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[生物统计学家在剂量确定中的作用]

[The role of the biometrician in dosage finding].

作者信息

Schneider B

出版信息

Arzneimittelforschung. 1977 Feb;27(2A):257-64.

PMID:577172
Abstract

Biometrics is the science of mathematical models for biological processes and of methods for the design and analysis of biological experiments. By these tasks the role of the biometrician in the problem of dose-scheduling is determined. He has to develope mathematical models for the dose-response relationship and methods for the design and analysis of pharmacological and clinical experiments. In the paper the probit and logit model are discussed as examples of the mathematical approach to dose-response relationship. The problems of planning and analyzing bioassays are demonstrated. The pharmacological results can be applied to clinical investigations if they are related to standard drugs. The safety or risk of a drug can be measured by the therapeutic index, which is most important for the connection between pharmacological and clinical results. Finally the problem of repeated doses and accumulation is dealt with.

摘要

生物统计学是关于生物过程数学模型以及生物实验设计与分析方法的科学。通过这些任务确定了生物统计学家在剂量安排问题中的作用。他必须开发剂量反应关系的数学模型以及药理和临床实验的设计与分析方法。本文讨论了概率单位模型和对数单位模型,作为剂量反应关系数学方法的示例。展示了生物测定的规划和分析问题。如果药理结果与标准药物相关,那么这些结果可应用于临床研究。药物的安全性或风险可以通过治疗指数来衡量,这对于药理结果与临床结果之间的联系最为重要。最后讨论了重复给药和蓄积问题。

相似文献

1
[The role of the biometrician in dosage finding].[生物统计学家在剂量确定中的作用]
Arzneimittelforschung. 1977 Feb;27(2A):257-64.
2
[Mathematical models of pharmacokinetics in chemotherapy].[化疗中药代动力学的数学模型]
Pharmazie. 1976;31(12):825-39.
3
[Mathematical analysis concerning the dosage regimen of intravenous infusion of two-compartment model drugs (author's transl)].二室模型药物静脉滴注给药方案的数学分析(作者译)
Yao Xue Xue Bao. 1980 Dec;15(12):741-9.
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New generalized equations for multiple dose kinetics by i.v. injection.静脉注射多剂量动力学的新广义方程。
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Dose finding - a challenge in statistics.剂量确定——统计学中的一项挑战。
Biom J. 2008 Aug;50(4):480-504. doi: 10.1002/bimj.200810438.
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Fitting a general sigmoid model to pharmacological response curves [proceedings].将通用S形模型拟合到药理反应曲线[会议论文集]
Br J Pharmacol. 1976 Oct;58(2):289P-290P.
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Pharmacokinetic and pharmacodynamic modeling in vivo.体内药代动力学和药效学建模
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[Problem of the evaluation of experimental research for clinical testing of new drugs in man].
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In vitro kinetics of drug release from oral dosage forms, lyophilized and conventional rectal suppositories. I. Mathematical considerations applicable to a two compartment open model system simulating more realistic in vivo conditions.口服剂型、冻干直肠栓剂和传统直肠栓剂的体外药物释放动力学。I. 适用于模拟更真实体内条件的双室开放模型系统的数学考量。
Pharm Acta Helv. 1975;50(9):279-82.

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The biometric evaluation of the acute-toxic-class method (oral).急性毒性分级法(口服)的生物统计学评估
Arch Toxicol. 1994;68(10):599-610. doi: 10.1007/BF03208339.