the evidence: how the pharmaceutical industry biases the outcomes of clinical trials of medicationsJoel Lexchin
School of Health Policy and Management, York University, 4700 Keele St, Toronto, ON, M3J 1P3, Canada
Sci Eng Ethics 18:247-61. 2012..What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials...
- Trends in antimicrobial drug development: implications for the futureBrad Spellberg
Research and Education Institute and Department of Medicine, Harbor University of California, Los Angeles Medical Center, Torrance, California 90502, USA
Clin Infect Dis 38:1279-86. 2004..Despite the critical need for new antimicrobial agents, the development of these agents is declining. Solutions encouraging and facilitating the development of new antimicrobial agents are needed...
- Effect of educational interventions and medical school policies on medical students' attitudes toward pharmaceutical marketing practices: a multi-institutional studyAudiey C Kao
Ethics Group, American Medical Association, Chicago, Illinois 60654, USA
Acad Med 86:1454-62. 2011....
- An assessment of R&D productivity in the pharmaceutical industryNicola Dimitri
Department of Economics, University of Siena, Siena, Italy
Trends Pharmacol Sci 32:683-5. 2011..However, a cost-benefit probabilistic analysis reveals that despite high costs, the clinical phase shows healthy productivity, whereas the early phase, particularly lead optimization, exhibits very low productivity...
- Modified versus standard intention-to-treat reporting: are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional studyAlessandro Montedori
Regional Health Authority of Umbria, Perugia, Italy
Trials 12:58. 2011....
- Estimated research and development costs of rotavirus vaccinesDonald W Light
University of Medicine and Dentistry of New Jersey, 10 Adams Drive, Princeton, NJ 08540, USA
Vaccine 27:6627-33. 2009..Better vaccines are a shared project between companies and public health agencies; greater transparency and consistency in reporting of R&D costs is needed so that fair prices can be established...
- Trade, TRIPS, and pharmaceuticalsRichard D Smith
Health Policy Unit, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK
Lancet 373:684-91. 2009..Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus...
- Norwegian medical students' attitudes towards the pharmaceutical industryDordi Lea
Department of Laboratory Medicine, Children s and Women s Health, Norwegian University of Science and Technology, Trondheim, Norway
Eur J Clin Pharmacol 66:727-33. 2010..We have assessed the extent of contact between Norwegian medical students and the pharmaceutical industry as well as the attitudes of these students towards the pharmaceutical industry...
- Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines AgencyJan Regnstrom
European Medicines Agency EMEA, London, UK
Eur J Clin Pharmacol 66:39-48. 2010....
- The impact of disclosing financial ties in research and clinical care: a systematic reviewAdam Licurse
Section of General Internal Medicine, Yale School of Medicine, PO Box 208025, New Haven, CT 06520 8025, USA
Arch Intern Med 170:675-82. 2010..Despite increased demand for disclosure of physician and researcher financial ties (FTs) to industry, little is known about patients', research participants', or journal readers' attitudes toward FTs...
- Invited Article: Conflicts of interest for authors of American Academy of Neurology clinical practice guidelinesR G Holloway
Department of Neurology, University of Rochester, 601 Elmwood Avenue, Box 673, Rochester, NY 14642, USA
Neurology 71:57-63. 2008..Clinical practice guidelines (CPGs) shape clinical care worldwide but are prone to potential error and bias due to conflicts of interest (COI)...
- Antibiotics at the crossroadsCarl Nathan
Department of Microbiology and Immunology, Weill Cornell Medical College, and Weill Graduate School of Medical Sciences of Cornell University, 1300 York Avenue, New York 10021, USA
Nature 431:899-902. 2004
- The inverse benefit law: how drug marketing undermines patient safety and public healthHoward Brody
Institute for the Medical Humanities, Department of Family Medicine, University of Texas Medical Branch, Galveston, TX 77555 1311, USA
Am J Public Health 101:399-404. 2011..The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing...
- Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working GroupPaul Gallo
Novartis Pharmaceuticals, East Hanover, NJ 07936, USA
J Biopharm Stat 16:275-83; discussion 285-91, 293-8, 311-2. 2006..Three particular areas where it is felt that adaptive designs can be utilized beneficially are discussed: dose finding, seamless Phase II/III trials designs, and sample size reestimation...
