European Medicines Agency. Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function. Scientific Guideline. 2016.

European Medicines Agency. Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function. Scientific Guideline. 2005.

US Food and Drug Administration. Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing. GUIDANCE DOCUMENT. 2024.

US Food and Drug Administration. Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling. Guidance Document. 2003.

Mittur A, Madanick R, Langlois M, Boyd B. Effect of hepatic impairment on the pharmacokinetics of Fenfluramine and Norfenfluramine. J Clin Pharmacol. 2024;64(7):887–98.

Article  CAS  PubMed  Google Scholar 

Wu J, Yang X, Wu J, Wang J, Wu H, Wang Y, et al. Dose adjustment not required for contezolid in patients with moderate hepatic impairment based on pharmacokinetic/pharmacodynamic analysis. Front Pharmacol. 2023;14:1135007.

Article  CAS  PubMed  PubMed Central  Google Scholar 

McCabe J, Zhang J, Yang F, Benn V. Pharmacokinetics of the novel nonsteroidal mineralocorticoid receptor antagonist ocedurenone (KBP-5074) in individuals with moderate hepatic impairment. Eur J Drug Metab Pharmacokinet. 2024;49(2):229–37.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Weber E, Younis IR, Nelson C, Ding D, Qin A, Xiao D, et al. Effect of renal impairment on the pharmacokinetics of firsocostat, an acetyl-coenzyme A carboxylase inhibitor, and cilofexor, a selective nonsteroidal farnesoid X receptor agonist. J Clin Pharmacol. 2023;63(5):560–8.

Article  CAS  PubMed  Google Scholar 

Ji T, Rockich K, Epstein N, Overholt H, Wang P, Chen X, et al. Evaluation of the pharmacokinetics of pemigatinib in patients with impaired hepatic or renal function. Br J Clin Pharmacol. 2022;88(1):237–47.

Article  CAS  PubMed  Google Scholar 

Ozbey AC, Meneses-Lorente G, Simmons B, McCallum S, Annaert P, Parrott N, et al. Clinical Exploration and Physiologically Based Modelling of the Impact of Hepatic Impairment on Entrectinib Pharmacokinetics. Clin Pharmacokinet. 2025 Feb 11;

Lawitz EJ, Fraessdorf M, Neff GW, Schattenberg JM, Noureddin M, Alkhouri N, et al. Efficacy, tolerability and pharmacokinetics of survodutide, a glucagon/glucagon-like peptide-1 receptor dual agonist, in cirrhosis. J Hepatol. 2024;81(5):837–46.

Article  CAS  PubMed  Google Scholar 

Czerniak R, Cieslarová B, Kupčová V, Rosario M, Lock R, Dong C, et al. The effect of hepatic impairment on the pharmacokinetics of intravenously administered Felcisetrag (TAK-954). J Clin Pharmacol. 2022;62(8):1006–17.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Trivedi A, Oberoi RK, Jafarinasabian P, Zhang H, Flach S, Abbasi S, et al. Effect of varying degrees of renal impairment on the pharmacokinetics of Omecamtiv Mecarbil. Clin Pharmacokinet. 2021;60(8):1041–8.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Townsend RW, Akhtar S, Alcorn H, Berg JK, Kowalski DL, Mujais S, et al. Phase I trial to investigate the effect of renal impairment on isavuconazole pharmacokinetics. Eur J Clin Pharmacol. 2017;73(6):669–78.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Fradette C, Pichette V, Sicard É, Stilman A, Jayashankar S, Tsang YC, et al. Effects of renal impairment on the pharmacokinetics of orally administered deferiprone. Br J Clin Pharmacol. 2016;82(4):994–1001.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Li C, Mai J, Wu M, Zhang H, Li X, Li H, et al. Single-dose tolerability and pharmacokinetics of leritrelvir in Chinese patients with hepatic impairment and healthy matched controls. Antimicrob Agents Chemother. 2025Feb 13;69(2):e0137724.

Article  PubMed  Google Scholar 

Duncan KE, Carstens RP, Butterfield KL, Jin Y, Inbody LR, Schaeffer AK, et al. Assessment of pharmacokinetics and tolerability following single-dose administration of molnupiravir in participants with hepatic or renal impairment. Clin Transl Sci. 2024Dec;17(12):e70073.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Bhardwaj R, Donohue MK, Madonia J, Morris B, Marbury TC, Matschke KT, et al. Reduced hepatic impairment study to evaluate pharmacokinetics and safety of zavegepant and to inform dosing recommendation for hepatic impairment. Clin Transl Sci. 2024;17(7):e13813.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Zhou J, Zhang H, Chen H, Zhang G, Mao J, Zhang T, et al. Pharmacokinetics and safety of GST-HG171, a novel 3CL protease inhibitor, in Chinese subjects with impaired and normal liver function. Antimicrob Agents Chemother. 2024Aug 7;68(8):e0053924.

