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Generic Drug Product Development: International Regulatory Requirements for Bioequivalence (Drugs and the Pharmaceutical Sciences, 201) - Softcover

 
9780367384371: Generic Drug Product Development: International Regulatory Requirements for Bioequivalence (Drugs and the Pharmaceutical Sciences, 201)
Softcover
ISBN 10: 036738437X ISBN 13: 9780367384371
Publisher: CRC Press, 2019

Synopsis

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.

"synopsis" may belong to another edition of this title.

About the Author

Isadore Kanfer, Leon Shargel

From the Back Cover

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.

"About this title" may belong to another edition of this title.

Publisher
CRC Press
Publication date
2019
Language
English
ISBN 10 
036738437X
ISBN 13 
9780367384371
Binding
Paperback
Edition number
1
Number of pages
332
Editor
Kanfer Isadore, Shargel Leon