Regulatory Sub-Classification of Phase I Studies


A newly issued US FDA Guidance emphasises regulatory flexibility in the case of phase I clinical trials and introduces, and defines, a new term: ‘exploratory Investigational New Drug Application (IND) study’. The three types of study within this definition are microdose studies, studies exploring pharmacological endpoints, and mechanism of action studies relating to issues of drug efficacy. It is proposed that reduced amounts of preclinical documentation might support each type of Exploratory IND Study, although carte blanche is certainly not granted, and some of the concessions may have limited practical value. Issues of immunology and reproductive toxicology are not addressed in the new guidance, and the limitations of this type of regulatory publication (no rights conferred, not binding on any party) are rehearsed.

DOI: 10.2165/00124363-200519010-00002

Cite this paper

@article{Fox2012RegulatorySO, title={Regulatory Sub-Classification of Phase I Studies}, author={Dr Anthony W. Fox}, journal={International Journal of Pharmaceutical Medicine}, year={2012}, volume={19}, pages={3-5} }