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Determining the probability of an important difference in bioavailability
Author(s) -
Rodda Bruce E,
Davis Robert L
Publication year - 1980
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.1980.157
Subject(s) - bioavailability , statistical significance , significant difference , clinical pharmacology , premise , statistical analysis , bioequivalence , econometrics , psychology , statistics , mathematics , medicine , pharmacology , epistemology , philosophy
Bioavailability studies usually compare formulations of a drug under the premise of equal bioavailabilities. Analyses of such studies may be questioned when large differences exist, but are not statistically significant, or when small differences are found which do reach statistical significance. In either case, the question of clinical significance is not addressed and remains problematic regardless of the outcome. The important question is, “Given the results of the study, what is the probability that a clinically important difference exists?” To obviate dependence on statistical significance, we propose a methodology which permits computation of the probability that a clinically important difference in bioavailability exists between two products, regardless of the results of conventional tests of hypothesis. The methodology permits a strong statement which defines the likelihood of a meaningful difference, rather than the “nonstatement” of current approaches. The approach is illustrated by a study in which a 2% (nonsignificant) difference in bioavailability was observed. Using the proposed methodology the analysis concluded that the odds are about 5 to 1 against there being a 20% difference in bioavailability between the formulations. Clinical Pharmacology and Therapeutics (1980) 28, 247–252; doi: 10.1038/clpt.1980.157