Question

For a Phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure?

Answer 1

Answer: Preclinical data

Explanation: Preclinical data are information or reports of studies conducted on a patient or animals before commencement of treatment using a new drug. This data are gotten from medical tests or in the laboratory by trying the new drug using laboratory Animals such as Mice,White Rats etc. The main reason for conducting Pre-clinical trial is to understand the toxicity,safety and effectiveness of the new drug.