When the FDA Animal Rule, or Animal Efficacy Rule, became law in 2002, it created a pathway for assessing the safety and efficacy of drugs and biological products for “serious or life-threatening conditions caused by exposure to lethal or permanently disabling substances” when human clinical trials are not ethical or feasible.
Stem cell therapy has advanced significantly over the last decade. In particular, it has shown promising results in regenerating cells in certain tissues of critical importance for life but limited natural ability to regenerate, including the central nervous system and myocardium.
Are you considering the addition of immunohistochemistry (IHC) to your preclinical toxicology study design? IHC integrates molecular pathology and traditional histopathology to allow the visualization of test compounds or cellular targets in situ.
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