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.

USDA Policy #3 (Nov 7, 2007) requires the use of pharmaceutical compounds in animals, specifically covered species.  Interested in how other pharmaceutical companies and CROs are handling this new guideline with respect to any and all compounds other than NCEs or NBEs that are administered.  Materials used for analgesia, anesthesia, euthanasia and any animal health medications would most certainly be pharmaceutical grade, but what about reference compounds, competitor compounds and various pharmacological tool compounds used in the performance of many assays?

Do you have questions or comments about various topics in Safety Pharmacology, but did not know how to get feedback?  Or share ideas with other safety pharmacologists?  What can you do to get a timely answer to your question, or issue?  The new  Safety Pharmacology Society blog (aka SPeak) may be an ideal way to post your question, and get comments from members of the safety pharmacology community.

Have you blogged before?  If not, do not be afraid!  “Blog” is an abbreviation for “web log” or “weblog”, which is a term to describe a website that maintains or chronicles information.  How many safety pharmacology blogs are there?  That is unknown, but SPeak is the official blog established by the Safety Pharmacology Society for the benefit of its members.

So, do you have a question, topic or issue that needs to be discussed?  Consider posting your item (aka content) to this blog, and take advantage of the collective wisdom and experience of the membership.  We could all learn something.

If you have participated in a blog previously, especially a science-based forum, please post a comment and share your experience.

What makes a blog successful?  Good content and participation….so, SPeak UP!!