Results 31 to 40 of about 826 (178)

In Vitro Dissolution and in Silico Modeling Shortcuts in Bioequivalence Testing

Pharmaceutics, 2020
Purpose: To review in vitro testing and simulation platforms that are in current use to predict in vivo performances of generic products as well as other situations to provide evidence for biowaiver and support drug formulations development.
Moawia M. Al-Tabakha, Muaed J. Alomar
doaj   +2 more sources

Prediction of fasted and fed bioequivalence for immediate release drug products using physiologically based biopharmaceutics modeling (PBBM)

European Journal of Pharmaceutical Sciences, 2020
Bioequivalence studies are an integral part of clinical pharmacology strategy for drug development. Physiologically based biopharmaceutics modeling (PBBM) can be a helpful tool to assess potential bioequivalence risks and predict the outcome of bioequivalence studies.
Rebeka Jereb, Amitava Mitra
exaly   +3 more sources

GastroPlus® as simulating/ conducting software for modeling physiologically-based pharmacokinetics & physiologically based biopharmaceutics.

Ma’aen Journal for Medical Sciences
Yasir Qasim Almajidi, Rafif Raad Faisal, Ahmed Yaseen, Maher abdulrazzaq luqman al-hakeem   +3 more
doaj   +2 more sources

Impact of Food Physical Properties on Oral Drug Absorption: A Comprehensive Review [PDF]

Drug Design, Development and Therapy
Ziyang Wang,1 Wen Xu,2 Dan Liu,3 Xiuqi Li,1 Shupeng Liu,1 Xiaofei Wu,1 Hongyun Wang1 1Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s ...
Wang Z, Xu W, Liu D, Li X, Liu S, Wu X, Wang H   +6 more
doaj   +2 more sources

Predicting Pharmacokinetics of Multisource Acyclovir Oral Products Through Physiologically Based Biopharmaceutics Modeling [PDF]

Journal of Pharmaceutical Sciences, 2022
Highly variable disposition after oral ingestion of acyclovir has been reported, although little is known regarding the underlying mechanisms. Different studies using the same reference product (Zovirax ®) showed that Cmax and AUC were respectively 44 and 35% lower in Saudi Arabians than Europeans, consistent with higher frequencies of reduced-activity
Mauricio A. García, Michael B. Bolger, Sandra Suarez-Sharp, Peter Langguth   +3 more
openaire   +2 more sources

A text mining study on the utility of physiologically based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) in formulation development [PDF]

, 2023
Physiologically based pharmacokinetic (PBPK) modeling is an evolving tool that has a profound impact on drug discovery and formulation development processes.
Aleksandra Krstevska, Jelena Đjurić, Krstevska, Aleksandra, Svetlana Ibric, Sandra Cvijić, Ibrić, Svetlana, Cvijić, Sandra, Đuriš, Jelena   +7 more
core   +1 more source

In-Depth Analysis of Physiologically Based Pharmacokinetic (PBPK) Modeling Utilization in Different Application Fields Using Text Mining Tools

Pharmaceutics, 2022
In the past decade, only a small number of papers have elaborated on the application of physiologically based pharmacokinetic (PBPK) modeling across different areas. In this review, an in-depth analysis of the distribution of PBPK modeling in relation to
Aleksandra Krstevska, Jelena Đuriš, Svetlana Ibrić, Sandra Cvijić   +3 more
doaj   +1 more source

Physiological based pharmacokinetic and biopharmaceutics modelling of subcutaneously administered compounds – An overview of in silico models

International Journal of Pharmaceutics, 2022
Subcutaneous injection is a commonly used route of drug administration for both small molecules and biologics. To facilitate the development of new subcutaneously administered drugs, methods for prediction of drug absorption from the injection site are essential. For this purpose, in silico models have increasingly been used.
Dubbelboer, Ilse R., Sjögren, Erik
openaire   +3 more sources

Integrating In Vitro Biopharmaceutics into Physiologically Based Biopharmaceutic Model (PBBM) to Predict Food Effect of BCS IV Zwitterionic Drug (GSK3640254)

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. The PBBM model was developed, qualified and verified using clinical data of an immediate release (IR)-tablet (10–320 mg) obtained in healthy ...
Konstantinos Stamatopoulos, Paola Ferrini, Dung Nguyen, Ying Zhang, James M. Butler, Jon Hall, Nena Mistry   +6 more
openaire   +3 more sources

Understanding effect site pharmacology of uprifosbuvir, a hepatitis C virus nucleoside inhibitor: Case study of a multidisciplinary modeling approach in drug development

CPT: Pharmacometrics & Systems Pharmacology, 2021
Uprifosbuvir is a uridine nucleoside monophosphate prodrug inhibitor of the hepatitis C virus NS5B RNA polymerase. To quantitatively elucidate key metabolic pathways, assess the link between unmeasurable effect site concentrations and viral load ...
Paul van den Berg, Wei Gao, Maurice J. Ahsman, Leticia Arrington, Filippos Kesisoglou, Randy Miller, Teun M. Post, Matthew L. Rizk   +7 more
doaj   +1 more source