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

Edité par Marcel Dekker Incorporated, New York, NY, U.S.A., 1987

A propos de cet article

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.

N° de réf. du vendeur 350017A

Détails bibliographiques

• Titre: New Drug Approval Process : Clinical and Regulatory Management (Drugs and the Pharmaceutical Sciences Ser., No. 30)
• Éditeur: Marcel Dekker Incorporated, New York, NY, U.S.A.
• Date de parution: 1987
• Langue: anglais
• ISBN à 10 chiffres: 0824773829
• ISBN à 13 chiffres: 9780824773823
• Reliure: Hard Cover
• Édition: First Printing.
• État de l'article: Fine
• État de la jaquette: No Jacket
• Signé: Inscribed by Author

A propos de ce titre

Présentation de l'éditeur

Offering expert guidance on the clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs, biologicals, and medical devices, the Fourth Edition details the specific regulations, guidelines, and procedures that will advance and ensure approval of United States and global new product applications. It communicates and integrates a new approach to the world of pharmaceutical personnel on all aspects of new product development and alerts readers to clinical and regulatory tasks that require immediate attention and long-term follow-up in order to comply with the international acceptance of new product approvals.