In Vitro – In Vivo Correlation Strategy Applied to an Immediate-Release Solid Oral Dosage Form with a Biopharmaceutical Classification System IV Compound Case Study-Reference-Cited by-同舟云学术

In Vitro – In Vivo Correlation Strategy Applied to an Immediate-Release Solid Oral Dosage Form with a Biopharmaceutical Classification System IV Compound Case Study

Published:2014-07 Issue:7 Volume:103 Page:2125-2130
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Bredael Gerard M.,Bowers Niya,Boulineau Fabien,Hahn David

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference15 articles.

1. Stage appropriate dissolution methods in formulation development;Hawley;Am Pharm Rev,2013

2. Strategy for the development and validation of dissolution tests for solid oral dosage forms;Skoug;Pharm Tech,1996

3. <1092> The dissolution procedure: Development and validation;USP,2006

4. Regulatory status on the role of in vitro dissolution testing in quality control and biopharmaceutics in Europe;Limberg;Biopharm Drug Dispos,2013

5. Guidance for industry extended release oral dosage forms: Development, evaluation, and application of in vitro/in vivo correlations;FDA,1997

Cited by 14 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Evaluating the bioequivalence of two pitavastatin calcium formulations based on IVIVC modeling and clinical study;Clinical and Translational Science;2022-10-17

2. A novel combination of Soluplus®/Poloxamer for Meloxicam solid dispersions via hot melt extrusion for rapid onset of action. Part 2: comparative bioavailability and IVIVC;Drug Development and Industrial Pharmacy;2020-07-10

3. Establishment of a clinically relevant specification for dissolution testing using physiologically based pharmacokinetic (PBPK) modeling approaches;European Journal of Pharmaceutics and Biopharmaceutics;2020-06

4. Integration of In Silico Pharmacokinetic Modeling Approaches Into In Vitro Dissolution Profiles to Predict Bioavailability of a Poorly Soluble Compound;Journal of Pharmaceutical Sciences;2019-11

5. Primer on the Science of In Vitro Dissolution Testing of Oral Dosage Forms and Factors Influencing its Biological Relevance;Dissolution Technologies;2019