The Textbook of Pharmaceutical Medicine: Griffin/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 Development Part II: Regulation Part III: Healthcare marketplace (http://www.wiley.com/WileyCDA/WileyTitle/productCd-0470659874,descCd-tableOfContents.html) View Table of Contents in detail Content: Chapter 1 Discovery of New Medicines (pages 1–31): Yves J. Ribeill Chapter 2 Pharmaceutical Development (pages 32–41): Michael Gamlen and Paul Cummings Chapter 3 Preclinical Safety Testing (pages 42–81): Lutz Muller and Elisabeth Husar Chapter 4 Exploratory Development (pages 82–112): John Posner Chapter 5 Clinical Pharmacokinetics (pages 113–131): Paul Rolan and Valeria Molnar Chapter 6 Biological Therapeutics (pages 132–142): Peter Lloyd and Jennifer Sims Chapter 7 Objectives and Design of Clinical Trials (pages 143–154): John Posner and Steve Warrington Chapter 8 Conduct of Clinical Trials: Good Clinical Practice (pages 155–188): Kate L. R. Darwin Chapter 9 Medical Statistics (pages 189–218): Andrew P. Grieve Chapter 10 Development of Medicines: Full Development (pages 219–234): Peter D. Stonier Chapter 11 Pharmacovigilance (pages 235–253): Stephen F. Hobbiger, Bina Patel and Elizabeth Swain Chapter 12 Vaccines (pages 254–269): John Beadle Chapter 13 Drugs for Cancer (pages 270–285): James Spicer and Johann De Bono Chapter 14 Ethics of Human Experimentation (pages 286–294): Jane Barrett Chapter 15 Drug Development in Paediatrics and Neonatology (pages 295–305): Nazakat M. Merchant and Denis V. Azzopardi Chapter 16 Due Diligence and the Role of the Pharmaceutical Physician (pages 306–315): Geoffrey R. Barker Chapter 17 A History of Drug Regulation in the UK (pages 317–346): John P. Griffin Chapter 18 The Clinical Trials Directive (pages 347–359): Fergus Sweeney and Agnes Saint Raymond Chapter 19 Human Medicinal Products in the European Union: Regulations, Directives and Structures (pages 360–378): Agnes Saint Raymond and Anthony J. Humphreys Chapter 20 Human Medicinal Products in the European Union: Procedures (pages 379–417): Agnes Saint Raymond and Anthony J. Humphreys Chapter 21 European Regulation of Medical Devices (pages 418–434): Shuna Mason Chapter 22 Paediatric Regulation (pages 435–446): Heike Rabe and Agnes Saint?Raymond Chapter 23 Technical Requirements for Registration of Pharmaceuticals for Human Use: The ICH Process (pages 447–460): Dean W. G. Harron Chapter 24 The Regulation of Drug Products by the US Food and Drug Administration (pages 461–500): Peter Barton Hutt Chapter 25 The US FDA in the Drug Development, Evaluation and Approval Process (pages 501–517): Richard N. Spivey, Judith K. Jones, William Wardell and William W. Vodra Chapter 26 Future Prospects of the Pharmaceutical Industry and its Regulation in the USA (pages 518–536): Richard N. Spivey, William W. Vodra, Judith K. Jones and William Wardell Chapter 27 Regulatory and Clinical Trial Systems in Japan (pages 537–553): Mamiko Satake and Natsuko Hosoda Chapter 28 The Regulation of Therapeutic Products in Australia (pages 554–586): Elizabeth de Somer, Deborah Monk and Janice Hirshorn Chapter 29 An Introduction to Life Cycle Management of Medicines (pages 587–596): David Gillen Chapter 30 Availability of Medicines Online and Counterfeit Medicines (pages 597–609): Ruth Diazaraque and David Gillen Chapter 31 The Supply of Unlicensed Medicines for Individual Patient Use (pages 610–631): Ian Dodds?Smith and Ewan Townsend Chapter 32 Legal and Ethical Issues Relating to Medicinal Products (pages 632–652): Nick Beckett, Sarah Hanson and Shuna Mason Chapter 33 Medical Marketing (pages 653–669): David B. Galloway and Bensita M. V. Thottakam Chapter 34 Information and Promotion (pages 670–691): Charles De Wet Chapter 35 Economics of Health Care (pages 692–706): Carole A. Bradley and Jane R. Griffin Chapter 36 Controls on NHS Medicines Prescribing and Expenditure in the UK (a Historical Perspective) with some International Comparisons (pages 707–727): John P. Griffin and Geoffrey R. Barker Chapter 37 Pharmaceutical Medicine in the Emerging Markets (pages 728–743): Nadarajah Sreeharan, Jennie A. Sykes and Richard B. Nieman Chapter 38 Biosimilars (pages 744–750): Raymond A. Huml and John Posner __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 marketplace[View Table of Contents in detail](http://www.wiley.com/WileyCDA/WileyTitle/productCd-0470659874,descCd-tableOfContents.html) Content: Chapter 1 Discovery of New Medicines (pages 1–31): Yves J. RibeillChapter 2 Pharmaceutical Development (pages 32–41): Michael Gamlen and Paul CummingsChapter 3 Preclinical Safety Testing (pages 42–81): Lutz Muller and Elisabeth HusarChapter 4 Exploratory Development (pages 82–112): John