Article  PubMed  Google Scholar 

Greig G, Youssef NN, Bolognani F. Pharmacokinetics and tolerability of a single dose of Apraglutide, a novel, long-acting, synthetic glucagon-like peptide-2 analog with a unique pharmacologic profile, in individuals with impaired renal function. J Clin Pharmacol. 2024;64(6):744–54.

Article  CAS  PubMed  Google Scholar 

Matthews RP, Cao Y, Patel M, Weissler VL, Bhattacharyya A, De Lepeleire I, et al. Safety and Pharmacokinetics of Islatravir in Individuals with Severe Renal Insufficiency. Antimicrob Agents Chemother. 2022Dec 20;66(12):e0093122.

Article  PubMed  Google Scholar 

Yin W, Mitra P, Copalu V, Marbury TC, Rondon JC, Lawitz EJ, et al. Phase 1 pharmacokinetic and safety study of soticlestat in participants with mild or moderate hepatic impairment or normal hepatic function. Pharmacol Res Perspect. 2024;12(4):e1213.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Fukumura K, Yamada T, Yokota T, Kawasaki A. The Influence of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Naldemedine. Clin Pharmacol Drug Dev. 2020Feb;9(2):162–74.

Article  CAS  PubMed  Google Scholar 

Katsube T, Echols R, Arjona Ferreira JC, Krenz HK, Berg JK, Galloway C. Cefiderocol, a siderophore cephalosporin for Gram-negative bacterial infections: pharmacokinetics and safety in subjects with renal impairment. J Clin Pharmacol. 2017;57(5):584–91.

Article  CAS  PubMed  Google Scholar 

Berger B, Dingemanse J, Sabattini G, Delahaye S, Duthaler U, Muehlan C, et al. Effect of liver cirrhosis on the pharmacokinetics, metabolism, and tolerability of daridorexant, a novel dual orexin receptor antagonist. Clin Pharmacokinet. 2021;60(10):1349–60.

Article  CAS  PubMed  Google Scholar 

He P, Kerr D, Marbury T, Ries D, Farwell W, Stecher S, et al. Pharmacokinetics of renally excreted drug dexpramipexole in subjects with impaired renal function. J Clin Pharmacol. 2014;54(12):1383–90.

Article  CAS  PubMed  Google Scholar 

Bello CL, Garrett M, Sherman L, Smeraglia J, Ryan B, Toh M. Pharmacokinetics of sunitinib malate in subjects with hepatic impairment. Cancer Chemother Pharmacol. 2010;66(4):699–707.

Article  CAS  PubMed  Google Scholar 

El-Khoueiry AB, Sarantopoulos J, O’Bryant CL, Ciombor KK, Xu H, O’Gorman M, et al. Evaluation of hepatic impairment on pharmacokinetics and safety of crizotinib in patients with advanced cancer. Cancer Chemother Pharmacol. 2018;81(4):659–70.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Grechko N, Skarbova V, Tomaszewska-Kiecana M, Ramlau R, Centkowski P, Drew Y, et al. Pharmacokinetics and safety of rucaparib in patients with advanced solid tumors and hepatic impairment. Cancer Chemother Pharmacol. 2021;88(2):259–70.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Pérez-Elías MJ, Morellon ML, Ortega E, Hernández-Quero J, Rodríguez-Torres M, Clotet B, et al. Pharmacokinetics of fosamprenavir plus ritonavir in human immunodeficiency virus type 1-infected adult subjects with hepatic impairment. Antimicrob Agents Chemother. 2009;53(12):5185–96.

Article  PubMed  PubMed Central  Google Scholar 

Schöller-Gyüre M, Kakuda TN, De Smedt G, Woodfall B, Berckmans C, Peeters M, et al. Effects of hepatic impairment on the steady-state pharmacokinetics of etravirine 200 mg BID: an open-label, multiple-dose, controlled phase I study in adults. Clin Ther. 2010;32(2):328–37.

Article  PubMed  Google Scholar 

Tebas P, Bellos N, Lucasti C, Richmond G, Godofsky E, Patel I, et al. Enfuvirtide Does Not Require Dose Adjustment in Patients With Chronic Kidney Failure. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2008Mar 1;47(3):342–5.

Article  CAS  PubMed  Google Scholar 

Haroldsen PE, Sisic Z, Datt J, Musson DG, Ingenito G. Acetylator status impacts amifampridine phosphate (Firdapse™) pharmacokinetics and exposure to a greater extent than renal function. Clin Ther. 2017;39(7):1360–70.