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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 AreaDisease Model ComponentTrial Model ComponentLink
Alzheimer’s disease Placebo/Disease ProgressionDemographics, Drop-out Food and Drug Administration issued a letter in 2013 to endorse the fit-for-purpose application of the drug development tool submitted by Critical Path Institute’s (C-Path) consortium, the Coalition Against Major Diseases (CAMD). The tool is freely available at http://code.google.com/p/alzheimers-disease-progression-model-adascog/downloads/list.
Bipolar diseasePlacebo/Disease ProgressionDemographics, Drop-out Sun W, Laughren TP, Zhu H, Hochhaus G, Wang Y. (2013), Development of a placebo effect model combined with a dropout model for bipolar disorder, J Pharmacokinet Pharmacodyn. 40(3):359-68
ObesityPlaceboDemographics, Drop-outFood and Drug Administration. 2006.
Proceedings of the Clinical Pharmacology Sub-Committee Advisory Committee Meeting.
ParkinsonPlacebo/Disease ProgressionDemographics, Drop-outFood and Drug Administration. 2006.
Proceedings of the Clinical Pharmacology Sub-Committee Advisory Committee Meeting.
Non-small cell lung cancerTumor size-SurvivalSeparate model for patients with missing tumor dataFood and Drug Administration. 2008.
Proceedings of the Clinical Pharmacology Sub-Committee Advisory Committee Meeting.

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