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[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 …
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 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 …
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
Although oral drug delivery is the preferred administration route and has been used for
centuries, modern drug discovery and development pipelines challenge conventional …
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 …
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 …
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
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 …
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 …
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 …
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
Over the past few decades, physiologically based biopharmaceutics modeling (PBBM) has
demonstrated its utility in both new drug and generic product development. Applications of …
demonstrated its utility in both new drug and generic product development. Applications of …