Formulation-dependent food effects demonstrated for nifedipine modified-release preparations marketed in the European Union

Author:

Schug Barbara S,Brendel Erich,Wolf Dörte,Wonnemann Meinolf,Wargenau Manfred,Blume Henning H

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference10 articles.

1. Influence of food on the bioavailability of controlled/modified release products;Blume,1996

2. CPMP Note for Guidance, 1999. CPMP Note for Guidance on Quality of Modified Release Oral and Transdermal Dosage Forms (Section II: Pharmacokinetic and Clinical Evaluation), CPMP/EWP/280/96.

3. Behaviour of single unit and multiple unit dosage forms in the gastrointestinal tract;Davis,1989

4. Food and Drug Administration, 1997. Draft Guidance for Industry: food-effect bioavailability and bioequivalence studies. US Department of Health and Human Services, CDER.

5. Food-induced changes in theophylline absorption from controlled-release formulations. Part II: Importance of meal composition and dosing time relative to meal intake in assessing changes in absorption;Karim;Clin. Pharmacol. Ther.,1985

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