Evaluation of bioequivalence studies.
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Bayes Theorem↗
Biomedical subjects
A P Grieve
Publications and source records attributed to A P Grieve.
On the construction of shortest confidence intervals and Bayesian highest posterior density intervals.
In this note it is argued that the principal characteristic of the confidence intervals proposed by Bartoszynski & Powers (1990) is not primarily the fact that they are of minimum length but that they are Bayesian highest posterior density intervals. A simple iterative process for determining the ends of the interval is presented.
Algorithms↗
Confidence intervals and sample sizes.
In a recent paper, Beal (1989, Biometrics 45, 969-977) considers the problem of determining the appropriate sample size when inference about a parameter theta is to be made on the basis of a confidence interval (CI). He suggests that the sample size should be chosen so that the probability that the length of the CI is less than a given value, conditional on the interval including the true theta, is greater than a specified level. In this note, in which we concentrate on two-sided intervals, this suggestion is examined, as is the effect of uncertainty in our knowledge of the population variance sigma 2 on estimates of sample size.
Biometry↗
Predictive probability in clinical trials.
In a recent paper, Choi and Pepple (1989, Biometrics 45, 317-323) consider the use of predictive probabilities in the monitoring of clinical trials. In particular, they characterise the predictive probability as a "useful conservative measure" for monitoring purposes. In this note the nature and source of this "conservatism" are investigated.
Biometry↗
A two-stage procedure for bioequivalence studies.
A two-stage experimental procedure for bioequivalence studies is proposed. The procedure is based on the idea that information from a first-stage experiment can be used to form a predictive distribution for the outcome of a second-stage experiment, thus permitting an assessment of the probability of a successful overall outcome. A systematic numerical study of a variety of possible strategies results in the identification of procedures that lead to substantial increases in efficiency compared with single-stage studies.
Biometry↗
The role of Schmidt-Lanterman incisures in Wallerian degeneration.
The number of the Schmidt-Lanterman incisures and their intrasegmental distribution were studied at 36 h after transection of the rat sciatic nerve. Examination of teased, proximo-distally oriented, myelinated nerve fibers revealed no difference between the distal and the proximal stump. The results indicate that no proliferation of the incisures is required for the fiber fragmentation: numerous incisures are normally available in the midinternodal area where the degeneration begins.
Animals↗
A non-parametric confidence interval method.
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Biological Availability↗
A Bayesian analysis of the two-period crossover design for clinical trials.
Statisticians have been critical of the use of the two-period crossover designs for clinical trials because the estimate of the treatment difference is biased when the carryover effects of the two treatments are not equal. In the standard approach, if the null hypothesis of equal carryover effects is not rejected, data from both periods are used to estimate and test for treatment differences; if the null hypothesis is rejected, data from the first period alone are used. A Bayesian analysis based on the Bayes factor against unequal carryover effects is given. Although this Bayesian approach avoids the "all-or-nothing" decision inherent in the standard approach, it recognizes that with small trials it is difficult to provide unequivocal evidence that the carryover effects of the two treatments are equal, and thus that the interpretation of the difference between treatment effects is highly dependent on a subjective assessment of the reality or not of equal carryover effects.
Analysis of Variance↗
Fully automated and fast image analysis of autoradiographs with a TAS-Leitz. Determination of size, Feulgen fluorescence and grain counts of individual nuclei and their evaluation by a simplified cluster analysis.
A fully automatic analysis system based on television image analysis was developed to measure simultaneously three parameters in individual nuclei of microscopic autoradiographs prepared from mouse jejunal crypt cell squashes and ascites tumor cell smears: size, Feulgen fluorescence and reflection from silver grains. A dark light camera with an image intensified silicon tube (RCA-ISIT), an automatic scanning stage and an autofocus device were fitted to a Leitz-TAS microscope. The camera permitted localization of Feulgen stained nuclei and measurement of area and light intensity by means of incident of light fluorescence in the red. After automatic changes of the Opak-illuminator silver grains were determined by means of polarized incident light reflected from the grains in the blue. A 25 X oil objective (aperture 0.75) yielded sufficient resolution for measurements. The nadir between the proportions of labeled and unlabeled nuclei was calculated from the data of one specimen on a PDP-computer using a new algorithm based on the minimal variance of the logarithm of reflected light per nucleus. Labeling indices determined by visual grain counting and by automatic analysis of the autoradiographs were well correlated (r = 0.87 to 0.92). Visual grain counts/nucleus and reflected light/nucleus correlated well when individual nuclei were compared (r = 0.92 to 0.97) or means of labeled nuclei of various specimens prepared during a 5 year period (r = 0.90 to 0.93). Quenching of nuclear Feulgen fluorescence was minimal. The optimal labeling range is 30-100 grain counts/nucleus. The time interval between measurements of two specimens was 25 min for a squash of approximately 350 crypt cells within a 3 mm X 3 mm field, and 20 min for a meandering scan with 1,000 ascites tumor cells.
Animals↗
Seasonal variation of temperatures in rabbits.
Determinations of rectal temperatures were performed in a series of measurements in male and female drug-naive SPF rabbits of the Chinchilla type maintained under standard environmental conditions (temperature 19 degrees C, relative humidity 60%, light 14 h/day) in weekly tests collected over 3 1/2 years. The results indicated a seasonal variation in rectal temperature. The temperature was affected by restraint, and female animals showed significantly higher temperatures than males. Bodyweight had no effect on temperature.
Animals↗
Bayesian approach to bioequivalence assessment: an example.
The statistical methods required for a Bayesian analysis of bioequivalence are outlined and numerically illustrated. The analysis consists of the calculation of the posterior probability, given the experimental results, that the ratio of true means of a new and a standard formulation of a drug with respect to some biological response lies in a given interval. Nomograms helpful for the calculation of these probabilities are provided.
Bayes Theorem↗