Food Effect Studies for Oncology Drug Products

Oral antineoplastic agents provide convenience to the patient, but are accompanied by challenges distinct from parenteral cancer treatment. Challenges include a more complex pharmacokinetic profile, with food influencing the absorption of many agents. Standards for evaluating and labeling prandial i...

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Veröffentlicht in:Clinical pharmacology and therapeutics 2017-05, Vol.101 (5), p.606-612
Hauptverfasser: Parsad, S, Ratain, MJ
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creator Parsad, S
Ratain, MJ
description Oral antineoplastic agents provide convenience to the patient, but are accompanied by challenges distinct from parenteral cancer treatment. Challenges include a more complex pharmacokinetic profile, with food influencing the absorption of many agents. Standards for evaluating and labeling prandial implications on oral chemotherapy are inconsistent; studies to determine food effects should be conducted early, and potentially often, during drug development with standardization on how rational fasting or fed recommendations are presented in the package insert (PI).
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source MEDLINE; Wiley Journals
subjects Antineoplastic Agents - administration & dosage
Antineoplastic Agents - pharmacokinetics
Biological Availability
Drug Labeling
Food-Drug Interactions
Humans
Intestinal Absorption
title Food Effect Studies for Oncology Drug Products
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