R. W. Johnson Pharmaceutical Research Institute
Overall Score for Pharmacodynamics: +1
Positive Signal: Dysmorphogenesis
1) Therapeutic Index (TI = TD10/ED90) Score = 0
Using numbers available to us for the rat, the following were calculated:
TD = Lowest non-teratogenic dose in the rat = 100 mg/kg
2) Similarity Between Pharmacologic and Toxicologic Mechanisms Score = +1
Dysmorphogenesis is an extension of one of the pharmacological mechanisms of the drug (CA inhibition), but not necessarily an extension of the intended use of the drug
* When the TI10/90 is ? 5, the concern for human risk is enhanced. Conversely, when the TI10/90 is ? 20, concern for adverse human reproductive effects is diminished. Concern for reproductive risks in humans is unchanged when the TI10/90 falls between 5 and 20.