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FDA-University of Maryland CERSI Pharmacokinetic Evaluation in Pregnancy Workshop - Shared screen with speaker view
Daphne Guinn
01:20:28
Please provide any questions for the presenter in the Q&A box.
Elimika.Fletcher@fda.hhs.gov
01:26:54
feel free to answer some questions in the Q&A or mark to answer live if prefer
Elimika.Fletcher@fda.hhs.gov
02:03:58
feel free to answer question in Q&A box as we likely will have to skip Q&A time
Daphne Guinn
02:07:05
Please put your questions in the Q&A box.
Amy Cheung
02:22:18
I pressed the button wrong in the Q&A
Amy Cheung
02:22:25
could I answer the question again?
Devante Stephenson
02:24:06
You should be able to click on the answered tab within the Q&A. Go to the question and click type answer.
Daphne Guinn
02:27:00
Presenters, please feel free to respond to the questions in the Q&A box.
Daphne Guinn
02:31:51
Panelists and morning presenters, please raise your hand if you have a comment to contribute to the panel session.
Mary Hebert
02:52:41
There are many situations that we can not assume the PD is the same during pregnancy…e.g. drugs targeted to treat hemodynamic abnormalities.
Gilbert.Burckart@fda.hhs.gov
03:03:53
Regulatory Considerations for theMother, Fetus and Neonate in FetalPharmacology Modeling.Front. Pediatr. 9:698611.doi: 10.3389/fped.2021.698611
Devante Stephenson
03:25:16
The volume is a little low. You will need to turn up the volume on your computer to hear her better. Just a heads up
Daphne Guinn
03:31:37
Please submit your questions to the presenters in the Q&A box.
Daphne Guinn
03:58:50
Please submit your questions to the presenters/panelists in the Q&A box.
Jashvant Unadkat
04:07:34
Dr. Best,The darunavir is a good example of how understanding mechanisms of change in PK or lack thereof could help extrapolate to other drugs.
Daphne Guinn
04:11:34
Panelists - Please raise your hand if you would like to make a comment
Cate Stika
04:40:41
Jash has had his hand up for a while
Sara Quinney
04:51:05
For more information on the MPRINT Hub, please visit mprint.org or e-mail info@mprint.org. I also invite you to attend our annual meeting June 13-14 (virtual), where these conversations will continue.
Jashvant Unadkat
04:53:10
One important point missing in changing dose is the impact on fetal exposure. One way to address the fetal tox issue is to predict fetal exposure using PBPK models and then have the industry do their preclinical tox studies using those reference values so that those studies are informative. Currently they are done without regards to potential fetal exposure. Therefore they are conducted at conc. that are not relevant.
Venkat Raman
04:56:22
Agree Josh. Fetal exposure predicted by modeling is critical to design any tox studies that should be done.