ASCPT

ASCPT

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Development, Regulatory, & Outcomes

Member Services Networks and Communities Development, Regulatory, & Outcomes

Development, Regulatory, & Outcomes (DRO) Network

Description & Goals

Network Goals

Enhance communication, cross-training and collaborations among members from multiple sectors including industry, government, and academia.
Apply principles of clinical pharmacology in the continuum of drug development, regulation, and post-marketing research and surveillance, as well as safe and effective utilization of medicines.

Network Connection

Past Webinars

Using Concentration – QTc as the Primary Analysis in TQT & Phase 1 Studies: Considerations, Methods and Case Studies; and an Introduction to Comprehensive in vitro Proarrhythmia Assessment (CiPA) initiative
Breaking Down Barriers for Acceleration of Development of New Anti-Infectives
FDA’s Sentinel System and the Regulatory Process
PBPK Modeling and Clinical Evaluation of a Natural Product-Drug Interaction
When are Transporters Important in Drug Disposition Including Tissue Distribution of Drugs?

Leadership

Donald L. Heald, PhD

Network Chair

Robin O'Connor-Semmes, PharmD, PhD

Network Vice Chair

Lei Zhang, PhD

Network Past Chair

Communities Represented