Results 11 to 20 of about 23,818,397 (163)

Virtual Bioequivalence Assessment and Dissolution Safe Space Exploration for Fixed-Dose Metformin–Glyburide Tablet Using Physiologically Based Biopharmaceutics Modeling [PDF]

Pharmaceutics
Background/Objectives: Fixed-dose combinations (FDCs) hold significant clinical value for the management of hypertension, diabetes and other chronic diseases.
Chenshuang Zhao, Chaozhuang Shen, Yumeng Xiao, Ling Wang   +3 more
doaj   +3 more sources

Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report. [PDF]

Mol Pharm
This report summarizes the proceedings for Day 3 of the workshop titled “Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives”.
Tannergren C, Arora S, Babiskin A, Borges L, Chatterjee P, Cheng YH, Dallmann A, Govada A, Heimbach T, Hingle M, Kollipara S, Kotzagiorgis E, Lindahl A, Mackie C, Malamatari M, Mitra A, Moody R, Pepin X, Polli J, Raines K, Rullo G, Sanghavi M, Savkur R, Singh R, Sjögren E, Suarez-Sharp S, Thomas S, Veerasingham S, Wei K, Wu F, Xu Y, Yoon M, Rege B.   +32 more
europepmc   +3 more sources

The Evolving Role of In Vitro–In Vivo Correlation in Model‐Informed Drug Development: A Multi‐Stakeholder Perspective [PDF]

CPT: Pharmacometrics & Systems Pharmacology
In vitro–in vivo correlation/relationship (IVIVC/R) models such as physiologically based biopharmaceutics modeling (PBBM) are crucial tools that link biopharmaceutical properties to clinical performance.
Marylore Chenel, Sylvain Fouliard, Emma Hansson, Karl Brendel, Matthieu Jacobs, Hans Lennernäs, Erik Sjögren, Martin Bergstrand   +7 more
doaj   +2 more sources

Model-Integrated Bioequivalence (MIBE) in Generic Drug Research: Can We Ease the Bioequivalence Burden? [PDF]

Pharmaceutics
Bioequivalence (BE) studies are essential to file an abbreviated new drug application (ANDA) against an innovator drug product. Conventional BE studies can be complex, time-consuming, and operationally challenging, particularly for products with long ...
Sivacharan Kollipara, Rajkumar Boddu, Chandra Teja Uppuluri, Anuj Kumar Saini   +3 more
doaj   +2 more sources

Advances in Nasal Biopharmaceutics to Support Product Development and Therapeutic Needs [PDF]

Pharmaceutics
Background/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, Lucy Goodacre, Alison B. Lansley, Andrew R. Martin, Helen Palmer, Claire Patterson, Chris Roe, Regina Scherließ   +7 more
doaj   +2 more sources

DoE- and PBBM-Driven Formulation Development of an Extended-Release Donepezil Tablet [PDF]

Pharmaceuticals
Background/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, Leonardo Luiz Borges, Sivacharan Kollipara, Praveen Sivadasu, Renê Oliveira do Couto   +4 more
doaj   +2 more sources

Virtual bioequivalence-guided PBBM prediction for ibuprofen/diphenhydramine citrate tablets: impact of dissolution variability and clinical standard development [PDF]

Saudi Pharmaceutical Journal
This study aimed to integrate in vitro dissolution testing, in vivo pharmacokinetic (PK) studies, and computational simulation to develop a physiologically based biopharmaceutics model (PBBM) for fixed-dose combination ibuprofen/diphenhydramine citrate ...
Zilong Wang, Zhihai Cao, Chun Guo, Qian Zhang, Renpeng Zhou, Jian Chen, Feng Su, Wei Liu, Zhaoxing Chu, Liang Zheng, Wei Hu   +10 more
doaj   +2 more sources

Physiologically Based Biopharmaceutics Modeling of Regional and Colon Absorption in Dogs. [PDF]

Mol Pharm, 2021
Eckernäs E, Tannergren C.
europepmc   +2 more sources

The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development [PDF]

Arhiv za farmaciju, 2021
Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety of applications. Among these, physiologically-based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) emerged as a ...
Cvijić Sandra, Ignjatović Jelisaveta, Parojčić Jelena, Ibrić Svetlana   +3 more
doaj   +1 more source

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