Inferring Drug Efficacy Based on Data from One Subject

Weissman, Albert

doi:10.1177/009286159102500420

Cited by 2 publications

(1 citation statement)

References 14 publications

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“…A previous paper (50), for ex ample, emphasized that the FDA Guide line (1) appears fixated on how a sponsor should select an appropriate sample size for a clinical drug trial: Except for "practi cal limitations," the selection is to be based solely on the concepts of biostatistical analysis. Many clinical trials require biostatistics, but frameworks other than probability distributions can solve scien tific problems and, FDA Guidelines aside, under some circumstances considerations other than "alpha levels" and "power" should determine sample size.…”

Section: Discussionmentioning

confidence: 99%

Two Demographic Dichotomies: “Black Vs White,” “Left Vs Right”

Weissman

1992

Drug Information Journal

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The Food and Drug Administration (FDA) advises sponsors of new drugs to classify human subjects on the basis of four specific demographic categories-age, race, sex, and weight. The FDA provides no advice for other possible categories, such as hand edness. Sponsors' collection of data on race (a model requisite category) is seldom overridingly important, however, and sponsors' inattention to handedness (a model neglected category) can be very wasteful. For some drugs and some trials, an array of demographic characteristics other than those identified in the FDA Guideline should be analyzed.

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Section: Discussionmentioning

confidence: 99%

Two Demographic Dichotomies: “Black Vs White,” “Left Vs Right”

Weissman

1992

Drug Information Journal

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Bioequivalence assessment: a pharmaceutical industry perspective

Godbillon¹,

Cardot²,

Lecaillon³

et al. 1996

European Journal of Drug Metabolism and Pharmacokinetics

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Various aspects of bioequivalence are investigated in this paper. Some aspects dealing with bioequivalence studies conducted either during the development of the drug or after its marketing will be presented and discussed: Bioequivalence of highly variable drugs with the associated problem of widening the acceptance range or alternative solutions. Bioequivalence for the final market image. Bioequivalence for investigating the food effect. Bioequivalence in special population such as children, non Caucasian population. Bioequivalence based on in vitro data or literature. New approaches in bioequivalence interpretation. Bioequivalence and analytical methods which are not sensitive or specific enough.

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Inferring Drug Efficacy Based on Data from One Subject

Cited by 2 publications

References 14 publications

Two Demographic Dichotomies: “Black Vs White,” “Left Vs Right”

Two Demographic Dichotomies: “Black Vs White,” “Left Vs Right”

Bioequivalence assessment: a pharmaceutical industry perspective

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