Table 2

Information needed to support request for clinical testing of a drug candidate (IND filing to FDA).

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


FDA, Food and Drug Administration; IND, Notice of Claimed Investigational Exemption for a New Drug.

Hefti BMC Neuroscience 2008 9(Suppl 3):S7   doi:10.1186/1471-2202-9-S3-S7

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