Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series [PDF]
Pharmaceutics, 2022 A webinar series that was organised by the Academy of Pharmaceutical Sciences Biopharmaceutics focus group in 2021 focused on the challenges of developing clinically relevant dissolution specifications (CRDSs) for oral drug products.
Mark McAllister +20 more
doaj +8 more sources
Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives [PDF]
Pharmaceutics, 2019 A meeting that was organized by the Academy of Pharmaceutical Sciences Biopharmaceutics and Regulatory Sciences focus groups focused on the challenges of Developing Clinically Relevant Dissolution Specifications (CRDS) for Oral Drug Products.
Mark McAllister +8 more
doaj +5 more sources
Physiologically Based Biopharmaceutics Modelling—Best Scientific Practices to Define Drug Product Performance, Latest Regulatory and Industry Perspectives: Workshop Summary Report [PDF]
PharmaceuticsIn November 2024, a two-day meeting entitled “PBBM—Best Scientific Practices to Define Drug Product Performance: Latest Regulatory and Industry Perspectives” was organised by the Academy of Pharmaceutical Sciences Biopharmaceutics Focus group and hosted ...
Mark McAllister +23 more
doaj +2 more sources
The use of PBPK/PD to establish clinically relevant dissolution specifications for zolpidem immediate release tablets [PDF]
European Journal of Pharmaceutical Sciences, 2020 Zolpidem is a non-benzodiazepine hypnotic agent which has been shown to be effective in inducing and maintaining sleep in adults and is one of the most frequently prescribed hypnotics in the world. For drugs that are used to treat sleeping disorders, the time to reach the maximum concentration (Tmax) of the drug in plasma is important to achieving a ...
Nikoletta Fotaki, Jennifer B Dressman
exaly +5 more sources
Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen [PDF]
European Journal of Pharmaceutical Sciences, 2020 Physiologically-based population pharmacokinetic modeling (popPBPK) coupled with in vitro biopharmaceutics tools such as biorelevant dissolution testing can serve as a powerful tool to establish virtual bioequivalence and set clinically relevant specifications.
Ioannis Loisios-Konstantinidis +2 more
exaly +3 more sources
Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms [PDF]
AAPS Journal, 2017 This manuscript represents the perspective of the Dissolution Analytical Working Group of the IQ Consortium. The intent of this manuscript is to highlight the challenges of, and to provide a recommendation on, the development of clinically relevant dissolution specifications (CRS) for immediate release (IR) solid oral dosage forms. A roadmap toward the
André Hermans +2 more
exaly +3 more sources
European Journal of Pharmaceutical Sciences, 2021 The aim of this study was to explore clinically relevant dissolution specifications for weak acid drugs using an in silico drug absorption model. Loxoprofen sodium and ibuprofen were used as model drugs in this study. An in silico drug absorption model was developed using Stella Professional software and the prediction model accurately represented the ...
Atsushi Kambayashi
exaly +3 more sources
Virtual Bioequivalence Assessment and Dissolution Safe Space Exploration for Fixed-Dose Metformin–Glyburide Tablet Using Physiologically Based Biopharmaceutics Modeling [PDF]
PharmaceuticsBackground/Objectives: Fixed-dose combinations (FDCs) hold significant clinical value for the management of hypertension, diabetes and other chronic diseases.
Chenshuang Zhao +3 more
doaj +2 more sources
Biopharmaceutics and Drug Disposition, 2022 AbstractThe aim of this analysis was to use a physiologically based pharmacokinetic (PBPK) model to predict the impact of changes in dissolution rates on elagolix exposures and define clinically relevant acceptance criteria for dissolution. Varying in vitro dissolution profiles were utilized in a PBPK model to describe the absorption profiles of ...
Dwaipayan Mukherjee +2 more
exaly +3 more sources
Development of In Vitro–In Vivo Correlation for Amorphous Solid Dispersion Immediate-Release Suvorexant Tablets and Application to Clinically Relevant Dissolution Specifications and In-Process Controls [PDF]
Journal of Pharmaceutical Sciences, 2015 Although in vitro-in vivo correlations (IVIVCs) are commonly pursued for modified-release products, there are limited reports of successful IVIVCs for immediate-release (IR) formulations. This manuscript details the development of a Multiple Level C IVIVC for the amorphous solid dispersion formulation of suvorexant, a BCS class II compound, and its ...
Fílippos Kesisoglou, André Hermans
exaly +3 more sources