Tagged: FDA

A Holistic and Integrative Approach for Advancing Model‐Informed Drug Development

May 13, 2019

On this episode of PSPod, Dr. Rajanikanth Madabushi from the US Food and Drug Administration continues our recent discussion on model-informed drug development (MIDD) and its role in the successful implementation of PDUFA VI. This discussion is based on his co-authored Perspective article (with Drs. Yaning Wang and Issam Zineh) “A Holistic and Integrative Approach for Advancing Model‐Informed Drug Development” which published in the January 2019 issue of PSP. The article is available here.

PSPod

A Holistic and Integrative Approach for Advancing Model‐Informed Drug Development

00:00 / 11:34

PDUFA VI: It Is Time to Unleash the Full Potential of Model-Informed Drug Development with Drs. Lokesh Jain, Larissa Wenning, and Nitin Mehrotra from Merck

April 29, 2019

On this episode of PSPod, Drs. Lokesh Jain, Larissa Wenning, and Nitin Mehrotra from Merck discuss the important role model-informed drug development (MIDD) will play in the successful implementation of PDUFA VI. This discussion is based on their Perspective article “PDUFA VI: It’s Time to Unleash the Full Potential of Model-Informed Drug Development” which published in the January 2019 issue of PSP. The article is available here.

PSPod

PDUFA VI: It Is Time to Unleash the Full Potential of Model-Informed Drug Development with Drs. Lokesh Jain, Larissa Wenning, and Nitin Mehrotra from Merck

00:00 / 19:45

Databases as Tools in Pharmacometrics and Systems Pharmacology with guest Shiew-Mei Huang

June 1, 2015

In this episode, we interview Dr. Shiew-Mei Huang, Deputy Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research at the Food and Drug Administration about a drug interaction database–a tool for evaluating the impact of renal or hepatic impairment in a pharmacologic inhibition on the systemic exposure of drugs. Read the article here. An Editorial describing the new Database article type can also be found here.

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PSPod

Databases as Tools in Pharmacometrics and Systems Pharmacology with guest Shiew-Mei Huang

00:00 / 6:59