Physiologically Based Biopharmaceutics Model (PBBM) of Minimally Absorbed Locally Acting Drugs in the Gastrointestinal Tract—Case Study: Tenapanor [PDF]
Pharmaceutics, 2023 A physiologically based biopharmaceutics model (PBBM) was developed to predict stool and urine sodium content in response to tenapanor administration in healthy subjects.
Konstantinos Stamatopoulos +2 more
exaly +4 more sources
The Development of an Age-Appropriate Fixed Dose Combination for Tuberculosis Using Physiologically-Based Pharmacokinetic Modeling (PBBM) and Risk Assessment [PDF]
PharmaceuticsBackground/Objectives: The combination of isoniazid (INH) and rifampicin (RIF) is indicated for the treatment maintenance phase of tuberculosis (TB) in adults and children.
Xavier J H Pepin, Livia Deris Prado
exaly +4 more sources
Physiologically Based Biopharmaceutics Modelling—Best Scientific Practices to Define Drug Product Performance, Latest Regulatory and Industry Perspectives: Workshop Summary Report [PDF]
PharmaceuticsIn November 2024, a two-day meeting entitled “PBBM—Best Scientific Practices to Define Drug Product Performance: Latest Regulatory and Industry Perspectives” was organised by the Academy of Pharmaceutical Sciences Biopharmaceutics Focus group and hosted ...
Mark McAllister +23 more
doaj +2 more sources
Pharmaceutics, 2023 A strategy followed to integrate in vitro solubility and permeability data into a PBBM model to predict the food effect of a BCS IV zwitterionic drug (GSK3640254) observed in clinical studies is described.
Konstantinos Stamatopoulos +2 more
exaly +3 more sources
Virtual Bioequivalence Assessment and Dissolution Safe Space Exploration for Fixed-Dose Metformin–Glyburide Tablet Using Physiologically Based Biopharmaceutics Modeling [PDF]
PharmaceuticsBackground/Objectives: Fixed-dose combinations (FDCs) hold significant clinical value for the management of hypertension, diabetes and other chronic diseases.
Chenshuang Zhao +3 more
doaj +2 more sources
Physiologically Based Biopharmaceutics Model of Apixaban for Biopharmaceutics Risk Assessment [PDF]
PharmaceuticsBackground/Objectives: This study applies a Physiologically Based Biopharmaceutics Modeling (PBBM) framework to predict the bioavailability (BA) and bioequivalence (BE) of apixaban, a borderline BCS Class III/IV drug.
Paulo Paixão +2 more
doaj +2 more sources
Surge Dose® Formulations of NSAIDs Provide for Ultra-Rapid and Consistent Drug Absorption in Both the Fasted and Fed State as Predicted by Physiologically Based Biopharmaceutics Modelling [PDF]
PharmaceuticsBackground/Objectives: This paper describes the use of physiologically based biopharmaceutics modelling (PBBM) to predict the effect of food on diclofenac and ibuprofen absorption from ultra-rapid-release Surge Dose® tablets.
Harri Dickinson +4 more
doaj +2 more sources
DoE- and PBBM-Driven Formulation Development of an Extended-Release Donepezil Tablet [PDF]
PharmaceuticalsBackground/Objectives: This study explores the integration of Design of Experiments (DoE) with Physiologically Based Biopharmaceutics Modeling (PBBM) to streamline the development of extended-release (XR) formulations.
Frederico Severino Martins +4 more
doaj +2 more sources
Pharmaceutics, 2020 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 continuous optimization and validation.
Marival Bermejo +2 more
exaly +3 more sources
Application of New Approach Methodologies to Improve Oral Biopharmaceutic Assessments [PDF]
PharmaceuticsBackground/Objectives: The rapid expansion of New Approach Methodologies (NAMs) is transforming oral biopharmaceutics by offering mechanistically rich, human-relevant tools that can reduce reliance on animal testing while improving translational ...
Mauricio A. García +4 more
doaj +2 more sources