Workshop report: USP workshop on advancements in in vitro performance testing of drug products

Andre Hermans; Przemyslaw Dorozynski; Fernando J. Muzzio; Hanlin Li; Sarah Nielsen; Shirlynn Chen; Christos Reppas; Sandra Klein; Sanjaykumar Patel; Matthias Wacker; Kailas Thakker; Katharina Pruessmann; Anne Seidlitz; Tapash K. Ghosh; Yang Yang; Daniel Willett; Guenther Hochhaus; Justin Tay; Celine V. Liew; Paul W.S. Heng; Changquan Calvin Sun; Johannes Kraemer; Margareth R.C. Marques

doi:10.14227/DT270220P52

Workshop report: USP workshop on advancements in in vitro performance testing of drug products

Andre Hermans, Przemyslaw Dorozynski, Fernando J. Muzzio, Hanlin Li, Sarah Nielsen, Shirlynn Chen, Christos Reppas, Sandra Klein, Sanjaykumar Patel, Matthias Wacker, Kailas Thakker, Katharina Pruessmann, Anne Seidlitz, Tapash K. Ghosh, Yang Yang, Daniel Willett, Guenther Hochhaus, Justin Tay, Celine V. Liew, Paul W.S. HengChangquan Calvin Sun, Johannes Kraemer, Margareth R.C. Marques

Pharmaceutics

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Abstract

In December 2019, The United States Pharmacopeia (USP) organized a 2-day workshop to explore new approaches to assess in vitro performance of drug products. Experts from around the globe presented processes, techniques, systems that can be used to evaluate and model in vitro performance of different pharmaceutical dosage forms. The following is a summary of most of the presentations and the highlights of the discussions that ensued.

Original language	English (US)
Pages (from-to)	52-70
Number of pages	19
Journal	Dissolution Technologies
Volume	27
Issue number	2
DOIs	https://doi.org/10.14227/DT270220P52
State	Published - May 2020

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© 2020, Dissolution Technologies Inc. All rights reserved.

Keywords

Biorelevant
Dissolution
Food effect
In vitro performance
Modeling
Nanomaterials
Real-time reletest

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Hermans, A., Dorozynski, P., Muzzio, F. J., Li, H., Nielsen, S., Chen, S., Reppas, C., Klein, S., Patel, S., Wacker, M., Thakker, K., Pruessmann, K., Seidlitz, A., Ghosh, T. K., Yang, Y., Willett, D., Hochhaus, G., Tay, J., Liew, C. V., ... Marques, M. R. C. (2020). Workshop report: USP workshop on advancements in in vitro performance testing of drug products. Dissolution Technologies, 27(2), 52-70. https://doi.org/10.14227/DT270220P52

Hermans, A, Dorozynski, P, Muzzio, FJ, Li, H, Nielsen, S, Chen, S, Reppas, C, Klein, S, Patel, S, Wacker, M, Thakker, K, Pruessmann, K, Seidlitz, A, Ghosh, TK, Yang, Y, Willett, D, Hochhaus, G, Tay, J, Liew, CV, Heng, PWS, Sun, CC, Kraemer, J & Marques, MRC 2020, 'Workshop report: USP workshop on advancements in in vitro performance testing of drug products', Dissolution Technologies, vol. 27, no. 2, pp. 52-70. https://doi.org/10.14227/DT270220P52

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AU - Nielsen, Sarah

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AU - Klein, Sandra

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Workshop report: USP workshop on advancements in in vitro performance testing of drug products

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