{"product_id":"the-textbook-of-pharmaceutical-medicine-isbn-9780470659878","title":"The Textbook of Pharmaceutical Medicine","description":"\u003cp\u003e\u003ci\u003eThe Textbook of Pharmaceutical Medicine\u003c\/i\u003e 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.\u003c\/p\u003e \u003cp\u003eThis 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.\u003c\/p\u003e \u003cp\u003eWritten by an international team of leading academics, medical directors and lawyers, \u003ci\u003eThe Textbook of Pharmaceutical Medicine, Seventh Edition\u003c\/i\u003e meets the needs of both those working in pharmaceutical medicine and preparing for the Diploma in Pharmaceutical Medicine.\u003c\/p\u003e \u003cp\u003eThe text breaks down into three core sections:\u003c\/p\u003e \u003cp\u003ePart I: Research and Development\u003cbr\u003ePart II: Regulation\u003cbr\u003ePart III: Healthcare marketplace\u003cbr\u003e\u003cbr\u003e\u003ca href=\"http:\/\/www.wiley.com\/WileyCDA\/WileyTitle\/productCd-0470659874,descCd-tableOfContents.html\"\u003eView Table of Contents in detail\u003c\/a\u003e\u003c\/p\u003e \u003cp\u003eContributors vii\u003c\/p\u003e \u003cp\u003eThe editors x\u003c\/p\u003e \u003cp\u003eAcknowledgements xiii\u003c\/p\u003e \u003cp\u003eList of abbreviations xiv\u003c\/p\u003e \u003cp\u003ePreface xix\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I Research and development 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1 Discovery of new medicines 3\u003cbr\u003e\u003ci\u003eYves J. Ribeill\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 Pharmaceutical development 32\u003cbr\u003e\u003ci\u003eMichael Gamlen and Paul Cummings\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 Preclinical safety testing 42\u003cbr\u003e\u003ci\u003eLutz Müller and Elisabeth Husar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Exploratory development 82\u003cbr\u003e\u003ci\u003eJohn Posner\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Clinical pharmacokinetics 113\u003cbr\u003e\u003ci\u003ePaul Rolan and Valéria Molnár\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Biological therapeutics 132\u003cbr\u003e\u003ci\u003ePeter Lloyd and Jennifer Sims\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Objectives and design of clinical trials 143\u003cbr\u003e\u003ci\u003eJohn Posner and Steve Warrington\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 Conduct of clinical trials: Good Clinical Practice 155\u003cbr\u003e\u003ci\u003eKate L.R. Darwin\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 Medical statistics 189\u003cbr\u003e\u003ci\u003eAndrew P. Grieve\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 Development of medicines: full development 219\u003cbr\u003e\u003ci\u003ePeter D. Stonier\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 Pharmacovigilance 235\u003cbr\u003e\u003ci\u003eStephen F. Hobbiger, Bina Patel and Elizabeth Swain\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 Vaccines 254\u003cbr\u003e\u003ci\u003eJohn Beadle\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 Drugs for cancer 270\u003cbr\u003e\u003ci\u003eJames Spicer and Johann De Bono\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14 Ethics of human experimentation 286\u003cbr\u003e\u003ci\u003eJane Barrett\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15 Drug development in paediatrics and neonatology 295\u003cbr\u003e\u003ci\u003eNazakat M. Merchant and Denis V. Azzopardi\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16 Due diligence and the role of the pharmaceutical physician 306\u003cbr\u003e\u003ci\u003eGeoffrey R. Barker\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II Regulation 317\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e17 A history of drug regulation in the UK 319\u003cbr\u003e\u003ci\u003eJohn P. Griffin\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18 The Clinical Trials Directive 347\u003cbr\u003e\u003ci\u003eFergus Sweeney and Agnès Saint Raymond\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19 Human medicinal products in the European Union: Regulations Directives and structures 360\u003cbr\u003e\u003ci\u003eAgnès Saint Raymond and Anthony J. Humphreys\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20 Human medicinal products in the European Union: Procedures 379\u003cbr\u003e\u003ci\u003eAgnès Saint Raymond and Anthony J. Humphreys\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21 European regulation of medical devices 418\u003cbr\u003e\u003ci\u003eShuna Mason\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22 Paediatric regulation 435\u003cbr\u003e\u003ci\u003eHeike Rabe and Agnès Saint-Raymond\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23 