یادداشتهای مربوط به کتابنامه ، واژه نامه و نمایه های داخل اثر
متن يادداشت
Includes bibliographical references and index.
یادداشتهای مربوط به مندرجات
متن يادداشت
History of drug regulation in the UK / Rashmi R. Shah, John P. Griffin -- Regulation of human medicinal products in the European Union / Rashmi R. Shah, John P. Griffin -- European regulation of medical devices / Christopher Hodges -- The supply of unlicensed medicines for particular patient use / John O'Grady, Amanda Wearing -- Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) / John P. Griffin, Jane R. Griffin -- The regulation of therapeutic products in Australia / Janice Hirshorn, Deborah Monk -- Regulatory and clinical trial systems in Japan / Yuichi Kubo, John O'Grady -- The regulation of drug products by the United States Food and Drug Administration / Peter Barton Hutt -- The US FDA in the drug development, evaluation, and approval process / Richard N. Spivey, Louis Lasagna, Judith K. Jones, William Wardell -- Technical requirements for registration of pharmaceuticals for human use: the ICH process and the Common Technical Document / Patrick F. D'Arcy, Dean W.G. Harron -- Appendix 1: European guidelines relevant for pharmaceutical physicians.
بدون عنوان
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یادداشتهای مربوط به خلاصه یا چکیده
متن يادداشت
Understanding the licensing of medical products is fast becoming a requirement in clinical medicine. This text, written by specialists but tailored to the needs of the practising physician and pharmacist, explains the processes and regulations in the major drug producing countries.