New Drug Approval Process - Couverture rigide

Couverture rigide

ISBN 10 : 082478801X ISBN 13 : 9780824788018

Editeur : Marcel Dekker Inc, 1993

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.

A propos du livre

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.

Détails de l'édition

• Éditeur: Marcel Dekker Inc
• Date d'édition: 1993
• Langue: anglais
• ISBN 10: 082478801X
• ISBN 13: 9780824788018
• Reliure: Relié
• Numéro d'édition: 2
• Nombre de pages: 500
• Éditeur: Guarino Richard A.
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible