ArticleClinical cancer research : an official journal of the American Association for Cancer Research2010
Inconsistent labeling of food effect for oral agents across therapeutic areas: differences between oncology and non-oncology products.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed.
- Pharmacokinetics and Bioequivalence of Rasagiline Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions: An Open, Randomized, Single-Dose, Double-Cycle, Two-Sequence, Crossover Trial.Frontiers in pharmacology · 2020Trial
- A prospective phase I multicentre randomized cross-over pharmacokinetic study to determine the effect of food on abiraterone pharmacokinetics.Cancer chemotherapy and pharmacology · 2019Trial
- Prospective International Randomized Phase II Study of Low-Dose Abiraterone With Food Versus Standard Dose Abiraterone In Castration-Resistant Prostate Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018Trial
- Phase IB Study of Selinexor, a First-in-Class Inhibitor of Nuclear Export, in Patients With Advanced Refractory Bone or Soft Tissue Sarcoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016Trial
- Efficacy and safety of extended dosing schedules of CC-486 (oral azacitidine) in patients with lower-risk myelodysplastic syndromes.Leukemia · 2016Trial
- The effect of food on the pharmacokinetics of oral ibrutinib in healthy participants and patients with chronic lymphocytic leukemia.Cancer chemotherapy and pharmacology · 2015Trial
- Evaluation of food effect on pharmacokinetics of vismodegib in advanced solid tumor patients.Clinical cancer research : an official journal of the American Association for Cancer Research · 2013Trial
- Enhancing the pharmacokinetics of abiraterone acetate through lipid-based formulations: addressing solubility and food effect challenges.Drug delivery and translational research · 2025Article
- Playing Hide-and-Seek with Tyrosine Kinase Inhibitors: Can We Overcome Administration Challenges?The AAPS journal · 2024Review
- Low-Dose Abiraterone in Metastatic Prostate Cancer: Is It Practice Changing? Facts and Facets.JCO global oncology · 2020Article
- Safety and Tolerability of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors in Oncology.Drug safety · 2019Review
- Effects of food and grapefruit juice on single-dose pharmacokinetics of blonanserin in healthy Chinese subjects.European journal of clinical pharmacology · 2018Article
- Lipid-associated oral delivery: Mechanisms and analysis of oral absorption enhancement.Journal of controlled release : official journal of the Controlled Release Society · 2016Review
- Clinical trial simulation to evaluate population pharmacokinetics and food effect: capturing abiraterone and nilotinib exposures.Journal of clinical pharmacology · 2015Article
- Resistance to cancer chemotherapy: failure in drug response from ADME to P-gp.Cancer cell international · 2015Article
- Phase I studies of sirolimus alone or in combination with pharmacokinetic modulators in advanced cancer patients.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Article
- Phase I study of sunitinib and erlotinib in advanced nonsquamous non-small cell lung cancer.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2011Article
- United States Food and Drug Administration approved oral kinase inhibitors for the treatment of malignancies.Current problems in cancerReview
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2 authors.
Funding
Abstract
purposeSeveral recent oral oncology drugs were labeled for administration in fasted states despite the fact that food increases their bioavailability. Because this was inconsistent with the principles of oral drug delivery, we hypothesized that there were inconsistencies across therapeutic areas. EXPERIMENTAL
designOral agents approved by the U.S. Food and Drug Administration from January 2000 to May 2009 were included in our study. Comparison of the food labeling patterns between oncology and non-oncology drugs was made using Fisher's exact test.
resultsOf the 99 drugs evaluated, 34 showed significant food effects on bioavailability. When food markedly enhanced bioavailability, eight out of nine non-oncology drugs were labeled "fed" to take advantage of the food-drug interaction, whereas all oncology drugs (n = 3) were labeled to be administered in "fasted" states (Fisher's exact test, P = 0.01).
conclusionsDrug labeling patterns with respect to food-drug interactions observed with oncology drugs are in contradiction with fundamental pharmacologic principles, as exemplified in the labeling of non-oncology drugs. .
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