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Informationen zum Autor John Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM; Director, Asklepieion Consultancy Ltd; Visiting Professor, University of Surrey Postgraduate Medical School; Former Director, ABPI; Formerly Professional Head of the Medicines Division, DHSS, London. John Posner BSc PhD MBBS FRCP FFPM; Independent Consultant in Pharmaceutical Medicine, John Posner Consulting, Beckenham, Kent, UK; Chairman of the Board of Examiners of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians (UK). Geoffrey R. Barker TD, BSc, MSc, FDSRCD, FRCS, FFPM; Adj. Professor Immunology, Duke University Medical Center, NC, USA; Executive and Limited Partner, Pappas Ventures, NC, USA; Consultant to EGeen (USA), Abingworth LLP (UK), Reuters; Insight Community of Experts; Trustee Member of the Board of the Faculty of Pharmaceutical Physicians of The Royal Colleges of Physicians UK. Klappentext The Textbook of Pharmaceutical Medicine is the standard reference for everyone working and learning in pharmaceutical medicine. It is a comprehensive resource covering the processes and practices by which medicines are developed, tested and approved, and the recognised text for the Diploma in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine.This fully revised Seventh Edition, which includes two new Editors, encompasses current developments within pharmaceutical medicine with new chapters on biological therapeutics, pharmacovigilance, vaccines, drugs for cancer, drug development in paediatrics and neonatalogy, the clinical trials directive, life cycle management of medicines, counterfeit medicines and medical marketing. Also included for easy reference, and referred to throughout the text, are the Declaration of Helsinki, Guidelines and Documentation for Implementation of Clinical Trials, relevant European Directives and the Syllabus for Pharmaceutical Medicine.Written by an international team of leading academics, medical directors and lawyers, The Textbook of Pharmaceutical Medicine, Seventh Edition meets the needs of both those working in pharmaceutical medicine and preparing for the Diploma in Pharmaceutical Medicine.The text breaks down into three core sections:Part I: Research and DevelopmentPart II: RegulationPart III: Healthcare marketplaceView Table of Contents in detail "This book is expected to be useful for pharmaceutical physicians and for anyone interested in learning about the various issues in drug discovery and development. In addition to many other topics, the regulatory aspects of drug development in the U.S., Europe, and Japan are well covered ... Nevertheless, this is an admirable effort and the book deserves a place on the bookshelves of pharmaceutical physicians. " ( Doody's , 30 August 2013) Zusammenfassung Now in its seventh edition, The Textbook of Pharmaceutical Medicine is a standard reference for all those working in pharmaceutical medicine and the recognised text for the UK Faculty of Pharmaceutical Diploma. Inhaltsverzeichnis Contributors vii The editors x Acknowledgements xiii List of abbreviations xiv Preface xix Part I Research and development 1 1 Discovery of new medicines 3 Yves J. Ribeill 2 Pharmaceutical development 32 Michael Gamlen and Paul Cummings 3 Preclinical safety testing 42 Lutz Müller and Elisabeth Husar 4 Exploratory development 82 John Posner 5 Clinical pharmacokinetics 113 Paul Rolan and Valéria Molnár 6 Biological therapeutics 132 Peter Lloyd and Jennifer Sims 7 Objectives and design of clinical trials 143 John Posner and Steve Warrington 8 Conduct of clinical trials: Good Clinical Practice 155 Kate L.R. Darwin 9 Medical statistics 189 Andrew P. Grieve 10 Development of medicines: ...
