FDA Bioequivalence Standards - AAPS Advances in the Pharmaceutical Sciences Series 13 (Paperback)
  • FDA Bioequivalence Standards - AAPS Advances in the Pharmaceutical Sciences Series 13 (Paperback)
zoom

FDA Bioequivalence Standards - AAPS Advances in the Pharmaceutical Sciences Series 13 (Paperback)

(editor), (editor)
£109.99
Paperback 465 Pages / Published: 17/09/2016
  • We can order this

Usually dispatched within 3 weeks

  • This item has been added to your basket

This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products.

FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.

Publisher: Springer-Verlag New York Inc.
ISBN: 9781493955589
Number of pages: 465
Weight: 7197 g
Dimensions: 235 x 155 x 25 mm
Edition: Softcover reprint of the original 1st ed. 201

You may also be interested in...

Chemical Engineering Design
Added to basket
Whisky
Added to basket
£68.99
Hardback
Soapmakers Companion
Added to basket
The Undiscovered Self
Added to basket
£13.99
Paperback
Food Portion Sizes
Added to basket
Understanding Wine Technology
Added to basket
The Elements of Murder
Added to basket
Food: A Very Short Introduction
Added to basket
The Art of Making Fermented Sausages
Added to basket
From Vines to Wines
Added to basket
£12.99
Paperback
A Dictionary of Chemical Engineering
Added to basket
Pharmaceutical Chemistry
Added to basket
Principles of Brewing Science
Added to basket
Malt
Added to basket
£14.96
Paperback

Reviews

Please sign in to write a review

Your review has been submitted successfully.