thank you so much Ms. Varooni to understand in a broader level. I have some questions would you mind to make me understand those. as far as my knowledge every successful study need to pass all 4 levels of clinical trials(I-Iv). in this life cycle where does the ISS and ISE occurs. and how to collect the multiple study data for a single NDA. Does it mean for every NDA the studies should occur in multiple level, and does the same sponsor will conduct all the studies or how. Please, explan.
My Pleasure !! Glad it was helpful !! So nice of you !! Welcome !! Thanks for your feedback. Welcome Sir !! Sure, I can answer your questions. Yes, that's correct every successful study need to pass all 4 levels of clinical trials phases ( I - IV ). ISS / ISE studies facilitate broad views of the investigational product’s overall efficacy and safety profiles. ISS / ISE are required by the USFDA as a critical component in NDA submission. The ISE and ISS are detailed integrated analyses of all relevant data from the clinical study reports that belong on Module 5 in the Electronic Common Technical Document Structure Defined by FDA. Sponsor evaluates, determines and decides which individual studies will be part of the NDA submission. You will understand better practically if you get opportunity to work on ISS / ISE studies. Only when you work practically on ISS / ISE studies all your questions will be answered automatically !!
Yes, will see define.xml in future and will inform all when it's video is ready. For the ISS & ISE Pooled Data I have already explained the structure and strategy for creating ISS & ISE pooled data in SAS Programming Challenges in ISS & ISE -- ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-9MpYPVtaL00.html I don't have any ISS & ISE Pooled data maybe you can create yourself dummy data and practice on it. !!
