New Drug Approval Process 5th Edition
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New Drug Approval Process 5th Edition

SKU: 9781040169827

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Additional information

Full Title

New Drug Approval Process 5th Edition
Author(s)
Edition

5th Edition
ISBN

9781040169827, 9781420088496, 9780429137600, 9781420088502, 9781138044937
Publisher

CRC Press
Format

PDF and EPUB

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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