New Drug Approval Process, Fifth Edition
Guarino, Richard A.The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.
Updated chapters include:
- advances in international regulatory requirements, including ICH guidelines and harmonization
- a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
- the latest regulatory requirements for expediting new drug approvals
- strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development
श्रेणियाँ:
साल:
2009
संस्करण:
5
प्रकाशन:
CRC Press
भाषा:
english
पृष्ठ:
552
ISBN 10:
1420088505
ISBN 13:
9781420088502
श्रृंखला:
Drugs and the Pharmaceutical Sciences
फ़ाइल:
PDF, 4.18 MB
IPFS:
,
english, 2009