ABSTRACT

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 therapeutica

chapter 1|16 pages

Introduction

chapter 4|28 pages

Canada

chapter 5|19 pages

The European Union

chapter 6|50 pages

India

chapter 7|18 pages

Japan

chapter 10|10 pages

Taiwan

chapter 11|12 pages

Turkey