Successful Drug Development Despite Adverse Preclinical Findings Part 1: Processes to Address Issues and Most Important Findings

@inproceedings{Ettlin2010SuccessfulDD,
  title={Successful Drug Development Despite Adverse Preclinical Findings Part
                    1: Processes to Address Issues and Most Important Findings},
  author={Robert A. Ettlin and Junji Kuroda and Stephanie Plassmann and David E. Prentice},
  booktitle={Journal of toxicologic pathology},
  year={2010}
}
Unexpected adverse preclinical findings (APFs) are not infrequently encountered during drug development. Such APFs can be functional disturbances such as QT prolongation, morphological toxicity or carcinogenicity. The latter is of particular concern in conjunction with equivocal genotoxicity results. The toxicologic pathologist plays an important role in… CONTINUE READING