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Handbook Of Bioequivalence Testing, Vol.171

SKU: 9780849303951

Original price was: ₹2,995.00.Current price is: ₹2,396.00.

Navigate the complexities of bioequivalence testing with the essential ‘Handbook Of Bioequivalence Testing, Vol.171’. As the generic pharmaceutical market expands, mastering bioequivalence studies is crucial. This comprehensive guide details current analytical methods, their limitations, and global regulatory requirements for generic drug approval. It covers GLP, GCP, and 21 CFR compliance, offering real-world examples of regulatory-approved reports. Discover how to apply for waivers, gain regulatory approval, and secure facility certification. Perfect for pharmaceutical professionals, researchers, and regulatory affairs specialists seeking to ensure efficient and successful bioequivalence studies. Enhance your understanding and streamline your regulatory submissions with this indispensable resource from The Bookish Owl.

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Description

  • ISBN-10: 9780849303951
  • ISBN-13: 978-0849303951
  • Edition: 1st
  • Publisher: CRC Press
  • Publication date: 22 August 2007
  • Language: English
  • Dimensions: 18.42 x 3.18 x 25.4 cm
  • Print length: 550 pages