Автор: Richard A. Guarino and Richard Guarino
Название: New Drug Approval Process, 5th Edition
Издательство: CRC Press
Год: 2009
ISBN: 9781420088496; 1420088491
Серия: Drugs and the Pharmaceutical Sciences (Book 190)
Язык: English
Формат: pdf
Размер: 13,1 mb
Страниц: 664

Global registration of pharmaceutical drug, biologic, and device products is now the way pharmaceutical development and marketing are strategically planned. Since the publication of the fourth edition of New Drug Approval Process, there have been many changes in the regulations, requirements, and recommendations for international registration and approval of new products.

New Drug Approval Process, Fifth Edition offers, in detail, the necessary and vital information on how to develop and submit the research and the documentation required by worldwide agencies to obtain new pharmaceutical product approvals. The topics include a comprehensive as well as a pragmatic approach in addressing all aspects of clinical research development including statistical methodologies, global regulatory requirements for pharmaceutical product applications, and the mechanics necessary to understand and implement Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).