Before human testing, drugs undergo in vitro (test tube) and in vivo (animal) testing to assess basic safety and how the drug is metabolized. Clinical Research (The 4 Phases):

The FDA examines all data to determine if the drug's benefits outweigh its risks.

The drug development process in psychiatry is a multi-decade journey characterized by high scientific complexity, significant regulatory hurdles, and a historically low success rate compared to other medical fields.

Researchers identify a "target" in the brain—such as a specific receptor—and design molecules to interact with it.

The development of psychiatric medications typically follows five critical stages:

Psychiatric drug development is notoriously difficult, with only about successfully transitioning from Phase I to approval.