Adverse event
An unfavorable occurrence during a study.The event is not automatically caused by the intervention. Causality, seriousness and severity are separate judgments.
Related: Serious adverse event, Discontinuation10 · FEMETRIC REFERENCE
Glossary
Filter short definitions, expanded explanations and links to the relevant Femetric page.Assay
A quantitative test for amount or potency.The result depends on the method, reference standard and acceptance criteria. It does not by itself establish identity, purity or sterility.
Related: COA, PurityBioavailability
The rate and extent an active substance reaches circulation.Bioavailability is formulation and route dependent, so evidence from one dosage form should not be transferred to another.
Related: Formulation, RouteBlinding
Keeping treatment assignment concealed from participants or study staff.Who is blinded and how blinding is maintained affects the risk of biased behavior or outcome assessment.
Related: Randomization, ComparatorClinical trial
A prospective human study of a health-related intervention.Trial phase, population, comparator, endpoint and duration determine what a result can support.
Related: Endpoint, PopulationCOA
A certificate of analysis for a specific material or lot.A useful COA connects a lot to named tests, methods, specifications, numerical results, dates and an identifiable issuer.
Related: Identity, Purity, SterilityConfidence interval
A range expressing uncertainty around an estimate.Its width and clinically plausible values often matter more than whether one significance threshold was crossed.
Related: Effect estimate, P-valueConcentration
Amount of substance per unit volume.Common expressions include mg/mL and mcg/mL. Concentration is required to convert a mass target into a draw volume.
Related: U-100, ReconstitutionEndpoint
A prespecified outcome used to evaluate an intervention.Primary, secondary and exploratory endpoints have different roles in a trial's analysis plan.
Related: Clinical trial, MultiplicityEndotoxin
Bacterial lipopolysaccharide measured with a dedicated test.Endotoxin is not established by a chromatographic purity result and is separate from sterility testing.
Related: Sterility, COAFormulation
The specific composition and dosage form of a product.A blend nickname may refer to different component ratios. Each formula needs its own product record.
Related: Route, ConcentrationInvestigational
Under study and not approved for the described use.Investigational status does not identify one evidence level. Phase, study design and regulatory region still matter.
Related: Clinical trial, Regulatory statusPreclinical
Laboratory or animal research outside human clinical trials.Preclinical findings can explain mechanisms or support further study, but they do not establish human efficacy or dosing.
Related: In vitro, Clinical trialPurity
The proportion of primary material detected under a stated method.Purity is method dependent and does not substitute for identity, content, sterility or endotoxin testing.
Related: Assay, SterilityRandomization
Assignment by chance to study groups.Randomization helps reduce systematic baseline differences, but concealment and analysis still matter.
Related: Blinding, ComparatorSerious adverse event
An event meeting defined regulatory seriousness criteria.Seriousness can involve hospitalization, disability, life threat or death. It is not the same as symptom intensity.
Related: Adverse event, SeveritySterility
Absence of viable microorganisms under a validated test.Sterility testing is separate from purity and endotoxin testing. Sampling and method suitability matter.
Related: Endotoxin, COAU-100
A calibration where 100 marked units equal 1 mL.The markings indicate liquid volume. They do not state the mass of peptide without a known concentration.
Related: Concentration, SyringePrimary and authoritative context
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