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New Drug Approval Process de Richard A. Guarino

New Drug Approval Process: Drugs and the Pharmaceutical Sciences

Editat de Richard A. Guarino, Richard Guarino
en Limba Engleză Hardback – 24 iun 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
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Specificații

ISBN-13: 9781420088496
ISBN-10: 1420088491
Pagini: 548
Ilustrații: 80 b/w images
Dimensiuni: 152 x 229 x 33 mm
Greutate: 1.17 kg
Ediția:Revizuită
Editura: CRC Press
Colecția CRC Press
Seria Drugs and the Pharmaceutical Sciences

Locul publicării:Boca Raton, United States

Public țintă

Academic and Professional Practice & Development

Cuprins

Administrative Guidelines for New Product Development. Global Regulatory Submission of Drugs, Biologics and Devices for New Product Approval. Developing Clinical Research Trials. Global Regulations for Good Clinical Practices (GCP). Specific Areas of New Product Submissions.

Descriere

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.