| Obtaining human data earlier in development can better guide the appropriate selection and advancement of drug candidates with a higher probability of success in initial Phase I trials. The United States Food and Drug Administration and the European Medicines Evaluation Agency have recently issued regulatory guidelines that now allow administration of compounds to humans at sub-pharmacological doses at a very early stage of drug development. Drug candidates can now be tested in humans prior to traditional Phase I trials via the exploratory IND (eIND) route.
Corsidus is at the forefront of this paradigm shift in early drug development. Our expertise in the application of accelerator mass spectrometry to human microdose studies can improve the quality of development decisions by providing exploratory human ADME and PK data before large financial investments are made for full preclinical safety/toxicology studies and traditional Phase I trials. |
