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Edition: 1
Publisher: CRC Press
Binding: Hardcover
ISBN: 0849377854
Generic Drug Product Development: International Regulatory Requirements for Bioequivalence (Drugs and the Pharmaceutical Sciences)
Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. Medical books Generic Drug Product Development. Medical books Generic Drug Product Development: International Regulatory Requirements for Bioequivalence. Categories: Drug Design, Generic drugs->Law and legislation. Contributors: Isadore Kanfer - Editor. Format: Hardcover
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Categories: Drug Design, Generic drugs->Law and legislation. Contributors: Isadore Kanfer - Editor. Format: Hardcover
Generic Drug Product Development-regulatory Issues , ISBN-13: 9780849377853, ISBN-10: 0849377854
Store Search search Title, ISBN and Author Generic Drug Product Development: Bioequivalence Issues by Leon Shargel Estimated delivery 3-12 business days Format Hardcover Condition Brand New The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstrati
Generic Drug Product Development : Solid Oral Dosage Forms, Second Edition, ISBN-13: 9781420086355, ISBN-10: 1420086359
Medical Book Generic Drug Product Development
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.