ScholarGate
Trợ lý

So sánh phương pháp

Xem các phương pháp đã chọn cạnh nhau; những hàng khác biệt được làm nổi bật.

Thử nghiệm Tương đương / Không kém hơn×Thiết kế thử nghiệm chéo×
Lĩnh vựcThiết kế thí nghiệmThiết kế thí nghiệm
HọHypothesis testHypothesis test
Năm ra đời19871960
Người khởi xướngSchuirmann, D.J. / EMA regulatory frameworkEarly formalized in clinical research literature; widely used since mid-20th century
LoạiParametric equivalence / non-inferiority testWithin-subject repeated-measures design
Công trình gốcSchuirmann, D.J. (1987). A Comparison of the Two One-Sided Tests Procedure and the Power Approach. Journal of Pharmacokinetics and Biopharmaceutics, 15(6), 657–680. link ↗Senn, S. (2002). Cross-over Trials in Clinical Research (2nd ed.). Wiley. ISBN: 978-0471496533
Tên gọi khácnon-inferiority trial, bioequivalence study, active-control trial, Denklik ve Üstünlük Olmayan Çalışma (Equivalence / Non-Inferiority)within-subject crossover, cross-over design, AB/BA design, Çapraz Desen (Crossover Design)
Liên quan66
Tóm tắtAn equivalence or non-inferiority trial is a clinical study design that tests whether a new intervention is clinically equivalent to, or no worse than, an established standard by a pre-specified margin. Codified in Schuirmann's 1987 Two One-Sided Tests (TOST) framework and embedded in EMA and FDA regulatory guidance, this design is the regulatory standard for generic drug approval and medical device testing.A crossover design is an experimental design in which each participant receives all treatments under investigation, but in a different sequence and across separate time periods. Each subject thus acts as their own control, which substantially reduces between-subject variability and allows efficient treatment comparisons with smaller sample sizes. The approach has been central to clinical pharmacology and comparative research since the mid-20th century, with foundational methodology codified by Senn (2002) and Jones & Kenward (2014).
ScholarGateBộ dữ liệu
  1. v1
  2. 2 Nguồn tài liệu
  3. PUBLISHED
  1. v1
  2. 2 Nguồn tài liệu
  3. PUBLISHED

Đến trang tìm kiếm Tải xuống bản trình chiếu

ScholarGateSo sánh phương pháp: Equivalence / Non-Inferiority Trial · Crossover Design. Truy cập ngày 2026-06-18 từ https://scholargate.app/vi/compare