Albania Pharmacist State Exam (Provimi i Shtetit - Farmaci) key terms

The fraction of an administered dose of unchanged drug that reaches the systemic circulation, expressed as a percentage. Intravenous dosing defines 100%, and extravascular routes are compared against it. It depends on both the extent of absorption and first-pass metabolism.

Presystemic elimination of an orally absorbed drug by enzymes in the intestinal wall and liver before it enters the systemic circulation. It lowers oral bioavailability and can be saturated, causing nonlinear kinetics. Drugs with extensive first-pass loss often require higher oral 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, taste, or targeting. Examples include ester prodrugs of poorly absorbed carboxylic acids.

The absence of a significant difference in the rate and extent of absorption of two pharmaceutically equivalent products at the same molar dose. It is demonstrated statistically using AUC and Cmax with confidence intervals, usually 80 to 125 percent. It is the basis for approving generic medicines.

The specific spatial arrangement of chemical features in a molecule that is responsible for its biological activity at a target. It is used in medicinal chemistry to design analogues and to build pharmacophore models for virtual screening of compound libraries.

The systematic study of how changes in a molecule's chemical structure affect its potency, selectivity, and pharmacokinetic properties. It guides optimisation of a lead compound by identifying which functional groups are essential for binding and which can be modified.

An initial molecule that shows measurable activity at a biological target and serves as the starting point for chemical modification. It usually requires optimisation of potency, selectivity, and drug-like properties before becoming a development candidate.

The property of a molecule that is not superimposable on its mirror image, usually due to a carbon atom bearing four different substituents. Enantiomers may differ markedly in pharmacological activity, metabolism, and toxicity, so many drugs are developed as single enantiomers.

A 50:50 mixture of two enantiomers of a chiral compound. Because the enantiomers may have different potency or adverse effects, a racemate is not equivalent to a single-enantiomer product and may require separate analytical control.

Any pharmacologically inactive substance included in a dosage form to serve functions such as dilution, binding, lubrication, preservation, or taste masking. Excipients must be compatible with the active ingredient and are selected according to the route of administration and manufacturing process.

The industrial process in which a powder blend is compacted between punches and dies to form a tablet. Key parameters include compression force, granule flow, and lubrication, which together determine hardness, friability, disintegration, and dissolution behaviour of the finished tablet.

An in vitro pharmacopoeial test measuring the rate and extent of drug release from a solid dosage form into a specified medium under controlled agitation and temperature. It is used for quality control, batch release, and as a surrogate for bioequivalence assessment.

A dosage form free from viable microorganisms, prepared for parenteral, ophthalmic, or other routes requiring microbiological safety. It is produced under validated aseptic conditions or terminal sterilisation and tested for sterility, pyrogens, and particulate matter.

The extemporaneous preparation of a medicine for an individual patient from raw materials or bulk products, according to a prescription or a pharmacopoeial formula. It requires documented procedures, appropriate facilities, and trained personnel to ensure identity, purity, and correct dosage.

An official compendium of drug standards, including monographs on identity, purity, assay, and dosage forms, recognised by law in a country or region. The European Pharmacopoeia is the reference applied in Albania under its alignment with EU pharmaceutical legislation.

An analytical separation technique in which a liquid mobile phase is pumped through a column packed with a stationary phase, separating components for detection and quantification. It is the mainstay of pharmaceutical assay, impurity testing, and content uniformity determination.

The documented demonstration that an analytical procedure is suitable for its intended purpose, assessed through accuracy, precision, specificity, linearity, range, detection and quantification limits, and robustness. It is required before a method is used for regulatory batch release testing.

The set of regulatory requirements ensuring that medicinal products are consistently produced and controlled to quality standards appropriate to their intended use. It covers personnel, premises, equipment, documentation, production, quality control, and complaints and recalls.

The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. It relies on spontaneous reporting, signal detection, and periodic safety update evaluation to protect public health.

A noxious and unintended response to a medicine occurring at doses normally used in humans for prophylaxis, diagnosis, or therapy. ADRs are classified by mechanism and severity and must be reported through national pharmacovigilance systems when serious or unexpected.

