Generic Drug Product Development

International Regulatory Requirements for Bioequivalence

Isadore Kanfer, Leon Shargel (Herausgeber)

Buch | Softcover

332 Seiten

2019
CRC Press (Verlag)
978-0-367-38437-1 (ISBN)

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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.

Erscheinungsdatum	30.09.2019
Verlagsort	London
Sprache	englisch
Maße	152 x 229 mm
Gewicht	453 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Medizin / Pharmazie ► Pharmazie
	Technik
ISBN-10	0-367-38437-X / 036738437X
ISBN-13	978-0-367-38437-1 / 9780367384371
Zustand	Neuware