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Design and analysis of accelerated degradation tests for the stability of biological standards III. Principles of design.
J Biol Stand 1984; 12(2):215-24JB

Abstract

The principles of designing an accelerated degradation test for a biological standard are considered, with special emphasis on ensuring accuracy and precision of the predicted low temperature degradation rate. A three-stage design is proposed which initially monitors samples at the highest of the elevated temperatures, but which switches attention progressively to the lower temperatures as degradation begins to be detected. The advantages of this design over one where testing is carried out after a predetermined period are that it is (i) more efficient, (ii) more reliable and (iii) better suited to test the assumptions which underly the analysis of the results. Consideration is also given to additional checks which can be made on the stability of biological standards and to methods of monitoring long-term stability after the standard has been set up.

Authors

No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

6736050

Citation

Kirkwood, T B.. "Design and Analysis of Accelerated Degradation Tests for the Stability of Biological Standards III. Principles of Design." Journal of Biological Standardization, vol. 12, no. 2, 1984, pp. 215-24.
Kirkwood TB. Design and analysis of accelerated degradation tests for the stability of biological standards III. Principles of design. J Biol Stand. 1984;12(2):215-24.
Kirkwood, T. B. (1984). Design and analysis of accelerated degradation tests for the stability of biological standards III. Principles of design. Journal of Biological Standardization, 12(2), pp. 215-24.
Kirkwood TB. Design and Analysis of Accelerated Degradation Tests for the Stability of Biological Standards III. Principles of Design. J Biol Stand. 1984;12(2):215-24. PubMed PMID: 6736050.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Design and analysis of accelerated degradation tests for the stability of biological standards III. Principles of design. A1 - Kirkwood,T B, PY - 1984/1/1/pubmed PY - 1984/1/1/medline PY - 1984/1/1/entrez SP - 215 EP - 24 JF - Journal of biological standardization JO - J Biol Stand VL - 12 IS - 2 N2 - The principles of designing an accelerated degradation test for a biological standard are considered, with special emphasis on ensuring accuracy and precision of the predicted low temperature degradation rate. A three-stage design is proposed which initially monitors samples at the highest of the elevated temperatures, but which switches attention progressively to the lower temperatures as degradation begins to be detected. The advantages of this design over one where testing is carried out after a predetermined period are that it is (i) more efficient, (ii) more reliable and (iii) better suited to test the assumptions which underly the analysis of the results. Consideration is also given to additional checks which can be made on the stability of biological standards and to methods of monitoring long-term stability after the standard has been set up. SN - 0092-1157 UR - https://www.unboundmedicine.com/medline/citation/6736050/Design_and_analysis_of_accelerated_degradation_tests_for_the_stability_of_biological_standards_III__Principles_of_design_ DB - PRIME DP - Unbound Medicine ER -