Predicting Food Effects on Oral Extended-Release Drug Products: A Retrospective Evaluation

Author:

Zou Peng,Vaidyanathan Jayabharathi,Tran Doanh,Raines Kimberly,Chatterjee Parnali,Madabushi Rajanikanth,Seo Shirley K.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference35 articles.

1. FDA. FY2015 Regulatory Science Research Report: Modified Release Drug Products: Therapeutic Equivalence between Brand-Name Drugs and Generics. 2015; Available from: https://www.fda.gov/industry/generic-drug-user-fee-amendments/fy2015-regulatory-science-research-report-modified-release-drug-products-therapeutic-equivalence.

2. EMA. Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms. 2014; Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmacokinetic-clinical-evaluation-modified-release-dosage-forms_en.pdf.

3. FDA. Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations. 2019; Available from: https://www.fda.gov/media/121313/download.

4. FDA. Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies. 2002; Available from: https://www.fda.gov/media/70945/download.

5. Mudie DM, Amidon GL, Amidon GE. Physiological parameters for oral delivery and in vitro testing. Mol Pharm. 2010;7(5):1388–405. https://doi.org/10.1021/mp100149j.

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