Development and validation of an in vitro–in vivo correlation (IVIVC) model for propranolol hydrochloride extended-release matrix formulations

Author:

Cheng Chinhwa,Wu Pao-Chu,Lee Hsin-Ya,Hsu Kuang-Yang

Publisher

The Journal of Food and Drug Analysis (JFDA), Food and Drug Administration, Taiwan (TFDA)

Subject

Pharmacology,Food Science

Reference18 articles.

1. Guidance for industry—extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations;Center for Drug Evaluation and Research (CDER), USFDA,1997

2. Guidance for industry—SUPAC-MR: modified release solid oral dosage forms: scale-up and postapproval changes: chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation;Center for Drug Evaluation and Research (CDER), USFDA,1997

3. Identification of formulation and manufacturing variables that influence in vitro dissolution and in vivo bioavailability of propranolol hydrochloride tablets;Eddington;Pharm Dev Technol,1998

4. In vitro-in vivo correlation: perspectives on model development;Lu;Int J Pharm,2011

5. Interpretation and optimization of the dissolution specifications for a modified release product with an in vivo-in vitro correlation (IVIVC);Hayes;J Pharm Sci,2004

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