New Drug Approval Process Fifth Edition

New Drug Approval Process Fifth Edition (Drugs and the Pharmaceutical Sciences) PDF

New Drug Approval Process Fifth Edition PDF
Author Richard A. Guarino
File size 13.05 MB
Year 2009
Pages 664
Language English
File format PDF
Category
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Book 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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