[en] 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 log(10)(CCID(50)/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.
Disciplines :
Chemistry
Author, co-author :
Gibelin, N.
Dupont, Danielle ; Centre Hospitalier Universitaire de Liège - CHU > HOSPITALISATION - S.I. CORONAIRES (SI -2D)
Imbert, S.
Rozet, Eric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Use of Total Error concept in the validation of viral activity in cell cultures.
Publication date :
2009
Journal title :
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.
Bibliography
International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of analytical procedures: text and methodology, Geneva, 2005.
Ramond B., Gaillandre A., Gibelin N., Maignan N., Michalski C., Nabet P., Niewiaski C., Poirault D., Poirier B., and Rigal H. STP Pharma Pratiques 15 (2005) 364
Rozet E., Ceccato A., Hubert C., Ziemons E., Oprean R., Rudaz S., Boulanger B., and Hubert P. J. Chromatogr. A 1158 (2007) 111
ISO 5725, Application of the statistics-accuracy (trueness and precision) of the results and methods of measurement-Part 1 to 6, International Organization for Standardization (ISO), Geneva, 1994.
Hubert P., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewe W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., and Valat L. J. Pharm. Biomed. Anal. 36 (2004) 579
Hubert Ph., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L., and Rozet E. J. Pharm. Biomed. Anal. 45 (2007) 70
Hubert Ph., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Cohen N., Compagnon P.-A., Dewé W., Feinberg M., Laurentie M., Mercier N., Muzard G., Valat L., and Rozet E. J. Pharm. Biomed. Anal. 45 (2007) 82
Rozet E., Wascotte V., Lecouturier N., Preat V., Dewe W., Boulanger B., and Hubert P. Anal. Chim. Acta 591 (2007) 239
Rozet E., Hubert C., Ceccato A., Dewé W., Ziemons E., Moonen F., Michail K., Wintersteiger R., Streel B., Boulanger B., and Hubert Ph. J. Chromatogr. A 1158 (2007) 126
Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., and Weiner R. AAPS J. 9 (2007) E30. http://www.aapsj.org/ (http://www.aapsj.org)
Hubert Ph., Chiap P., Crommen J., Boulanger B., Chapuzet E., Mercier N., Bervoas-Martin S., Chevalier P., Grandjean D., Lagorce P., Lallier M., Lapara M.C., Laurentie M., and Nivet J.C. Anal. Chim. Acta 391 (1999) 135
Guidance for industry: Bioanalytical method validation, US Department of Health and Human Services, US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001.
Hahn G.J., and Meeker W.Q. Statistical Intervals: A Guide for Practitioners (1991), John Wiley & Sons, Inc., New York
Mee R. Technometrics 26 (1984) 251
International Conference on Harmonization (ICH): Quality Risk Management Q9, Geneva, 2005.
American Food and Drug Administration (FDA), Guidance for Industry PAT-A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, FDA, 2004.
Feinberg M., Boulanger B., Dewe W., and Hubert Ph. Anal. Bioanal. Chem. 380 (2004) 502
This website uses cookies to improve user experience. Read more
Save & Close
Accept all
Decline all
Show detailsHide details
Cookie declaration
About cookies
Strictly necessary
Performance
Strictly necessary cookies allow core website functionality such as user login and account management. The website cannot be used properly without strictly necessary cookies.
This cookie is used by Cookie-Script.com service to remember visitor cookie consent preferences. It is necessary for Cookie-Script.com cookie banner to work properly.
Performance cookies are used to see how visitors use the website, eg. analytics cookies. Those cookies cannot be used to directly identify a certain visitor.
Used to store the attribution information, the referrer initially used to visit the website
Cookies are small text files that are placed on your computer by websites that you visit. Websites use cookies to help users navigate efficiently and perform certain functions. Cookies that are required for the website to operate properly are allowed to be set without your permission. All other cookies need to be approved before they can be set in the browser.
You can change your consent to cookie usage at any time on our Privacy Policy page.