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ISBN
:
9788181930194
Publisher
:
BMJ Books
Subject
:
Medical Study & Revision Guides & Reference Material
Binding
:
Paperback
Pages
:
884
Year
:
2005
₹
550.0
₹
429.0
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The book has been recognised as a standard text used by courses in Pharmaceutical Medicine in and the . This edition has totally revised chapters on drug regulation in the, with new contributor, Dr Peter Barton Hutt formerly FDA Special Counsel. New contributions regarding pharmaco-economics are covered in two new chapters. There are22 chapters in all with contributions from pharmaceutical physicians, drug regulators, health economists and lawyers from , and . Table of Contents Research and development Discovery of new medicines Pharmaceutical development Toxicity testing Exploratory development Clinical pharmacologists Clinical trials and good clinical practice Medical Statistics Development of medicines: full development Medical department issues; the medical department Medical marketing Information and promotion The supply of unlicensed medicines for particular patient use Legal and ethical issues relating to medicinal products The safety of medicines Regulatory aspects The development of the control of human medicines in Europe from classical times to the year 2000 Technical requirements for registration of pharmaceuticals for human use: the ICH process and the common technical account The regulation of drug products by the United States Food and Drug Administration The US FDA in the drug development, evaluation and approval process Regulatory and clinical trial systems in Japan Pharmacological and other issues Economics of healthcare Controls on NHS medicines prescribing and expenditure in the UK(a historical perspective) Appendix 1: Declaration of Helsinki Appendix 2: Code of practice for the Pharmaceutical Industry.
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