Project With FDA
Drug P is a drug toxic to the kidneys that was studied extensively in the eighties and nineties. A physiologically based pharmacokinetic model was developed to help to assess drug concentration in the liver in order to assess liver toxicity. The model development suggests high tissular binding and likely accumulation in the liver. Although sensitivity analysis, model performance metrics, and monte carlo analysis all suggests either high population variance in distribution of the drug or a great deal of uncertainty in model parameters and structure. See txt file for more details, feel free to email me for any questions. Publication of PBPK study on drug pending. This work was done at NCTR under the direction of Dr. Jeffrey Fisher and Dr. Xiaoxia Yang.