Bioequivalence Requirements in Various Global Jurisdictions (AAPS Advances in the Pharmaceutical Sciences Series) 1st

Bioequivalence Requirements in Various Global Jurisdictions (AAPS Advances in the Pharmaceutical Sciences Series) 1st

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by Isadore Kanfer (Editor)

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    Bioequivalence Requirements in Various Global Jurisdictions (AAPS Advances in the Pharmaceutical Sciences Series) 1st 

    by Isadore Kanfer (Editor)

    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, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various  BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the

     

    USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.

     

    Product details

    • Series: AAPS Advances in the Pharmaceutical Sciences Series (Book 28)
    • Hardcover: 345 pages
    • Publisher: Springer; 1st ed. 2017 edition (December 6, 2017)
    • Language: English
    • Format:  PDF  Original 
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