Hi Everyone,
I am wondering if anyone has experience formulating a dose justification for a molecule that had no PK data?
PK data isn't available due to bioanalytical challenges and that means no surrogate (metabolite, etc) for any of the PK.
PD is available, also are clinical efficacy and safety.
I would appreciate if you can share your experience or any publication that demonstrated robust dose justification without any PK data.
Thank you!!!
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Jong Bong Lee
Associate Director
Novartis
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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