Dissolution/Release Test Data (Profile): Requirements, Analyses, and Regulatory Expectations

2022 ◽  
pp. 237-253
Keyword(s):  
2016 ◽  
Vol 32 (3) ◽  
pp. 204-214 ◽  
Author(s):  
Emilie Lacot ◽  
Mohammad H. Afzali ◽  
Stéphane Vautier

Abstract. Test validation based on usual statistical analyses is paradoxical, as, from a falsificationist perspective, they do not test that test data are ordinal measurements, and, from the ethical perspective, they do not justify the use of test scores. This paper (i) proposes some basic definitions, where measurement is a special case of scientific explanation; starting from the examples of memory accuracy and suicidality as scored by two widely used clinical tests/questionnaires. Moreover, it shows (ii) how to elicit the logic of the observable test events underlying the test scores, and (iii) how the measurability of the target theoretical quantities – memory accuracy and suicidality – can and should be tested at the respondent scale as opposed to the scale of aggregates of respondents. (iv) Criterion-related validity is revisited to stress that invoking the explanative power of test data should draw attention on counterexamples instead of statistical summarization. (v) Finally, it is argued that the justification of the use of test scores in specific settings should be part of the test validation task, because, as tests specialists, psychologists are responsible for proposing their tests for social uses.


1993 ◽  
Vol 69 (04) ◽  
pp. 344-350 ◽  
Author(s):  
B H Chong ◽  
J Burgess ◽  
F Ismail

SummaryThe platelet aggregation test is widely used for the diagnosis of heparin-induced thrombocytopenia (HIT), a potentially serious complication of heparin therapy. We have evaluated its sensitivity and specificity in comparison with those of the 14C-serotonin release test. The sensitivity of the platelet aggregation test was found to vary with the heparin concentration and the donor of the platelets used in the test. The optimal heparin concentrations were between 0.1 and 1.0 U/ml. Using these heparin concentrations, the mean sensitivity varied from 39% (with the least reactive platelets) to 81% (with the most reactive platelets). In comparison, the sensitivity of the release test ranged from 65% to 94%. The specificities of the platelet aggregation test were 82%, 90% and 100% for the following control groups: (1) non-thrombocytopenic patients given heparin, (2) patients with thrombocytopenia due to other causes, and (3) normal controls not given heparin, respectively. The corresponding specificities for the release test was 94%, 90% and 100%. The specificities can be further increased to 100% for all controls with the adoption of a two-point system which defines a positive result as one in which platelet aggregation occurs with a low heparin concentration (0.5 U/ml) but not with 100 U heparin/ml. For optimal results, a two-point platelet aggregation test should be performed with heparin concentrations of 0.5 and 100 U/ml and using platelets of more reactive donors.


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