Technical requirements for registration of pharmaceuticals for human use: The ICH process 447\u003cbr\u003e\u003ci\u003eDean W.G. Harron\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e24 The regulation of drug products by the US Food and Drug Administration 461\u003cbr\u003e\u003ci\u003ePeter Barton Hutt\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e25 The US FDA in the drug development evaluation and approval process 501\u003cbr\u003e\u003ci\u003eRichard N. Spivey, Judith K. Jones, William Wardell and William W. Vodra\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26 Future prospects of the pharmaceutical industry and its regulation in the USA 518\u003cbr\u003e\u003ci\u003eRichard N. Spivey, William W. Vodra, Judith K. Jones and William Wardell\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e27 Regulatory and clinical trial systems in Japan 537\u003cbr\u003e\u003ci\u003eMamiko Satake and Natsuko Hosoda\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e28 The regulation of therapeutic products in Australia 554\u003cbr\u003e\u003ci\u003eElizabeth de Somer, Deborah Monk and Janice Hirshorn\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III Health care marketplace 587\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e29 An Introduction to life cycle management of medicines 589\u003cbr\u003e\u003ci\u003eDavid Gillen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e30 Availability of medicines online and counterfeit medicines 597\u003cbr\u003e\u003ci\u003eRuth Diazaraque and David Gillen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e31 The supply of unlicensed medicines for individual patient use 610\u003cbr\u003e\u003ci\u003eIan Dodds-Smith and Ewan Townsend\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e32 Legal and ethical issues relating to medicinal products 632\u003cbr\u003e\u003ci\u003eNick Beckett, Sarah Hanson and Shuna Mason\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e33 Medical marketing 653\u003cbr\u003e\u003ci\u003eDavid B. Galloway and Bensita M.V. Thottakam\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e34 Information and promotion 670\u003cbr\u003e\u003ci\u003eCharles De Wet\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e35 Economics of health care 692\u003cbr\u003e\u003ci\u003eCarole A. Bradley and Jane R. Griffin\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e36 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons 707\u003cbr\u003e\u003ci\u003eJohn P. Griffin and Geoffrey R. Barker\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e37 Pharmaceutical medicine in the emerging markets 728\u003cbr\u003e\u003ci\u003eNadarajah Sreeharan, Jennie A. Sykes and Richard B. Nieman\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e38 Biosimilars 744\u003cbr\u003e\u003ci\u003eRaymond A. Huml and John Posner\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eAppendix 1 Declaration of Helsinki 751\u003c\/p\u003e \u003cp\u003eAppendix 2 Agreements and Guidelines for Implementation of Clinical Trials 755\u003c\/p\u003e \u003cp\u003eAppendix 3 Directive 2001\/20\/EC of the European Parliament and of the Council of 4 April 2001 771\u003c\/p\u003e \u003cp\u003eAppendix 4 PharmaTrain Syllabus 2010 783\u003c\/p\u003e \u003cp\u003eIndex 788\u003c\/p\u003e  \u003cp\u003e“This comprehensive volume covers the processes by which medicines are developed, tested and approved. The chapters are written by leading academics, medical directors and legal experts in the field of harmaceutical medicine and provide authorative and in-depth information for both physicians working in and those who are currently training in the pharmaceutical industry.”  (\u003ci\u003eBritish Journal of Clinical Pharmacology\u003c\/i\u003e, 22 April 2014)\u003c\/p\u003e \u003cp\u003e“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. ”  (\u003ci\u003eDoody’s\u003c\/i\u003e, 30 August 2013)\u003c\/p\u003e  \u003cp\u003e\u003cstrong\u003eJohn Griffin\u003c\/strong\u003e 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. \u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eJohn Posner\u003c\/strong\u003e 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). \u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eGeoffrey R. Barker\u003c\/strong\u003e 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.\u003c\/p\u003e","brand":"BMJ Books","offers":[{"title":"Default Title","offer_id":47990352937189,"sku":"NP9780470659878","price":330.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470659878.jpg?v=1761787477","url":"https:\/\/k12savings.com\/products\/the-textbook-of-pharmaceutical-medicine-isbn-9780470659878","provider":"K12savings","version":"1.0","type":"link"}