- Stategic trends in the drug industryJürgen Drews
Bear Stearns Health Innoventures, LLC, New York, NY, USA
Drug Discov Today 8:411-20. 2003..The first tier of the biotechnology industry has now become the most productive segment of the drug industry. It combines a high degree of innovative spirit with solid pharmaceutical professionalism...
- Reform of drug regulation--beyond an independent drug-safety boardWayne A Ray
Center for Education and Research on Therapeutics, Vanderbilt University School of Medicine, Nashville, USA
N Engl J Med 354:194-201. 2006
- Association of funding and findings of pharmaceutical research at a meeting of a medical professional societyThomas E Finucane
Division of Geriatric Medicine and Gerontology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland 21224, USA
Am J Med 117:842-5. 2004..To evaluate the association between funding and findings of pharmaceutical research presented at an annual meeting of a medical professional society...
- The ADVANTAGE seeding trial: a review of internal documentsKevin P Hill
McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA
Ann Intern Med 149:251-8. 2008..Seeding trials, clinical studies conducted by pharmaceutical companies that are designed to seem as if they answer a scientific question but primarily fulfill marketing objectives, have not been described in detail...
- Accuracy of pharmaceutical advertisements in medical journalsPilar Villanueva
Fundación Instituto de Investigación en Servicios de Salud, Valencia, Spain
Lancet 361:27-32. 2003..We aimed to assess whether the references about efficacy, safety, convenience, or cost of antihypertensive and lipid-lowering drugs included in advertisements supported the promotional claims...
- Productivity in pharmaceutical-biotechnology R&D: the role of experience and alliancesPatricia M Danzon
University of Pennsylvania, Health Care Management Department, The Wharton School, 3641 Locust Walk, Philadelphia, PA 19104, USA
J Health Econ 24:317-39. 2005..Products developed in an alliance tend to have a higher probability of success, at least for the more complex phase 2 and phase 3 trials, and particularly if the licensee is a large firm...
- Prevalence of counterfeit anthelminthic medicines: a cross-sectional survey in CambodiaMohiuddin Hussain Khan
Department of Drug Management and Policy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Ishikawa, Japan
Trop Med Int Health 15:639-44. 2010..To assess the prevalence of counterfeit anthelminthic medicines in Cambodia, and to determine influential factors...
- Disease mongering in drug promotion: do governments have a regulatory role?Barbara Mintzes
Therapeutics Initiative, Department of Anaesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, British Columbia, Canada
PLoS Med 3:e198. 2006
- Computational toxicology--a tool for early safety evaluationCedric Merlot
Genyotex SA, Chemin des Aulx 14, 1228 Plan les Ouates, Geneva, Switzerland
Drug Discov Today 15:16-22. 2010..The current trend is to make simpler predictions, closer to the mechanism of action, and to follow them up with in vitro or in vivo assays as appropriate...
- Examining the production costs of antiretroviral drugsEloan Pinheiro
Department of HIV AIDS, World Health Organization, Geneva, Switzerland
AIDS 20:1745-52. 2006....
- Managing conflicts of interest in the conduct of clinical trialsKarine Morin
Council on Ethical and Judicial Affairs, Ethics Standards Group, American Medical Association, 515 N State St, Chicago, IL 60610, USA
JAMA 287:78-84. 2002..Finally, the article addresses disclosure of financial incentives and related funding issues...
- Spending on new drug development1Christopher Paul Adams
Bureau of Economics, Federal Trade Commission, Washington, DC 20580, USA
Health Econ 19:130-41. 2010..The paper also estimates expenditure on drugs in various therapeutic categories...
- An innovative approach to educating medical students about pharmaceutical promotionM S Wilkes
University of California Davis School of Medicine, 95616, USA
Acad Med 76:1271-7. 2001..The authors also provide information suggesting that the program increased the uncertainty many students felt about the accuracy and ethics of standard drug "detailing."..
- Pharmacokinetic drug-drug interaction potentials for therapeutic monoclonal antibodies: reality checkKathleen Seitz
Pharmacokinetics, Modeling and Simulation, Clinical Pharmacology and Experimental Medicine, Centocor Research and Development, Malvern, PA 19355, USA
J Clin Pharmacol 47:1104-18. 2007..In particular, pharmacokinetic interaction studies with any marketed drugs that are likely to be coadministered with the monoclonal antibody will yield the most clinically useful information for practitioners and patients alike...
