Research glossary
Clear definitions for the study, evidence and documentation terms used throughout EternaGen.
Browse the glossary
Each entry explains what the term means and why it matters when you read a study or batch record.
53 terms
An unfavourable medical occurrence observed during a study, whether or not the study intervention caused it.
Event counts need severity, timing, attribution rules and a denominator. The term alone does not establish causality.
RelatedA documented procedure used to identify, separate, detect or quantify something in a sample.
A result has meaning only in relation to the method that produced it, its validated scope and its limitations.
RelatedA test used to measure the presence, amount or activity of a target under stated conditions.
The word does not identify a single technique. Readers still need the method, units, controls and acceptance criteria.
RelatedThe loss of participants, samples or observations between enrolment and final analysis.
Uneven or unexplained loss can change group balance and make an apparently precise result less reliable.
RelatedA defined quantity of material produced or handled under a shared set of conditions and assigned a traceable identifier.
Analytical results describe the batch or sample tested, not every material sold under the same compound name.
RelatedA measured biological characteristic used as an indicator of a process, exposure or response.
A biomarker may help explain a signal without proving that people feel or function better. Validation and context determine what it can support.
RelatedKeeping participants, investigators, outcome assessors or analysts unaware of assigned study groups.
Blinding can reduce expectation and measurement bias, but who was blinded and whether blinding held should be reported.
RelatedA document reporting selected analytical results for a stated sample, batch or lot.
A useful COA connects identity, method, result, batch and source. It is not a universal certificate of safety, approval or future stability.
RelatedThe practical importance of a measured effect for health, function or decision-making.
A statistically detectable difference can still be too small, uncertain or indirect to matter in practice.
RelatedThe control, placebo, standard treatment or alternate condition against which an intervention is evaluated.
A measured change is difficult to interpret without knowing what it was compared with and whether groups were otherwise treated similarly.
RelatedA range calculated from study data that expresses the precision and plausible values of an estimated effect under the statistical model.
The width and location of the interval often reveal more than a yes-or-no significance label.
RelatedThe relationship between the amount or concentration of an exposure and a measured response in a defined model.
A laboratory concentration-response curve does not translate directly into a human dose, route or treatment schedule.
RelatedHeat-stable bacterial components that can trigger strong biological responses and may be measured as a material-quality attribute.
Chemical identity or chromatographic purity does not establish an acceptable endotoxin result.
RelatedA prespecified measurement used to evaluate an outcome at a defined time point.
Readers need to know whether an endpoint was primary, secondary or exploratory and how it was measured.
RelatedA plain-language description of how direct and mature the available research is, such as laboratory, animal, early human or controlled clinical evidence.
It helps prevent mechanistic or preclinical findings from being read as if they were established human outcomes.
RelatedAn outcome used to investigate a possible signal or generate a future hypothesis rather than provide definitive confirmation.
Exploratory analyses are useful, but multiple testing and flexible analysis make chance findings more likely.
RelatedThe complete physical and chemical composition in which an active material is prepared, including excipients and presentation.
Results from one formulation cannot automatically be transferred to another source, concentration, route or delivery system.
RelatedOne complete change from frozen storage to a thawed state, often tracked during sample handling and stability work.
Repeated cycles can alter some materials. Conclusions require defined conditions, a validated method and batch-specific evidence.
RelatedGlucose-dependent insulinotropic polypeptide, an incretin hormone that signals through the GIP receptor and is studied in metabolic regulation.
GIP biology is context-dependent. Activity in a dual- or triple-receptor molecule cannot be interpreted from the acronym alone.
RelatedGlucagon-like peptide-1, an incretin hormone involved in glucose-dependent insulin signalling, glucagon regulation, gastric emptying and appetite-related pathways.
A pathway description is not a product claim. Evidence depends on the exact molecule, formulation, population, comparator, endpoint and regulatory status studied.
RelatedA molecule designed to activate the GLP-1 receptor. Approved medicines and investigational research compounds can belong to this broad class.
Class membership does not make products interchangeable. Sequence, receptor profile, exposure, formulation, evidence and authorization can differ materially.
RelatedAn analysis used to assess whether a sample is consistent with the material it is represented to contain.
Identity and purity answer different questions. A high purity value does not independently establish that the main peak is the named compound.
RelatedResearch performed outside a living organism, commonly in cells, tissues or a controlled laboratory system.
In-vitro findings can clarify mechanisms and generate hypotheses, but they do not establish exposure, safety or outcomes in a whole organism.
RelatedA gut-derived hormone, including GLP-1 and GIP, that contributes to nutrient-responsive metabolic signalling.
Incretin pathway research spans physiology, approved therapies and investigational molecules; those evidence categories should not be collapsed.
RelatedAn analysis approach that generally evaluates participants in the groups to which they were randomized.
It helps preserve randomization, but the exact estimand and missing-data approach still need to be examined.
RelatedThe lowest amount of an analyte that a method can reliably distinguish from background under stated conditions.
