QCM : Medicinal Product Knowledge — 35 questions

Explication

The active ingredient is the natural, chemical, or biotechnological substance that produces the therapeutic action. An excipient supports administration and preservation but does not provide the therapeutic effect.

Explication

An excipient facilitates the formulation, administration, and preservation of the active ingredient while remaining inert toward the organism and the active ingredient.

Explication

A medicinal product may have curative or preventive properties, support diagnosis, or restore, correct, or modify physiological functions through pharmacological, immunological, or metabolic action.

Explication

A pharmaceutical specialty is industrially prepared in advance, packaged specifically, given a special name, and requires marketing authorization. A magistral preparation is made for an individual patient by prescription.

Explication

A generic medicine matches the reference specialty in active-ingredient composition and must demonstrate bioequivalence. A me-too medicine has a modified but similar structure.

Explication

A magistral preparation is produced according to a prescription for a specific patient when no suitable authorized pharmaceutical specialty is available.

Explication

Drug discovery proceeds from selecting a target through designing bioactive molecules, synthesizing compound libraries, analyzing structure–activity relationships, and structurally optimizing a hit.

Explication

Drug targets include receptors, enzymes, transport molecules, ion channels, idiosyncratic targets, and nucleic acids. The other options are product or administrative components, not biological targets.

Explication

In vitro experiments are performed outside a living organism, such as in cultured cells. In vivo experiments are conducted inside a living organism.

Explication

A hit is a first molecule with promising biological activity but insufficient optimization to become a medicine. A lead is more optimized, has an improved activity profile, and can progress toward preclinical development.

Explication

Molecular modeling uses computational chemistry and graphical visualization to investigate molecular structures and properties and produce a plausible three-dimensional representation under defined conditions.

Explication

Homology modeling uses a structurally known sequence analogue, aligns the sequences, replaces differing amino acids to build the model, and then performs energy minimization and validation.

Explication

A pharmacophore is the spatial arrangement of chemical functions necessary for biological activity. Other parts of the molecular key mainly contribute to pharmacokinetics.

Explication

A me-too drug is structurally close to an original medicine and acts through a similar mechanism, but differs sufficiently in structure to be patentable. A generic has the same active-ingredient composition as the reference.

Explication

Salicylic acid, the lead compound of the arylcarboxylic-acid series, contains a benzene ring, a carboxylic-acid function, and a hydroxyl function.

Explication

Drug development progresses through in vitro research and development, in vivo preclinical development, clinical development in humans, and marketing authorization when the molecule is sufficiently safe and effective.

Explication

Drug research and development lasts approximately 10 years and costs more than one billion euros overall. The resulting product is protected by a patent lasting 20 years.

Explication

Clinical development uses progressively larger groups, ranging from fewer than 100 subjects in phase I to several thousand in phase III.

Explication

Phase I examines the maximum tolerated dose, pharmacokinetics, and, when possible, pharmacodynamics, usually in fewer than 100 healthy volunteers.

Explication

Phase II evaluates potential efficacy and toxicity, the dose-effect relationship, and the optimal dose in fewer than 500 volunteer patients.

Explication

Phase III evaluates the benefit-risk ratio, defines the indication and special populations, and can support marketing authorization.

Explication

Pharmacokinetics describes what the organism does to the medicine through the dose-concentration relationship; pharmacodynamics describes what the medicine does to the organism through concentration and effect.

Explication

ADME stands for absorption, distribution, metabolism, and elimination in that order.

Explication

Passive diffusion follows a concentration gradient without energy or a transporter and is not saturable. Facilitated diffusion instead uses saturable transporters.

Explication

Drug metabolism mainly occurs in the liver, where phase I functionalization involves oxidation, reduction, or hydrolysis, followed by phase II conjugation with endogenous polar molecules.

Explication

Medicine quality requires assessment of quality, safety, and efficacy, while analytical quality control determines both the identity or presence of substances and their quantities.

Explication

The WHO acts internationally, the Council of Europe operates at the European level through the European Pharmacopoeia, and France's ANSM applies the framework nationally.

Explication

Good Manufacturing Practices are quality-assurance elements designed to ensure uniform manufacture and control according to standards appropriate to the product's use and its marketing authorization. The definition is attributed to the WHO.

Explication

Analytical controls determine what is present, how much is present, identify substances, and detect impurities or related substances above permitted limits.

Explication

A galenic form is the concrete physical presentation of a medicine. It differs from the route of administration, which describes how the medicine enters the organism.

Explication

Parenteral administration penetrates through the skin and includes intramuscular, intravenous, subcutaneous, and intradermal routes. Oral and nonpenetrating cutaneous administration are not parenteral.

Explication

Physicians are primary prescribers, while midwives, dental surgeons, and physiotherapists may prescribe within specific scopes. Pharmacists generally dispense medicines and have limited prescribing authority, such as for certain vaccines.

Explication

Prescribing should follow the marketing authorization and Summary of Product Characteristics while considering benefit-risk and patient-specific information such as pathology, history, allergies, and previous treatments.

Explication

An ordonnance must contain several identification and treatment details, and the prescriber's signature must appear immediately below the last line.

Explication

The four ordonnance types include simple forms, secured forms for narcotics, two-zone forms for certain long-term conditions, and exceptional-medicine forms printed on CERFA documents.