What type of studies are involved in preclinical testing for FDA approval?

Preclinical testing for FDA approval primarily involves animal studies. This phase is crucial for determining the safety and efficacy of a new drug or medical device before it can be tested in humans. In these studies, researchers assess how the product behaves in a living organism, including its pharmacokinetics, pharmacodynamics, and potential toxic effects.

Animal studies allow researchers to gather vital data regarding the biological effects and safety profile of the product, which helps inform the next steps in the development process, including whether to proceed to human clinical trials. This approach is essential as it provides an initial assessment of how a treatment might work in humans without exposing human subjects to untested compounds.

Other types of studies, such as human studies, occur only after preclinical testing and are part of the clinical trial phases. Anecdotal studies do not provide the rigorous data required for regulatory approval, and market surveys are unrelated to the scientific evaluation of product safety and efficacy. Thus, animal studies are the appropriate answer for the context of preclinical testing in the FDA approval process.