Skip to contentScholarGate
LibraryBookshelfDeskReview StudioAssistant
Sign in
Equivalence / Non-Inferiority Trial/Evidence
Method evidence record

Equivalence / Non-Inferiority Trial

An 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.

Sources recorded, not reviewed

Source record

Citations copied verbatim from the method’s source record. No claim-level verification is inferred from them.

Equivalence and Non-Inferiority Clinical Trial Design
Taxonomic method record · hypothesis-test / experimental-design
  • Schuirmann, 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. · URL
  • EMA (2010). Guideline on the Investigation of Bioequivalence. CPMP/EWP/QWP/1401/98 Rev. 1. European Medicines Agency. · URL
Open full method

Curated claims

Claims persisted in the evidence ledger, each with its own assessment.

No curated claims yet

This view does not invent a claim assessment when the ledger has none.

Related methods

Generated from the method graph and shown as machine-suggested relations — no evidence claim is inferred.

Same method familyAdaptive Clinical Trial Designmachine-suggested · Relational suggestion, not evidence.Same method familyCrossover Designmachine-suggested · Relational suggestion, not evidence.Same method familyEquivalence Test (TOST)machine-suggested · Relational suggestion, not evidence.Same method familyPower Analysis for t-testmachine-suggested · Relational suggestion, not evidence.Same method familyRandomized Controlled Trialmachine-suggested · Relational suggestion, not evidence.Same method familySequential Analysismachine-suggested · Relational suggestion, not evidence.

Evidence status

Sources recorded, not reviewed

Bibliographic sources are present. Claim-level evidence review has not been performed.

Sources

2 recorded citations, copied from the method source record.

Actions

Open method page
ScholarGate

A content-first reference library for research methods — what each one is, how it works, and where it comes from.

Open data (CC-BY)

Explore

  • Library
  • Search the library…
  • Browse by field
  • Fields
  • Journey
  • Compare
  • Which method?

Reference

  • Subjects
  • Atlas
  • Glossary
  • Methodology
  • Philosophy

Your tools

  • Bookshelf
  • Desk
  • Chat

Company

  • About
  • Pricing
  • Contact
  • Suggest a method

Entries are compiled from published sources for reference. Verifying the accuracy and suitability of any information for your own use remains your responsibility.

© 2026 ScholarGate · A research-method reference library
  • Privacy
  • Cookies
  • Terms
  • Delete account