New Drug Approval Process by Guarino, Richard A.

New Drug Approval Process (Hardcover) (ISBN-13: 9781420088496)

Vendor: Richard A. Guarino
Product type: Books
Format: Hardcover
$265.00
$265.00
$265.00
Subtotal: $265.00
New Drug Approval Process by Guarino, Richard A.

New Drug Approval Process

$265.00
New Drug Approval Process by Guarino, Richard A.

New Drug Approval Process

$265.00
Format: Hardcover
Description
Description
x

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


Author: Richard A. Guarino
ISBN-10: 1420088491
ISBN-13: 9781420088496
Publisher: CRC Press
Language: English
Published: 06/01/2009
Pages: 548
Format: Hardcover
Weight: 1.90lbs
Size: 9.00h x 6.20w x 1.30d
By Richard A. Guarino
By Richard A. Guarino
x
Frank Hoffmann, Marshall Fishwick, Beulah B Ramirez

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