Description

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

More Details about New Drug Approval Process Accelerating Global Registrations 5e (HB)

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