April 13 &14, 2010 – Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Agenda: On April 13, 2010, the committee will receive presentations from the Office of Generic Drugs and discuss two bioequivalence topics relevant to generic drug approval: (1) Revising the BE approaches for critical dose drugs and (2) the use of partial area under the curve (AUC) for the evaluation of abbreviated new drug applications for products with complex pharmacokinetic profiles. Bioequivalence refers to the evaluation of equivalence in the rate and extent of drug absorption between two preparations of the same drug. Critical dose drugs are medicines that require a narrow (or ``critical'') dose range to achieve and maintain their intended effects and to reduce serious adverse drug reactions. The ``area under the curve'' is the area under a plot of drug concentration in the bloodstream versus time; it is a measure of the extent of exposure to a drug after a dose is administered.
Agenda: On April 14, 2010, the committee will: (1) Receive presentations from the Office of Generic Drugs (OGD) on a proposal for revision of the bioequivalence (BE) approaches, specifically to discuss the addition of a limitation on point estimates; (2) receive presentations on an awareness topic to highlight some issues associated with product instability (failure of a marketed product to meet stability specifications through the expiration date), and the potential research needs to address those issues; and (3) receive and discuss presentations from Office of Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive intracellular accumulation of phospholipids, a kind of fatty molecule, due to the use of certain drugs).
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