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Generic Drug Product Development
- International Regulatory Requirements for Bioequivalence
Engelsk
Bogcover for Generic Drug Product Development af , 9780367384371
Specifikationer
Sprog:
Engelsk
Sider:
332
ISBN-13:
9780367384371
Indbinding:
Paperback
ISBN-10:
036738437X
Udg. Dato:
5 sep 2019
Størrelse i cm:
15,2 x 22,9 x 2,0
Oplagsdato:
5 sep 2019

Generic Drug Product Development

- International Regulatory Requirements for Bioequivalence
Engelsk
Paperback 2019
Format:

Bog beskrivelse
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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Specifikationer
Sprog:
Engelsk
Sider:
332
ISBN-13:
9780367384371
Indbinding:
Paperback
ISBN-10:
036738437X
Udg. Dato:
5 sep 2019
Størrelse i cm:
15,2 x 22,9 x 2,0
Oplagsdato:
5 sep 2019
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