Bioequivalence Requirements in Various Global Jurisdictions is popular PDF and ePub book, written by Isadore Kanfer in 2017-12-05, it is a fantastic choice for those who relish reading online the Medical genre. Let's immerse ourselves in this engaging Medical book by exploring the summary and details provided below. Remember, Bioequivalence Requirements in Various Global Jurisdictions can be Read Online from any device for your convenience.
Bioequivalence Requirements in Various Global Jurisdictions Book PDF Summary
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.
Detail Book of Bioequivalence Requirements in Various Global Jurisdictions PDF
- Author : Isadore Kanfer
- Release : 05 December 2017
- Publisher : Springer
- ISBN : 9783319680781
- Genre : Medical
- Total Page : 348 pages
- Language : English
- PDF File Size : 10,5 Mb
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