Establishment of Level a In Vitro–In Vivo Correlation (IVIVC) via Extended DoE-IVIVC Model: A Donepezil Case Study [PDF]
Pharmaceutics, 2022 This study aimed to establish an extended design of experiment (DoE)-in vitro in vivo correlation (IVIVC) model that defines the relationship between formulation composition, in vitro dissolution, and in vivo pharmacokinetics. Fourteen sustained-release (
Da Young Lee +3 more
doaj +4 more sources
In Vitro–In Vivo Correlation (IVIVC) Population Modeling for the In Silico Bioequivalence of a Long-Acting Release Formulation of Progesterone [PDF]
Pharmaceutics, 2021 Health authorities carefully evaluate any change in the batch manufacturing process of a drug before and after regulatory approval. In the absence of an adequate in vitro–in vivo correlation (Level A IVIVC), an in vivo bioequivalence (BE) study is ...
Elena M. Tosca +7 more
doaj +4 more sources
Physiologically Relevant In Vitro-In Vivo Correlation (IVIVC) Approach for Sildenafil with Site-Dependent Dissolution [PDF]
Pharmaceutics, 2019 This study aimed to establish a physiologically relevant in vitro-in vivo correlation (IVIVC) model reflecting site-dependent dissolution kinetics for sildenafil based on population-pharmacokinetic (POP-PK) modeling.
Tae Hwan Kim +4 more
doaj +4 more sources
Developing In Vitro–In Vivo Correlation for Bicalutamide Immediate-Release Dosage Forms with the Biphasic In Vitro Dissolution Test [PDF]
PharmaceuticsBackground/Objectives: Reflecting the interaction between dissolution and absorption, the biphasic dissolution system is an appealing approach for estimating the intestinal absorption of drugs in humans.
Nihal Tugce Ozaksun, Tuba Incecayir
doaj +2 more sources
Potency Evaluation and Predictive Quality Control System Construction Strategy for Respiratory Syncytial Virus mRNA Vaccines [PDF]
VaccinesThe rapid advancement of respiratory syncytial virus (RSV) mRNA vaccines has created an urgent need for robust, standardized, and predictive potency evaluation systems.
Su Zhang, Changgui Li, Yaru Quan
doaj +2 more sources
Molecular Therapy: Nucleic Acids, 2020 There has been a renewed interest in therapeutic small interfering RNAs (siRNAs) over the past few years. This is particularly the result of successful and efficient delivery of N-acetylgalactosamine (GalNAc)-conjugated siRNAs to the liver.
Babak Basiri +8 more
doaj +3 more sources
Improving In Vitro–In Vivo Correlation (IVIVC) for Lipid-Based Formulations: Overcoming Challenges and Exploring Opportunities [PDF]
PharmaceuticsLipid-based formulations (LBFs) play a crucial role in enhancing the oral bioavailability of poorly water-soluble drugs by leveraging lipid digestion and solubilization processes. However, developing robust in vitro–in vivo correlations (IVIVCs) for LBFs
Arnaud Bourderi-Cambon +7 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 PharmacologyIn 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 +7 more
doaj +2 more sources
Compositional profiling for biodegradable medical devices: a framework for degradation-informed exposure and risk assessment [PDF]
Frontiers in ToxicologyBiodegradable polymers (BPs) present unique challenges for chemical characterization and toxicological risk assessment. Methodological requirements for devices with prolonged tissue contact often involve exhaustive extraction—an approach impractical for ...
Jared Wilsey +8 more
doaj +2 more sources
Development and Evaluation of Bilayer Sustained-Release Tablets of Ruxolitinib Using Discriminative Pharmacokinetic Analysis and IVIVC [PDF]
PharmaceuticsObjectives: This study explores the development and evaluation of a bilayer sustained-release (SR) tablet formulation of ruxolitinib. As a BCS Class 1 drug, ruxolitinib requires twice-daily dosing due to its short half-life.
Namhyuck Kim +6 more
doaj +2 more sources