TY - JOUR T1 - Current status and future opportunities for incorporation of dissolution data in PBPK modeling for pharmaceutical development and regulatory applications: OrBiTo consortium commentary. AU - Jamei,Masoud, AU - Abrahamsson,Bertil, AU - Brown,Jonathan, AU - Bevernage,Jan, AU - Bolger,Michael B, AU - Heimbach,Tycho, AU - Karlsson,Eva, AU - Kotzagiorgis,Evangelos, AU - Lindahl,Anders, AU - McAllister,Mark, AU - Mullin,James M, AU - Pepin,Xavier, AU - Tistaert,Christophe, AU - Turner,David B, AU - Kesisoglou,Filippos, Y1 - 2020/08/08/ PY - 2020/01/29/received PY - 2020/07/03/revised PY - 2020/08/06/accepted PY - 2020/8/12/pubmed PY - 2021/6/23/medline PY - 2020/8/12/entrez KW - Biorelevant dissolution KW - Dissolution KW - Oral drug absorption KW - PBBM (Physiologically Based Biopharmaceutical Model) KW - PBPK SP - 55 EP - 68 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 155 N2 - In vitro dissolution experiments are used to qualitatively assess the impact of formulation composition and process changes on the drug dosage form performance. However, the use of dissolution data to quantitatively predict changes in the absorption profile remains limited. Physiologically-based Pharmacokinetic(s) (PBPK) models facilitate incorporation of in vitro dissolution experiments into mechanistic oral absorption models to predict in vivo oral formulation performance, and verify if the drug product dissolution method is biopredictive or clinically relevant. Nevertheless, a standardized approach for using dissolution data within PBPK models does not yet exist and the introduction of dissolution data in PBPK relies on a case by case approach which accommodates from differences in release mechanism and limitations to drug absorption. As part of the Innovative Medicines Initiative (IMI) Oral Biopharmaceutics Tools (OrBiTo) project a cross-work package was set up to gather a realistic understanding of various approaches used and their areas of applications. This paper presents the approaches shared by academic and industrial scientists through the OrBiTo project to integrate dissolution data within PBPK software to improve the prediction accuracy of oral formulations in vivo. Some general recommendations regarding current use and future improvements are also provided. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/32781025/Current_status_and_future_opportunities_for_incorporation_of_dissolution_data_in_PBPK_modeling_for_pharmaceutical_development_and_regulatory_applications:_OrBiTo_consortium_commentary_ DB - PRIME DP - Unbound Medicine ER -