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Generic Drug Product Development -

Generic Drug Product Development

International Regulatory Requirements for Bioequivalence

Isadore Kanfer, Leon Shargel (Herausgeber)

Buch | Hardcover
336 Seiten
2010
Crc Press Inc (Verlag)
978-0-8493-7785-3 (ISBN)
CHF 296,75 inkl. MwSt
Generic Drug Product Development
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.

Isadore Kanfer, Leon Shargel

Introduction. Australasia. Brazil. Canada. The European Union. India. Japan. South Africa. South America and Pan American Health Organization. Taiwan. Turkey. United States of America. The World Health Organization.

Erscheint lt. Verlag 25.3.2010
Verlagsort Bosa Roca
Sprache englisch
Maße 152 x 229 mm
Gewicht 589 g
Themenwelt Medizin / Pharmazie Medizinische Fachgebiete Pharmakologie / Pharmakotherapie
Medizin / Pharmazie Pharmazie
Naturwissenschaften Biologie
Technik Umwelttechnik / Biotechnologie
ISBN-10 0-8493-7785-4 / 0849377854
ISBN-13 978-0-8493-7785-3 / 9780849377853
Zustand Neuware
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