A common, and generally satisfactory, use of the 2×2 crossover design is to demonstrate the bioequivalence of two formulations of the same medication.〔【出典】ICHガイドライン 〕
In E14, the recommended metric to analyze for a cross-over study is the largest time-matched mean difference between the drug and placebo (baseline-adjusted) over the collection period.〔【出典】ICHガイドライン 〕
Crossover or parallel group study designs can be suitable for trials assessing the potential of a drug to cause QT/QTc interval prolongation.〔【出典】ICHガイドライン 〕
Perhaps, I'm someone hard to categorize because my interests tend to spread over various fields."〔【出典】Hiragana Times, 2001年5月号◆【出版社】株式会社ヤック企画 〕"HT175010", "2431148"
よって通常は、クロスオーバー試験において「投薬前」ベースラインを用いることは適切である。
The 'pre-dose' baseline is therefore usually adequate for cross-over studies.〔【出典】ICHガイドライン 〕
Within this general description there is a wide variety of designs that can be used successfully: parallel or cross-over designs (see ICH E9), single fixed dose or titration in the active drug group, several fixed doses.〔【出典】ICHガイドライン 〕
ベースラインの選択は、試験が並行群間比較試験かクロスオーバー試験かにより異なる。
The choice of baseline is influenced by whether the study is parallel or cross-over.〔【出典】ICHガイドライン 〕
In contrast, in a cross-over study a time-matched baseline is usually not necessary because adjustments for subject- and study-specific diurnal variation are implicit by design in the assessment of time-matched drug-placebo differences in QT/QTc effect.〔【出典】ICHガイドライン 〕
For a crossover design, for example, there should be consideration, among other things, of the likelihood of spontaneous change in the disease and of carry-over effects of treatment during the study.〔【出典】ICHガイドライン 〕
The overall study plan and design (configuration) of the study (e.g., parallel, cross-over) should be described briefly but clearly, using charts and diagrams as needed.〔【出典】ICHガイドライン 〕
It's been reported that the Crossfire and a sports wagon "crossover" called Pacifica are the vehicles to take the Chrysler brand "up-market" into more expensive -- and profitable -- vehicles."VOA-S006", "2384194"
In addition to the type of control, other critical design features that may need discussion are use of a cross-over design and selection of patients with particular prior history, such as response or non-response to a specific drug or member of a drug class.〔【出典】ICHガイドライン 〕
In the simplest situation it is a sequential list of treatments (or treatment sequences in a crossover trial) or corresponding codes by subject number.〔【出典】ICHガイドライン 〕
次元クロスオーバー
dimensionality crossover
盲検性が破れる懸念は、クロスオーバー試験の場合に特に問題となる。
This concern may be particularly relevant in cross-over studies.〔【出典】ICHガイドライン 〕
Examples of study design include parallel group, cross-over, factorial, dose escalation, and fixed dose-dose response. (See ICH E4, E6, E9 and E10).〔【出典】ICHガイドライン 〕