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Predicting the stability of biological standards and products.
Biometrics. 1977 Dec; 33(4):736-42.B

Abstract

A high level of stability is essential for any biological standard and is desirable in most other biological products. It is in general impossible to observe directly the rate of degradation of a biological standard since no independent scale of measurement is available. An indirect method is therefore required. The most common approach is the accelerated degradation test in which samples are stored for a time at elevated temperatures and then compared with samples stored continuously at low temperature. The relative degradation rates are used to fit the Arrhenius equation (relating degradation rate to temperature) and hence to predict stability under normal storage conditions. Previous statistical work on this problem is reviewed and a maximum likelihood ML approach is suggested which overcomes some of the limitations of the existing methodology. The accelerated degradation test also finds wide application in the shelf-life prediction of biological products where the same statistical methods are appropriate.

Authors

No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

588659

Citation

Kirkwood, T B.. "Predicting the Stability of Biological Standards and Products." Biometrics, vol. 33, no. 4, 1977, pp. 736-42.
Kirkwood TB. Predicting the stability of biological standards and products. Biometrics. 1977;33(4):736-42.
Kirkwood, T. B. (1977). Predicting the stability of biological standards and products. Biometrics, 33(4), 736-42.
Kirkwood TB. Predicting the Stability of Biological Standards and Products. Biometrics. 1977;33(4):736-42. PubMed PMID: 588659.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Predicting the stability of biological standards and products. A1 - Kirkwood,T B, PY - 1977/12/1/pubmed PY - 1977/12/1/medline PY - 1977/12/1/entrez SP - 736 EP - 42 JF - Biometrics JO - Biometrics VL - 33 IS - 4 N2 - A high level of stability is essential for any biological standard and is desirable in most other biological products. It is in general impossible to observe directly the rate of degradation of a biological standard since no independent scale of measurement is available. An indirect method is therefore required. The most common approach is the accelerated degradation test in which samples are stored for a time at elevated temperatures and then compared with samples stored continuously at low temperature. The relative degradation rates are used to fit the Arrhenius equation (relating degradation rate to temperature) and hence to predict stability under normal storage conditions. Previous statistical work on this problem is reviewed and a maximum likelihood ML approach is suggested which overcomes some of the limitations of the existing methodology. The accelerated degradation test also finds wide application in the shelf-life prediction of biological products where the same statistical methods are appropriate. SN - 0006-341X UR - https://www.unboundmedicine.com/medline/citation/588659/Predicting_the_stability_of_biological_standards_and_products_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0006-341X&date=1977&volume=33&issue=4&spage=736 DB - PRIME DP - Unbound Medicine ER -