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Principles and practice of pharmaceutical medicine / Andrew J. Fletcher ... [et al., editors].

Contributor(s): Fletcher, Andrew JMaterial type: TextTextPublication details: Chichester, UK : Wiley, 2002. Description: xii, 541 p. : ill. ; 25 cmISBN: 0471986550Subject(s): Drug industry -- organization and administration | Drug evaluationDDC classification: 615/.19 LOC classification: RM301.25 | .P75 2002NLM classification: | QV 736 2002PR
Contents:
Overview of Pharmaceutical Medicine -- Pharmaceutical medicine as a medical speciality / Michael D Young -- What pharmaceutical medicine is and who does it / W Wardell and Susan Toland -- Competency-based training system for clinical research staff / Jay D Miller -- Drug Discover and Development: Introduction / Tony Fox and Lionel Edwards -- Design and Serendipity / Leslie J Molony -- Pharmaceutics / Anthony W. Fox -- Non-clinical toxicology / Frederick Reno -- Informed consent / Anthony W Fox -- Good Clinical Practices / Wendy Bohaychuk and Graham Ball -- Quality Assurance, quality control and audit / Donna Cullen -- Phase I: The first opportunity for extrapolation from animal data to human experience / Stephen Cyrt, Dennis McCarthy, Helen Heyn, Matthew Marler and Johan Gabrielsson -- Phase II and Phase III clinical studies / Anthony W Fox -- Phase IV development: Post-marketing studies / Lisa R Johnson-Pratt -- Over-the counter medicines / Paul Starkey -- Special Populations / Lionel D Edwards -- Biotechnology products and their development / David Shapiro and Anthony W Fox -- Orphan drugs / Bert Spilker -- Pharmacoeconomics: Economic evaluation and Humanistic outcomes / Raymond J Townsend, Jane T Osterhaus and J Gregory Boyer -- Pharmacoepidemiology and the pharmaceutical physician / Hugh Tilson -- Statistical principles and their application in bio-pharmaceutical research / Dan Anbar -- Data Management / Ty Lee and Michael Minor -- Patient compliance / Jean-Michel Metry -- Complementary medicine / Anthony W. Fox -- Drug Registration: Introduction / Anthony W Fox -- US Regulation / William Kennedy -- Emergency and compassionate-use INDs and accelerated NDA and ANDA approvals - Procedures, benefits and pitfalls / Anthony W Fox -- Japanese Regulations / Etienne Labbe -- EC Regulations / John Griffin -- International Committee on Harmonisation / Lionel D Edwards -- Medical Services -- Advertising Material / Gill Price -- Drug Labelling / Anthony W Fox -- Scientific Conferences / Z Dziewanovska -- Drug Surveillance / Howard J Dreskin and Win M Castle -- Disease Management - what does it mean / Roy Lilley -- Publishing Clinical Studies / Anthony W Fox -- Legal and Ethical Aspects: Introduction / Sara Croft and T Pratt -- Pharmaceutical product liability / Han W Choi and Howard B Yeon -- Patents / Gabriel Lopez -- Fraud and misconduct in clinical research / Frank Wells -- Business Aspects -- The Multinational Corporations: Cultural challenges, the legal/regulatory framework and the medico-commercial environment / R Drucker and RG Hughes -- Outsourcing clinical drug development activities to contract research organisation: Critical success factors / John R Vogel -- Third World / G Hammad -- Financial aspects of clinical trials / R G Hughes and N Brancaccio -- The Impact of Managed Care on the US Pharmaceutical Industry / Robert J Chaponis ... et al
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Overview of Pharmaceutical Medicine -- Pharmaceutical medicine as a medical speciality / Michael D Young -- What pharmaceutical medicine is and who does it / W Wardell and Susan Toland -- Competency-based training system for clinical research staff / Jay D Miller -- Drug Discover and Development: Introduction / Tony Fox and Lionel Edwards -- Design and Serendipity / Leslie J Molony -- Pharmaceutics / Anthony W. Fox -- Non-clinical toxicology / Frederick Reno -- Informed consent / Anthony W Fox -- Good Clinical Practices / Wendy Bohaychuk and Graham Ball -- Quality Assurance, quality control and audit / Donna Cullen -- Phase I: The first opportunity for extrapolation from animal data to human experience / Stephen Cyrt, Dennis McCarthy, Helen Heyn, Matthew Marler and Johan Gabrielsson -- Phase II and Phase III clinical studies / Anthony W Fox -- Phase IV development: Post-marketing studies / Lisa R Johnson-Pratt -- Over-the counter medicines / Paul Starkey -- Special Populations / Lionel D Edwards -- Biotechnology products and their development / David Shapiro and Anthony W Fox -- Orphan drugs / Bert Spilker -- Pharmacoeconomics: Economic evaluation and Humanistic outcomes / Raymond J Townsend, Jane T Osterhaus and J Gregory Boyer -- Pharmacoepidemiology and the pharmaceutical physician / Hugh Tilson -- Statistical principles and their application in bio-pharmaceutical research / Dan Anbar -- Data Management / Ty Lee and Michael Minor -- Patient compliance / Jean-Michel Metry -- Complementary medicine / Anthony W. Fox -- Drug Registration: Introduction / Anthony W Fox -- US Regulation / William Kennedy -- Emergency and compassionate-use INDs and accelerated NDA and ANDA approvals - Procedures, benefits and pitfalls / Anthony W Fox -- Japanese Regulations / Etienne Labbe -- EC Regulations / John Griffin -- International Committee on Harmonisation / Lionel D Edwards -- Medical Services -- Advertising Material / Gill Price -- Drug Labelling / Anthony W Fox -- Scientific Conferences / Z Dziewanovska -- Drug Surveillance / Howard J Dreskin and Win M Castle -- Disease Management - what does it mean / Roy Lilley -- Publishing Clinical Studies / Anthony W Fox -- Legal and Ethical Aspects: Introduction / Sara Croft and T Pratt -- Pharmaceutical product liability / Han W Choi and Howard B Yeon -- Patents / Gabriel Lopez -- Fraud and misconduct in clinical research / Frank Wells -- Business Aspects -- The Multinational Corporations: Cultural challenges, the legal/regulatory framework and the medico-commercial environment / R Drucker and RG Hughes -- Outsourcing clinical drug development activities to contract research organisation: Critical success factors / John R Vogel -- Third World / G Hammad -- Financial aspects of clinical trials / R G Hughes and N Brancaccio -- The Impact of Managed Care on the US Pharmaceutical Industry / Robert J Chaponis ... et al

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