What is an active ingredient in a medicinal product?
It is the substance responsible for the therapeutic action.
What role does an excipient play in a medicinal product?
It facilitates administration, formulation, and preservation of the active ingredient.
What must an excipient be toward the organism and active ingredient?
It must be inert.
How is a medicinal product defined according to the Code de la Santé Publique?
As a substance or composition with curative, preventive, diagnostic, or physiological modifying properties.
Which actions can a medicinal product perform on physiological functions?
Pharmacological, immunological, or metabolic actions.
By what criteria can a medicinal product be defined?
By presentation, function, or composition.
What type of dietary products can be considered medicinal products?
Dietary products containing chemical or biological substances with therapeutic-dietetic properties.
What defines a pharmaceutical specialty?
A medicine prepared in advance by industry with specific packaging and marketing authorization.
What must a generic medicine demonstrate compared to the reference specialty?
Bioequivalence with the same active-ingredient composition.
How does a me-too medicine differ from a generic medicine?
It has a modified but similar structure.
What is a magistral preparation?
A medicine prepared by prescription for a specific patient when no authorized specialty is suitable.
What functions does a pharmacy for internal use (PUI) perform?
It supplies hospitalized patients, manages medicines, prepares and dispenses them, and may manage sterile devices and experimental medicines.
Who is responsible for compliance in a pharmaceutical establishment?
A pharmacist responsible for compliance with the Code de la Santé Publique.
What are the main steps in drug discovery?
Target selection, bioactive-molecule design, compound-library synthesis, structure-activity analysis, and structural optimization.
Which types of molecules can be drug targets?
Receptors, enzymes, transport molecules, ion channels, idiosyncratic targets, and nucleic acids.
What distinguishes in vitro from in vivo experiments?
In vitro experiments occur outside living organisms; in vivo experiments occur inside living organisms.
What defines a hit in drug discovery?
A first molecule with promising biological activity not yet optimized for medicine.
What characterizes a lead molecule?
An optimized molecule with improved biological activity suitable for preclinical development.
What does molecular modeling investigate using computational chemistry?
Molecular structures and properties.
What is the first step in homology modeling?
Searching for a structurally known sequence analogue.
What is UniProt a database of?
Protein or nucleic-acid sequences.
What does the Protein Data Bank database contain?
Three-dimensional structures.
What is a pharmacophore?
A spatial arrangement of chemical functions necessary for biological activity.
How many pharmacophore functions are there?
Seven pharmacophore functions.
Name one pharmacophore function related to charge.
Positive charge.
Name one pharmacophore function related to hydrogen bonding.
Hydrogen-bond donor.
What defines a me-too drug in pharmaceuticals?
A new active ingredient structurally close to an original medicine but patentably different.
Which suffix groups beta-blockers in international nonproprietary names?
-olol
Which suffix groups benzodiazepines in international nonproprietary names?
-azepam
What is the first step in developing a me-too drug?
Monitoring competitors' patents.
What chemical groups does salicylic acid contain?
A benzene ring, a carboxylic acid, and a hydroxyl group.
How is acetylsalicylic acid (aspirin) chemically obtained?
By adding acetic acid to salicylic acid's hydroxyl group via an ester bond.
How long does drug research and development typically last?
Approximately 10 years.
What is the overall cost of drug research and development?
More than one billion euros.
How long does a drug patent usually last?
20 years.
What are the main stages of drug development?
In vitro research, in vivo preclinical development, clinical development, and marketing authorization.
What triggers marketing authorization in drug development?
The molecule being sufficiently safe and effective.
What is the approximate cost of preclinical development?
10 to 20 million euros.
What is the failure rate of the early preclinical stage?
90%.
Which studies are performed after lead identification to prepare the medicine?
Galenic, pharmacokinetic, pharmacodynamic, and toxicological studies.
How does clinical development progress through trial phases?
It progresses from phase I to phase IV with increasing subject numbers.
What does phase I study in clinical trials?
Maximum tolerated dose, pharmacokinetics, and pharmacodynamics in fewer than 100 healthy volunteers.
