Enrollment of healthy control group in pharmacokinetics studies in participants with organ (renal or hepatic) impairment, can raise ethical and practical issues. Repetitive evaluations of pharmacokinetic (PK) in healthy participants may not be warranted when the PK profile of the drug is adequately characterized. Moreover, the enrollment of healthy control group can be time-consuming, especially when attempting to match study participants with organ impairment by demographics and other physiological characteristics. In this presentation, the International Consortium for Innovation and Quality (IQ) Clinical Pharmacology Organ Impairment will present the results of a retrospective analysis which evaluated the feasibility of utilizing virtual population to replace matching healthy control group in organ impairment studies. The presentation will also discuss pros and cons for the different methods used to replace matching healthy control group in organ impairment studies. Finally, the challenges, opportunities, and future steps for implementing the virtual population approach in organ impairment studies will be discussed.