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Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.
- Sales Rank: #2449871 in eBooks
- Published on: 2016-04-19
- Released on: 2016-04-19
- Format: Kindle eBook
Review
"This is a must for pharmaceutical researchers who are involved in developing generic specialty products with proven bioequivalence."
―Doody's Book Review Service
About the Author
Leon Shargel, PhD, RPh, is an Adjunct Associate Professor in the School of Pharmacy at the University of Maryland, Baltimore Maryland.
Susanna Wu-Pong, PhD, RPh, is in the Department of Pharmaceutics at the Medical College of Virginia Campus at the Virginia Commonwealth University, Richmond, Virginia.
Andrew B.C. Yu, Phd, Rph, is a Registered Pharmacist in Gaithersburg, Maryland.
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