Articoli correlati a Generic Drug Product Development: International Regulatory...

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

 
9780367384371: Generic Drug Product Development: International Regulatory Requirements for Bioequivalence
Brossura
ISBN 10: 036738437X ISBN 13: 9780367384371
Casa editrice: CRC Press, 2019

Sinossi

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.

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

Informazioni sull'autore

Isadore Kanfer, Leon Shargel

Dalla quarta di copertina

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.

Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

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
Kanfer Isadore, Shargel Leon
Contatto del produttore
Taylor and Francis, GPSR Taylor and Francis
gpsr@taylorandfrancis.com

Taylor & Francis Verlag GmbH, Kaufingerstraße 24
München
80331
Germania