State Medical Faculty Diploma in Pharmacy Final Exam key terms

The fraction of an administered dose of a drug that reaches the systemic circulation unchanged, together with the rate at which it does so. It is assessed from plasma concentration-time data and determines whether a formulation delivers drug effectively.

A regulatory finding that two pharmaceutical products containing the same active ingredient are therapeutically interchangeable because their rate and extent of absorption do not differ significantly. It is usually demonstrated by comparative bioavailability studies in healthy volunteers.

A relationship in which two products contain identical amounts of the same active ingredient in the same dosage form and meet the same compendial standards, but may differ in excipients or manufacturing. It does not by itself prove therapeutic interchangeability.

Loss of a fraction of an orally absorbed drug during passage through the intestinal wall and liver before it reaches the systemic circulation. It lowers oral bioavailability and can be avoided by parenteral or other non-oral routes.

Any pharmacologically inactive substance included in a dosage form to serve functions such as diluent, binder, disintegrant, lubricant, preservative, or colourant. Excipients influence manufacture, stability, and drug release, and some can cause adverse reactions.

A dosage-form design that slows drug release so that plasma concentrations remain within the therapeutic range for an extended period after a single dose. It reduces dosing frequency and fluctuation but risks dose dumping if the release mechanism fails.

A preparation free from viable microorganisms, intended for injection, infusion, ophthalmic use, or application to broken skin. Its manufacture requires validated aseptic processing or terminal sterilisation plus environmental monitoring and container integrity testing.

A substance, typically a lipopolysaccharide from gram-negative bacterial cell walls, that produces fever when introduced into the body. Pyrogens are heat-stable and are controlled by depyrogenation of glassware and by compendial testing of parenteral products.

A set of practices that keep preparations and equipment free from microbial contamination during handling, including hand hygiene, sterile gloves, disinfection, and working within a laminar airflow cabinet. It is essential for products that cannot be terminally sterilised.

A chemically modified derivative that is inactive as administered and must undergo enzymatic or chemical conversion in the body to release the active drug. Prodrugs are used to improve absorption, stability, or targeting.

The systematic link between particular features of a molecule, such as functional groups, stereochemistry, or lipophilicity, and its observed biological activity. Understanding it guides rational modification of lead compounds to improve potency or reduce toxicity.

The property of a molecule that is not superimposable on its mirror image, usually because of a carbon atom bearing four different substituents. Enantiomers can differ markedly in pharmacologic activity, metabolism, and toxicity.

A mixture containing equal amounts of the two enantiomers of a chiral compound. Because the enantiomers may have different potency or disposition, a racemic drug can behave differently from a single-enantiomer product.

A published compendial standard that specifies the identity, purity, strength, and quality tests a substance or preparation must meet to be recognised as official. Compliance is legally enforceable in jurisdictions that adopt the pharmacopoeia.

A highly characterised substance of established purity and potency against which unknown samples are compared in compendial assays. Its traceability underpins the accuracy of identity, potency, and impurity testing.

An official book, issued by a recognised authority, that sets legally binding standards for drug substances, preparations, and analytical methods. It provides the quality benchmarks used in licensing, manufacturing, and inspection.

A plant constituent in which a sugar moiety is linked to a non-sugar aglycone through a glycosidic bond. Many glycosides are pharmacologically active, and their polarity and stability are strongly influenced by the sugar portion.

A naturally occurring, usually basic nitrogen-containing compound found mainly in plants, often with pronounced pharmacological activity. Examples include morphine and quinine, and their basicity is exploited in extraction and salt formation.

A group of polyphenolic plant constituents that bind and precipitate proteins, giving an astringent taste and the ability to tan leather. In pharmacy they are used for astringent and haemostatic effects and can inactivate other drugs.

The study of medicinal substances of natural origin, covering their botanical or biological source, cultivation, collection, identification, chemistry, and standardisation. It links crude drugs and their extracts to reproducible pharmaceutical use.

A ratio expressing the margin of safety of a drug, commonly the toxic dose divided by the effective dose. A low value indicates that toxic effects may occur close to therapeutic concentrations, so careful monitoring is needed.

The clinical practice of measuring plasma concentrations of selected drugs and adjusting doses accordingly, used for agents with narrow therapeutic ranges or unpredictable kinetics. It relies on correctly timed sampling at steady state.

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

The time required for the plasma concentration of a drug to fall by half during elimination. It determines the time to steady state, the duration of effect after stopping therapy, and the appropriate dosing interval.

The volume of plasma from which a drug is completely removed per unit time by metabolism and excretion. It determines the maintenance dose needed to achieve a target steady-state concentration.

A substance that counteracts the toxic effect of a poison, either by binding it, accelerating its elimination, or reversing its pharmacologic action. Examples include activated charcoal and specific receptor antagonists.

A harmful or unintended response to a medicine occurring at doses normally used for prevention, diagnosis, or treatment. Reactions are classified by mechanism and are the subject of pharmacovigilance reporting and causality assessment.

The science of detecting, assessing, understanding, and preventing adverse effects or other drug-related problems after marketing. It depends on spontaneous reporting systems and periodic safety update review.

A written or electronic order from a prescriber authorising the supply of a medicine for a named patient, containing the drug, dose, directions, and prescriber details. Legal requirements for its content and validity are set by medicines legislation.

The professional act of preparing and supplying a medicine to a patient in response to a prescription, including interpretation, labelling, and counselling. It carries legal and ethical duties of accuracy and record keeping.

A medicine subject to special legal restrictions because of abuse or dependence potential, requiring secure storage, record keeping, and restricted prescribing or supply. Schedules define the level of control applied.

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

A continually revised list of medicines approved for use in a particular hospital, together with prescribing information and therapeutic guidance. It is maintained by a pharmacy and therapeutics committee to promote safe, cost-effective prescribing.

A patient-oriented practice in which pharmacists apply pharmacotherapeutic knowledge to optimise medicine use, including medication review, dose adjustment, and counselling. It operates within the healthcare team rather than being limited to product supply.

The prescribing and use of medicines appropriate to a patient's clinical needs, in doses meeting individual requirements, for an adequate period, at the lowest cost to the patient and community. It is promoted through treatment guidelines and education.

A catalogue of medicines selected because they satisfy the priority healthcare needs of a population, chosen on the basis of efficacy, safety, and cost. It guides procurement and supply in public health systems.

The extent to which a patient's behaviour, such as taking medicine or following dietary advice, matches the prescriber's recommendations. It is now often described as adherence and is supported by counselling and simplified regimens.

The study of what a drug does to the body, including receptor binding, signal transduction, and the resulting dose-response relationship. It explains the intensity and type of therapeutic and toxic effects observed.

The study of what the body does to a drug, described through absorption, distribution, metabolism, and excretion. These processes determine the concentration-time profile used to design dosing regimens.