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Hi
I have a specific query on the RLD and the how is this being decided
is their any reference in this regard.
If yes and in case of some drugs is it possible that if it follows
linear pharmacokinetics all the strengths are RLDs. In case of drugs
that follow non linear pharmacokinetics only the highest strength is
the RLD.
Can a company which has listed a drug from time to time change the RLD
status of its formulation.
regards
kathy
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The following message was posted to: PharmPK
Hi,
Specifically to the last part of your query "Can a company which has
listed a drug from time to time change the RLD
status of its formulation", I came across one example of Coreg, where
the RLD was changed from 25mg (the highest dose) to 12.5mg. Another
example, I think was Lemictal where 200mg RLD status was withdrawn and
the new RLD is the 25 mg dose(the lowest strength).
Now this remains a question whether FDA is suggesting these changes
(keeping in mind the safety of healthy volunteers) or the companies are
proposing these changes based on some valid reasons.
Hope this helps.
Regards
Manoj K. Paruthi
Manager, R&D
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