New Drug Approval Process
Richard A. Guarino and Richard Guarino
Global registration of pharmaceutical drug, biologic, and device products is now the way pharmaceutical development and marketing are strategically planned. Since the publication of the fourth edition of New Drug Approval Process, there have been many changes in the regulations, requirements, and recommendations for international registration and approval of new products.
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).
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).
Kategoriler:
Yıl:
2009
Baskı:
5th Edition
Yayımcı:
CRC Press
Dil:
english
Sayfalar:
550
ISBN 10:
1420088491
ISBN 13:
9781420088496
Seriler:
Drugs and the Pharmaceutical Sciences
Dosya:
PDF, 13.05 MB
IPFS:
,
english, 2009