| Compound Efficacy Studies | |||||
When developing an animal model to test its efficacy of a compound, what are your concerns? |
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Compound efficacy is often measured in vitro by the activity in specific cell lines. Later, selected compounds are tested in vivo. Pathologic examination, including microscopic analysis, immunohistochemistry, in situ hybridization, and morphometric analysis should be an integral part of the in vivo evaluation of candidate compounds. |
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| 1. Apoptosis or programmed cell death (arrows). 2. Mitoses (arrows) and nuclear atypia or variation in nuclear size and shape, prominent nucleoli, and sparse chromatin. 3. Neoplastic multilayered mammary epithelium (arrow) and inflammatory reaction surrounding it. 4. Single-layered mammary epithelium (arrow) and eosinophilic secretion. |
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This goes beyond the routine GLP (good laboratory practice) pathologic evaluation demanded by FDA for approval. However, this evaluation can significantly contribute to the discovery process by shedding light into the mechanism of activity of the compound. |
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