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The following message was posted to: PharmPK
Greetings. I have been asked to perform PK simulations to support a
proposed change in the dosing labeling of the prescribing
information. The compound is a short-acting parenteral compound.
The Guidances on Exposure-Response, Labeling, and PK submissions do
not directly address this issue. May I inquire from the group:
1. Are you aware of other drugs for which the dosing information was
modified based upon simulations?
2. I would anticipate that following the sims, a confirming clinical
trial would be required by the FDA. Does anyone disagree?
3. Most importantly, what level of evidence would the FDA require
from the PK/PD simulations for a labeling change? I plan to try to
show that the revised administration guidelines are simpler yet fall
within the existing method's Conc x T profile.
4. Other suggestions or observations?
Take care, and thanks in advance.
Paul R. Hutson, Pharm.D.
UW School of Pharmacy
777 Highland Avenue
Madison WI 53705-2222
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Hi Paul -
I have some experience with this with a couple of regulatory bodies -
but it has been several years and well before the more recent
advances in model validation etc. Could I suggest that you set up a
telecon with the FDA? Make sure that Joga is involved. We have
found that it is best to talk with folks rather than trying to
anticipate what they want - and have almost always found the
discussions to be very helpful in clarifying the issues.
Hope all is well with you.
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