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.
Department of Analytical Sciences, Abbott Vascular, Inc., 3200 Lakeside Drive, Santa Clara, CA 95054-2807, USA.
This article was published in the following journal.
Name: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
- 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
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.
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.
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