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題名 | 藥性動力學上的食物影響及藥物交互性的統計實驗及分析 |
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作者姓名(中文) | 張正道; | 書刊名 | 中國統計學報 |
卷期 | 33:2 1995.06[民84.06] |
頁次 | 頁187-213 |
分類號 | 418.1 |
關鍵詞 | 藥性動力學; 食物影響; 藥物交互影響; 個體與個體間與內之變差數; 最低平方估計; 信賴區間; Pharmacokinetics; PK; Food effect; Drug-drug interaction; Between subjects and within subjects variances; Least square estimate; Confidence interval; |
語文 | 中文(Chinese) |
中文摘要 | 在藥學研究第一階段(Phase1)有關藥性動力學上包含許多不同之研究方向。這篇文章重點在於兩方面:食物的影響及藥物的交互作用。藥性動力學的研究通常運用於健康人及給予一次的藥物。有四樣的食物影響的研究將會討論:(1) 飯前與飯後藥性的比較,(2)飯前與低脂或高脂藥性的比較,(3)對於二種不同類人 (像性別、年紀、健康狀況,如有肝病或沒肝病) 的飯前與飯後藥性的比較,(4)對於二種不同的藥品方式或藥量的飯前與飯後藥性的比較。至於藥物的交互影響,有三種情形將會討論:(1)研究中的藥用一種藥量及市場上的藥用一種藥量的交互影響,(2)研究中的藥用二種藥量及市場上的藥用一種藥量的交互影響,(3)研究中的藥用一種藥量及市場上的藥用二種藥量的交互影響。 |
英文摘要 | The Pharmacokinetic studies in Phase I trials are composed of many different aspects. This paper only concentrates on two of them: investigation of food effect and drug-drug interaction. Pharmacokinetic studies are generally done in healthy volunteers with single-dose administration. This paper discusses the study designs and statistical analyses for some important Phase 1 single dose pharmacokinetic studies with focus on the investigation of either food effect or drug-drug interaction. Four food effect studies are discussed:(1 )comparison of the pharmacokinetic profile for the study drug taken with food or without food, (2)comparison of the pharmacokinetics for the study drug administered in three dietary conditions: fasted, Low-fat meal and high-fat meal, (3)comparison of the pharmacokinetic profiles for the study drug received with food or without food between and within two different demographic groups, such as gender, age, health condition (for example, hepatic patients v.s. non –hepatic patients.), and (4) comparison of the pharmacokinetic profiles for the study drug with food or without food between and within two different dosage forms or dosage levels. As for the drug-drug interaction, the following studies are covered: (1) the interaction of study drug at one dosage level with a given marketed drug at one dosage level, (2) the interaction of study drug at two dosage levels with a given marketed durg at one dosage level, and (3) the interaction of study drug at one dosage level with a given marketed drug at two dosage levels. |
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