Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

Mitra, Amitava; Suarez-Sharp, Sandra; Pépin, Xavier; Flanagan, Talia; Zhao, Yang; Kotzagiorgis, Evangelos; Parrott, Neil; Sharan, Satish; Tistaert, Christophe; Heimbach, Tycho; Zolnik, Banu S.; Sjögren, Erik; Wu, Fang; Anand, Om; Kakar, Shefali; Li, Min; Veerasingham, Shereeni; Kijima, Shinichi; Santos, Gustavo Mendes Lima; Ning, Baoming; Raines, Kimberly; Rullo, Greg; Mandula, Haritha; Delvadia, Poonam; Dressman, Jennifer B.; Dickinson, Paul; Babiskin, Andrew

doi:10.1016/j.xphs.2020.10.059

Cited by 34 publications

(18 citation statements)

References 4 publications

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“…The assessors had a negative opinion due to the lack of qualification and less than satisfactory performance of the model and advised the sponsor to pursue an in vitro data comparison approach instead. Indeed, in a survey published by Mitra et al [ 9 ], among applications of PBPK, modelling biowaivers based on VBE have been those associated with the highest risk. The acceptability of risks associated with the uncertainties introduced by a model should be viewed within the perspective of the potential patients’ medical benefit from the respective decision, i.e., in a context of a benefit–risk ratio.…”

Section: Summary Of Webinarsmentioning

confidence: 99%

“…In the period since the first workshop, there has been significant activity in this area, particularly with the application of physiologically based biopharmaceutics modelling (PBBM), to support the development of CRDSs. In addition to publications describing the use of PBBM to support product development [ 2 , 3 , 4 , 5 , 6 ] and continued dialogue between academic, industrial, and regulatory scientists [ 7 , 8 , 9 ], the FDA has published a Draft Guidance document on the use of physiologically based pharmacokinetic (PBPK) analyses to support oral drug product development, manufacturing changes, and controls [ 10 ]. The aim of the 2021 webinar series was to continue the dialogue from the previous workshop and share and discuss progress and challenges through scientific presentations and Q&A sessions.…”

Section: Introductionmentioning

confidence: 99%

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Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

McAllister

Flanagan

Cole³

et al. 2022

Pharmaceutics

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A webinar series that was organised by the Academy of Pharmaceutical Sciences Biopharmaceutics focus group in 2021 focused on the challenges of developing clinically relevant dissolution specifications (CRDSs) for oral drug products. Industrial scientists, together with regulatory and academic scientists, came together through a series of six webinars, to discuss progress in the field, emerging trends, and areas for continued collaboration and harmonisation. Each webinar also hosted a Q&A session where participants could discuss the shared topic and information. Although it was clear from the presentations and Q&A sessions that we continue to make progress in the field of CRDSs and the utility/success of PBBM, there is also a need to continue the momentum and dialogue between the industry and regulators. Five key areas were identified which require further discussion and harmonisation.

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Section: Summary Of Webinarsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

McAllister

Flanagan

Cole³

et al. 2022

Pharmaceutics

Self Cite

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“…In this work, we have attempted to link the in vitro dissolution of the drug product to its in vivo performance based on dissolution-based PBBM. Establishing a link between the in vitro drug release and mechanistic oral absorption modeling could create opportunities for biowaivers regardless of the active's classification according to the Biopharmaceutics Classification System (BCS) 17 . The approaches described above may prove useful when developing biopharmaceutical strategies to address in vitro dissolution-based biowaiver challenges for drug products with strength-dependent dissolution.…”

Section: Objectives Of the Current Workmentioning

confidence: 99%

A Novel Approach to Justify Dissolution Differences in an Extended Release Drug Product using Physiologically Based Biopharmaceutics Modeling and Simulation

Aishwarya

Murthy

Ahmed

et al. 2022

Journal of Pharmaceutical Sciences

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“…PBPK guidance documents are not existing at this moment for other markets such as Brazil, Canada, China and through some of the recent workshops, it seems these agencies are also ready to accept such approaches. As these workshops discussed in detail about drug-drug dose selection, drug-drug interaction studies, IVIVC, safe space, dissolution, product quality aspects, it is expected in near future from other regulatory agencies that they will also come up with PBPK and absorption modeling approaches to support generic drug development (Heimbach et al, 2019;Luzon et al, 2016;Mitra et al, 2021;Wagner et al, 2015). Until them it is recommended to contact each agency for opinion for approaches related to PBPK modeling and simulations.…”

Section: Future Perspectives and Way Forwardmentioning

confidence: 99%

In vitro and In silico biopharmaceutic regulatory guidelines for generic bioequivalence for oral products: Comparison among various regulatory agencies

Kollipara

Ahmed

Bhattiprolu

et al. 2021

Biopharm & Drug Disp

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Generic drug development is a complex process that involves development of formulation similar to reference product. Because of the complexity associated with generic drug development, many regulatory agencies have come up with various guidelines. Out of many guidelines, the biopharmaceutics classification system that was introduced in 1995 based on aqueous solubility and permeability helped many pharmaceutical scientists across the globe to utilize the tool for formulation development, waiver of in vivo studies. Later on in vitro guidelines based on dissolution and in vitro in vivo correlation were introduced by many regulatory agencies with an intent to reduce number of in vivo human testing thereby facilitating shorter development time and faster approvals and launch. Most recently, understanding the importance in silico approaches such as physiologically based pharmacokinetic modelling, regulatory agencies such as United States Food and Drug Administration (USFDA) and European Middle East and Africa (EMA) came up with modelling guidance documents. Even though consensus exists between guidance documents from various regulatory agencies, still there are many minor to major differences exists between these guidance documents that needs to be considered while submitting a generic drug application. This review aims to compare all the in vitro and in silico guidance documents from major regulatory agencies with emphasis on latest trends and technologies combined with regulatory acceptability with an intention to harmonize regulations. Guidance documents from major regulatory agencies such as USFDA, EMA, World Health Organization, International Council for Harmonization and other emerging markets were compared. Similarities &differences among these guidance documents are critically reviewed to provide the reader a detailed overview of these guidance documents at one place.

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Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

Cited by 34 publications

References 4 publications

Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

A Novel Approach to Justify Dissolution Differences in an Extended Release Drug Product using Physiologically Based Biopharmaceutics Modeling and Simulation

In vitro and In silico biopharmaceutic regulatory guidelines for generic bioequivalence for oral products: Comparison among various regulatory agencies

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