ABSTRACT

Therapeutic Equivalence and Generic Drug Products ...............................................2 Pharmaceutical Equivalents and Pharmaceutical Alternatives ..............................2 Therapeutic Equivalence .......................................................................................3 Economic Savings .................................................................................................3

Therapeutic Equivalence, Drug Product Quality, and Drug Product Performance ....3 Generic Drug Product Development ..........................................................................4 Selection of a Generic Drug Product for Manufacture ..............................................5 Legislative and Regulatory Issues ..............................................................................6