ABSTRACT

In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral

chapter 2|12 pages

Active Pharmaceutical Ingredients

chapter 4|44 pages

Experimental Formulation Development

chapter 6|32 pages

Drug Stability

chapter 7|12 pages

Quality Control and Quality Assurance

chapter 8|24 pages

Drug Product Performance: In Vitro

chapter 9|12 pages

ANDA Regulatory Approval Process