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 +6 more sources
Integrating In Vitro Biopharmaceutics into Physiologically Based Biopharmaceutic Model (PBBM) to Predict Food Effect of BCS IV Zwitterionic Drug (GSK3640254) [PDF]
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, James Butler
exaly +6 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, Jh Pepin, Livia D Prado
exaly +6 more sources
Use of In Vitro Dynamic Colon Model (DCM) to Inform a Physiologically Based Biopharmaceutic Model (PBBM) to Predict the In Vivo Performance of a Modified-Release Formulation of Theophylline [PDF]
Pharmaceutics, 2023 A physiologically based biopharmaceutic model (PBBM) of a modified-release formulation of theophylline (Uniphyllin Continus® 200 mg tablet) was developed and implemented to predict the pharmacokinetic (PK) data of healthy male volunteers by integrating ...
Konstantinos Stamatopoulos +2 more
exaly +7 more sources
In Silico Evaluation of the Biopharmaceutical and Pharmacokinetic Behavior of Metronidazole from Coated Colonic Release Matrix Tablets [PDF]
PharmaceuticsBackground: Physiologically based biopharmaceutics modeling (PBBM) models can help to predict drug release and in vivo absorption behaviors. Colon drug delivery systems have gained interest over the past few years due to the advantages they provide in ...
Roberto Arévalo-Pérez +2 more
doaj +5 more sources
Advances in Nasal Biopharmaceutics to Support Product Development and Therapeutic Needs [PDF]
PharmaceuticsBackground/Objectives: Nasal biopharmaceutics is the scientific understanding of product and patient factors that determine the rate and extent of drug exposure following nasal administration. The authors considered whether current biopharmaceutics tools
Ben Forbes +7 more
doaj +5 more sources
Food and bile micelle binding of quaternary ammonium compounds [PDF]
ADMET and DMPK, 2023 Background and Purpose: Physiologically-based biopharmaceutics modeling (PBBM) has been widely used to predict the oral absorption of drugs. However, the prediction of food effects on oral drug absorption is still challenging, especially for negative ...
Sumiji Takeru, Kiyohiko Sugano
doaj +5 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
Physiologically Based Biopharmaceutics Modeling of Food Effect for Basmisanil: A Retrospective Case Study of the Utility for Formulation Bridging [PDF]
Pharmaceutics, 2023 Basmisanil, is a lipophilic drug substance, exhibiting poor solubility and good permeability (BCS class 2). A validated physiologically based biopharmaceutics model (PBBM) has been previously described for tablets dosed in the fed state.
Tejashree Belubbi +3 more
doaj +2 more sources