Generic drug product equivalence: current status.
This activity is designed for healthcare professionals involved in the selection of multisource drug products.


OBJECTIVE
To understand the basis for approval of generic drug products by the Food and Drug Administration.


OBJECTIVE
1. Identify the criteria employed by the Food and Drug Administration to approve generic drug products. 2. Discuss controversial issues that have been raised relative to generic drug products. 3. Identify narrow therapeutic index drugs. 4. Describe the different types of bioequivalence studies that are required by the Food and Drug Administration. 5. Discuss the responsibilities underlying the selection of multisource drug products by healthcare professionals.
Meyer
M C
MC
College of Pharmacy, University of Tennessee, Memphis, TN 38163, USA.
D003692:Delayed-Action Preparations; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D016568:Drugs, Generic; D004513:Education, Pharmacy, Continuing; D010595:Pharmacists; D010818:Practice Patterns, Physicians'; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
D003692:Delayed-Action Preparations; D016568:Drugs, Generic