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 -- ua-cam.com/video/9MpYPVtaL00/v-deo.html I don't have any ISS & ISE Pooled data maybe you can create yourself dummy data and practice on it. !!
what a wonderful explanation 🌷🙏🌷
So nice of you !! Welcome !! Thanks for your feedback. 🌷🙏🌷
Thanks madam for bringing very important topic with well explanation 🎉🎉
My Pleasure !! Glad it was helpful !! So nice of you !! Welcome !! Thanks for your feedback.
I am new to SAS programming and you have explained very well.
My Pleasure !! Glad it was helpful !! So nice of you !! Welcome !! Thanks for your feedback.
Thank you for uploading this training class, wonderful explanation and I have learned a lot...
My Pleasure !! Glad it was helpful !! So nice of you !! Welcome !! Thanks for your feedback.
Thanks Varooni ! its very helpful and I got all the necessary information which I required for ISS ISE submission.
My Pleasure !! Glad it was helpful !! So nice of you !! Welcome !! Thanks for your feedback.
Thank you very much mam for uploading very useful information, really wonderful explanation
My Pleasure !! Glad it was helpful !! So nice of you !! Welcome !! Thanks for your feedback.
Wonderful explanation, thank you so much
My Pleasure !! Glad it was helpful !! So nice of you !! Welcome !! Thanks for your feedback.
Thanks a lot for making this video
My Pleasure !! Glad it was helpful !! So nice of you !! Welcome !! Thanks for your feedback.
Thank you for so much for wonderful explanation. Is it possible to get this document or notes from you . Thanks in Advance !!
My Pleasure !! Glad it was helpful !! So nice of you !! Welcome !! Thanks for your feedback.
Thank you a lot, a real Treasure, would it be possible for you to share slide? Thanks again for the wealth of information.
My Pleasure !! Glad it was helpful !! So nice of you !! Welcome !! Thanks for your feedback.
Extremely useful🙂
My Pleasure !! Glad it was helpful !! So nice of you !! Welcome !! Thanks for your feedback. 🙂
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 !!
Gm Mam, will you teach define xml and iss and ise pooled data?
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 -- ua-cam.com/video/9MpYPVtaL00/v-deo.html
I don't have any ISS & ISE Pooled data maybe you can create yourself dummy data and practice on it. !!