Parameterization of physiologically based biopharmaceutics models: workshop summary report
X Pepin, S Arora, L Borges, M Cano-Vega… - Molecular …, 2024 - ACS Publications
This Article shares the proceedings from the August 29th, 2023 (day 1) workshop
“Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product …
“Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product …
Applications of PBPK/PBBM modeling in generic product development: an industry perspective
K Yuvaneshwari, S Kollipara, T Ahmed… - Journal of Drug Delivery …, 2022 - Elsevier
Physiologically based pharmacokinetic (PBPK) modeling and physiologically based
biopharmaceutics modeling (PBBM) are invaluable tools with wide applications during drug …
biopharmaceutics modeling (PBBM) are invaluable tools with wide applications during drug …
Current status and future opportunities for incorporation of dissolution data in PBPK modeling for pharmaceutical development and regulatory applications: OrBiTo …
M Jamei, B Abrahamsson, J Brown, J Bevernage… - European Journal of …, 2020 - Elsevier
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 …
composition and process changes on the drug dosage form performance. However, the use …
[HTML][HTML] A mechanistic physiologically-based biopharmaceutics modeling (PBBM) approach to assess the in vivo performance of an orally administered drug product …
M Bermejo, B Hens, J Dickens, D Mudie, P Paixão… - Pharmaceutics, 2020 - mdpi.com
The application of in silico modeling to predict the in vivo outcome of an oral drug product is
gaining a lot of interest. Fully relying on these models as a surrogate tool requires …
gaining a lot of interest. Fully relying on these models as a surrogate tool requires …
Best practices for integration of dissolution data into physiologically based biopharmaceutics models (PBBM): a biopharmaceutics modeling scientist perspective
Dissolution is considered as a critical input into physiologically based biopharmaceutics
models (PBBM) as it governs in vivo exposure. Despite many workshops, initiatives by …
models (PBBM) as it governs in vivo exposure. Despite many workshops, initiatives by …
Physiologically based absorption modelling to explore the impact of food and gastric pH changes on the pharmacokinetics of entrectinib
N Parrott, C Stillhart, M Lindenberg, B Wagner… - The AAPS Journal, 2020 - Springer
Entrectinib is a potent and selective tyrosine kinase inhibitor (TKI) of TRKA/B/C, ROS1, and
ALK with both systemic and CNS activities, which has recently received FDA approval for …
ALK with both systemic and CNS activities, which has recently received FDA approval for …
Progressive tools and critical strategies for development of best fit PBPK model aiming better in vitro-in vivo correlation
Nowadays, conducting discriminative dissolution experiments employing physiologically
based pharmacokinetic modeling (PBPK) or physiologically based biopharmaceutical …
based pharmacokinetic modeling (PBPK) or physiologically based biopharmaceutical …
[HTML][HTML] Prediction of in vitro drug dissolution into fed-state biorelevant media: contributions of solubility enhancement and relatively low colloid diffusivity
A model was previously derived to predict in vitro dissolution of drug into surfactant solution
and showed good predictability for pharmaceutical surfactants, where surfactant-mediated …
and showed good predictability for pharmaceutical surfactants, where surfactant-mediated …
Scientific considerations to move towards biowaiver for biopharmaceutical classification system class III drugs: How modeling and simulation can help
F Wu, R Cristofoletti, L Zhao… - … & Drug Disposition, 2021 - Wiley Online Library
Abstract The 2017 Guidance by US Food and Drug Administration (FDA) has recommended
the criteria to qualify for a Biopharmaceutical Classification System (BCS)‐based biowaiver …
the criteria to qualify for a Biopharmaceutical Classification System (BCS)‐based biowaiver …
Dissolution challenges associated with the surface pH of drug particles: integration into mechanistic oral absorption modeling
B Hens, N Seegobin, M Bermejo, Y Tsume, N Clear… - The AAPS Journal, 2022 - Springer
The present work aimed to differentiate between in vitro dissolution profiles of ibuprofen as
input for GastroPlus™ and to see the impact on systemic exposure. In vitro dissolution …
input for GastroPlus™ and to see the impact on systemic exposure. In vitro dissolution …