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Record W4406808516 · doi:10.1002/sim.10321

Bioequivalence Design With Sampling Distribution Segments

2025· article· en· W4406808516 on OpenAlex

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

affAt least one author lists a Canadian institution in the pinned OpenAlex snapshot.
fundA Canadian funder is recorded on the work.

Bibliographic record

VenueStatistics in Medicine · 2025
Typearticle
Languageen
FieldDecision Sciences
TopicOptimal Experimental Design Methods
Canadian institutionsUniversity of WaterlooMcGill University
FundersNatural Sciences and Engineering Research Council of Canada
KeywordsBioequivalenceSampling (signal processing)Sample size determinationComputer scienceStatisticsSampling distributionSampling designMathematicsEconometricsMedicine

Abstract

fetched live from OpenAlex

In bioequivalence design, power analyses dictate how much data must be collected to detect the absence of clinically important effects. Power is computed as a tail probability in the sampling distribution of the pertinent test statistics. When these test statistics cannot be constructed from pivotal quantities, their sampling distributions are approximated via repetitive, time-intensive computer simulation. We propose a novel simulation-based method to quickly approximate the power curve for many such bioequivalence tests by efficiently exploring segments (as opposed to the entirety) of the relevant sampling distributions. Despite not estimating the entire sampling distribution, this approach prompts unbiased sample size recommendations. We illustrate this method using two-group bioequivalence tests with unequal variances and overview its broader applicability in clinical design. All methods proposed in this work can be implemented using the developed dent package in R.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.005
metaresearch head score (Gemma)0.008
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: none
GenreCandidate signal: Methods · Consensus signal: Methods
Teacher disagreement score0.442
Threshold uncertainty score0.955

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0050.008
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.224
GPT teacher head0.523
Teacher spread0.299 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it