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 |
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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). |
doi_str_mv | 10.1002/cpt.610 |
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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).</description><identifier>ISSN: 0009-9236</identifier><identifier>EISSN: 1532-6535</identifier><identifier>DOI: 10.1002/cpt.610</identifier><identifier>PMID: 28073144</identifier><language>eng</language><publisher>United States</publisher><subject>Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - pharmacokinetics ; Biological Availability ; Drug Labeling ; Food-Drug Interactions ; Humans ; Intestinal Absorption</subject><ispartof>Clinical pharmacology and therapeutics, 2017-05, Vol.101 (5), p.606-612</ispartof><rights>2017 American Society for Clinical Pharmacology and Therapeutics</rights><rights>2017 American Society for Clinical Pharmacology and Therapeutics.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3170-779dec0fdb0c6d42511aa8d3123a0dc16911252959830ae175d194ae7cd9c1633</citedby><cites>FETCH-LOGICAL-c3170-779dec0fdb0c6d42511aa8d3123a0dc16911252959830ae175d194ae7cd9c1633</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fcpt.610$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fcpt.610$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28073144$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Parsad, S</creatorcontrib><creatorcontrib>Ratain, MJ</creatorcontrib><title>Food Effect Studies for Oncology Drug Products</title><title>Clinical pharmacology and therapeutics</title><addtitle>Clin Pharmacol Ther</addtitle><description>Oral antineoplastic agents provide convenience to the patient, but are accompanied by challenges distinct from parenteral cancer treatment. 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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).</abstract><cop>United States</cop><pmid>28073144</pmid><doi>10.1002/cpt.610</doi><tpages>7</tpages></addata></record> |
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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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