- Tackling corruption in the pharmaceutical systems worldwide with courage and convictionJ C Cohen
Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario, Canada
Clin Pharmacol Ther 81:445-9. 2007....
- European Medicines Agency workshop on biosimilar monoclonal antibodies: July 2, 2009, London, UKJanice M Reichert
Tufts Center for the Study of Drug Development, Boston, MA, USA
MAbs 1:394-416. 2009..Proceedings of the workshop are presented in Part 1 of this report, and discussed within the context of the legal, regulatory and business environments of the European Union, Asia and the United States in Parts 2, 3 and 4, respectively...
- Confidentiality laws and secrecy in medical research: improving public access to data on drug safetyAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Boston, Massachusetts, USA
Health Aff (Millwood) 26:483-91. 2007..We suggest regulatory and legislative policy changes regarding how the FDA handles confidential information that can improve understanding of the risks of prescription drugs...
- An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophreniaJohn H Montgomery
Department of Psychiatry and Human Behavior, University of Mississippi Medical Center, Jackson, MS, USA
Control Clin Trials 25:598-612. 2004..In this article, randomized controlled trials of second generation antipsychotics in schizophrenia are reviewed and analyzed with respect to funding source (industry vs. non-industry funding)...
- Drug-review deadlines and safety problemsDaniel Carpenter
Department of Government, Faculty of Arts and Sciences, Harvard University, Cambridge, MA 02138, USA
N Engl J Med 358:1354-61. 2008..Critics have suggested that these deadlines may result in rushed approvals and the emergence of unanticipated safety problems once a product is in clinical use...
- Pharmaceutical risk-sharing agreementsJoseph P Cook
NERA Economic Consulting, White Plains, NY, USA
Pharmacoeconomics 26:551-6. 2008..While there may be difficulties in devising such schemes for every product, such risk-sharing plans may become a staple feature of the market in the future...
- New drugs for neglected diseases: from pipeline to patientsBernard Pecoul
Drugs for Neglected Diseases Initiative, Geneva, Switzerland
PLoS Med 1:e6. 2004
- Characteristics of primary health care units with focus on drug information from the pharmaceutical industry and adherence to prescribing objectives: a cross-sectional studyDaniel Carlzon
Department of Clinical Pharmacology, Sahlgrenska University Hospital, 413 45 Goteborg, Sweden
BMC Clin Pharmacol 10:4. 2010....
- Closing the door on pharma? A national survey of family medicine residencies regarding industry interactionsAdriane Fugh-Berman
Department of Pharmacology, Georgetown University Medical Center, Washington, DC 20057, USA
Acad Med 86:649-54. 2011..To assess the extent and type of interactions U.S. family medicine residencies permit industry to have with medical students and residents...
- Getting to yes: corporate power and the creation of a psychopharmaceutical blockbusterKalman Applbaum
Department of Anthropology, University of Wisconsin Milwaukee, Milwaukee, WI 53201, USA
Cult Med Psychiatry 33:185-215. 2009..The paper concludes with a discussion of corporate power...
- Financial ties between DSM-IV panel members and the pharmaceutical industryLisa Cosgrove
University of Massachusetts, Boston, USA
Psychother Psychosom 75:154-60. 2006..The authors examined the degree and type of financial ties to the pharmaceutical industry of panel members responsible for revisions of the Diagnostic and Statistical Manual of Mental Disorders(DSM)...
- The influence of market exclusivity on drug availability and medical innovationsGregory J Glover
Pharmaceutical Law Group, PC, Washington, DC 20036 4305, USA
AAPS J 9:E312-6. 2007....
- Regulatory agencies, pharmaceutical information and the Internet: a European perspectiveRafael Bauschke
Max Weber Institute of Sociology, University of Heidelberg, Germany
Health Policy 104:12-8. 2012..The reluctant position of agencies can be attributed to sectoral path dependencies, the regulatory approach and a lack of regulatory resources...
- The gold industry standard for risk and cost of drug and vaccine development revisitedE S Pronker
Vacceleron, Utrecht, The Netherlands
Vaccine 29:5846-9. 2011..Published cumulative success rates range from 7% to 78% and investments calculations span US$ 0.8 to 1.7 Billion. Obviously this disserves further clarification?..
- The high cost of free lunchL Lewis Wall
Department of Obstetrics and Gynecology, Washington University, St Louis, Missouri 63110, USA
Obstet Gynecol 110:169-73. 2007..We argue that physician prescribing habits should be based upon careful consideration of what medication is really in the patient's best clinical interests, not on who most recently provided the doctor with a free lunch...
