Results 11 to 20 of about 17,488 (290)

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

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

Physiologically Based Biopharmaceutics Model of Apixaban for Biopharmaceutics Risk Assessment [PDF]

Pharmaceutics
Background/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, Zvonimir Petric, José A. G. Morais   +2 more
doaj   +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

Production of Recombinant E.coli Asparaginase on a Laboratory Scale [PDF]

مجله دانشکده پزشکی اصفهان, 2023
Background: L-asparaginase is an enzyme derived from E. coli and is one of the drugs used to treat acute lymphoblastic leukemia. Decreased blood asparagine after the use of the asparaginase can lead to death for these cells. The aim of this project is to
Zahra Zeinali, Hamid Bakherad
doaj   +1 more source

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.
Konstantinos Stamatopoulos, Paola Ferrini, Dung Nguyen, Ying Zhang, James M. Butler, Jon Hall, Nena Mistry   +6 more
doaj   +1 more source

Shared IVIVR for Five Commercial Enabling Formulations Using the BiPHa+ Biphasic Dissolution Assay

Pharmaceutics, 2021
The present study intended to confirm the in vivo relevance of the BiPHa+ biphasic dissolution assay using a single set of assay parameters. Herein, we evaluated five commercial drug products formulated by various enabling formulation principles under ...
Alexander Denninger, Ulrich Westedt, Karl G. Wagner   +2 more
doaj   +1 more source

Regional Intestinal Drug Absorption: Biopharmaceutics and Drug Formulation

Pharmaceutics, 2021
The gastrointestinal tract (GIT) can be broadly divided into several regions: the stomach, the small intestine (which is subdivided to duodenum, jejunum, and ileum), and the colon. The conditions and environment in each of these segments, and even within
Arik Dahan, Isabel González-Álvarez
doaj   +1 more source

Method development for quantification of DMET-proteins in the paediatric intestinal tract via LC-MS/MS using a QconCAT technique

British Journal of Pharmacy, 2022
Physiologically based pharmacokinetic (PBPK) modelling is a powerful alternative for paediatric clinical trials. Paediatric PBPK models require data on intestinal drug metabolising enzymes and transporter (DMET)-protein abundances, however only limited ...
Jan Goelen, Richard D Horniblow, Hannah Batchelor   +2 more
doaj   +1 more source

Diammonium Glycyrrhizinate-Based Micelles for Improving the Hepatoprotective Effect of Baicalin: Characterization and Biopharmaceutical Study

Pharmaceutics, 2022
Saponins are an important class of surface-active substances. When formulated as an active ingredient or co-used with other drugs, the effect of their surface activity on efficacy or safety must be considered.
Xingxing Dai, Yuyao Liao, Cuiting Yang, Yingying Zhang, Minfang Feng, Yuting Tian, Qingsong Qu, Mengke Sheng, Zhixun Li, Xinhui Peng, Shuai Cen, Xinyuan Shi   +11 more
doaj   +1 more source