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(Ebook) New Drug Approval Process, Fifth Edition by Guarino, Richard A. ISBN 9781420088496, 9781420088502, 1420088491, 1420088505

  • SKU: EBN-4647866
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Instant download (eBook) New Drug Approval Process, Fifth Edition after payment.
Authors:Guarino, Richard A.
Pages:552 pages.
Year:2009
Editon:5
Publisher:CRC Press
Language:english
File Size:4.18 MB
Format:pdf
ISBNS:9781420088496, 9781420088502, 1420088491, 1420088505
Categories: Ebooks

Product desciption

(Ebook) New Drug Approval Process, Fifth Edition by Guarino, Richard A. ISBN 9781420088496, 9781420088502, 1420088491, 1420088505

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

*Free conversion of into popular formats such as PDF, DOCX, DOC, AZW, EPUB, and MOBI after payment.

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