- Remuneration for non-interventional studies--results of a survey in the pharmaceutical industry in GermanyThorsten Ruppert
vfa Research Based Pharmaceutical Companies, Berlin, Germany
Ger Med Sci 10:Doc04. 2012..Accordingly, the fee varies based on the fee schedule for physicians (German: Gebührenordnung für Ärzte) by taking into account the actual efforts at the study center...
- A tragically naive Canadian law for tragically neglected global healthAmir Attaran
Canada Research Chair in Law, Population Health and Global Development Policy, Institute of Population Health and Faculties of Law and Medicine, University of Ottawa, Ottawa, Ont
CMAJ 176:1726-7. 2007
- False Claims Act prosecution did not deter off-label drug use in the case of neurontinAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, Boston, Massachusetts, USA
Health Aff (Millwood) 30:2318-27. 2011....
- Off-label or off-limits?Mark Ratner
Nat Biotechnol 26:867-75. 2008
- Health advocacy organizations and the pharmaceutical industry: an analysis of disclosure practicesSheila M Rothman
Division of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, USA
Am J Public Health 101:602-9. 2011..Absent this disclosure, legislators, regulators, and the public cannot evaluate possible conflicts of interest or biases in HAO advocacy...
- Cannabinoid Mechanisms in Human Gastrointestinal Motor and Sensory FunctionsMICHAEL L CAMILLERI; Fiscal Year: 2010..These actions may be relevant to develop new treatments for IBS. The studies will also provide further understanding of the potential of medications like medical marijuana on stomach function that may be relevant to appetite control. ..
- Genome-wide case-only study of antihypertensive drug-gene interactionsBruce M Psaty; Fiscal Year: 2010....
- Conflict of Interest in Clinical Practice Guideline DevelopmentSusan L Norris; Fiscal Year: 2010..Understanding the impact of industry relationships will help guideline sponsors to develop appropriate policies for managing conflict of interest. ..
- ANTIHYPERTENSIVE DRUG/GENE INTERACTIONS AND CV EVENTSBruce Psaty; Fiscal Year: 2004..58 (the difference between an odds ratio of 0.46 and 0.79 in subjects with and without the variant, respectively). Power for other primary aims is excellent; power for secondary aims is good to excellent. ..
- Transciption-independent Signaling by IL1 in NeuronsTamas Bartfai; Fiscal Year: 2006..molecular mechanisms of action will contribute to a better understanding of the neuronal effects of IL-1Beta in the hypothalamus, where it regulates the HPA axis, the temperature setpoint, and fever response [unreadable] [unreadable]..
- Trends in and Outcomes of Medication Use in Older AdultsBruce Psaty; Fiscal Year: 2004..abstract_text> ..
- Pharmacogenetics and Cardiovascular EventsBruce Psaty; Fiscal Year: 2006..The primary defense is replication: we would therefore welcome collaboration from others in the Pharmacogenetics Network in validation efforts. ..
- Function of galanin receptor subtypes in the hippocampusTamas Bartfai; Fiscal Year: 2006..Also, because galanin has been shown to have anti-epileptic actions, understanding how this peptide regulates seizures could have clinical applications in the treatment of epilepsy. ..
- Informed Consent in Private Sector Mental Health ResearchJill Fisher; Fiscal Year: 2004..Additionally, the results will begin to provide a basis for valid recommendations to address the ethical challenges raised by the privatization of medical research. ..
- Hormone Replacement Therapy and Prothrombotic VariantsBruce Psaty; Fiscal Year: 2005..Power for primary and secondary aims is excellent. Information from this project may help physicians counsel women about HRT to maximize either effectiveness, or safety, or both. ..
- A Paradox of Genetic Research: Race, Ethnicity & DiseaseSHEILA ROTHMAN; Fiscal Year: 2005..The project will generate four products that seek to contribute to a climate of increased communication and cooperation between these two groups. ..
- ALPHA 2 ADRENERGIC CONTROL IN IRRITABLE BOWEL SYNDROMEMichael Camilleri; Fiscal Year: 2008..Significance: This project will characterize pharmacogenetic mechanisms determining the response to clonidine through studies of candidate genes that control alpha2-adrenoreceptor function and norepinephrine transport in IBS. ..
