Title: The textbook of pharmaceutical medicine /
Authors: O'Grady, John,; Griffin, J. P.
Publisher: BMJ,
Year: 2002
Subjects: Clinical Trials as Topic; Drug Approval; Pharmacology; Pharmacology; Pharmaceutical chemistry; Pharmacy
Contents: Research and development -- Discovery of new medicines -- Pharmaceutical development -- Toxicity testing -- Exploratory development -- Clinical pharmacokinetics -- Clinical trials and good clinical practice -- Medical statistics -- Development of medicines: full development -- Medical department issues -- Medical department -- Medical marketing -- Information and promotion -- Supply of unlicensed medicine for particular patient use -- Legal and ethical issues relating to medicinal products -- Safety of medicines -- Regulatory aspects -- Development of 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 document -- Regulation of drug products by the United States Food and Drug Administration -- US FDA in the drug department, evaluation and approval process -- Regulatory and clinical trial systems in Japan -- Pharmacoeconomic and other issues -- Economics of healthcare -- Controls of NHS medicines prescribing and expenditure in the UK (a historical perspective) -- Declaration of Helsinki -- Code of practice for the pharmaceutical industry.