Start with the population
A study in healthy volunteers, a disease population, animals, or cells answers different questions.
Checklist
Check the comparator
A controlled trial tells you more than an open-label study, case report, or anecdote.
Separate route and formulation
Evidence for one route does not automatically apply to another route, such as topical, oral, intranasal, IV, or injectable use.
Keep outcomes specific
Mechanism markers, surrogate endpoints, symptoms, imaging, and hard clinical outcomes answer different questions.
Sources
- 1.
FDA. Compounding and the FDA: Questions and Answers 2026.
Accessed 2026-06-08.
FDA explains that compounded drugs are not FDA-approved and that FDA does not verify their safety, effectiveness, or quality before marketing.