New Drug Approval Process
Taylor & Francis

New Drug Approval Process - Hardback

Edition: 5th Edition
Subjects: Maths & Science, Biology, life sciences
ISBN13: 9781420088496
Published: 21 Aug 1970

Format - Hardback
By Richard A. Guarino

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A$311.20
A$311.20 A$389.00
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New Drug Approval Process - Hardback

A$311.20
A$311.20 A$389.00
Product description

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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