The active ingredient
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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.
To facilitate formulation and administration
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An excipient facilitates the formulation, administration, and preservation of the active ingredient while remaining inert toward the organism and the active ingredient.
A substance or composition with curative, preventive, diagnostic, or physiological-modifying effects
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A medicinal product may have curative or preventive properties, support diagnosis, or restore, correct, or modify physiological functions through pharmacological, immunological, or metabolic action.
It is prepared in advance industrially and marketed under a special name
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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.
A generic has the same active-ingredient composition and must demonstrate bioequivalence, while a me-too has a modified but similar structure
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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.
When a specific patient needs a medicine for which no suitable authorized specialty is available
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A magistral preparation is produced according to a prescription for a specific patient when no suitable authorized pharmaceutical specialty is available.
Target selection, bioactive-molecule design, library synthesis, structure–activity analysis, and hit optimization
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Drug discovery proceeds from selecting a target through designing bioactive molecules, synthesizing compound libraries, analyzing structure–activity relationships, and structurally optimizing a hit.
An ion channel
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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.
An in vitro experiment
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In vitro experiments are performed outside a living organism, such as in cultured cells. In vivo experiments are conducted inside a living organism.
A hit is a promising but insufficiently optimized molecule, whereas a lead has an improved activity profile suitable for preclinical progression
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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.
A plausible three-dimensional representation of a molecule
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Molecular modeling uses computational chemistry and graphical visualization to investigate molecular structures and properties and produce a plausible three-dimensional representation under defined conditions.
Find a structural analogue, align sequences, build by residue replacement, minimize energy, and validate
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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.
It is the spatial arrangement of chemical functions required for biological activity
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A pharmacophore is the spatial arrangement of chemical functions necessary for biological activity. Other parts of the molecular key mainly contribute to pharmacokinetics.
A structurally related new active ingredient with a similar mechanism and sufficient differences for patenting
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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.
A benzene ring, a carboxylic-acid function, and a hydroxyl function
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Salicylic acid, the lead compound of the arylcarboxylic-acid series, contains a benzene ring, a carboxylic-acid function, and a hydroxyl function.
In vitro research, in vivo preclinical development, clinical development, and marketing authorization
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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.
About 10 years and more than one billion euros
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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.
It increases from fewer than 100 to several thousand
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Clinical development uses progressively larger groups, ranging from fewer than 100 subjects in phase I to several thousand in phase III.
Determining maximum tolerated dose and pharmacokinetic behavior
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Phase I examines the maximum tolerated dose, pharmacokinetics, and, when possible, pharmacodynamics, usually in fewer than 100 healthy volunteers.
Phase II
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Phase II evaluates potential efficacy and toxicity, the dose-effect relationship, and the optimal dose in fewer than 500 volunteer patients.
Definition of the indication and support for marketing authorization
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Phase III evaluates the benefit-risk ratio, defines the indication and special populations, and can support marketing authorization.
Pharmacokinetics links dose to concentration, while pharmacodynamics links concentration to effect
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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.
Absorption, distribution, metabolism, elimination
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ADME stands for absorption, distribution, metabolism, and elimination in that order.
Passive diffusion
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Passive diffusion follows a concentration gradient without energy or a transporter and is not saturable. Facilitated diffusion instead uses saturable transporters.
Phase I functionalization followed by phase II conjugation
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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.
Both what is present and how much is present
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Medicine quality requires assessment of quality, safety, and efficacy, while analytical quality control determines both the identity or presence of substances and their quantities.
WHO internationally, Council of Europe through the European Pharmacopoeia, ANSM nationally in France
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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.
To ensure products are manufactured and controlled uniformly according to appropriate standards
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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.
Qualifying and quantifying substances while detecting impurities
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Analytical controls determine what is present, how much is present, identify substances, and detect impurities or related substances above permitted limits.
The physical presentation of a medicine, such as a tablet or ointment
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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.
Intramuscular administration
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Parenteral administration penetrates through the skin and includes intramuscular, intravenous, subcutaneous, and intradermal routes. Oral and nonpenetrating cutaneous administration are not parenteral.
Physicians generally prescribe medicines, while other professionals may prescribe within defined legal scopes
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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.
The marketing authorization, product characteristics, benefit-risk assessment, and relevant patient information
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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.
The prescriber's signature
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An ordonnance must contain several identification and treatment details, and the prescriber's signature must appear immediately below the last line.
A secured ordonnance
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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.
Merke dir die Antworten mit 74 Karteikarten zu Medicinal Product Knowledge.
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.
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