Webinar

I found the Webinar on ICH S9 very interesting and informative. The Panel discussion was particularly interesting to me. There seems to be a preference for rolling large molecule work into the Toxicology studies. Here are my questions.

1) If we perform Cardiovascular, CNS and Respiratory studies in toxicology studies, should the model all be tested with positive controls to indicate that the study design would detect an effect if it was present?

2) Are the standards for sensitivity the same for these add-ons to Toxicology studies the same as for safety pharmacology?

3) What would be a reasonable positive control study to show the sensitivity and specificity?

I look forward to your insights.