- ALPHA-2 ADRENERGIC CONTROL OF COLONIC FUNCTION IN IBSMichael Camilleri; Fiscal Year: 2007..abstract_text> ..
- MUTATIONS, HORMONE THERAPY, AND VENOUS THROMBOEMBOLISMBruce Psaty; Fiscal Year: 2001....
- WGA Study to Identify Genetic Variants Associated with CV Events in CHSBruce Psaty; Fiscal Year: 2009..The proposed three-part study is efficient, has excellent power to detect small to modest-sized hazard ratios, provides a large sample of WG scans for aim 2, and includes an external replication. (End of Abstract) ..
- MOLECULAR ANALYSIS OF CHROMOSOME SEGREGATION IN YEASTPeter Sorger; Fiscal Year: 2005..The relevance of yeast kinetochores to human biology is emphasized by the extensive homology between the yeast proteins that are the focus of this study and as-yet poorly understood human kinetochore proteins...
- Impact of Hand Hygiene Guideline on Infections and CostsElaine Larson; Fiscal Year: 2005..abstract_text> ..
- Government Industry Relationships in ScienceEric Campbell; Fiscal Year: 2008..unreadable] [unreadable] [unreadable]..
- Lipoxygenases in AtherosclerosisGarret FitzGerald; Fiscal Year: 2007..Overall, these studies will illuminate the importance of lipoxygenase pathways in macrophages in relation to atherosclerotic disease. ..
- Interdisciplinary Research:Antimicrobial Resistance(RMI)Elaine Larson; Fiscal Year: 2006..In the final year, plans for a sustainable Consortium on antimicrobial resistance will be formalized. [unreadable] [unreadable]..
- NEW MEDIATORS OF CLINICAL LUNG MATURATIONAlan Jobe; Fiscal Year: 2007..A goal is to identify a mediator with potential for clinical use to induce lung maturation. ..
- Academic Industry Relationships in GeneticsEric Campbell; Fiscal Year: 2006..Results will be disseminated through publications in peer-reviewed journals and presentations at scientific meetings. ..
- NMR spectroscopy instrumentation for probing intermolecular interationsMaurizio Pellecchia; Fiscal Year: 2007..unreadable] [unreadable] [unreadable]..
- Women's physical activity and eating habits: Influence of work-family balanceJoseph G Grzywacz; Fiscal Year: 2011..The results can also be used to inform workplace programs designed to promote healthy physical activity and eating habits. ..
- Targeted Liposomal Doxorubicin Delivery to LeukemiaRobert Lee; Fiscal Year: 2007..abstract_text> ..
- Database Software for Complex Cell Biological PathwaysROBERT PHAIR; Fiscal Year: 2005....
- Potent and Safe Inhibitors of B. anthracis Lethal FactorMaurizio Pellecchia; Fiscal Year: 2009..The inhibitors of LF we will develop, most likely when used in combination with antibiotics, should facilitate and assure the recovery of patients who harbor the disease. ..
- Reimbursement Policy and Cancer ChemotherapyJoseph Newhouse; Fiscal Year: 2009..Understanding its impact on chemotherapy treatment patterns has important implications not only for Medicare spending but also for the welfare of beneficiaries with cancer. ..
- PHARMACOKINETICS AND FETAL EXPOSURE TO NARCOTICSHazel Szeto; Fiscal Year: 2002..The proposed studies will provide new information on the functional roles of opiate receptor subtypes in the fetus, and should be helpful in the design of better analgesics for perinatal use. ..
- Effects of Mental Parity on High-Cost and Severely-Ill IndividualsHaiden A Huskamp; Fiscal Year: 2011..We will estimate a combination of two-part random-effects models for longitudinal data, latent class random-effects models, logistic regression models, Poisson regression models, and hazard models to address these aims. ..
- INTRACEULLULAR ANTI-TAT ANTIBODIES FOR AIDS GENE THERAPYWayne Marasco; Fiscal Year: 2002..Our immediate goal is to use this knowledge to aid in small molecule inhibitor design, our long term goal is to use these intrabodies in a clinical gene therapy trial. ..
- Purchase of BIAcore 3000 InstrumentSatya Yadav; Fiscal Year: 2003..In this way, the authentic presentation of the cytoplasmic domain as visualized from the interior of the cell will be maintained. ..
