Pharmacometric Modeling and Simulation for Generic Drugs Evaluation

The objectives of this project are to develop quantitative models for generic drugs evaluation in the following areas: 1. Population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The goal is to develop models and modeling approaches that will help FDA classify drugs as having a narrow therapeutic index and identify those products that have a clinical use profile that requires tighter control of product quality and equivalence attributes. 2. Pharmacometric modeling and simulation for generic drug substitutability evaluation and post marketing risk assessment. The goal is to develop pharmacometic approaches (including clinical trial simulation and clinical use/substitution simulation) that will aid OGD in the evaluation of post-market risk and the interpretation of post-market adverse event reports or product substitution complaints. 3. Pharmacometric modeling and simulation for partial AUC (area under the concentration vs. time curve) as bioequivalence criteria. The goal is to develop modeling and simulation tools that will aid FDA in identifying which generic drug products require greater degrees of pharmacokinetic profile similarity in order to assure therapeutic equivalence. Detailed Description: Applicants who wish to apply for more than one subtopic should submit separate proposals for each subtopic as listed below: Subtopic 1: Population pharmacokinetic and pharmacodynamic...
Source: Grants.gov - Category: Research Tags: Health Science and Technology and other Research and Development Source Type: funding