Detection does not necessarily mean the method can quantify the analyte accurately at that level.
RelatedThe lowest amount of an analyte that a method can measure with acceptable performance under stated conditions.
Values below the validated quantitation range should not be treated as equally precise numerical results.
RelatedThe biological interaction or pathway through which an intervention is proposed to produce an effect.
A plausible mechanism can support a hypothesis but does not establish a clinical benefit or acceptable risk.
RelatedMeasurements that were planned or expected but were not observed or retained.
Why data are missing and how they are handled can materially change an estimate and its uncertainty.
RelatedAn engineered molecule designed to activate more than one receptor, such as dual GIP/GLP-1 or triple GIP/GLP-1/glucagon receptor agonism.
The contribution and balance of each receptor cannot be inferred from a class label; they require molecule-specific pharmacology and trials.
RelatedWhat a compound does to a biological system, including target engagement and the relationship between exposure and response.
A pharmacodynamic signal may confirm biological activity without establishing a meaningful clinical outcome.
RelatedHow a compound is absorbed, distributed, transformed and eliminated over time in a defined model or population.
Exposure can differ by molecule, formulation, route, population and study conditions, limiting direct comparisons.
RelatedA comparison condition designed to resemble an intervention without its active study component.
Placebo control can help separate treatment effects from expectation and study participation, but background care and blinding still matter.
RelatedA measure of the amount or concentration needed to produce a defined biological effect in a specified assay.
Potency is assay- and context-dependent and should not be confused with purity, dose, clinical effectiveness or safety.
RelatedLaboratory and animal research conducted before or outside adequately controlled human clinical evaluation.
It can identify biological signals and safety questions, but translation to people is uncertain and often incomplete.
RelatedThe main outcome a study is designed and statistically planned to evaluate.
Secondary, exploratory and post-hoc findings usually carry a different evidentiary weight than a prespecified primary endpoint.
RelatedThe original record that directly reports a study, registry entry, regulatory decision, standard or analytical result.
Primary sources expose the methods, dates and limitations that summaries often compress or omit.
RelatedThe documented origin, custody and change history of a material, sample, dataset or claim.
Traceable provenance helps a reviewer connect a conclusion to the exact source record rather than a similar name or later copy.
RelatedAn estimate of the proportion of the measured sample represented by the main analyte under a stated analytical method.
Purity depends on the method and does not by itself establish identity, sterility, potency, safety, approval or suitability.
RelatedA process that assigns study participants or experimental units to groups using chance.
Proper randomization helps reduce systematic differences between groups, but it does not correct poor measurement, attrition or selective reporting.
RelatedThe current authorization, approval, investigational or non-authorized standing of a specific product or use in a stated jurisdiction.
Status is product-, indication-, formulation-, route- and jurisdiction-specific and can change over time.
RelatedStructurally related impurities, degradation products or process variants assessed using a stated analytical method.
A single headline purity number may not explain which related substances were resolved, identified or quantified.
RelatedA scope statement indicating that a material is intended for legitimate laboratory research and education rather than human or veterinary use.
The label defines intended scope. It does not create regulatory authorization, establish clinical safety or replace applicable legal requirements.
RelatedThe date on which a source, claim or record was last checked against current evidence and status.
Research and regulatory information changes; an undated summary cannot show whether it reflects the current record.
RelatedThe path by which a studied intervention enters the body, such as oral, subcutaneous or intranasal administration.
Route can materially change exposure and response. Evidence from one route should not be transferred to another without direct support.
RelatedA prespecified outcome that supplements the primary endpoint and addresses additional study questions.
Secondary endpoints may have multiplicity rules or lower statistical power and should be interpreted within the analysis plan.
RelatedAn adverse event meeting defined seriousness criteria, such as death, life threat, hospitalization, disability or another medically important outcome.
Seriousness is not the same as severity or proven causality; the study's definitions and adjudication process matter.
RelatedA method of prioritizing direct records—such as original studies, registries, regulators and standards—over summaries or promotional interpretation.
Following a claim back to its primary source makes study design, wording, dates and limitations easier to verify.
RelatedThe extent to which a material retains specified attributes over time under defined storage, container and handling conditions.
Stability evidence is condition- and formulation-specific; a result cannot be generalized beyond what was actually tested.
RelatedA model-based assessment of how compatible observed data are with a stated null hypothesis, often summarized by a p-value or interval.
It does not measure effect size, practical importance, study quality or the probability that a claim is true.
RelatedThe absence of viable contaminating microorganisms as assessed by a validated sterility assurance process or test.
Identity and purity testing do not establish sterility, and sterility is not inferred from a sealed vial or visual appearance.
RelatedThe planned structure used to answer a research question, including population, intervention, comparator, measurements and analysis.
Different designs support different conclusions. A case report, animal model and randomized trial should not be interpreted as equivalent evidence.
RelatedThe uncertainty involved in moving a finding from one model, population, route or formulation to another.
A result in cells, animals or a specific clinical formulation cannot automatically be transferred to people or a separately sourced material.
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