[HTML][HTML] Approaches of formulation bridging in support of orally administered drug product development
M Han, J Xu, Y Lin - International Journal of Pharmaceutics, 2022 - Elsevier
As a drug advances through the late stages of clinical development, formulation changes
are common to meet clinical, manufacturing, and/or business needs. Since some formulation …
are common to meet clinical, manufacturing, and/or business needs. Since some formulation …
The benefits and challenges of antibiotics–non-steroidal anti-inflammatory drugs non-covalent reaction
I Nugrahani, D Herawati, MS Wibowo - Molecules, 2023 - mdpi.com
Recently, non-covalent reactions have emerged as approaches to improve the
physicochemical properties of active pharmaceutical ingredients (API), including antibiotics …
physicochemical properties of active pharmaceutical ingredients (API), including antibiotics …
[HTML][HTML] Biowaiver based on biopharmaceutics classification system: Considerations and requirements
PR Dhake, ST Kumbhar, VL Gaikwad - Pharmaceutical Science Advances, 2024 - Elsevier
Biowaiver allows for the waiver of bioequivalence studies for regulatory approval of certain
drug products with saving of time, and money. Before approval of the application for …
drug products with saving of time, and money. Before approval of the application for …
[HTML][HTML] Multi-Compartmental Dissolution Method, an Efficient Tool for the Development of Enhanced Bioavailability Formulations Containing Poorly Soluble Acidic …
MT Katona, L Nagy-Katona, R Szabó, E Borbás… - Pharmaceutics, 2023 - mdpi.com
The purpose of this study was to investigate the applicability of the Gastrointestinal Simulator
(GIS), a multi-compartmental dissolution model, to predict the in vivo performance of …
(GIS), a multi-compartmental dissolution model, to predict the in vivo performance of …
Effect of poly (ε-caprolactone) microspheres on population pharmacokinetic/pharmacodynamic model of a simple coumarin
PA Cárdenas, IA Alves, BV De Araujo… - Journal of …, 2024 - Taylor & Francis
This study aims to evaluated the impact of poly (ε-caprolactone)(PCL) microspheres on the
pharmacokinetics and pharmacodynamics (PopPK/PD) of 6-methylcoumarin (6MC). For this …
pharmacokinetics and pharmacodynamics (PopPK/PD) of 6-methylcoumarin (6MC). For this …
Predictive Potential of Acido-Basic Properties, Solubility and Food on Bioequivalence Study Outcome: Analysis of 128 Studies
D Krajcar, R Jereb, I Legen, J Opara, I Grabnar - Drugs in R&D, 2023 - Springer
Abstract Background and Objectives Risk assessment related to bioequivalence study
outcome is critical for effective planning from the early stage of drug product development …
outcome is critical for effective planning from the early stage of drug product development …