How Does Preclinical Research Translate to Human Studies?
The main goal of preclinical research is to gather enough evidence to support the transition to clinical trials. This involves several steps:
1. Proof of Concept: Initial studies demonstrate that a treatment has the desired effect in vitro or in animal models. 2. Dose-Response Relationship: Determining the optimal dose that produces the desired effect without causing unacceptable side effects. 3. Safety Profile: Comprehensive toxicology studies to ensure the treatment is safe for use in humans. 4. Regulatory Submission: Compiling the data into a regulatory submission (such as an Investigational New Drug application) to seek approval for human testing.
