Abstract
Drugs intended for oral administration have to pass through the gastrointestinal tract before they can enter the blood stream and eventually reach their target site of action. Often already profiled using a food screen in the First-in-Man study, the assessment of the influence of food intake on the bioavailability of a drug belongs to the most important steps when describing the drug pharmacokinetics in early clinical development. The outcome of such food screens or formal food interaction studies has a considerable impact on the design of ensuing studies and forms the basis for later labeling recommendations and for the package insert (US FDA Guidance for Industry 2002).
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REFERENCES AND FURTHER READING
EU CPMP: Note for Guidance on Modified Release Oral and Transdermal Dosage Forms: Section II (Pharmacokinetic and Clinical Evaluation). July 1999
EU CPMP/EWP/1875/03/Final: Points to Consider on the Clinical Requirements of Modified Release Products Submitted as a Line Extension of an Existing Marketing Authorization. December 2003
US FDA Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations. September 1997
US FDA Guidance for Industry: SUPAC-MR: Modified Release Solid Oral Dosage Forms. September 1997
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Wesch, R. (2011). Effects of Food Intake. In: Vogel, H.G., Maas, J., Gebauer, A. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-89891-7_6
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DOI: https://doi.org/10.1007/978-3-540-89891-7_6
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-540-89890-0
Online ISBN: 978-3-540-89891-7
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