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HERO ID
7438613
Reference Type
Journal Article
Title
Pharmacokinetic Considerations for Organ Dysfunction Clinical Trials in Early Drug Development
Author(s)
Azaro, A; Demirhan, ME; Lim, J; Rodon, J; ,
Year
2020
Publisher
Springer International Publishing
Location
Cham
Book Title
Phase I Oncology Drug Development
Page Numbers
313-342
DOI
10.1007/978-3-030-47682-3_18
URL
http://link.springer.com/10.1007/978-3-030-47682-3_18
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Abstract
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.
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