Preclinical Studies

The stage of drug development conducted before human clinical trials, encompassing in vitro assays, in vivo animal studies, and computational modeling to evaluate safety, efficacy, pharmacokinetics, and toxicology. Required to file an Investigational New Drug (IND) application. Must comply with Good Laboratory Practice (GLP) standards for regulatory submissions.

Exemples

• 28-day repeat-dose toxicology in rats and dogs
• GLP pharmacokinetic studies for IND filing
• Efficacy studies in patient-derived xenograft (PDX) models