Assessment of average, population and individual bioequivalence in two- and four-period crossover studies.

Wijnand HP

首页> 外文期刊>Computer Methods and Programs in Biomedicine: An International Journal Devoted to the Development, Implementation and Exchange of Computing Methodology and Software Systems in Biomedical Research and Medical Practice >Assessment of average, population and individual bioequivalence in two- and four-period crossover studies.

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Assessment of average, population and individual bioequivalence in two- and four-period crossover studies.

机译：在两期和四期交叉研究中评估平均，人群和个体的生物等效性。

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The aim of bioequivalence studies is to assess the equivalence of two pharmaceutical formulations of the same active drug substance. Currently three types of bioequivalence are distinguished: average, population and individual bioequivalence. Average and population bioequivalence can be assessed in two-period (non-replicated) crossover studies, whereas individual bioequivalence requires three- or four-period replicated studies, with a preference for four-period studies. The PC-program BIOEQV80 is presented for the statistical analysis of average and population bioequivalence from two-period crossover studies. The program BIOEQ2X2 is presented for the statistical analysis of all three types of bioequivalence from four-period replicated crossover studies. The statistical aspects of population and individual bioequivalence are based on a recent Guidance issued by the US Food and Drug Administration.

机译：生物等效性研究的目的是评估相同活性药物的两种药物制剂的等效性。当前区分出三种生物等效性：平均值，种群和个体生物等效性。平均和群体生物等效性可以在两期（非重复）交叉研究中进行评估，而单个生物等效性需要三或四期重复研究，而优先选择四期研究。提出了PC程序BIOEQV80，用于对两期交叉研究的平均值和种群生物等效性进行统计分析。提出了程序BIOEQ2X2，用于对来自四个时期的重复交叉研究的所有三种生物等效性进行统计分析。人口和个体生物等效性的统计方面基于美国食品和药物管理局发布的最新指南。

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《Computer Methods and Programs in Biomedicine: An International Journal Devoted to the Development, Implementation and Exchange of Computing Methodology and Software Systems in Biomedical Research and Medical Practice》 |2003年第1期|共15页
作者
Wijnand HP;
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正文语种 eng
中图分类计算机的应用;
关键词
statistical; Assessment: Cognition; Analysis of substances; Preferences;

机译：统计;评估：认知;物质分析;偏好;

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1. Assessment of average, population and individual bioequivalence in two- and four-period crossover studies. [J] . Wijnand HP Computer Methods and Programs in Biomedicine: An International Journal Devoted to the Development, Implementation and Exchange of Computing Methodology and Software Systems in Biomedical Research and Medical Practice . 2003,第1期

机译：在两期和四期交叉研究中评估平均，人群和个体的生物等效性。
2. Random-effects linear modeling and sample size tables for two special crossover designs of average bioequivalence studies: The four-period, two-sequence, two-formulation and six-period, three-sequence, three-formulation designs [J] . DiazF.J., BergM.J., KrebillR., Clinical pharmacokinetics . 2013,第12期

机译：两种平均生物等效性研究的特殊交叉设计的随机效应线性建模和样本量表：四周期，二序列，两配方和六周期，三序列，三配方设计
3. Random-effects linear modeling and sample size tables for two special crossover designs of average bioequivalence studies: The four-period, two-sequence, two-formulation and six-period, three-sequence, three-formulation designs [J] . DiazF.J., BergM.J., KrebillR., Clinical pharmacokinetics . 2013,第12期

机译：随机效应线性建模和样品尺寸表，用于平均生物等效性研究的两个特殊交叉设计：四个时期，双序，双制剂和六期，三序，三种配方设计
4. Evaluation of the Bioequivalence of the 20 mg /10 ml Doses of Two Injectable Preparations of Eptifibatide: A Randomized, Open-Label, Two-Period Crossover Study in Healthy Adult Male Chinese Volunteers [C] . Yanhui Gao, Baoqiu Li, Jun Sun Chinese international peptide symposium . 2011

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5. The assessment of individual and population bioequivalence in crossover designs. [D] . Hyslop, Terry. 2001

机译：对交叉设计中的个体和群体生物等效性的评估。
6. Single-dose bioequivalence assessment of two formulations of polysaccharide iron complex capsules in healthy adult male Chinese volunteers: A sequence-randomized double-blind two-way crossover study [O] . Yuan-Yuan Zhang, Jun-Hong Liu, Feng Su, 2009

机译：在健康的成年男性中国志愿者中两种糖铁复合胶囊制剂的单剂量生物等效性评估：序列随机双盲双向交叉研究
7. Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Acetylsalicylic Acid in Fixed-Dose Combination with Clopidogrel Versus Enteric Aspirin in Chinese Subjects Under Fasting Conditions: A Phase 1, Open-Label, Randomized, Crossover Study [O] . Lu Wang, Yujing Di, Tingting Guo, 2020

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8. Estimation of the Daily Average Food Intake by Age and Sex for Use in Assessing the Radionuclide Intake of Individuals in the General Population [R] . Yang, Y. Y. , Nelson, C. B. 1984

机译：评估按年龄和性别划分的每日平均食物摄入量，用于评估一般人群中个体的放射性核素摄入量

Assessment of average, population and individual bioequivalence in two- and four-period crossover studies.

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