Dear all,

Do you know any CRO which has good experience with telemetered rabbits in Europe?

What is the success rate for CV risk translation from rat telemetry to dog telemetry (both true positives and true negatives)?

We are currently looking for an established peripheral arterial occlusive disease (PAOD) model and if possible contract labs who have experience with it.  Your help would be much appreciated.

Mark

Dear members

I would like to hear your thoughts on what safety margins you believe we need when evaluating results from ex vivo action potential recordings (e.g. GP papillary muscle APD90).

Any references would also be greatly appreciated.

Also, how big an effect do you consider to be relevant?

Best regards, Morten - H. Lundbeck A/S

Does anybody know a method to study the effects of compounds on gap junctions?

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.

I’m looking for input regarding the outsourcing of abuse liability testing.  I’m curious as to which models are being used and which contract organizations have offerings and experience in this area.

In models where in-vivo tests are monitored over days and not hours, a tremendous amount of data is generated. How are other researchers handling these large databases and what tools are used to select the subsets of the total data set for analysis?

Does anyone have any suggestions for in vitro or in vivo models to evaluate the potential for a drug to cause pericarditis?

How do others handle the issue of loosing a telemetry animal in a 4×4 Latin square design. For example if you loose one animal after two doses and still have two additional dosing periods.

What is the current practice in the industry when this occurs? One suggestion was to substitute in an animal and simply finish out the study in the normal 4 doses. Another was to substitute in an animal and give 4 more doses. Yet another is to continue on with missing cells. What is your opinion or experience?

I would also like to get the perspective on how you feel these options might impact the statistics.