التفاصيل البيبلوغرافية
| العنوان: |
Use of Total Error concept in the validation of viral activity in cell cultures |
| المؤلفون: |
Gibelin, N.1 nicole.gibelin@sanofipasteur.com, Dupont, D.2, Imbert, S.3, Rozet, E.4 |
| المصدر: |
Journal of Chromatography B: Analytical Technologies in the Biomedical & Life Sciences. Aug2009, Vol. 877 Issue 23, p2407-2411. 5p. |
| مصطلحات موضوعية: |
*BIOLOGICAL assay, *ERROR analysis in mathematics, *CELL culture, *DRUG standards, *DECISION making, *CONFIDENCE intervals, *ANALYTICAL chemistry, *RELIABILITY (Personality trait) |
| مستخلص: |
Abstract: Due to the high variability inherent of experimental recipients, validating biological methods is often a complex exercise, and following ICH Q2R1 recommendations is not always feasible and/or meaningful. Linking systematic error and random error to obtain a unique criterion, as defined in ISO guideline, could be of interest to capture the total variability in biological assays. In this paper, the use of Total Error concept in the validation of biological assays was for the first time investigated and compared to a conventional interpretation of the ICH guideline. Both decision methodologies concluded that the assay was valid from 2.13 to 5.83 log10(CCID50/ml). However, only the Total Error approach using accuracy profile as decision tool allowed to guarantee that accurate and reliable results will be obtained during the future routine application of the assay. In addition, the risk to obtain out of acceptance limits results was estimated using this approach and was found out to be at the most 3.1% irrespective of the concentration level, thus demonstrating the reliability of the biological assay. [Copyright &y& Elsevier] |
| قاعدة البيانات: |
Academic Search Index |
