摘要:

A critical aspect of biomedical research is the characterization of the dose response reiationship of a compound. This is true in laboratory experiments and clinical trials and pertains to efficacy, safety, and the resulting benefit/risk ratio. Presented here is Part I of this article, which deals with some clinical trial design issues surrounding dose response studies. Some additional comments are made about trials for identifying the minimum effective dose, randomized concentration controlled trials, and the use of one-sided hypotheses in designing suck trials. Part II is a separate paper reviewing some analysis strategies for dose response studies.

ISSN:1054-3406    

DOI:10.1080/10543409508835096

出版商:Marcel Dekker, Inc.    

年代:1995

数据来源: Taylor

摘要:

The primary focus of this paper is to examine analysis strategies for parallel randomized dose response studies with particular emphasis on identifying the minimum effective dose. Such studies have become a standard for drug development iin the pharmaceutical in dustry. Particular attention is paid to ANOVA followed by multiple comparison procedures with some additional discussion on the utility of regression models. When there are three or fewer dose groups and a placebo in a study, ANOVA techniques are preferred with a larger number of dose groups, regression analysis has greater utility and reliability. Analysis of factorial dose response studies is reviewed only slightly as this is an emerging area of interest, and further development is necessary

ISSN:1054-3406    

DOI:10.1080/10543409508835097

出版商:Marcel Dekker, Inc.    

年代:1995

数据来源: Taylor

摘要:

Fisher's exact test and Pearson's chi-square with continuity correction are frequently employed in the analysis of epidemiological data involving a 2×2 contingency table. This paper reviews the concepts and controversies underlying these procedures and discusses their appropriateness and adequacies in analyzing such data. Other related procedures such as unconditional exact tests and randomized and mid-ptests including some generalizations to ar x ctable are also briefly reviewed

ISSN:1054-3406    

DOI:10.1080/10543409508835098

出版商:Marcel Dekker, Inc.    

年代:1995

数据来源: Taylor

摘要:

As a consequence of a hearing on bioequivalence conducted by the Food and Drug Administration in 1986, the identification and the treatment of a potential outlier in bioequivalence trials has become an important issue in the assessment of bioequivalence because the exclusion of a statistically identified outlier may lead to a totally different conclusion on bioequivalence. In this paper, we examine the impact of a statistically identified outlying subject on the decision of bioequivalence through a simulation study under the structure or a standard two-way crossover design based on interval hypotheses for bioequivalence. The HotellingT2test suggested by Liu and Weng (1) is used for detection of an outlying subject.

ISSN:1054-3406    

DOI:10.1080/10543409508835099

出版商:Marcel Dekker, Inc.    

年代:1995

数据来源: Taylor

摘要:

The Food and Drug Administration has collected spontaneous reports on adverse events (AE) from manufacturers and individuals. These data provide useful information on the safety of marketed drugs. Due to many unique characteristics of this reporting system, the information is difficult to evaluate. Incidence rates for specific adverse events and drug combinations cannot be estimated. However, reporting rates (number oi reports per market share) based on prescriptions can be computed. These reporting rates provide signals of serious adverse experience that may deserve mention. when the ratio of reporting rates is used for the comparison of two drugs

ISSN:1054-3406    

DOI:10.1080/10543409508835100

出版商:Marcel Dekker, Inc.    

年代:1995

数据来源: Taylor

摘要:

Generalized linear models (GLM) are now widely used in analyzing data from clinical trials and in epidemiological studies. In Poisson, regression, which fits in the framework of a GLM, the response variable is a count that follows the Poisson distribution. This article describes the basic methodology of Poisson regression analysis and its application to clinical research. Overdispersiun, model diagnostics, and sample size issues are discussed. The methodology is illustrated on a data set from a clinical trial for the treatment of bladder cancer, using a new procedure (PROC GENMOD) in the statistical package SAS.

ISSN:1054-3406    

DOI:10.1080/10543409508835101

出版商:Marcel Dekker, Inc.    

年代:1995

数据来源: Taylor

摘要:

This paper proposes a normal mixed effects model for stability analysis. An EM algorithm is developed to compute the maximum likelihood estimates of regression coefficients of the fixed effects and random effects, and variance components. The likelihood ratio test is used for the preliminary testing of batch-to-batch variation. An example from a marketing stability study is given to illustrate the proposed procedure.

ISSN:1054-3406    

DOI:10.1080/10543409508835102

出版商:Marcel Dekker, Inc.    

年代:1995

数据来源: Taylor

ISSN:1054-3406    

DOI:10.1080/10543409508835095

出版商:Marcel Dekker, Inc.    

年代:1995

数据来源: Taylor