Abstract:
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After entering the body, a drug is usually eliminated by excretion and/or by metabolism, which mainly involves renal/hepatic function. Impaired renal/hepatic function usually alters the drug's pharmacokinetics (PK) to an extent that the dosage regimen needs to be changed from that used in patients with normal renal/hepatic function. Since the PK is most likely to be affected by both rental/hepatic function and demographic aspects, the study usually includes a healthy volunteer control group whose demographic data matches the typical impaired renal/hepatic function group. FDA guidance gives the recommendations when a study of PK in patients with impaired renal function should be performed as a full study or a reduced study and when it is not necessary. However, it does not give details about matching and modeling/analysis. This presentation reviews the most popular designs, and modeling/analysis options. Ideally, an ANOVA model is used if the control group matches the impaired renal/hepatic function group perfectly; otherwise, an ANCOVA model is considered for removing the unmatched demographic effect. Presenting real clinical studies, we show the ANCOVA model results can be biased
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