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New drug approval process - v. 190 (5th ed.)

Guarino, Richard A.,

Part of the Drugs and the pharmaceutical sciences series

See all formats and editions

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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Product Details

Publisher/Imprint Informa Healthcare

ISBN/Ean1420088505 / 9781420088502

FormateBook (Adobe Pdf)

Dewey615.1

Published19/04/2016

Book LanguageEnglish

Pages525 pages

Copy LimitsCopy: 30%; print: 30%

BIC