New Drug Approval Process : Clinical and Regulatory Management (Drugs and the Pharmaceutical Sciences Ser., No. 30)

Guarino, Richard (editor)

ISBN 10: 0824773829 / ISBN 13: 9780824773823

Published by Marcel Dekker Incorporated, New York, NY, U.S.A., 1987

About this Item

Delineates the most expeditious methods for bringing new prescription and over-the-counter drugs into the marketplace. Burgundy boards have almost no signs of wear. Guarino's inscription dated 10/16/87, on fep. Pages are bright, text clean & unmarked, binding is tight. Size: 8vo - over 7¾" - 9¾" tall. Seller Inventory # 350017A

Bibliographic Details

Title: New Drug Approval Process : Clinical and ...

Publisher: Marcel Dekker Incorporated, New York, NY, U.S.A.

Publication Date: 1987

Binding: Hard Cover

Condition: Fine

Dust Jacket Condition: No Jacket

Signed: Inscribed by Author

Edition: First Printing.

About this title

Synopsis:

Reflects current rules, regulations, and guidelines in Title 21 of the Code of Federal Regulations and presents the latest advances in expediting drug development procedures. The book is designed to be of interest to research and development personnel in the pharmaceutical industry, including clinical and research pharmacists and pharmacologists, organic, medicinal, cosmetic, analytical, and clinical chemists and biochemists, clinical toxicologists, biostatisticians, government regulatory personnel, international pharmaceutical manufacturers and students in drug development courses.

Review:

..."a useful road map to understanding the requirements that a drug product must fulfill to achieve approval." Journal of Medicinal Chemistry "There are very useful formats, brochures, statistics, addresses and checklists provided...in order to have a clean picture of the entire drug approval process. "The book has accomplished the laborious task of obtaining about 600 indispensable acronyms.a must for researchers, libraries, project consultants and...regulatory personnel." Pharmaceutical Development and Technology