Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report. Mitra, A., Suarez-Sharp, S., Pepin, X. J. H., Flanagan, T., Zhao, Y., Kotzagiorgis, E., Parrott, N., Sharan, S., Tistaert, C., Heimbach, T., Zolnik, B., Sjogren, E., Wu, F., Anand, O., Kakar, S., Li, M., Veerasingham, S., Kijima, S., Lima Santos, G. M., Ning, B., Raines, K., Rullo, G., Mandula, H., Delvadia, P., Dressman, J., Dickinson, P. A., & Babiskin, A. J Pharm Sci, 110(2):594–609, February, 2021.
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This report summarizes the proceedings for Day 3 of the workshop titled "Current State and Future Expectations of Translational Modeling Strategies toSupportDrug Product Development, Manufacturing Changes and Controls". From a drug product quality perspective, patient-centric product development necessitates the development of clinically relevant drug product specifications (CRDPS). In this regard, Physiologically Based Biopharmaceutics modeling (PBBM) is a viable tool to establish links between in-vitro to in-vivo data, and support with establishing CRDPS. The theme of day 3 was practical applications of PBBM to support drug product quality. In this manuscript, case studies from US FDA, EMA and pharmaceutical industry on applications of PBBM in drug product quality are summarized which include 1) regulatory agency's perspectives on establishing the safe space and achieving study waivers, 2) model-informed risk assessment on the effects of acid reducing agents, bridging of dissolution methods, food effect, and formulation selection, and 3) understanding clinical formulation performance. Breakout session discussions focused on four topics - 1) terminologies related to physiologically based modeling in support of drug product quality, 2) regulatory harmonization on evidentiary standards, 3) CRDPS approaches and 4) bridging between biorelevant and quality control (QC) dissolution methods.
@article{mitra_applications_2021,
	title = {Applications of {Physiologically} {Based} {Biopharmaceutics} {Modeling} ({PBBM}) to {Support} {Drug} {Product} {Quality}: {A} {Workshop} {Summary} {Report}},
	volume = {110},
	issn = {1520-6017 (Electronic) 0022-3549 (Linking)},
	doi = {10.1016/j.xphs.2020.10.059},
	abstract = {This report summarizes the proceedings for Day 3 of the workshop titled "Current State and Future Expectations of Translational Modeling Strategies toSupportDrug Product Development, Manufacturing Changes and Controls". From a drug product quality perspective, patient-centric product development necessitates the development of clinically relevant drug product specifications (CRDPS). In this regard, Physiologically Based Biopharmaceutics modeling (PBBM) is a viable tool to establish links between in-vitro to in-vivo data, and support with establishing CRDPS. The theme of day 3 was practical applications of PBBM to support drug product quality. In this manuscript, case studies from US FDA, EMA and pharmaceutical industry on applications of PBBM in drug product quality are summarized which include 1) regulatory agency's perspectives on establishing the safe space and achieving study waivers, 2) model-informed risk assessment on the effects of acid reducing agents, bridging of dissolution methods, food effect, and formulation selection, and 3) understanding clinical formulation performance. Breakout session discussions focused on four topics - 1) terminologies related to physiologically based modeling in support of drug product quality, 2) regulatory harmonization on evidentiary standards, 3) CRDPS approaches and 4) bridging between biorelevant and quality control (QC) dissolution methods.},
	number = {2},
	journal = {J Pharm Sci},
	author = {Mitra, A. and Suarez-Sharp, S. and Pepin, X. J. H. and Flanagan, T. and Zhao, Y. and Kotzagiorgis, E. and Parrott, N. and Sharan, S. and Tistaert, C. and Heimbach, T. and Zolnik, B. and Sjogren, E. and Wu, F. and Anand, O. and Kakar, S. and Li, M. and Veerasingham, S. and Kijima, S. and Lima Santos, G. M. and Ning, B. and Raines, K. and Rullo, G. and Mandula, H. and Delvadia, P. and Dressman, J. and Dickinson, P. A. and Babiskin, A.},
	month = feb,
	year = {2021},
	keywords = {*Biopharmaceutics, *Pharmaceutical Preparations, *dissolution, *physiologically based biopharmaceutics modeling (PBBM), *physiologically based pharmacokinetics modeling (PBPK), *product quality, *safe space, *virtual bioequivalence (VBE), Humans, Models, Biological, Research Report, Solubility},
	pages = {594--609},
}
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