Food effects bioavailability/bioequivalence studie

EMEA CPMP/EWP/560/95 (1997) Note for guidance on the investigation of drug interactions. December 1997 Guidance for Industry Food effect bioavailability and bioequivalence studies. December 2002... 

EU CPMP (1999) Note for Guidance on Modified Release Oral and Transdermal Dosage Forms Section II (Pharmacokinetic and Clinical Evaluation) July 1999 US FDA Guidance for Industry Food-Effect Bioavailability and FED Bioequivalence Studies December 2002... 

Food-effect bioavailability and fed bioequivalence studies Study design, data analysis, and labeling. In Draft Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, October, 2001. 

Center for Drug Evaluation and Research (CDER). Guidance for Industry Food-Effect Bioavailability and Fed Bioequivalence Studies, December 2002. 

FDA. 1997c. Guidance for industry—Food-effect bioavailability and bioequivalence studies. Rockville, Md., USA Food and Drug Administration. 

Some medicines are normally given with food to reduce gastrointestinal side-effects in certain cases coadministration with food increases bioavailability of orally administered preparations. If the labelling states that the pharmaceutical product should be taken with food then a fed study should be used to assess bioequivalence. Fed state studies are also required in bioequivalence studies of modified release formulations. In these cases the objective is to select a meal that will challenge the robustness of the new multisource formulation to prandial effects on bioavailability (see 6.2.4). The test meal selected should take account of local custom and diet and should be consumed within 20 minutes. The product should be administered according to the protocol and within 30 minutes after the meal has been eaten. 

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