Pharmacometrics at FDA - Disease Specific Model Library

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FDA/Center for Drug Evaluation and Research

Pharmacometrics at FDA
Disease Specific Model Library

Overview

Quantitative disease-drug-trial models are mathematical representations of the time course of biomarker-clinical outcomes, placebo effects, drug’s pharmacologic effects and trial execution characteristics for both the desired and undesired responses, and across experiments.

FDA Pharmacometrics group is involved in disease-drug-trial models research for diseases of public health importance. Drug models are not included here. These models are never complete and can be extended as new information is collected. Our modeling objectives were mainly driven by the drug development/ regulatory challenge at hand. These models are by no means comprehensive, but would still allow researchers/drug developers to employ them for making important development decisions. Routine use of these models and expansion would make the models more informative in future.

The technical reports of the currently available models from our group are listed below.

Library

Disease Area	Disease Model Component	Trial Model Component	Link
Obesity	Placebo	Demographics, Drop-out	Food and Drug Administration. 2006. Proceedings of the Clinical Pharmacology Sub-Committee Advisory Committee Meeting.
Parkinson	Placebo/Disease Progression	Demographics, Drop-out	Food and Drug Administration. 2006. Proceedings of the Clinical Pharmacology Sub-Committee Advisory Committee Meeting.
Non-small cell lung cancer	Tumor size-Survival	Separate model for patients with missing tumor data	Food and Drug Administration. 2008. Proceedings of the Clinical Pharmacology Sub-Committee Advisory Committee Meeting.

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Date created: November 19, 2008