Setting acceptance criteria for validation of analytical methods of drug eluting stents: Minimum requirements for analytical variability.
Summary of "Setting acceptance criteria for validation of analytical methods of drug eluting stents: Minimum requirements for analytical variability."
Accuracy and reliability of the analytical results are crucial for ensuring quality, safety and efficacy of drug eluting stents (DESs). Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results. Validation of analytical methods includes the identification of the performance parameters relevant for the given procedure, the definition of appropriate acceptance criteria and the appropriate design of the validation studies. Achieving an appropriate consideration of the analytical variability in assay procedures and setting acceptance criteria for analytical validations is however much more difficult than usually described. Criteria which are too wide may lead to unnecessary and incorrect out-of-specification (OOS) cases, resulting in bad reject decision for products. This study concentrates on analysis, through simulation, of the relation of method variability with specification limits for the total loaded dose of the active substance on the DES. The findings of this study point what levels of precision and accuracy are needed, in other words what is the magnitude of the allowable total error from all possible effects (both systematic and random) in an assay method in order to achieve the level of performance required for the methods applied routinely for the evaluation of the total loaded dose of DES as part of lot release/stability testing.
Affiliation
Department of Analytical Sciences, Abbott Vascular, Inc., 3200 Lakeside Drive, Santa Clara, CA 95054-2807, USA.
Journal Details
This article was published in the following journal.
Name: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
ISSN: 1879-0720
Pages: 230-7
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21126583
- DOI: http://dx.doi.org/10.1016/j.ejps.2010.11.013
Medical and Biotech [MESH] Definitions
Chromatography, Paper
An analytical technique for resolution of a chemical mixture into its component compounds. Compounds are separated on an adsorbent paper (stationary phase) by their varied degree of solubility/mobility in the eluting solvent (mobile phase).
Analytic Sample Preparation Methods
Use of various chemical separation and extraction methods, such as SOLID PHASE EXTRACTION; CHROMATOGRAPHY; and SUPERCRITICAL FLUID EXTRACTION; to prepare samples for analytical measurement of components.
Drug-eluting Stents
Stents that are covered with materials that are embedded with chemicals that are gradually released into the surrounding milieu.
Rate Setting And Review
A method of examining and setting levels of payments.
Patient Acceptance Of Health Care
The seeking and acceptance by patients of health service.
PubMed Articles
Dissolution tests are key elements to ensure continuing product quality and performance. The ultimate goal of these tests is to assure consistent product quality within a defined set of specification...
The aim of this study was to demonstrate the usefulness of the size exclusion chromatography with evaporative light scattering detection (SEC-ELSD) method in the identification and quantitative analys...
NonClinical Dose Formulation Analysis Method Validation and Sample Analysis.
Nonclinical dose formulation analysis methods are used to confirm test article concentration and homogeneity in formulations and determine formulation stability in support of regulated nonclinical stu...
Is it really necessary to validate an analytical method or not? That is the question.
Method validation is an important requirement in the practice of chemical analysis. However, awareness of its importance, why it should be done and when, and exactly what needs to be done, seems to be...
An improved method for the assay of trifluoroacetic acid (TFA) in a cyclosporin-like drug substance is presented, based on ion chromatography with suppressed conductivity detection. Column fouling by...
Clinical Trials
The DEScover Registry is designed to observe the results of using Drug Eluting Stents (DES) in patients in a real-world setting. The stents being observed are not investigational, that is,...
The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month...
Drug Eluting Balloon Versus Drug Eluting Stent in PCI
Drug eluting balloons (DEB) have been developed to overcome the limitations of drug eluting stent (DES), but clinical results of different studies about DEB are not consistent. Thus, we p...
A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System
The objective of this study is the assessment of the performance, safety and efficacy of the ProNOVA XR Polymer Free Drug Eluting Stent System in the treatment of patients with de novo nat...
Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents
The purpose of this study is to compare coronary endothelium function in patients with a zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical coherenc...
