New Drug Approval Process Accelerating Global Registrations
Richard A. Guarino
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.
Kategoriler:
Yıl:
2004
Yayımcı:
CRC Press
Dil:
english
Sayfalar:
581
ISBN 10:
0824750411
ISBN 13:
9780824750411
Seriler:
Drugs and the Pharmaceutical Sciences
Dosya:
PDF, 12.11 MB
IPFS:
,
english, 2004
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