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Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.J Pharm Sci. 2021 Feb; 110(2):594-609.JPAbstract

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.

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Authors+Show Affiliations

Mitra A Clinical Pharmacology and Pharmacometrics, Janssen Research & Development, Spring House, Pennsylvania. Electronic address: [email protected].Suarez-Sharp S Regulatory Affairs, Simulations Plus Inc., Lancaster, California.Pepin XJH New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.Flanagan T Pharmaceutical Development, UCB Pharma SA, Braine l'Alleud, Belgium.Zhao Y Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.Kotzagiorgis E Pharmaceutical Quality Office, European Medicines Agency (EMA), Amsterdam, the Netherlands.Parrott N Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.Sharan S Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.Tistaert C Pharmaceutical Sciences, Janssen Research & Development, Beerse, Belgium.Heimbach T PK Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey.Zolnik B Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.Sjögren E Pharmatheus, Uppsala, Sweden.Wu F Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.Anand O Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.Kakar S PK Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey.Li M Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.Veerasingham S Therapeutic Products Directorate, Health Products and Food Branch, Health Canada, Ottawa, Canada.Kijima S Office of Advanced Evaluation with Electronic Data, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.Lima Santos GM General Office of Medicines and Biological Products, Brazilian Health Regulatory Agency (Anvisa), Brasilia, Brazil.Ning B National Institutes for Food and Drug Control (NIFDC), Beijing, China.Raines K Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.Rullo G Regulatory Excellence, Oncology R&D, AstraZeneca, Gaithersburg, Maryland.Mandula H Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.Delvadia P Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.Dressman J Fraunhofer Institute for Molecular Biology and Applied Ecology, and Goethe University, Frankfurt, Germany.Dickinson PA Seda Pharmaceutical Development Services, Alderley Park, Alderley Edge, Cheshire, UK.Babiskin A Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.

MeSH

BiopharmaceuticsHumansModels, BiologicalPharmaceutical PreparationsResearch ReportSolubility

Pub Type(s)

Journal ArticleResearch Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

33152375

Citation

Mitra, Amitava, et al. "Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: a Workshop Summary Report." Journal of Pharmaceutical Sciences, vol. 110, no. 2, 2021, pp. 594-609.Mitra A, Suarez-Sharp S, Pepin XJH, et al. Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report. J Pharm Sci. 2021;110(2):594-609.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., Sjögren, E., Wu, F., Anand, O., Kakar, S., Li, M., Veerasingham, S., Kijima, S., Lima Santos, G. M., ... Babiskin, A. (2021). Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report. Journal of Pharmaceutical Sciences, 110(2), 594-609. https://doi.org/10.1016/j.xphs.2020.10.059Mitra A, et al. Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: a Workshop Summary Report. J Pharm Sci. 2021;110(2):594-609. PubMed PMID: 33152375.* Article titles in AMA citation format should be in sentence-caseCopyDownloadMLAAMAAPAVANCOUVERTY - JOUR T1 - Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report. AU - Mitra,Amitava, AU - Suarez-Sharp,Sandra, AU - Pepin,Xavier J H, AU - Flanagan,Talia, AU - Zhao,Yang, AU - Kotzagiorgis,Evangelos, AU - Parrott,Neil, AU - Sharan,Satish, AU - Tistaert,Christophe, AU - Heimbach,Tycho, AU - Zolnik,Banu, AU - Sjögren,Erik, AU - Wu,Fang, AU - Anand,Om, AU - Kakar,Shefali, AU - Li,Min, AU - Veerasingham,Shereeni, AU - Kijima,Shinichi, AU - Lima Santos,Gustavo Mendes, AU - Ning,Baoming, AU - Raines,Kimberly, AU - Rullo,Greg, AU - Mandula,Haritha, AU - Delvadia,Poonam, AU - Dressman,Jennifer, AU - Dickinson,Paul A, AU - Babiskin,Andrew, Y1 - 2020/11/03/ PY - 2020/09/22/received PY - 2020/10/23/revised PY - 2020/10/26/accepted PY - 2020/11/6/pubmed PY - 2021/6/22/medline PY - 2020/11/5/entrez KW - dissolution KW - physiologically based biopharmaceutics modeling (PBBM) KW - physiologically based pharmacokinetics modeling (PBPK) KW - product quality KW - safe space KW - virtual bioequivalence (VBE) SP - 594 EP - 609 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 110 IS - 2 N2 - 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. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/33152375/Applications_of_Physiologically_Based_Biopharmaceutics_Modeling_(PBBM)_to_support_Drug_Product_Quality:_A_Workshop_Summary_Report. DB - PRIME DP - Unbound Medicine ER - Grapherence [↓23]

• Links
• Publisher Full Text (DOI)
• Authors
• Mitra A
• Suarez-Sharp S
• Pepin XJH
• Flanagan T
• Zhao Y
• Kotzagiorgis E
• Parrott N
• Sharan S
• Tistaert C
• Heimbach T
• Zolnik B
• Sjögren E
• Wu F
• Anand O
• …
• MESH
• Biopharmaceutics
• Humans
• Models, Biological
• Pharmaceutical Preparations
• Research Report
• Solubility

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