Bioequivalence Requirements in Various Global Jurisdictions

Name: Bioequivalence Requirements in Various Global Jurisdictions
Brand: Springer Nature
SKU: 9783319680774
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Springer Nature

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9783319680774

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Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such asdefinitions 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 standardisationshould 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 ofBioequivalence Requirements in Various Global Jurisdictionsis 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.

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