Generic Drug Product Development: International Regulatory Requirements for Bioequivalence - Brossura

Brossura

ISBN 10: 036738437X ISBN 13: 9780367384371

Casa editrice: CRC Press, 2019

Riassunto

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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Informazioni sull?autore

Isadore Kanfer, Leon Shargel

Dettagli dell?edizione

• Editore: CRC Press
• Data di pubblicazione: 2019
• Lingua: Inglese
• ISBN 10: 036738437X
• ISBN 13: 9780367384371
• Rilegatura: Copertina flessibile
• Numero edizione: 1
• Numero di pagine: 332
• Redattore: Shargel Leon, Kanfer Isadore
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile