Biomaterial Database

Prediction approaches to sequentially searching for an optimal dose. 1989

W J Shih

Merck Sharp & Dohme Research Laboratories, Rahway, New Jersey 07065-0914.

The search for an optimal dose of a drug has been investigated in a sequential setting to ensure the safety level by Eichhorn and Zacks (1973, Journal of the American Statistical Association 68, 594-598; 1981, Communications in Statistics--Theory and Methods A10, 931-953), Eichhorn (1974, Communications in Statistics 3, 263-271), and Robinson (1978, Biometrika 65, 75-78). In this paper the procedure proposed by Robinson is given a new interpretation in terms of mean coverage tolerance prediction, and a new procedure in terms of guaranteed coverage tolerance prediction is proposed. The new procedure has better properties and is more stringent, and hence more desirable for safety consideration.

UI	MeSH Term	Description	Entries
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004361	Drug Tolerance	Progressive diminution of the susceptibility of a human or animal to the effects of a drug, resulting from its continued administration. It should be differentiated from DRUG RESISTANCE wherein an organism, disease, or tissue fails to respond to the intended effectiveness of a chemical or drug. It should also be differentiated from MAXIMUM TOLERATED DOSE and NO-OBSERVED-ADVERSE-EFFECT LEVEL.	Drug Tolerances,Tolerance, Drug,Tolerances, Drug
D004364	Pharmaceutical Preparations	Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.	Drug,Drugs,Pharmaceutical,Pharmaceutical Preparation,Pharmaceutical Product,Pharmaceutic Preparations,Pharmaceutical Products,Pharmaceuticals,Preparations, Pharmaceutical,Preparation, Pharmaceutical,Preparations, Pharmaceutic,Product, Pharmaceutical,Products, Pharmaceutical
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001699	Biometry	The use of statistical and mathematical methods to analyze biological observations and phenomena.	Biometric Analysis,Biometrics,Analyses, Biometric,Analysis, Biometric,Biometric Analyses
D015233	Models, Statistical	Statistical formulations or analyses which, when applied to data and found to fit the data, are then used to verify the assumptions and parameters used in the analysis. Examples of statistical models are the linear model, binomial model, polynomial model, two-parameter model, etc.	Probabilistic Models,Statistical Models,Two-Parameter Models,Model, Statistical,Models, Binomial,Models, Polynomial,Statistical Model,Binomial Model,Binomial Models,Model, Binomial,Model, Polynomial,Model, Probabilistic,Model, Two-Parameter,Models, Probabilistic,Models, Two-Parameter,Polynomial Model,Polynomial Models,Probabilistic Model,Two Parameter Models,Two-Parameter Model