From: Requirements for a lead compound to become a clinical candidate
Information | Details |
---|---|
Chemistry, Manufacturing and Control (CMC) | Compound with acceptable stability and formulation |
 | Controlled production under cGMP (current Good Manufacturing Processes) |
Absorption, distribution, metabolism and excretion (ADME) | Route of administration, half-life |
 | Metabolic pathways |
 | Potential drug-drug interactions (including effects on cytochrome P450 enzymes) |
Toxicology | Systemic and organ toxicity: gross and microscopic changes; two animal species, covering time periods of intended human exposure |
 | Estimated safety window between efficacious dose and 'no observed adverse effect level' (NOAEL) |
 | Initial data on potential genotoxicity and cardiotoxicity |
Mechanism of action and pharmacology | Effects on receptor in vitro |
 | Efficacy in animal models in vivo |
Clinical development plans | Detailed protocol of initial studies |