Inactive Total Small Business Set-Aside (FAR 19.5)

The purpose of this requirement is to increase OB scientist and technical staff’s knowledge, skills, and abilities to perform their duties in working at the drug discovery interface responsible for le... The purpose of this requirement is to increase OB scientist and technical staff’s knowledge, skills, and abilities to perform their duties in working at the drug discovery interface responsible for lead optimization and candidate selection thereby aiding OB in serving FDA’s mission. Current approaches in the field of Pharmacokinetic-Pharmacodynamic involve development of models based on mechanisms of drug action and their alteration of physiologic processes. This course will provide a comprehensive overview of the principles, techniques, and applications of PK/PD modeling with a partial emphasis on modeling for bioequivalence (BE) assessment. Such modeling allows the optimal design and interpretation of pharmacologic experiments that range from molecular biology to human responses and can expedite the drug development process. Lectures and examples from the literature will be provided with course notes for all participants. Selected models or examples will include computer code to show how to quantitate typical experimental data. At the conclusion of this course, the biomedical scientist with basic knowledge in pharmacokinetic will be able to understand the diverse array of available PK/PD models and begin to apply them to experimental data and simulate anticipated drug responses. Specific topics that will be considered in this training include the following: Modeling and simulation of modified release solid oral products to ensure the consistency and quality of BE recommendations. Modeling and simulation to reduce/replace in vivo BE studies (i.e. in vivo PK BE studies, clinical endpoint or pharmacodynamic endpoint BE studies) for complex generic products and other generic products with clinical study challenges including long acting injectable and implantable products, oncology drug products, and orphan drug products. PK/PD modeling of narrow therapeutic index drugs and complex drug products and clinical trial simulations to aid risk-based BE evaluation. PK/PD modeling and simulation to determine the appropriate study design and evaluate sensitivity for BE assessment.