title: Regulatory forum opinion piece*: reversibility groups: the "hows" and "how-nots".
abstract: Adding a few animals to a toxicology study in order to document whether any lesions observed are reversible and at what level is a common practice but it is often unjustified, as most of the findings observed, particularly in the early stages of drug development, are easily categorized in regard to reversibility potential. The scientific application of all knowledge regarding the compound and the lesion in question is necessary to develop specific studies to address reversibility when this is a necessary step.
authors: Pre-Clinical Safety Inc., Niantic, CT 06357, USA. ochoar@pre-clinicalsafety.com
authors: Ricardo
authors: R
authors: Ochoa
mesh_terms: D000818:Animals; D055808:Drug Discovery; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D006801:Humans; D012107:Research Design; D018570:Risk Assessment; D018675:Toxicity Tests / Q000379:methods*