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

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

Sinopsis

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.

"Sinopsis" puede pertenecer a otra edición de este libro.

Acerca del autor

Isadore Kanfer, Leon Shargel

De la contraportada

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.

"Sobre este título" puede pertenecer a otra edición de este libro.

Editorial
CRC Press
Año de publicación
2019
Idioma
Inglés
ISBN 10 
036738437X
ISBN 13 
9780367384371
Encuadernación
Tapa blanda
Número de edición
1
Número de páginas
332
Editor
Kanfer Isadore, Shargel Leon
Contacto del fabricante
Taylor and Francis, GPSR Taylor and Francis
gpsr@taylorandfrancis.com

Taylor & Francis Verlag GmbH, Kaufingerstraße 24
München
80331
Alemania