Results 121 to 130 of about 1,005 (158)

A Perspective on Model-Informed IVIVC for Development of Subcutaneous Injectables

Pharmaceutical Research, 2023
Subcutaneously administered drugs are growing in popularity for both large and small molecule drugs. However, development of these systems - particularly generics - is slowed due to a lack of formal guidance regarding preclinical testing and in vitro - in vivo correlations (IVIVC).
Clairissa D, Corpstein, Tonglei, Li
openaire   +2 more sources

Population pharmacokinetics and IVIVC for mesalazine enteric-coated tablets

Journal of Controlled Release, 2022
Although in-vivo bioequivalence (BE) study serves as a golden standard for establishing interchangeability of oral dosage forms, it remains challenging for products with high inter-subject variability such as mesalazine enteric-coated tablet to fulfil the BE criteria set by regulatory authorities.
Yufeng, Zhang, Siu Kwan, Wo, Wei, Leng, Fang, Gao, Xiaoyu, Yan, Zhong, Zuo   +5 more
openaire   +2 more sources

Power law IVIVC: An application of fractional kinetics for drug release and absorption

European Journal of Pharmaceutical Sciences, 2010
Most correlations between in vitro and in vivo data (IVIVC) rely on linear relationships. However, non-linear IVIVC can be also observed, justified and validated. The purpose of the present work was the development of a methodology for power law IVIVC, which mirror power law kinetics under in vitro and in vivo conditions.
Aristides Dokoumetzidis, Panos Macheras   +1 more
exaly   +4 more sources

In vivo-in vitro correlations (IVIVC) for the assessment of pyrethroid bioavailability in honey

Food Chemistry, 2023
Bioaccessibility/bioavailability is an important factor in assessing the potential human health risk via oral exposure. However, methods for accurately predicting the bioaccessibility/bioavailability of pesticide residues are still limited, preventing accurate measurements of actual exposure to pesticide residues.
Yuying, Liu, Siyuan, Jiang, Yuxin, Xiang, Fengxiang, Lin, Xingyu, Yue, Minkun, Li, Jinjing, Xiao, Haiqun, Cao, Yanhong, Shi   +8 more
openaire   +2 more sources

A Comparison of the Prediction Accuracy of Two IVIVC Modelling Techniques

Journal of Pharmaceutical Sciences, 2008
The goal when developing an in vitro-in vivo correlation (IVIVC) model is the ability to accurately predict the in vivo plasma concentration profile of a drug formulation using only its in vitro dissolution data. The prediction accuracy of any model depends on the reliability of the method used to develop it. Some statistical concerns regarding methods
Adrian Dunne, John D Davis
exaly   +3 more sources

The Effects of Averaging on Accuracy of IVIVC Model Predictions

Journal of Pharmaceutical Sciences, 2009
When using the method of deconvolution to establish an IVIVC model, the choice of whether or not to average the data before analysis is a crucial one. Averaging the data leads to a loss of information and current advice on best practise suggests that deconvolution take place at the individual subject level.
Clare, Gaynor, Adrian, Dunne, John, Davis   +2 more
openaire   +2 more sources

Bioequivalence assessment of pharmaceutical aerosol products through IVIVC

Advanced Drug Delivery Reviews, 2021
Many pharmaceutical developers of generic orally inhaled products (OIPs) are facing significant issues in passing the regulatory requirement to show pharmacokinetic (PK) bioequivalence (BE) to the originator product. The core of the issue is that no reliable in vitro-in vivo correlation (IVIVC) is available to guide their development.
openaire   +2 more sources

Dissolution stability and IVIVC investigation of a buccal tablet

Analytica Chimica Acta, 2001
Abstract Using a recently developed bending point criterion to describe certain dissolution profiles, a physical stability screening study of a mucoadhesive buccal tablet was performed in order to obtain a fast and useful in-vitro testing system that allows the assessment of the physical stability of new formulations in a much faster way compared ...
Bart De Spiegeleer
exaly   +2 more sources

IVIVC approach based on carbamazepine bioequivalence studies combination

Die Pharmazie, 2017
The aim of the present study was to explore the feasibility of obtaining an IVIVC by combination of data from two bioequivalence (BE) studies of carbamazepine (CBZ) in order to assess if the previously published dissolution media and conditions could be applicable to any other oral immediate release (IR) CBZ products with conventional excipients ...
Gonzáles-García, I., Mangas-Sanjuan, V., Merino-Sanjuán, M., Álvarez-Álvarez, C., Díaz-Garzón Marco, J., Rodríguez-Bonnín, M. A., Langguth, T., Torrado-Durán, J. J., Langguth, P., García-Arieta, A., Beremjo, M.   +10 more
openaire   +2 more sources

Formulation, Pharmacokinetics evaluation, and IVIVC Assessment of Gliclazide Multiparticulates in Rat Model

AAPS PharmSciTech, 2021
In vitro and in vivo studies of gliclazide (GLZ)-loaded freeze-dried alginate-gelatin (AL-GL) beads were carried out, aiming to modify its oral bioavailability. Crosslinked freeze-dried GLZ AL-GL beads (particle size: 1.5- and 3.0-mm) were prepared.
Ahmed A. El-Ashmawy, Aya R. Abdou, Nesrin F. Taha, Ebtesam W. Elsayed, Khaled M. Mahmoud, Laila H. Emara   +5 more
openaire   +2 more sources