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English
CRC Press Inc
24 June 2009
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

Edited by:   , , , , ,
Imprint:   CRC Press Inc
Country of Publication:   United States
Edition:   5th edition
Volume:   190
Dimensions:   Height: 229mm,  Width: 152mm,  Spine: 33mm
Weight:   861g
ISBN:   9781420088496
ISBN 10:   1420088491
Series:   Drugs and the Pharmaceutical Sciences
Pages:   548
Publication Date:  
Audience:   Professional and scholarly ,  Undergraduate
Format:   Hardback
Publisher's Status:   Active

Richard A. Guarino, Richard Guarino

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