The Textbook of Pharmaceutical Medicine

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

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

Contributors, xxThe Editors, xxAcknowledgements, xxList of Abbreviations, xxPreface, xxPart I: Research and Development1 Discovery of new medicinesYves J. Ribeill2 Pharmaceutical developmentMichael Gamlen3 Preclinical safety testingLutz Müller, Elisabeth Husar4 Exploratory developmentJohn Posner5 Clinical pharmacokineticsPaul Rolan, Valéria Molnár6 Biological therapeuticsPeter Lloyd, Jennifer Sims7 Objectives and design of clinical trialsJohn Posner, 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, Elizabeth Swain12 VaccinesJohn Beadle13 Drugs for cancerJames Spicer, Johann De Bono14 Ethics of human experimentationJane Barrett15 Drug development in paediatrics and neonatologyNazakat M. Merchant, Denis V. Azzopardi16 Due diligence and the role of the pharmaceutical physicianGeoffrey R. BarkerPart II: Regulation17 History of drug regulationJohn P. Griffin18 The clinical trials directiveFergus Sweeney, Agnès Saint Raymond19 Human medicinal products in the European Union: Regulations, directives and structuresAgnès Saint Raymond, Anthony J. Humphreys20 Human medicinal products in the European Union: ProceduresAgnès Saint Raymond, Anthony J. Humphreys21 European regulation of medical devicesShuna Mason22 Paediatric regulationHeike Rabe, Agnès Saint Raymond23 Technical requirements for registration of pharmaceuticals for human use: the ICH processDean W.G. Harron24 The regulation of drug products by the US Food and Drug AdministrationPeter Barton Hutt25 The US FDA in the drug development evaluation and approval processRichard N. Spivey, Judith K. Jones, William Wardell, William Vodra26 Future prospects of the pharmaceutical industry and its regulation in the USARichard N. Spivey, William Vodra, Judith K. Jones, William Wardell27 Regulatory and clinical trial systems in JapanMamiko Satake, Natsuko Hosoda28 The regulation of therapeutic products in AustraliaElizabeth de SomerPart III: Healthcare marketplace29 An introduction into lifecycle management of medicinesDavid Gillen30 Availability of medicines on-line, counterfeit medicinesRuth Diazaraque-Marin, David Gillen31 The supply of unlicensed medicines for individual patient useIan Dodds-Smith, Ewan Townsend32 Legal and ethical issues relating to medicinal productsNick Bennett, Sarah Hanson, Shuna Mason33 Medical marketingDavid B. Galloway, Bensita M.V.Thottakam34 Information and promotionCharles De Wet35 Economics of health careCarole A. Bradley, Jane R. Griffin36 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisonsJohn P. Griffin, Geoffrey R. Barker37 Pharmaceutical medicine in the emerging marketsNadarajah Sreeharan, Jennie A. Sykes, Richard B. NiemanAppendix 1 Declaration of HelsinkiAppendix 2 Guidelines and Documentation for implementation of clinical trialsAppendix 3 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001Appendix 4 The Syllabus for Pharmaceutical MedicineContributors