Clinical research in pharmaceutical development
著者
書誌事項
Clinical research in pharmaceutical development
(Drugs and the pharmaceutical sciences, v. 75)
Dekker, c1996
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注記
Includes index
内容説明・目次
内容説明
This multidisciplinary resource examines the role of the clinical research process in the development and approval of new pharmaceutical agents-discussing the practical application of techniques and providing the theoretical and philosophical foundations necessary for the creation of novel drugs.
目次
Introduction
Clinical Research in Pharmaceutical Development: An Overview, Barry Bleidt and Michael Montagne
Pharmageny: The New Product Development Process, Barry Bleidt
Keynote Section
Planned Research and Chance Discovery in Pharmaceutical Development, Albert Hofmann
The Drug Development Process
A Brief History of Clinical Research in Pharmaceutical Development, Donald D. Vogt and Michael Montagne
The Role of Clinical Research in the Drug Development Process, Michael Montagne
The FDA and the Regulatory Oversight of the Clinical Research Process in Drug Development, Loren Miller and Lloyd G. Millstein
Clinical Drug Research
Pharmacokinetics: Interactions of New Drugs and the Human Body, Gamal Hussein and Barry Bleidt
Planning, Coordinating, and Monitoring Clinical Trials, Barry Bleidt
The Protocol, Case Report Forms, and Patient Consent, Barry Bleidt
Patient Outcomes and Drug Usefulness, Barry Bleidt
Pharmacoeconomics and Quality of Life: Evaluating the Economic and Social Impact of Pharmaceuticals, William F. McGhan
Social and Legal Aspects
Pharmaceutical Marketing, Mickey Smith and Lisa Ruby Basara
Ethics in Clinical Drug Research, Robert L. McCarthy
Legal Aspects of Prescription Drugs Development in the Unites States, Horace D. Nalle
Social Aspects of Pharmaceutical Development, Michael Montagne
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