Albania Pharmacist Certification Exam (Provimi i Certifikimit) key terms

The fraction of an administered dose of a drug that reaches the systemic circulation unchanged, together with the rate at which it arrives. Intravenous dosing is taken as 100 percent; oral values are lower when absorption or first-pass metabolism limits entry.

The demonstration that two pharmaceutical products containing the same active substance release it into the body at a rate and extent that are not significantly different. It is the regulatory basis for approving generic medicines without repeating full clinical trials.

Presystemic elimination of an orally absorbed drug by enzymes in the gut wall or liver before it reaches the systemic circulation. It lowers oral bioavailability and explains why some drugs need much larger oral than intravenous doses.

An inactive or less active chemical derivative that must be converted in the body, usually by enzymatic hydrolysis or oxidation, to release the active drug. It is used to improve absorption, stability, or targeting of the parent molecule.

Enzymatic chemical alteration of a drug in the body, mainly in the liver, generally producing more water-soluble metabolites that are easier to excrete. Reactions are classically divided into phase I functionalisation and phase II conjugation.

One of a family of haem-containing liver and intestinal enzymes that oxidise many drugs. Individual isoforms differ in substrate specificity, and their inhibition or induction is a common cause of clinically important drug interactions.

Increased synthesis or activity of drug-metabolising enzymes after repeated exposure to a chemical, leading to faster clearance of substrate drugs. The effect develops over days to weeks and can reduce the efficacy of co-administered medicines.

Reduction of drug-metabolising enzyme activity by another substance, causing slower clearance and higher plasma concentrations of substrate drugs. Unlike induction it usually appears quickly and can precipitate toxicity.

A ratio comparing the dose producing toxicity with the dose producing the desired effect. A narrow index means small dose changes can cause harm, so such drugs require careful dosing and often therapeutic drug monitoring.

Measurement of plasma drug concentrations to individualise dosing, used for drugs with a narrow therapeutic index, unpredictable kinetics, or serious toxicity. Interpretation requires knowing the sampling time relative to the last dose.

The time required for the plasma concentration of a drug to fall by half during elimination. It determines how long a drug accumulates with repeated dosing and how long it takes to reach steady state, roughly four to five half-lives.

The volume of plasma from which a drug is completely removed per unit time. It reflects the combined activity of hepatic metabolism and renal excretion and determines the maintenance dose needed to sustain a target concentration.

A theoretical volume relating the amount of drug in the body to its plasma concentration. A large value indicates extensive tissue distribution; it determines the loading dose required to achieve a target concentration.

The condition during repeated dosing in which the amount of drug entering the body equals the amount eliminated per dosing interval, so plasma concentrations fluctuate around a stable average. It is generally reached after four to five half-lives.

A molecule that binds a receptor and activates it, producing a biological response. Full agonists produce maximal effect; partial agonists produce a smaller maximal response even when all receptors are occupied.

A molecule that binds a receptor without activating it and blocks the effect of agonists. Competitive antagonists can be overcome by more agonist; non-competitive antagonists reduce the maximal achievable response.

A protein molecule, usually on a cell surface or inside the cell, that recognises a specific chemical signal and converts binding into a cellular response. Receptors largely determine the selectivity and potency of drugs.

The study of how inherited genetic variation influences drug response, including metabolism, transport, and target sensitivity. It supports individualised prescribing, for example adjusting doses according to metaboliser phenotype.

Any inactive component of a medicine, such as a filler, binder, disintegrant, lubricant, preservative, or colourant, included to aid manufacture, stability, or patient acceptability. Excipients can occasionally cause adverse reactions.

The physical presentation in which an active substance is delivered to the patient, such as a tablet, capsule, solution, cream, or suppository. The form determines the route of administration and the release characteristics of the drug.

A validated process that destroys or removes all viable microorganisms, including bacterial spores, from a product or device. Common methods include moist heat, dry heat, filtration, irradiation, and aseptic processing.

A set of practices that keep sterile products and equipment free from microbial contamination during handling, such as hand disinfection, sterile gloves, laminar airflow, and avoiding contact with non-sterile surfaces.

A substance, typically a lipopolysaccharide endotoxin from Gram-negative bacterial cell walls, that causes fever when it enters the bloodstream. Pyrogens are not reliably removed by ordinary sterilisation and require depyrogenation or endotoxin testing.

The lowest concentration of an antimicrobial agent that prevents visible growth of a standardised bacterial inoculum under defined laboratory conditions. It guides selection and dosing of antibiotics and is used to define susceptibility categories.

The ability of microorganisms to survive and multiply in the presence of an antimicrobial concentration that would normally inhibit or kill them. It arises through mutation or acquisition of resistance genes and is a major public health threat.

