On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants: an Exploratory Study Highlighting the Importance of Infant Food-Reference-Cited by-同舟云学术

On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants: an Exploratory Study Highlighting the Importance of Infant Food

Published:2019-12-02 Issue:1 Volume:22 Page:
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Statelova Marina,Goumas Konstantinos,Fotaki Nikoletta,Holm René,Symillides Mira,Reppas Christos,Vertzoni Maria

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-019-0380-4.pdf

Reference73 articles.

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2. Guimarães M, Statelova M, Holm R, Reppas C, Symilllides M, Vertzoni M, et al. Biopharmaceutical considerations in paediatrics with a view to the evaluation of orally administered drug products - a PEARRL review. J Pharm Pharmacol. 2019;71(4):603–42.

3. Strickley RG. Pediatric oral formulations: an updated review of commercially available pediatric oral formulations since 2007. J Pharm Sci. 2019;108(4):1335–65.

4. European Medicines Agency (EMA). Guideline on pharmaceutical development of medicines for paediatric use. Guid Doc. 2013;44(May):1–23. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmaceutical-development-medicines-paediatric-use_en.pdf.

5. European Medicines Agency (EMA). Guideline on the investigation of drug interactions Guid Doc. 2012;44(June):1–59. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/07/WC500129606.pdf.

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