Glossary
Medical glossary
Package leaflets, registers and news about medicines use words that are rarely explained in plain language. Here they are grouped by stage of the journey — from research to the pharmacy — and explained briefly, without examples of specific products and without medical advice.
You don't need to understand the word "bioequivalence" to get treatment. But it helps you stay calm when the package at the pharmacy turns out to be different.
Research
- Preclinical research
- Study of a substance in the lab before it is tested in people.
- Clinical trial
- Study of a medicine involving volunteers, following an approved plan and under medical supervision.
- Trial phase
- A stage of clinical testing: I — safety in a small group, II — effectiveness and regimen, III — large comparative studies, IV — monitoring after registration.
- Placebo
- An inactive product that looks like the one being studied; it is used for comparison to separate the medicine's effect from expectations.
- Informed consent
- A document in which a participant confirms that the aims, procedure and risks of the study have been explained and that they agree voluntarily.
Registration and names
- INN
- International Nonproprietary Name — the generally accepted name of an active substance, which belongs to no company.
- Brand name
- The name under which a manufacturer markets its product; one active substance can have several.
- Government registration
- A government decision, made after expert review, that a medicine may be used and sold in the country.
- GRLS
- Russia's State Register of Medicines, kept by the Russian Ministry of Health; it shows whether a medicine is registered in Russia. Other countries keep their own registers.
Originator and generic
- Originator medicine
- A medicine first developed and studied through the full cycle of research.
- Generic
- A medicine with the same active substance as the originator, made by a different manufacturer.
- Bioequivalence
- A generic's correspondence to the originator, confirmed by studies, in how the active substance enters the body.
- Active substance
- The component the medicine is made for; the other components help preserve it and make it possible to take.
Quality and distribution
- Falsified medicine
- A fake passed off as a genuine medicine, with false information about its composition, origin or manufacturer.
- Substandard medicine
- A product that does not meet the established requirements, for example because of errors in manufacturing or storage.
- Batch
- A quantity produced in one manufacturing cycle; its number is shown on the package.
- Storage conditions
- Requirements for temperature, humidity and light that must be met along the medicine's entire journey.
- Prescription-only dispensing
- A rule under which a pharmacy supplies a medicine only on presentation of a doctor's prescription.
- Pharmacovigilance
- Collecting and analysing information about the adverse effects of medicines after they have gone on the market.
Where these words appear in the reference
- How it works
How development, registration and oversight, manufacturing and storage of medicines work — without names or regimens.
- Research
How to read news about a "new drug" and about clinical trials without mistaking a headline for a conclusion.
- Safety
How to avoid fakes: checking a pharmacy, warning signs and habits that protect you from falsified medicines.
- Questions
What to ask a doctor and pharmacist about prescribed treatment, a different package and taking part in trials.
Related sections
- How it works
How development, registration and oversight, manufacturing and storage of medicines work — without names or regimens.
- Research
How to read news about a "new drug" and about clinical trials without mistaking a headline for a conclusion.
- Sources
Which official materials the reference relies on, what it leaves out and why much of it is written in general terms.
Sources
- State Register of Medicines (Ministry of Health of Russia)
- Roszdravnadzor (Russian federal health-care watchdog)
- WHO — substandard and falsified medical products
Information is current as of the preparation date. Rules for registering medicines and selling them at a distance change from time to time, so check the official registers — in Russia, those of the Ministry of Health and Roszdravnadzor; elsewhere, your national medicines regulator — and ask a doctor or pharmacist about treatment.