A laboratory report or local surveillance summary showing which antimicrobial agents are active against an isolated organism or against common pathogens in a population. It supports empirical therapy and stewardship decisions.

A harmful and unintended response to a medicine occurring at doses normally used in humans. Reactions are classified by mechanism and predictability and must be reported through pharmacovigilance systems.

The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Spontaneous reporting systems and signal evaluation are central to it.

A change in the effect of one medicine caused by another substance, including drugs, food, alcohol, or herbal products. Interactions may be pharmacokinetic, altering absorption or clearance, or pharmacodynamic, altering the effect at the target.

A structured process of obtaining and comparing a patient's complete medication list at transitions of care, such as admission, transfer, or discharge, to identify discrepancies and prevent errors.

Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a health professional, patient, or consumer. It includes prescribing, dispensing, and administration errors.

A patient-centred practice in which the pharmacist takes responsibility for the outcomes of drug therapy, working with the patient and other professionals to identify, resolve, and prevent drug-related problems.

A patient's voluntary agreement to a health intervention after receiving understandable information about its purpose, benefits, risks, and alternatives. It must be obtained without coercion and documented appropriately.

The pharmacist's legal and ethical duty to keep confidential all information about patients learned in the course of practice, disclosing it only with consent or where required by law.

A set of professional principles and standards guiding pharmacists' conduct, including competence, honesty, respect for patients, confidentiality, and avoidance of conflicts of interest. Breach may lead to disciplinary action.

A medicine that has the same qualitative and quantitative composition of active substance and the same pharmaceutical form as a reference product, and whose bioequivalence with the reference has been demonstrated.

The set of quality-assurance requirements ensuring that medicinal products are consistently produced and controlled to quality standards appropriate to their intended use. It covers premises, personnel, documentation, validation, and quality control.

Standards governing the storage, transport, and distribution of medicinal products so that quality is preserved through the supply chain. It covers temperature control, traceability, and handling of returns and recalls.

An official compendium of recognised quality standards for medicines, active substances, and excipients, including specifications, analytical methods, and monographs. Compliance with its monographs is legally expected for medicinal products.

The discipline that compares the costs and consequences of pharmaceutical products and services to inform resource allocation. Common analyses include cost-minimisation, cost-effectiveness, cost-utility, and cost-benefit approaches.

An economic evaluation comparing the cost per unit of a natural health outcome, such as cost per life-year gained or per case prevented, between alternative interventions. It helps decision-makers judge value for money.

A health outcome measure combining length of life with quality of life, where one year in perfect health equals 1 and death equals 0. It is used in cost-utility analysis to compare interventions across diseases.

A national or institutional list of medicines considered necessary to meet the priority health care needs of a population, selected on efficacy, safety, and cost. It guides procurement, prescribing, and availability.

A naturally occurring nitrogen-containing organic compound, usually basic and pharmacologically active, found in plants such as poppy, cinchona, and belladonna. Many alkaloids are used therapeutically or are important poisons.

A plant compound in which a sugar moiety is linked to a non-sugar aglycone, often through an oxygen atom. Cardiac glycosides such as digoxin and many saponins and flavonoids belong to this group.

The process of controlling the identity, purity, and content of a herbal material or extract, using macroscopic, microscopic, chromatographic, and assay methods against defined specifications. It aims to ensure consistent quality between batches.

A substance that counteracts the toxic effect of a poison, either by binding it, neutralising it, or interfering with its mechanism of action. Examples include activated charcoal, naloxone, and acetylcysteine.

A highly porous carbon preparation that adsorbs many drugs and chemicals in the gastrointestinal tract, reducing their absorption. It is most useful when given soon after ingestion and is contraindicated in some caustic or hydrocarbon exposures.

The systematic approach to a suspected overdose: stabilise airway, breathing, and circulation, identify the toxin, limit absorption, enhance elimination when indicated, and give specific antidotes. History and clinical signs guide treatment.

The body's ability to maintain internal stability, such as constant temperature, pH, and blood glucose, despite changes in the external environment. It depends on negative feedback control by nervous and endocrine systems.

The regulation of hydrogen ion concentration in body fluids, achieved mainly by buffer systems, respiratory control of carbon dioxide, and renal handling of bicarbonate. Disturbances are described as acidosis or alkalosis.

The movement of water across a semipermeable membrane from a region of lower solute concentration to one of higher solute concentration. It underlies fluid shifts between body compartments and the design of isotonic intravenous solutions.

A protein catalyst that speeds up a specific biochemical reaction by lowering its activation energy. Enzymes are central to drug metabolism and are frequent targets of therapeutic inhibition.