Generic Drug Product Development : International Regulatory Requirements for Bioequivalence
Book Details
Format
Hardback or Cased Book
ISBN-10
0849377854
ISBN-13
9780849377853
Publisher
Taylor & Francis Inc
Imprint
CRC Press Inc
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Mar 25th, 2010
Print length
336 Pages
Weight
586 grams
Dimensions
23.70 x 15.30 x 2.30 cms
Product Classification:
Pharmaceutical industriesBiology, life sciencesEngineering: generalPharmaceutical technology
Ksh 33,300.00
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Generic Drug Product Development
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.
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