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.
Episodes: PSPod
PSPod is our channel from CPT: Pharmacometrics & Systems Pharmacology (PSP). Join us as we delve into advances in quantitative methods as applied in pharmacology, physiology and therapeutics in humans.
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
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.
Mathematical Biology Models of Parkinson’s Disease with guests Piet van der Graaf, Suruchi Bakshi, and Chao Chen
On this episode of PSPod, Drs. Piet van der Graaf and Suruchi Bakshi from Certara QSP and Leiden University, and Dr. Chao Chen from Clinical Pharmacology Modelling & Simulation at GlaxoSmithKline, discuss quantitative systems pharmacology (QSP) modeling in relation to the study of Parkinson’s disease. This discussion is based on a Review article that published in the February 2019 issue of PSP, which is available here.
Quantitative Systems Toxicology Modeling with guest Dr. Paul Watkins
On today’s episode, Dr. Paul Watkins, the Howard Q. Ferguson Distinguished Professor at Eshelman School of Pharmacy, University of North Carolina at Chapel Hill and the Director of the University of North Carolina Institute for Drug Safety Sciences, discusses quantitative systems toxicology (QST) and quantitative systems pharmacology (QSP) modeling, recent examples of their application, and how they might better inform decision-making in the pharma industry. Dr. Watkins recently wrote a Commentary in PSP related to this topic and it is available here.
Reverse Translation Special Joint Episode
On this special joint episode of ClinPharmPod, the official podcast for Clinical Pharmacology and Therapeutics, and PSPod, the official podcast of CPT: Pharmacometrics and Systems Pharmacology Karthik Venkatakrishnan from Takeda Pharmaceuticals and Associate Editor for Clinical Pharmacology and Therapeutics, Lang Li, from the Ohio State University and Associate Editor for CPT: Pharmacometrics and Systems Pharmacology, and Valentina Shakhnovich from Children’s Mercy Hospital in Kansas City and Associate Editor for Clinical and Translational Science discuss reverse translation, the theme of a joint issue of articles recently published in the ASCPT journal family. They discuss the concept of reverse translation as a means to maximize the value of the ever-growing reservoir of real-world data in order to more effectively drive future research using retrospective analysis. Please visit the full joint virtual issue by clicking here.