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New Drug Approval Process (190) (Drugs and the Pharmaceutical Sciences, 190, Band 190) - Hardcover

Buch 48 von 80: Drugs and the Pharmaceutical Sciences
 
9781420088496: New Drug Approval Process (190) (Drugs and the Pharmaceutical Sciences, 190, Band 190)

Inhaltsangabe

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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Über die Autorin bzw. den Autor

Richard A. Guarino, Richard Guarino

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