Bioequivalence Studies in Drug Development: Methods and Applications by Volker Steinijans
English | Feb 27, 2007 | ISBN: 0470094753 | 328 Pages | PDF | 5 MB
Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence.
For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities.
Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities.
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