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New Drug Approval Process
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New Drug Approval Process

Book Details

Format Hardback or Cased Book
ISBN-10 1420088491
ISBN-13 9781420088496
Publisher Taylor & Francis Inc
Imprint CRC Press Inc
Country of Manufacture GB
Country of Publication GB
Publication Date Jun 24th, 2009
Print length 548 Pages
Weight 868 grams
Dimensions 23.70 x 16.00 x 3.50 cms
Ksh 36,000.00
Werezi Extended Catalogue 0 in stock

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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.

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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