Results 21 to 30 of about 2,897 (211)

Model‐Informed Drug Development of a Sustained Release Formulation of Flucytosine in the Treatment of Cryptococcal Meningitis: A Case Study Using Physiologically Based Pharmacokinetic Modeling [PDF]

CPT: Pharmacometrics & Systems Pharmacology
This paper presents a case study demonstrating the application of model‐informed drug development (MIDD) and early modeling integration in the development of a sustained release (SR) formulation of flucytosine for cryptococcal meningoencephalitis (CM) in
Johanna Eriksson, Erik Sjögren, Jean‐Yves Gillon, Henri Caplain, Vishal Goyal, Vijay Satam, Stephen Robinson, Isabela Ribeiro, Marylore Chenel   +8 more
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, Albin Kristl, Amitava Mitra   +2 more
openaire   +4 more sources

Integrating In Vitro Dissolution and Physiologically Based Pharmacokinetic Modeling for Generic Drug Development: Evaluation of Amorphous Solid Dispersion Formulations for Tacrolimus [PDF]

Pharmaceutics
Objectives: Tacrolimus, a Biopharmaceutics Classification System (BCS) class II drug, is widely used for transplant patients to prevent graft rejection.
Evangelos Karakitsios, Maria-Faidra-Galini Angelerou, Iasonas Kapralos, Georgia Tsakiridou, Lida Kalantzi, Aristides Dokoumetzidis   +5 more
doaj   +2 more sources

Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions. [PDF]

Mol Pharm
Pharmaceutical innovators and generic companies use Physiologically Based Biopharmaceutics Models (PBBMs) to guide drug product development and potentially waive clinical pharmacokinetic studies for both pre- and postapproval changes. This modeling approach can assist with biopharmaceutics risk assessment and the establishment of patient centric ...
Arora S, Pepin X, Jamei M, Sharma P, Heimbach T, Wagner C, Bransford P, Kollipara S, Ahmed T, Hingle M, Dallmann A, Scherholz M, Stamatis SD, Cano-Vega M, Mistry N, Tannergren C, Borges L, Lindahl A, Rullo G, Mackie C, Mitra A, Kushner J, Harish Jain KM, Polli JE.   +23 more
europepmc   +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

Integrated biopharmaceutical approach in pharmaceutical development and drug characterization: General concept and application [PDF]

Hemijska Industrija, 2020
The importance of biopharmaceutical considerations in pharmaceutical development and drug characterization has been well recognized both by pharmaceutical industry and regulatory authorities as a tool to establish predictive relationships ...
Cvijić Sandra V., Ibrić Svetlana R., Parojčić Jelena V.   +2 more
doaj   +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