New Drug Approval Process (Drugs and The Pharmaceutical Sciences; Vol 190)

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).

The New Drug Approval Process, Fifth Edition, is not only a text to educate people who plan to work in the areas of new pharmaceutical product development but also acts as a reference and guide for those personnel who have questions in specific areas of their expertise. The book addresses and details all the most recent regulations, guidelines, and procedures necessary for global registrations of new pharmaceutical products.

The contributors of this book approach every topic with a practical understanding of the subject matter based on their experience gained by working in their fields of expertise. Readers will gain insights and ideas of how to apply their research and regulatory capabilities in order to bring pharmaceutical products to market more efficiently, expeditiously, and economically.

Informa Healthcare | Price: $299.95

Amazon.com | Price: $260.15

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