- Enhancement of Tuberculosis Vaccine by ThymosinCynthia Tuthill; Fiscal Year: 2003..Findings that indicate superior performance to BCG vaccinated controls will provide the basis for further evaluations in the more sensitive guinea pig model of infection. ..
- Role of Grb3-3 in T-cell Activation & HIV-1 ReplicationWayne Marasco; Fiscal Year: 2003..These studies will advance our understanding of HIV-1/cellular protein interactions are involved in the pathogenesis of HIV-1-infection and AIDS. ..
- Innate Effectors of rAls3p-N Anti-Candida VaccineBrad J Spellberg; Fiscal Year: 2010..PNS 398/2590 (Rev. 11/07) Page - Continuation Format Page ..
- COMPLEX CARBOHYDRATES IN NEURONAL CELL FUNCTIONRONALD SCHNAAR; Fiscal Year: 2004....
- Pharmacotherapy for Minor DepressionRobert Howland; Fiscal Year: 2004..The results of this study will have profound public health implications by improving our understanding of the efficacy of SJW and standard antidepressants for the treatment of MinorD. ..
- PROPHYLACTIC COGNITIVE THERAPY FOR DEPRESSIONMichael E Thase; Fiscal Year: 2010....
- Psychobiology of IV Naloxone & Lactate in NormalsDonald Klein; Fiscal Year: 2005..This would further validate this model. It may also suggest new approaches to anti-panic agents, such as mixed opiate agonist-antagonist. ..
- Dihydrolipoamide Acyltransferase:Target for ChemotherapyCarl Nathan; Fiscal Year: 2004..abstract_text> ..
- Phase II Study of 44Gy from 131I-81C6 for CNS TumorsDavid Reardon; Fiscal Year: 2004..To further define the toxicity of this approach and Specific Aim 3.To determine the impact of this therapy on quality of life. ..
- BcI-2 family proteins as targets for chemoprevention an*Maurizio Pellecchia; Fiscal Year: 2005....
- Mobile Tool for Adolescent Diabetes ManagementAaron Carroll; Fiscal Year: 2008..This research request will form the foundation of an R01 proposal to rigorously study the tool's impact on adolescent diabetes management ..
- Novel Chemotypes Against Influenza A VirusMaurizio Pellecchia; Fiscal Year: 2007..The chemical structures, SAR data and range of biochemical activities of the resulting compounds will provide a framework onto which to develop potentially novel anti-influenza therapies. [unreadable] [unreadable] [unreadable]..
- Building a Technology Trust in GenomicsANTHONY SO; Fiscal Year: 2008..In so doing, perhaps those in resource-poor settings may trust that IP barriers do not delay or block their access to genomic technology. [unreadable] [unreadable]..
- Adrenergic Antagonism During Murine CandidiasisBrad Spellberg; Fiscal Year: 2008..For these reasons, the potential for adrenergic antagonism to act as an effective immunotherapy is highly meritorious of investigation in this training application. ..
- Anti-apoptotic compounds for treatment of brain ischemiaMaurizio Pellecchia; Fiscal Year: 2010..abstract_text> ..
- RESEARCH TRAINING IN CHILD PSYCHOPATHOLOGY & TREATMENTMark Riddle; Fiscal Year: 2008..This training program is thoughtfully organized to produce a cadre of graduates who will become productive independent interventions researchers in child and adolescent major mental disorders. ..
- PHASE III TRIAL OF TETRATHIOMOLYBDATE IN PRIMARY BILIAR*George Brewer; Fiscal Year: 2007..Abstract Not Provided ..
- Enhancing axon regeneration by multi-inhibitor blockingRONALD SCHNAAR; Fiscal Year: 2005..The resulting data may provide insight on the relative contributions of the different ARI's in an in vivo model, and may support evaluation of new approaches to enhance axon regeneration after CNS injury. ..
- Antidepressant Use and SuicideSusan Busch; Fiscal Year: 2009..The significance of this project lies in its potential to help clinicians and policymakers assess and manage competing risk and benefit claims. ..
- A MULTI-CENTER THERAPY TRIAL FOR ACUTE LIVER FAILUREWilliam Lee; Fiscal Year: 2004..The overall goal is to apply modern clinical, epidemiological and virological techniques to the study of this rare but devastating illness. ..
- Human Anti-Macaque CCR5 Mabs for Passive ImmunotherapyWayne Marasco; Fiscal Year: 2007..These studies will supply important information that may be directly applicable to similar human clinical settings. ..
