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Phase I Clinical Trial/Bevis
Metodebevisregistrering

Phase I Clinical Trial

A Phase I clinical trial is the first stage of human testing for a new drug, biologic, or intervention. Its primary objective is to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) rather than therapeutic efficacy. Small cohorts of participants — typically healthy volunteers or patients with advanced disease — receive sequentially increasing doses to identify the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) that define the boundary for subsequent trials.

Sources recorded, not reviewed

Kilderegistrering

Citater kopieret ordret fra metodens kilderegistrering. Ingen påstandsniveauverifikation er udledt heraf.

Phase I Clinical Trial (First-in-Human / Dose-Escalation Study)
Taksonomisk metoderegistrering · process-pipeline / epidemiology
  • Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937. · DOI 10.2307/2531693
  • International Council for Harmonisation (ICH). (2016). ICH E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). ICH Harmonised Guideline. · URL
Åbn fuld metode

Kuraterede påstande

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Relaterede metoder

Genereret fra metodegrafen og vist som maskinelt foreslåede relationer — ingen bevispåstand er udledt.

Taxonomic bucketAdaptive Randomized Clinical Trialmachine-suggested · Relational suggestion, not evidence.Same method familyDiagnostic Accuracy Study Designmachine-suggested · Relational suggestion, not evidence.Taxonomic bucketDose-Response Analysismachine-suggested · Relational suggestion, not evidence.Taxonomic bucketPhase II clinical trialmachine-suggested · Relational suggestion, not evidence.Taxonomic bucketPhase III clinical trialmachine-suggested · Relational suggestion, not evidence.Taxonomic bucketRandomized clinical trialmachine-suggested · Relational suggestion, not evidence.

Bevisstatus

Sources recorded, not reviewed

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

Kilder

2 registrerede citater, kopieret fra metodens kilderegistrering.

Handlinger

Åbn metodeside
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