11/9/2016
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`Estimating the minimum therapeutically effective dose of a compound via regression modelling and percentile estimation. - PubMed - NCBI
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`Stat Med. 1995 May 15-30;14(9-10):925-32; discussion 933.
`Estimating the minimum therapeutically effective dose of a compound via
`regression modelling and percentile estimation.
`1
`Filloon TG .
`Author information
`1
`Biometrics & Statistical Sciences Department, Procter & Gamble Pharmaceuticals, Miami Valley
`Laboratories, Cincinnati, Ohio 45239-8707, USA.
`
`Abstract
`Estimation of the minimum effective dose (MED) of a compound from a typical placebo-controlled
`dose-response study can be carried out in several ways. Current approaches compare treatment
`doses against a placebo dose via selected contrasts to determine the lowest dose level at which the
`contrast is statistically significant. Ruberg shows how this approach works for various choices of
`contrasts. Instead, the MTED (minimum therapeutically effective dose) might be defined as the
`lowest dose level that yields a therapeutic benefit to patients, on average, or to a given percentage of
`patients. One could use a lower confidence limit for the mean approach to determine the dose
`yielding (on average) a therapeutic benefit via regression modelling of the continuous treatment dose
`response. More importantly, a patient relevant approach would be to actually estimate regression
`percentiles or construct regression tolerance intervals. Such an approach addresses the question
`'What percentage of patients are receiving therapeutic (yet safe) doses', instead of just knowing that
`a dose is effective 'on average', and thus would help to understand the distribution of patient
`responses at a given treatment dose. This further enables one to better evaluate the efficacy versus
`safety trade-off as dose increases and provides better guidelines for prescribed dose levels.
`
`PMID: 7569511
`[PubMed - indexed for MEDLINE]
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`11/9/2016
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`Estimating the minimum therapeutically effective dose of a compound via regression modelling and percentile estimation. - PubMed - NCBI
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