The Textbook of Pharmaceutical Medicine

John P. Griffin 지음

BMJ Books 2013년 03월 29일 출간

작품소개

책소개

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

목차

ContributorsThe editorsAcknowledgementsList of abbreviationsPrefacePart I Research and development1 Discovery of new medicinesYves J. Ribeill2 Pharmaceutical developmentMichael Gamlen and Paul Cummings3 Preclinical safety testingLutz Müller and Elisabeth Husar4 Exploratory developmentJohn Posner5 Clinical pharmacokineticsPaul Rolan and Val&e'ria Moln&a'r6 Biological therapeuticsPeter Lloyd and Jennifer Sims7 Objectives and design of clinical trialsJohn Posner and Steve Warrington8 Conduct of clinical trials: Good Clinical PracticeKate L.R. Darwin9 Medical statisticsAndrew P. Grieve10 Development of medicines: full developmentPeter D. Stonier11 PharmacovigilanceStephen F. Hobbiger, Bina Patel and Elizabeth Swain12 VaccinesJohn Beadle13 Drugs for cancerJames Spicer and Johann De Bono14 Ethics of human experimentationJane Barrett15 Drug development in paediatrics and neonatologyNazakat M. Merchant and Denis V. Azzopardi16 Due diligence and the role of the pharmaceutical physicianGeoffrey R. BarkerPart II Regulation17 A history of drug regulation in the UKJohn P. Griffin18 The Clinical Trials DirectiveFergus Sweeney and Agnès Saint Raymond19 Human medicinal products in the European Union: Regulations, Directives and structuresAgnès Saint Raymond and Anthony J. Humphreys20 Human medicinal products in the European Union: ProceduresAgnès Saint Raymond and Anthony J. Humphreys21 European regulation of medical devicesShuna Mason22 Paediatric regulationHe

출판사 서평

“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)

작가정보

저자(글) John P. Griffin