Name: New Drug Approval Process
SKU: 2673445
Price: 11553.00 TWD
Availability: InStock
Author: Guarino, Richard A. ; Guarino, Richard
ISBN: 9781420088496

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Type

Physical Book

Publisher

CRC Press

Author

Guarino, Richard A. ; Guarino, Richard

Language

English

Pages

548

Format

Hardcover

Dimensions

22.9x15.7x3.3 cm

Weight

0.86 kg.

ISBN

1420088491

ISBN13

9781420088496

Edition No.

0005

Synopsis "New Drug Approval Process"

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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New Drug Approval Process - Guarino, Richard A. ; Guarino, Richard

Synopsis "New Drug Approval Process"

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