PosnerChapter 5 Clinical Pharmacokinetics (pages 113–131): Paul Rolan and Valeria MolnarChapter 6 Biological Therapeutics (pages 132–142): Peter Lloyd and Jennifer SimsChapter 7 Objectives and Design of Clinical Trials (pages 143–154): John Posner and Steve WarringtonChapter 8 Conduct of Clinical Trials: Good Clinical Practice (pages 155–188): Kate L. R. DarwinChapter 9 Medical Statistics (pages 189–218): Andrew P. GrieveChapter 10 Development of Medicines: Full Development (pages 219–234): Peter D. StonierChapter 11 Pharmacovigilance (pages 235–253): Stephen F. Hobbiger, Bina Patel and Elizabeth SwainChapter 12 Vaccines (pages 254–269): John BeadleChapter 13 Drugs for Cancer (pages 270–285): James Spicer and Johann De BonoChapter 14 Ethics of Human Experimentation (pages 286–294): Jane BarrettChapter 15 Drug Development in Paediatrics and Neonatology (pages 295–305): Nazakat M. Merchant and Denis V. AzzopardiChapter 16 Due Diligence and the Role of the Pharmaceutical Physician (pages 306–315): Geoffrey R. BarkerChapter 17 A History of Drug Regulation in the UK (pages 317–346): John P. GriffinChapter 18 The Clinical Trials Directive (pages 347–359): Fergus Sweeney and Agnes Saint RaymondChapter 19 Human Medicinal Products in the European Union: Regulations, Directives and Structures (pages 360–378): Agnes Saint Raymond and Anthony J. HumphreysChapter 20 Human Medicinal Products in the European Union: Procedures (pages 379–417): Agnes Saint Raymond and Anthony J. HumphreysChapter 21 European Regulation of Medical Devices (pages 418–434): Shuna MasonChapter 22 Paediatric Regulation (pages 435–446): Heike Rabe and Agnes Saint?RaymondChapter 23 Technical Requirements for Registration of Pharmaceuticals for Human Use: The ICH Process (pages 447–460): Dean W. G. HarronChapter 24 The Regulation of Drug Products by the US Food and Drug Administration (pages 461–500): Peter Barton HuttChapter 25 The US FDA in the Drug Development, Evaluation and Approval Process (pages 501–517): Richard N. Spivey, Judith K. Jones, William Wardell and William W. VodraChapter 26 Future Prospects of the Pharmaceutical Industry and its Regulation in the USA (pages 518–536): Richard N. Spivey, William W. Vodra, Judith K. Jones and William WardellChapter 27 Regulatory and Clinical Trial Systems in Japan (pages 537–553): Mamiko Satake and Natsuko HosodaChapter 28 The Regulation of Therapeutic Products in Australia (pages 554–586): Elizabeth de Somer, Deborah Monk and Janice HirshornChapter 29 An Introduction to Life Cycle Management of Medicines (pages 587–596): David GillenChapter 30 Availability of Medicines Online and Counterfeit Medicines (pages 597–609): Ruth Diazaraque and David GillenChapter 31 The Supply of Unlicensed Medicines for Individual Patient Use (pages 610–631): Ian Dodds?Smith and Ewan TownsendChapter 32 Legal and Ethical Issues Relating to Medicinal Products (pages 632–652): Nick Beckett, Sarah Hanson and Shuna MasonChapter 33 Medical Marketing (pages 653–669): David B. Galloway and Bensita M. V. ThottakamChapter 34 Information and Promotion (pages 670–691): Charles De WetChapter 35 Economics of Health Care (pages 692–706): Carole A. Bradley and Jane R. GriffinChapter 36 Controls on NHS Medicines Prescribing and Expenditure in the UK (a Historical Perspective) with some International Comparisons (pages 707–727): John P. Griffin and Geoffrey R. BarkerChapter 37 Pharmaceutical Medicine in the Emerging Markets (pages 728–743): Nadarajah Sreeharan, Jennie A. Sykes and Richard B. NiemanChapter 38 Biosimilars (pages 744–750): Raymond A. Huml and John Posner

"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 Medicine Diploma. This is a comprehensive volume covering the processes by which medicines are developed, tested and approved. Regulations for drug development in the UK, EU, USA, Australia and Japan are discussed, providing relevant information for drug approval in the main continents where new drugs are developed." The chapters are written by leading academics, medical directors and lawyers, providing authoritative and in-depth information for trainees on the Faculty course, and for physicians working in the pharmaceutical industry. As well as thorough updating of the regulatory chapters, the 6th edition includes chapters on vital new areas.

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. This new edition reflects the enormous changes in the environment in which the pharmaceutical industry and the pharmaceutical physician operate, many of which have occurred since 2009 when the last edition was published. There are new chapters and new authors in each section, and more consideration given to ethical issues across all areas of the book