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Bioequivalence Requirements in Various Global Jurisdictions Softcover Repri Edition
Contributor(s): Kanfer, Isadore (Editor)
ISBN: 3319885421     ISBN-13: 9783319885421
Publisher: Springer
OUR PRICE:   $237.49  
Product Type: Paperback - Other Formats
Published: September 2018
Qty:
Temporarily out of stock - Will ship within 2 to 5 weeks
Additional Information
BISAC Categories:
- Medical | Pharmacy
- Science | Chemistry - Organic
Dewey: 615.19
Series: Aaps Advances in the Pharmaceutical Sciences
Physical Information: 345 pages
 
Descriptions, Reviews, Etc.
Publisher Description:

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.