[HTML][HTML] Impact of gastrointestinal physiology on drug absorption in special populations––An UNGAP review

C Stillhart, K Vučićević, P Augustijns, AW Basit… - European Journal of …, 2020 - Elsevier
The release and absorption profile of an oral medication is influenced by the
physicochemical properties of the drug and its formulation, as well as by the anatomy and …

Crosstalk of physiological pH and chemical pKa under the umbrella of physiologically based pharmacokinetic modeling of drug absorption, distribution, metabolism …

L Gaohua, X Miao, L Dou - Expert opinion on drug metabolism & …, 2021 - Taylor & Francis
Introduction: Physiological pH and chemical pKa are two sides of the same coin in defining
the ionization of a drug in the human body. The Henderson-Hasselbalch equation and pH …

The biopharmaceutics classification system (BCS) and the biopharmaceutics drug disposition classification system (BDDCS): beyond guidelines

A Charalabidis, M Sfouni, C Bergström… - International journal of …, 2019 - Elsevier
The recent impact of the Biopharmaceutics Classification System (BCS) and the
Biopharmaceutics Drug Disposition Classification System (BDDCS) on relevant scientific …

[HTML][HTML] Current challenges and future perspectives in oral absorption research: An opinion of the UNGAP network

Z Vinarov, B Abrahamsson, P Artursson… - Advanced drug delivery …, 2021 - Elsevier
Although oral drug delivery is the preferred administration route and has been used for
centuries, modern drug discovery and development pipelines challenge conventional …

Physiologically based pharmacokinetic modelling for first-in-human predictions: an updated model building strategy illustrated with challenging industry case studies

NA Miller, MB Reddy, AT Heikkinen, V Lukacova… - Clinical …, 2019 - Springer
Physiologically based pharmacokinetic modelling is well established in the pharmaceutical
industry and is accepted by regulatory agencies for the prediction of drug–drug interactions …

Use of physiologically based pharmacokinetic (PBPK) modeling for predicting drug-food interactions: an industry perspective

AE Riedmaier, K DeMent, J Huckle, P Bransford… - The AAPS journal, 2020 - Springer
The effect of food on pharmacokinetic properties of drugs is a commonly observed
occurrence affecting about 40% of orally administered drugs. Within the pharmaceutical …

[HTML][HTML] Best practices in current models mimicking drug permeability in the gastrointestinal tract-An UNGAP review

JP O'Shea, P Augustijns, M Brandl, DJ Brayden… - European Journal of …, 2022 - Elsevier
The absorption of orally administered drug products is a complex, dynamic process,
dependant on a range of biopharmaceutical properties; notably the aqueous solubility of a …

Biopharmaceutics applications of physiologically based pharmacokinetic absorption modeling and simulation in regulatory submissions to the US Food and Drug …

F Wu, H Shah, M Li, P Duan, P Zhao, S Suarez… - The AAPS Journal, 2021 - Springer
Physiologically based pharmacokinetic (PBPK) absorption modeling and simulation is
increasingly used as a tool in drug product development, not only in support of clinical …

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 …

Role of physiologically based biopharmaceutics modeling (PBBM) in fed bioequivalence study waivers: regulatory outlook, case studies and future perspectives

S Kollipara, FS Martins, M Sanghavi… - Journal of …, 2024 - Elsevier
Over the past few decades, physiologically based biopharmaceutics modeling (PBBM) has
demonstrated its utility in both new drug and generic product development. Applications of …