Results 11 to 20 of about 2,897 (211)

A Mechanistic Physiologically-Based Biopharmaceutics Modeling (PBBM) Approach to Assess the In Vivo Performance of an Orally Administered Drug Product: From IVIVC to IVIVP [PDF]

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, Bart Hens, Joseph Dickens, Deanna Mudie, Paulo Paixão, Yasuhiro Tsume, Kerby Shedden, Gordon L. Amidon   +7 more
doaj   +2 more sources

Physiologically based biopharmaceutics modeling of regional and colon absorption in humans

European Journal of Pharmaceutics and Biopharmaceutics, 2023
Colon absorption is a key determinant for successful development of extended release and colon targeted drug products. This is the first systematic evaluation of the ability to predict in vivo regional differences in absorption and the extent of colon absorption in humans using mechanistic physiologically based biopharmaceutics modeling (PBBM).
Tannergren, Christer, Jadhav, Harshad, Eckernas, Emma, Fagerberg, Jonas, Augustijns, Patrick, Sjogren, Erik   +5 more
openaire   +5 more sources

Integrating In Vitro BE Checker with In Silico Physiologically Based Biopharmaceutics Modeling to Predict the Pharmacokinetic Profiles of Oral Drug Products [PDF]

Pharmaceutics
Objective: The objective of this study was to develop a Physiologically Based Biopharmaceutics Modeling (PBBM) framework that can predict PK profiles in humans based on data generated from the BE Checker.
Takuto Niino, Takato Masada, Toshihide Takagi, Makoto Kataoka, Hiroyuki Yoshida, Shinji Yamashita, Atsushi Kambayashi   +6 more
doaj   +2 more sources

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   +2 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

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". This day focused on the current and future drug product quality applications of PBBM from the innovator and generic industries as well as the ...
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

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

The Provisional No-Effect Threshold of Sugar Alcohols on Oral Drug Absorption Estimated by Physiologically Based Biopharmaceutics Model [PDF]

Journal of Pharmaceutical Sciences, 2021
Sugar alcohols reduce oral drug bioavailability by osmotic effects, but the magnitude of these effects differs among different drugs. This study aimed to identify the drug-related critical attributes of osmotic effects and estimate the impact of a "practical" sugar alcohol dose on the pharmacokinetics of various molecules using modeling and simulation ...
Miki, Yamane, Kazuki, Matsui, Masahisa, Sugihara, Yuji, Tokunaga   +3 more
openaire   +4 more sources

In Silico Evaluation of the Biopharmaceutical and Pharmacokinetic Behavior of Metronidazole from Coated Colonic Release Matrix Tablets [PDF]

Pharmaceutics
Background: 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, Cristina Maderuelo, José M. Lanao   +2 more
doaj   +2 more sources

Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development—Industry Case Studies [PDF]

Journal of Pharmaceutical Sciences, 2016
In recent years, there has been a significant increase in use of physiologically based pharmacokinetic models in drug development and regulatory applications. Although most of the published examples have focused on aspects such as first-in-human (FIH) dose predictions or drug-drug interactions, several publications have highlighted the application of ...
Filippos, Kesisoglou, John, Chung, Judith, van Asperen, Tycho, Heimbach   +3 more
openaire   +4 more sources