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New Drug Approval Process Accelerating Global Registrations 5E (Hb) at Meripustak

New Drug Approval Process Accelerating Global Registrations 5E (Hb) by Guarino, Routledge Taylor and Francis group

Books from same Author: Guarino

Books from same Publisher: Routledge Taylor and Francis group

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General Information  
Author(s)Guarino
PublisherRoutledge Taylor and Francis group
Edition5
ISBN9781420088496
Pages529
BindingHard Back
LanguageEnglish
Publish YearJanuary 2010

Description

Routledge Taylor and Francis group New Drug Approval Process Accelerating Global Registrations 5E (Hb) by Guarino

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.

Key Features:-

  • 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, ND
  • the latest regulatory requirements for expediting new drug approvals
  • strategies for effective communication and integration of pharmaceutical personnel in all aspects of

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