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09 · FEMETRIC REFERENCE

Glossary

Search definitions for study, route, status, calculation and product-testing terminology.LAST REVIEWED 2026-09-13
22 TERMS

Adverse event

An unfavorable medical occurrence during a study; it is not automatically caused by the intervention.

Assay

A quantitative test estimating the amount or potency of a substance in a sample.

Bioavailability

The rate and extent at which an active substance reaches systemic circulation.

Blinding

Keeping participants, investigators or assessors unaware of treatment assignment to reduce bias.

Clinical trial

A prospective study in human participants designed to answer a health-related intervention question.

COA

Certificate of analysis: a lot-specific report of tests, acceptance criteria and results.

Confidence interval

A range describing uncertainty around an estimated effect.

Concentration

Amount of substance per unit volume, commonly expressed as mg/mL or mcg/mL.

Endpoint

A prespecified outcome used to evaluate an intervention.

Endotoxin

Bacterial lipopolysaccharide measured separately from identity, purity and sterility.

Excursion

A temporary departure from a product's labeled storage conditions.

Formulation

The specific composition and dosage form of a product; blend names alone may not define one.

In vitro

Research performed in cells, tissues or another controlled environment outside a living organism.

Investigational

Under study and not established as approved for the described use.

Preclinical

Laboratory or animal research conducted before or outside human clinical trials.

Primary source

The original study report, trial registry, regulator document or product label.

Purity

The measured proportion of the primary substance relative to detected material under a stated method.

Randomization

Assignment by chance to study groups to reduce systematic differences.

Route

How a substance is administered, such as oral, subcutaneous or intravenous.

Serious adverse event

An event meeting defined seriousness criteria such as hospitalization or life threat; seriousness differs from severity.

Sterility

Absence of viable contaminating microorganisms under a validated test; it is not shown by purity.

U-100

A syringe calibration in which 100 marked units correspond to 1 mL of volume.

SOURCES

Primary and authoritative context

NCBI BookshelfClinical research glossaryReviewed 2026-09-13
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