Advances in In Vivo Predictive Dissolution Testing of Solid Oral Formulations: How Closer to In Vivo Performance?

Author:

Shrivas Meera,Khunt Dignesh,Shrivas Meenakshee,Choudhari Manisha,Rathod Rajeshwari,Misra ManjuORCID

Funder

Department of Science and Technology, Ministry of Science and Technology

Science and Engineering Research Board

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science

Reference134 articles.

1. Culen M, Dohnal J. Advances in dissolution instrumentation and their practical applications. Drug Dev Ind Pharm. 2014;40(10):1277–82. https://doi.org/10.3109/03639045.2013.841184 .

2. USFDA. Guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. In: U.S. Department of Health and Human Services FaDA, Center for Drug Evaluation and Research (CDER), editor. 2017.

3. Patadia R, Vora C, Mittal K, Mashru R. Dissolution criticality in developing solid oral formulations: from inception to perception. Crit Rev Ther Drug Carrier Syst. 2013;30(6):495–534.

4. USFDA. Guidance for industry; immediate release solid oral dosage forms: scale-up and postapproval changes: chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation. In: U.S. Department of Health and Human Services FaDA, Center for Drug Evaluation and Research (CDER), editor. 1995.

5. Grignard E, Taylor R, McAllister M, Box K, Fotaki N. Considerations for the development of in vitro dissolution tests to reduce or replace preclinical oral absorption studies. Eur J Pharm Sci. 2017;99:193–201. https://doi.org/10.1016/j.ejps.2016.12.004 .

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