Bioequivalence Requirements in Various Global Jurisdictions

Bioequivalence Requirements in Various Global Jurisdictions (AAPS Advances in the Pharmaceutical Sciences Series)

Bioequivalence Requirements in Various Global Jurisdictions (AAPS Advances in the Pharmaceutical Sciences Series) by Isadore Kanfer
English | 3 Jan. 2018 | ISBN: 3319680773 | 356 Pages | PDF (True) | 4.27 MB

Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria,