Bioequivalence Standards for Narrow Therapeutic Index (NTI) Drugs: Are They Stringent Enough to Ensure Safety and Efficacy?

Date & Time

Mar 5th at 1:00 PM until 2:30 PM

Track

Location

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This is the first workshop that attempts to utilize PK/PD modeling and simulation approaches in tackling the challenges within complicated narrow therapeutic index (NTI) drugs field at an ASCPT annual meeting. This workshop will cover a broad spectrum of BE assessment of generic NTI drugs, focusing on the NTI drugs classification and quantitative assessment of current BE standards using innovative modeling and simulation approaches. At the completion of the workshop, the participants will be able to conduct the NTI drugs classification on a scientific basis using population pharmacokinetic (PK)-pharmacodynamic (PD) methodologies.