- Heart Rate Variability Response to CAM in PediatricsKathi Kemper; Fiscal Year: 2007..The K24 award will free her from clinical, teaching and administrative demands, and allow her to focus her time and attention on research and mentoring activities described in this application. ..
- The Medial Entorhinal Cortex and Temporal Lobe EpilepsyKAREN WILCOX; Fiscal Year: 2007..These experiments will set the stage for the development of future therapeutic interventions for the treatment of pharmacoresistant epilepsy. [unreadable] [unreadable]..
- EFFECTS OF PARTNER VIOLENCE VICTIMIZATION IN DRUG USEMerrill Singer; Fiscal Year: 2002....
- Biacore T100Charles Arntzen; Fiscal Year: 2007..unreadable] [unreadable]..
- EMPLOYMENT DYNAMICS IN RESPONSE TO WELFARE REFORMIsaac Montoya; Fiscal Year: 2002..Analyses will yield an Employment Readiness Profile that summarizes the changes over time within and between the samples of drug users and non-drug users and the independent effect of drug use on achieving employment. ..
- Zeiss LSM510 Confocal Multiphoton/META MicroscopeSteven Finkbeiner; Fiscal Year: 2004..The NIH will benefit because the microscope will significantly expand the abilities of the major users, enabling them to achieve funded aims and to perform previously unfeasible experiments. ..
- Central betal adrenergic receptors and behaviorHan Ting Zhang; Fiscal Year: 2004..This will lead to the better understanding of pathophysiology and pharmacotherapy of depression. ..
- Differential Trust & Cancer Care within Black SubgroupsLaVera Crawley; Fiscal Year: 2007..By building on the strengths of national datasets, this study addresses several of the limitations of our current understanding of cancer prevention behaviors among black ethnic subgroups. ..
- 2008 Engineering in Medicine and Biology Conference (EMBC)Paolo Vicini; Fiscal Year: 2008..The intent of this is to broaden participation by junior scientists in the scientific activities of this large international meeting. [unreadable] [unreadable] [unreadable]..
- RESOURCE FACILITY FOR POPULATION KINETICSDavid Foster; Fiscal Year: 2007..RFPK involves four major universities, all of which contribute unique expertise to the individual projects. Its Administrative Core is located at the University of Washington. ..
- Exploratory Trial of Curcumin in Pancreatic CancerRazelle Kurzrock; Fiscal Year: 2005..These studies should provide the foundation for the development of curcumin as an anticancer agent and may lead to a novel approach to the management of pancreatic cancer. ..
- Animal Models in Type 1 Diabetes and Multiple SclerosisMatthias von Herrath; Fiscal Year: 2006..Additionally, we expect that this symposium will be of interest to junior faculty working in the areas of autoimmune disease research, as well as patient advocacy groups. [unreadable] [unreadable] [unreadable]..
- Role of a Non-Tolerant Autoantigen in AutoimmunityMatthias von Herrath; Fiscal Year: 2007..abstract_text> ..
- Apoptosis in myelofibrosis with myeloid metaplasiaRuben Mesa; Fiscal Year: 2006..abstract_text> ..
- CXCR3 Chemokines in Type I DiabetesMatthias von Herrath; Fiscal Year: 2009..Aim 1: Importance of IP-10 in the pathogenesis of T1D - therapeutic blockade and mechanistic analyses. Aim 2: Importance of IP-10 during islet allograft rejection - therapeutic blockade and mechanistic analyses. ..
- MECHANISMS OF CARDIOTOXICITY OF ANTIPSYCHOTIC DRUGSDavid Flockhart; Fiscal Year: 2001....
- DNA Vaccination & Regulatory Cells in Type I DiabetesMatthias von Herrath; Fiscal Year: 2006..abstract_text> ..
- IMMUNE TOLERANCE INDUCTION BY APOPTOTIC BODIESMatthias von Herrath; Fiscal Year: 2005..abstract_text> ..
- How Does blockade of CD40/CD40L Prevent Autoimmunity?Matthias von Herrath; Fiscal Year: 2005..Therefore, the direct comparison of three autoimmune models will enable us to define, which in vivo consequences of costimulation blockade occur more commonly and which are restricted to a given experimental situation. ..
- Farnesyltransferase Inhibitor Therapy for MyelodysplasiaRazelle Kurzrock; Fiscal Year: 2002....