EHPLE Pharmacy key terms

The amount or concentration associated with a defined response in a specified comparison, distinct from the maximum achievable effect.

The capacity to produce a specified effect under the relevant conditions, distinguished from potency and individual clinical suitability.

The relative preference for a biological target, which can depend on exposure and does not imply absolute specificity.

The proportional removal of drug relative to its measured concentration, expressed as a volume per unit time under the relevant model.

A model quantity relating the amount of drug in the body to concentration, rather than a literal anatomical fluid container.

The relevant fraction of an administered dose reaching systemic circulation under the stated route, product and comparison assumptions.

The breakup of a dosage form into smaller components, which is distinct from dissolving the active ingredient and absorbing it.

Movement of a substance into solution under specified conditions, influenced by the actual material, environment and dosage-form design.

A delivery design altering release characteristics, whose safe manipulation depends on the actual formulation and current product instructions.

Agreement among repeated measurements under defined conditions, which does not alone establish agreement with an appropriate true or reference value.

The ability to assess the intended target in the presence of relevant other components under the validated method conditions.

Data supporting the behavior of a particular product over time under specified conditions, rather than one universal expiry convention.

A problem arising before measurement through identification, collection, handling or storage, which can change the reported laboratory result.

An initial classification under a defined testing purpose, interpreted with performance and population context rather than automatic final diagnosis.

A threshold used for a defined clinical decision under a particular framework, which need not equal a population reference-interval boundary.

A structured assessment of the actual medicine list, indications, benefit, risk and practical use in the context of the patient.

A communication method checking the explanation through the person account of understanding, used to improve clarity rather than assign blame.

The intended patient-relevant benefit used to assess whether a medicine plan is useful, with monitoring for harms and limitations.

Comparison and investigation of medicine information across care transitions to distinguish intended changes from unintended discrepancies.

A detected medication-process problem that did not result in the feared harm but can still reveal a useful system weakness.

A medicine associated with important harm potential when used incorrectly, requiring controls matched to the actual risk and process.

The comparator risk minus the intervention risk for a defined outcome and follow-up, interpreted with uncertainty and actual applicability.

Protection against knowledge of the next randomized assignment during recruitment, distinct from blinding later assessment or treatment.

The specified viewpoint defining which resources and outcomes enter an economic comparison, rather than acquisition price alone.

The actual organizer, level, professional role and assessment purpose of a credential, distinguished from a similar title in another jurisdiction.

Records connecting a product, preparation or treatment with its relevant identity and history so appropriate investigation and action remain possible.

The actual permission for a defined service under current local requirements, which is not conferred by a scientific practice question.