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Body & HealthHow it works

How a compound gets from the lab to the pharmacy.

Phase 1: 20–100 healthy volunteers, safety only. Phase 2: a few hundred patients – does it work at all? Phase 3: thousands of patients, compared to placebo or standard care. Only then do regulators like the EMA or FDA review the data. Phase 4 continues after approval. Of 10 candidates entering phase 1, about one makes it.

Useful: “Effective in cell cultures” means the road to the pharmacy is often still ten-plus years.

Source: en.wikipedia.org

MedikamenteZulassung

Difficulty:

Question on this card

What is mainly tested in phase 1 of a clinical trial?

  1. Whether the drug beats placebo
  2. Safety in a few healthy volunteers
  3. The price
  4. Long-term effects after approval
Show the answer

Correct: Safety in a few healthy volunteers

Phase 1 tests tolerability in 20–100 healthy people.

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