New Drug Approval Process

5th Edition

Richard A. Guarino, Richard Guarino

CRC Press
Published June 24, 2009
Reference - 552 Pages - 80 B/W Illustrations
ISBN 9781420088496 - CAT# H8849
Series: Drugs and the Pharmaceutical Sciences

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Summary

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

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