What are the Phases of a Toxicology Clinical Trial?
Toxicology clinical trials typically follow a structured framework similar to other clinical trials, with some unique considerations:
Preclinical Phase: This phase involves in vitro and in vivo studies to assess the initial safety profile and potential toxic effects in animal models. Phase 1: Conducted on a small group of healthy volunteers to determine the safe dosage range and identify any acute adverse effects. Phase 2: Focuses on a larger group to further evaluate safety and begin assessing the effectiveness of the intervention. Phase 3: Expands the participant pool to confirm the safety and efficacy, monitoring for any long-term adverse effects. Phase 4: Post-marketing surveillance to detect any rare or long-term side effects in the general population.
