Cambodia Pharmacy Exit Exam key terms

The fraction of an administered dose of unchanged drug that reaches systemic circulation, expressed as a percentage. Intravenous dosing is defined as 100%; oral values are lower when absorption or first-pass metabolism limits entry.

Metabolic breakdown of an orally absorbed drug in gut wall or liver before it reaches systemic circulation, reducing oral bioavailability. It explains why some drugs need higher oral doses or are given parenterally.

The absence of a significant difference in rate and extent of absorption between two pharmaceutically equivalent products. Regulators usually require the 90% confidence interval of the ratio to fall within 80-125%.

Any inactive ingredient added to a formulation to serve functions such as filling, binding, disintegrating, lubricating, preserving, or flavoring. Excipients must be compatible with the active ingredient and safe at the intended dose.

The designed composition of a medicine, combining active pharmaceutical ingredient with excipients and a defined manufacturing process to give the required dosage form, performance, and shelf life.

The period during which a medicine is expected to remain within its approved specification when stored under labeled conditions. It is set from stability data and ends at the labeled expiry date.

A structured program of testing a product under defined temperature, humidity, and light conditions over time to establish shelf life and storage instructions. Accelerated and long-term studies are both used.

The set of quality-assurance requirements ensuring medicines are consistently produced and controlled to quality standards. It covers premises, personnel, documentation, validation, and quality control in manufacturing.

Documented evidence that a process, method, or system consistently produces a result meeting predetermined specifications. In manufacturing it covers processes, cleaning, equipment, and analytical methods.

The sampling, testing, and release activities that confirm raw materials and finished products meet specifications. It includes identity, assay, dissolution, and microbiological tests performed against pharmacopoeial or in-house methods.

An official reference book of drug standards, including monographs on identity, purity, assay, and dosage. Examples include the International Pharmacopoeia and national pharmacopoeias recognized by regulators.

A highly characterized material used as the benchmark in quantitative assays and identification tests. Its assigned potency allows calculation of the content of unknown samples by comparison.

A plot of instrument response against known concentrations of an analyte, used to quantify unknown samples. Linearity, slope, and correlation coefficient indicate whether the analytical method performs acceptably.

An analytical separation technique in which a liquid mobile phase is pumped through a packed column, separating components for detection and quantification. It is widely used for assay, impurity, and dissolution testing of medicines.

The relationship between a molecule's chemical structure and its biological effect. Medicinal chemists modify functional groups to improve potency, selectivity, or pharmacokinetic behavior while tracking which changes matter.

An inactive or less active chemical derivative that is converted in the body to the active drug, usually to improve absorption, stability, or targeting. Examples include ester prodrugs hydrolyzed after absorption.

The collection of steric and electronic features a molecule must present to bind a target and produce activity. It is used to design new analogs and to compare structurally different active compounds.

Adjusting a plant extract so that a defined marker compound or group of compounds falls within a specified range. It supports batch-to-batch consistency of phytomedicines whose full active composition is unknown.

A chemically identifiable constituent of a plant extract used to verify identity, quality, or consistency, whether or not it is responsible for the therapeutic effect. It anchors specification and analytical testing.

Preliminary chemical tests on plant material or extracts to detect classes of compounds such as alkaloids, flavonoids, tannins, saponins, and terpenoids. Results guide further isolation and pharmacological study.

A nitrogen-containing basic plant compound with diverse pharmacological activity, such as morphine, quinine, and atropine. Many are potent and require careful identification, dosing, and control.

Dried or fresh plant or animal material used medicinally, usually in unprocessed or simply processed form. Its quality depends on correct botanical identification, collection, drying, and storage.

A drug that binds a receptor and activates it, producing a biological response. Full agonists produce maximal response; partial agonists produce a lower maximal response even at full occupancy.

A drug 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 response.

A ratio comparing the dose producing toxicity with the dose producing therapeutic effect. A narrow index means small dose changes can cause harm, so monitoring and careful dosing are required.

Measurement of drug concentrations in blood to individualize dosing for drugs with narrow therapeutic indices or unpredictable pharmacokinetics. Timing of sampling relative to the dose is essential for interpretation.

A harmful or unintended response to a medicine occurring at doses normally used for treatment. Reactions are classified by mechanism and severity and should be reported through pharmacovigilance systems.

The science of detecting, assessing, understanding, and preventing adverse effects of medicines. Activities include spontaneous reporting, signal detection, and regulatory action such as label changes.

Any preventable event that may cause or lead to inappropriate medication use or patient harm, including prescribing, dispensing, and administration mistakes. Reporting systems focus on system causes rather than blame.

Prescribing and using medicines that are appropriate to the patient's clinical need, at correct dose, for adequate duration, and at affordable cost. It is assessed through prescribing indicators and treatment guidelines.

A national or institutional list of medicines selected to meet priority health needs, chosen for efficacy, safety, and cost-effectiveness and intended to be available at all times.

The process of selecting, ordering, receiving, and paying for medicines and supplies. Good procurement balances quality assurance, price, lead time, and reliable supply to prevent stock-outs.

Managing stock levels of medicines to avoid both stock-outs and expiry waste, using consumption records, minimum and maximum levels, and stock rotation. It supports continuous availability and financial efficiency.

A medicine or chemical subject to special legal restrictions because of abuse or dependence potential. It requires specific licensing, secure storage, record keeping, and prescription controls under national law.

Official authorization granted by a regulatory body permitting a person to practice pharmacy. It typically requires approved education, internship, examination, and continuing professional development for renewal.

A patient's voluntary agreement to a treatment or procedure after receiving understandable information about benefits, risks, and alternatives. It is a core ethical and legal requirement in care and research.

An independent committee that reviews research involving humans to protect participants' rights, safety, and welfare. It examines protocol design, consent documents, and risk-benefit balance before approving studies.

A study in which participants are randomly assigned to intervention or control groups, reducing selection bias and supporting causal inference. Randomization, blinding, and intention-to-treat analysis strengthen its validity.

A range of values, calculated from sample data, expected to contain the true population parameter with a stated probability, commonly 95%. It conveys both the size of an effect and the precision of its estimate.

The number of new cases of a disease arising in a population over a specified period, divided by the population at risk. It measures the speed of new disease occurrence rather than total burden.

The proportion of a population that has a condition at a given time, including both new and existing cases. It reflects disease burden and is useful for planning health services and drug supply.

Activities that enable people to increase control over and improve their health, through education, policy, and supportive environments. In pharmacy it includes counseling, screening, and adherence support.

A written, approved instruction describing how a routine task must be performed to ensure consistency and quality. In pharmacy it covers dispensing, storage, cleaning, and complaint handling.