## Equivalence Trials(等效試驗)到底是什麼？

Equivalence Trials 等效試驗 - Guidance has been published in the reporting non-inferiority and equivalence trials (Piaggio et al.^{[1]}Such studies are called noninferiority trials, which we describe in this paper in relation to superiority trials and equivalence trials.

^{[2]}Despite differences were observed, uncertainty remains on the clinical relevance of these data as by golden standard it should still be confirmed by bioequivalence trials.

^{[3]}Efficacy trials should usually be designed as equivalence trials to ensure that the efficacy of the biosimilar is neither decreased nor increased compared with the reference product.

^{[4]}The primary statistical analysis will be per protocol rather than intention-to-treat analysis because the latter increases type I error in non-inferiority or equivalence trials.

^{[5]}Three out of the four participants with delayed emergence in Condition MixB initially failed in symmetry trials, the other two in Condition PTB failed exclusively in equivalence trials.

^{[6]}Tang derived the exact power formulas for t tests and analysis of covariance (ANCOVA) in superiority, noninferiority (NI), and equivalence trials.

^{[7]}bioequivalence trials, Schuirmann in J Pharmacokinet Pharmacodyn 15(6):657–680, 1987) would be appropriate instead.

^{[8]}Further research is required on comparisons of psychodynamic therapy to other treatments (equivalence trials), the treatment of specific mental disorders such as obsessive-compulsive disorder or posttraumatic stress disorder, and mechanisms of change, as well as on the effects specific to psychodynamic therapy (added value), transdiagnostic and unified protocols, and the question of who benefits most from which treatment.

^{[9]}This study is reported using CONSORT Extension checklist for non-inferiority and equivalence trials.

^{[10]}However, routine bioequivalence trials using subjects with normal gastric pH (i.

^{[11]}Guidelines for paediatric bioequivalence trials are warranted.

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指南已在報告的非劣效性和等效性試驗中發表（Piaggio et al.

^{[1]}此類研究稱為非劣效性試驗，我們在本文中將其描述為與優勢性試驗和等效性試驗有關。

^{[2]}儘管觀察到差異，但這些數據的臨床相關性仍存在不確定性，因為按照黃金標準，仍應通過生物等效性試驗來證實。

^{[3]}功效試驗通常應設計為等效性試驗，以確保生物類似藥的功效與參考產品相比既不降低也不提高。

^{[4]}主要的統計分析將根據方案而不是意向治療分析，因為後者會增加非劣效性或等效性試驗中的 I 型錯誤。

^{[5]}在 Condition MixB 中出現延遲的四名參與者中有三人最初在對稱試驗中失敗，另外兩名在 Condition PTB 中完全在等效試驗中失敗。

^{[6]}Tang 在優效性、非劣效性 (NI) 和等效性試驗中推導出了 t 檢驗和協方差分析 (ANCOVA) 的確切功效公式。

^{[7]}生物等效性試驗，Schuirmann in J Pharmacokinet Pharmacodyn 15(6):657–680, 1987）將是合適的。

^{[8]}需要進一步研究心理動力學療法與其他療法的比較（等效性試驗）、特定精神障礙（如強迫症或創傷後應激障礙）的治療、變化機制以及心理動力學療法的特定效果。附加值）、跨診斷和統一方案，以及誰從哪種治療中獲益最多的問題。

^{[9]}本研究報告使用 CONSORT Extension 檢查表進行非劣效性和等效性試驗。

^{[10]}然而，常規的生物等效性試驗使用胃 pH 值正常的受試者（即。

^{[11]}兒科生物等效性試驗指南是必要的。

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