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New Drug Approval Process (5 ed)

Guarino, Richard(Edited by), Guarino, Richard A.(Edited by)

Part of the Drugs and the pharmaceutical sciences series

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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 harmonizationa step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAsthe latest regulatory requirements for expediting new drug approvalsstrategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development

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£157.25 Save 15.00%
RRP £185.00

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Product Details

Publisher/Imprint CRC Press Inc

ISBN/Ean1420088491 / 9781420088496

FormatHardback

Dewey615.1

Published24/06/2009

Country of PubUnited States

Book LanguageEnglish

Pages548 pages, 80 Illustrations, black and white

Dimensions152 x 229 mm, 861 grams

BIC MBGR1 Clinical trials, PS Biology, life sciences, TDCW Pharmaceutical technology