1st Edition
Generic Drug Product Development International Regulatory Requirements for Bioequivalence
332 Pages
by
CRC Press
336 Pages
by
CRC Press
332 Pages
by
CRC Press
Also available as eBook on:
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.... Read more
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.
Biography
Isadore Kanfer, Leon Shargel