A spontaneous reporting scheme through which health professionals and patients notify suspected adverse drug reactions to the national regulatory authority. Reports are assessed for causality and contribute to signal detection and regulatory action such as label changes.

The measurement of plasma drug concentrations to individualise dosing for drugs with narrow therapeutic indices, such as digoxin, lithium, and aminoglycosides. Interpretation requires knowledge of sampling time, half-life, and the patient's clinical status.

A property of drugs for which the difference between therapeutic and toxic doses is small, so that modest changes in concentration can cause treatment failure or toxicity. Such drugs require careful dosing, monitoring, and often bioequivalence demonstration with tighter limits.

The study of what the body does to a drug, described by absorption, distribution, metabolism, and excretion. These processes determine the time course of drug concentration and are quantified by parameters such as clearance, volume of distribution, and half-life.

The study of what a drug does to the body, including receptor binding, signal transduction, and the resulting physiological effect. It explains dose-response relationships, potency, efficacy, and the mechanisms of drug interactions and antagonism.

A ligand that binds to a receptor and activates it to produce a biological response. Full agonists produce maximal response, whereas partial agonists produce submaximal response even at full receptor occupancy.

A ligand that binds to a receptor without activating it and blocks the effect of agonists. Competitive antagonists can be overcome by increasing agonist concentration, whereas non-competitive antagonists reduce the maximal response.

A naturally occurring nitrogen-containing basic compound found mainly in plants, often with potent pharmacological activity, such as morphine, atropine, and quinine. Alkaloids are usually extracted by acid-base methods and identified by specific colour and precipitation reactions.

A natural product in which a sugar moiety is linked to a non-sugar aglycone, found in plants such as foxglove and willow. Cardiac glycosides act on the sodium-potassium pump, and their therapeutic and toxic effects depend on the aglycone structure.

A plant preparation adjusted so that a defined marker compound or group of compounds falls within a specified range, ensuring consistent composition between batches. Standardisation supports reproducible efficacy and safety of phytopharmaceutical products.

A change in the effect of a medicine caused by concurrent use of a herbal product, often through induction or inhibition of metabolic enzymes or transporters. St John's wort, for example, induces CYP3A4 and can reduce the efficacy of many co-administered drugs.

A substance used to counteract the toxic effect of a poison by chemical, pharmacological, or physiological means. Examples include N-acetylcysteine for paracetamol overdose and naloxone for opioid toxicity. Administration should follow supportive care and decontamination.

A highly adsorptive carbon preparation given orally to bind poisons remaining in the gastrointestinal tract and reduce their absorption. It is most effective within one hour of ingestion and is contraindicated in corrosive ingestion and unprotected airway.

Measures intended to reduce absorption or enhance elimination of a toxic substance, including gastric lavage, activated charcoal, and urinary alkalinisation. Indications are limited because of risks, and supportive care and antidote administration take priority.

A medicine that contains the same active substance as an originator product and whose bioequivalence has been demonstrated, marketed after patent and data protection expiry. It is approved on the basis of quality, safety, and efficacy data without repeating full clinical trials.

A reimbursement policy in which the payer sets a maximum amount it will cover for a group of therapeutically interchangeable medicines. Patients pay the difference if they choose a product priced above the reference level, encouraging price competition.

The process by which a health insurer or state scheme pays pharmacies for dispensed medicines and professional services. It typically combines the medicine's cost with a fixed or percentage dispensing fee and is governed by contractual and pricing rules.

The quality standards governing storage, transport, and distribution of medicinal products to preserve their quality and integrity through the supply chain. It covers temperature control, traceability, authorised premises, and qualification of suppliers and customers.

The responsible provision of drug therapy to achieve definite outcomes that improve a patient's quality of life. It involves identifying and resolving medication-related problems, monitoring outcomes, and collaborating with other health professionals.

The extent to which a patient's behaviour matches agreed recommendations from a prescriber regarding timing, dose, and duration of therapy. Poor adherence reduces therapeutic benefit and is addressed through education, simplification of regimens, and shared decision-making.

Structured communication by the pharmacist to ensure the patient understands how to use a medicine correctly, including dose, timing, storage, and expected effects. It improves adherence, reduces errors, and supports early recognition of adverse reactions.