Development of In Vitro – In Vivo Correlation for Extended‐Release Niacin After Administration of Hypromellose‐Based Matrix Formulations to Healthy Volunteers

Author:

Kesisoglou Filippos,Rossenu Stefaan,Farrell Colm,Van Den Heuvel Michiel,Prohn Marita,Fitzpatrick Shaun,De Kam Pieter‐Jan,Vargo Ryan

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference20 articles.

1. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). 1997. Guidance for industry: Extended release oral dosage forms: Development, evaluation, and application of in vitro/in vivo correlations.

2. European Medicines Agency. 2013. Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1) Draft XXIII.

3. Draft guideline on quality of oral modified release products,2012

4. Testing and correlation for oral controlled/modified‐release dosage forms;Skelly;Pharm Res,1990

5. In vitro/in vivo correlations: Scientific implications and standardisation;Cardot;Eur J Drug Metab Pharmacokinet,1993

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