Exploring the Relationship of Drug BCS Classification, Food Effect, and Gastric pH-Dependent Drug Interactions

Author:

Owens Katie,Argon Sophie,Yu Jingjing,Yang Xinning,Wu Fang,Lee Sue-Chih,Sun Wei-Jhe,Ramamoorthy Anuradha,Zhang Lei,Ragueneau-Majlessi Isabelle

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference112 articles.

1. US Food and Drug Administration. Guidance for Industry: assessing the effects of food on drugs in INDs and NDAs - Clinical Pharmacology Considerations (Draft Guidance). Silver Spring, MD: US Food and Drug Administration; 2019.

2. US Food and Drug Administration. Guidance for Industry: bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA (Draft Guidance). Silver Spring, MD: US Food and Drug Administration; 2013.

3. O'Shea JP, Holm R, O'Driscoll CM, Griffin BT. Food for thought: formulating away the food effect - a PEARRL review. J Pharm Pharmacol. 2019;71(4):510–35.

4. Fleisher D, Li C, Zhou Y, Pao LH, Karim A. Drug, meal and formulation interactions influencing drug absorption after oral administration. Clinical implications. Clin Pharmacokinet. 1999;36(3):233–54.

5. Wu CY, Benet LZ. Predicting drug disposition via application of BCS: transport/absorption/ elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm Res. 2005;22(1):11–23.

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