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7438613 
Journal Article 
Pharmacokinetic Considerations for Organ Dysfunction Clinical Trials in Early Drug Development 
Azaro, A; Demirhan, ME; Lim, J; Rodon, J; , 
2020 
Springer International Publishing 
Cham 
Phase I Oncology Drug Development 
313-342 
It is not infrequent that patients with different cancers are affected by bodily organ dysfunction. Factors such as comorbidities, prior anticancer therapies and tumor-related issues are frequent causes of organ impairment. Since patients with bodily organ dysfunction are not frequently enrolled in conventional clinical trials due to standard study eligibility criteria, such patients are placed at a disadvantage in receiving appropriate anticancer treatment. Renal and hepatic impairment may also have potential detrimental effects on the pharmacokinetic profile of drugs, with subsequent implications for both safety and efficacy.