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.

About the Author
Isadore Kanfer, Leon Shargel


Book Information
ISBN 9780367384371
Author Isadore Kanfer
Format Paperback
Page Count 332
Imprint CRC Press
Publisher Taylor & Francis Ltd
Weight(grams) 453g