Generic Drug Product Development: International Regulatory Requirements for Bioequivalence

Author:   Isadore Kanfer ,  Leon Shargel ,  Leon Shargel ,  Leon Shargel
Publisher:   Taylor & Francis Ltd
ISBN:  

9780367384371


Pages:   332
Publication Date:   05 September 2019
Format:   Paperback
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Our Price $126.00 Quantity:  
Add to Cart

Share |

Generic Drug Product Development: International Regulatory Requirements for Bioequivalence


Add your own review!

Overview

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.

Full Product Details

Author:   Isadore Kanfer ,  Leon Shargel ,  Leon Shargel ,  Leon Shargel
Publisher:   Taylor & Francis Ltd
Imprint:   CRC Press
Weight:   0.453kg
ISBN:  

9780367384371


ISBN 10:   036738437
Pages:   332
Publication Date:   05 September 2019
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table of Contents

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.

Reviews

Author Information

Isadore Kanfer, Leon Shargel

Tab Content 6

Author Website:  

Customer Reviews

Recent Reviews

No review item found!

Add your own review!

Countries Available

All regions
Latest Reading Guide

wl

Shopping Cart
Your cart is empty
Shopping cart
Mailing List