Major pharmaceutical companies and drug regulatory agencies are using physiologically-based pharmacokinetic (PBPK) modeling in virtual populations to investigate the impact of hepatic or renal impairment on drug exposure as a supplement to clinical investigation and help guide dosage adjustment in these patient groups.
Impaired hepatic or renal function can have a major impact on pharmacokinetics and there is a high risk of adverse events in patients with these conditions.
Thorough investigation of all the potential risks of drug therapy has to be carefully balanced with the ethical concerns of conducting studies in vulnerable subjects. The Simcyp Consortium of pharmaceutical companies identified the need to extend PBPK modeling to special populations to assist in decision-making as to whether, when and how to conduct clinical trials.
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