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Barnes and Noble

Bioequivalence Requirements in Various Global Jurisdictions

Current price: $249.99
Bioequivalence Requirements in Various Global Jurisdictions
Bioequivalence Requirements in Various Global Jurisdictions

Barnes and Noble

Bioequivalence Requirements in Various Global Jurisdictions

Current price: $249.99
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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 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.

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Barnes & Noble does business -- big business -- by the book. As the #1 bookseller in the US, it operates about 720 Barnes & Noble superstores (selling books, music, movies, and gifts) throughout all 50 US states and Washington, DC. The stores are typically 10,000 to 60,000 sq. ft. and stock between 60,000 and 200,000 book titles. Many of its locations contain Starbucks cafes, as well as music departments that carry more than 30,000 titles.

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