What is evaluated in phase II clinical trials?
Potential efficacy, toxicity, dose-effect relationship, and optimal dose in fewer than 500 volunteer patients.
What does phase III assess in clinical trials?
Benefit-risk ratio, indication, special populations, and supports marketing authorization in fewer than 5000 ill patients.
When does phase IV occur and what does it study?
After marketing, it studies comparison with existing treatments, usefulness, pharmacoeconomics, tolerance, and marketing within phase III indication.
What does pharmacokinetics describe in medicine?
What the organism does to the medicine through dose-concentration relationship.
What four processes does the ADME sequence include?
Absorption, distribution, metabolism, and elimination.
How does passive diffusion differ from facilitated diffusion?
Passive diffusion uses no energy or transporter and is not saturable, unlike facilitated diffusion.
What characterizes facilitated diffusion in drug transport?
It uses saturable transporters and can involve competition between medicines.
How does active transport move molecules in pharmacokinetics?
Against their concentration gradient through influx or efflux proteins.
What does drug distribution separate in the bloodstream?
The active free fraction from the protein-bound reserve fraction.
What happens to protein binding during hypoalbuminemia?
Protein binding is reduced due to less competition from weak reversible binding.
Where does drug metabolism mainly occur and what are its phases?
In the liver, with phase I functionalization and phase II conjugation.
What three aspects define medicine quality?
Quality, safety, and efficacy define medicine quality.
Which organizations act internationally, at European, and national levels in drug quality control?
WHO acts internationally, Council of Europe at European level, and ANSM nationally in France.
What are Good Manufacturing Practices according to OMS?
They are quality-assurance elements ensuring uniform manufacturing and control per standards and marketing authorization.
Into what categories is the European Pharmacopoeia divided?
Monographs on active ingredients, excipients, reagents, pharmaceutical forms, containers, and analytical methods.
What are the four functions of analytical controls in drug quality?
They qualify presence, quantify amount, identify substances, and detect impurities or related substances.
What is a galenic form in pharmaceuticals?
The concrete pharmaceutical appearance of a medicine.
How can galenic forms be classified by physical appearance?
As solid, liquid, semisolid, or gaseous.
How can galenic forms be classified by administration route?
As oral, parenteral, or cutaneous.
What defines a syrup in pharmaceutical preparations?
An aqueous preparation with at least 45% m/m sucrose or sweetener and a sweet, viscous consistency.
What does an emulsion consist of in pharmaceuticals?
Liquid globules dispersed in another immiscible liquid phase.
What is the function of gastro-resistant tablets?
They resist gastric juice and release active substances in intestinal juice.
What does parenteral administration involve?
Penetration through the skin for local or systemic action.
Which routes are included in parenteral administration?
Intravenous, intramuscular, subcutaneous, and intradermal routes.
Who can prescribe medicines within their scope besides physicians?
Midwives, dental surgeons, and physiotherapists can prescribe certain medical devices.
Since 2019, what can pharmacists prescribe and dispense?
Pharmacists can prescribe and dispense certain vaccines.
What must prescribing follow regarding authorization and product information?
Prescribing must follow marketing authorization and the Summary of Product Characteristics.
What patient factors must be considered in prescribing?
Patient pathology, history, allergies, previous treatments, and expectations must be considered.
What essential elements must an ordonnance include?
Date, prescriber and patient identification, medicine details, renewal instruction, and prescriber signature.
What are the four types of ordonnance?
Simple, secured for narcotics, two-zone for 29 long-term conditions, and exceptional CERFA forms.
What distinguishes hospital-prescription from hospital-initial-prescription medicines?
Hospital-prescription medicines must be prescribed in a health establishment but can be dispensed in the community; hospital-initial-prescription medicines can be renewed by any prescriber after the initial hospital prescription.
Who can renew a medicine initially reserved for specialists?
Any physician can renew it after the initial specialist prescription.
Teste seu conhecimento com 35 perguntas sobre Medicinal Product Knowledge.
1. Which component of a medicinal product is directly responsible for its therapeutic action?
2. What is the primary role of an excipient in a medicinal product?
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