Well designed and meticulously implemented preclinical toxicology studies are crucial for the success of any drug development program. Pre-clinical toxicology studies should reliably assess the safety of new drug entities, thus building a multi-faceted understanding of compounds to lay the groundwork for clinical trials and regulatory approval. The objectives of preclinical toxicology studies are as follows:

• Identify toxicity/delayed effects/reversibility in the target organ(s)
• Identify appropriate parameters to monitor in the clinic
• Identify potentially “at-risk” populations
• Determine NOAEL (no observed adverse effect level) and MTD (maximum tolerated dose)
• Determine the initial safe starting dose for phase 1 clinical trials