Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report

Author:

Abend Andreas,Heimbach Tycho,Cohen Michael,Kesisoglou Filippos,Pepin Xavier,Suarez-Sharp SandraORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference40 articles.

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2. Selen A, Dickinson PA, Müllertz A, Crison JR, Mistry HB, Cruañes MT, et al. The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance. J Pharm Sci. 2014;103(11):3377–97.

3. United States Pharmacopeia and the National Formulary (USP-NF). Chapter 711 in US Pharmacopeial Convention. 2015. Rockville, MD.

4. Takeuchi S, Tsume Y, Amidon GE, Amidon GL. Evaluation of a three compartment in vitro gastrointestinal simulator dissolution apparatus to predict in vivo dissolution. J Pharm Sci. 2014;103(11):3416–22.

5. U.S. Department of Health and Human Services—Food and Drug Administration, CDER., Guidance for industry—dissolution testing of immediate release solid oral dosage forms. 1997.

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