Hi Joanna,
Usually following the guidelines is the best; however, all programs should be run on a case-by-case basis. I usually run the 2 species parallel to each other.
I hope that helps!
Best regards,
Robin
------------------------------
Robin Guy MS, DABT, RQAP-GLP
Toxicology and GLP Consultant
Robin Guy Consulting, LLC
Lake Forest IL
United States
robinguy@robinguy.com------------------------------
Original Message:
Sent: 02-Nov-2017 10:30
From: Anonymous Member
Subject: selsction of reproduction toxicity studies (EU)
This message was posted by a user wishing to remain anonymous
Dear colleagues,
I'm looking for an advice on drafting up the appropriate non-clinical program that would support the CTA for a 1-year study in patients (phase 2 clinical trial, projected number of subjects: 200 – both men and WOCBP). According to the draft ICH S5 (R3) guideline (paragraph 3.3.3.) performing pEFD study in 1st species and enhanced pEFD or definitive EFD study in 2nd species seems to be sufficient. I'm wondering if it is recommended to follow this draft guideline. Would it be more appropriate (safe) to perform definitive nonclinical development toxicity studies in two species? Is it typical to run the studies in two <g class="gr_ gr_15 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="15" data-gr-id="15">specis</g> in parallel or sequentially?
I'm very much looking forward to your <g class="gr_ gr_13 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="13" data-gr-id="13"><g class="gr_ gr_14 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="14" data-gr-id="14">advices</g></g>.
Best regards,
Joanna