Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation

Ross Walenga from the Office of Generic Drugs discusses (1) Current knowledge gap between regional deposition and systemic PK data of Orally Inhaled and Nasal Drug Products (OINDPs) for inference of local lung tissue PK, (2) Available modeling and simulation techniques as well as utility and limitations for each technique with respect to predicting various aspects of OINDP delivery, (3) Modeling strategies for producing and connecting regional deposition, systemic PK, and local lung tissue PK predictions, and (4) Model verification and validation for resulting predictions.

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