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.
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"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.
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