Selection of points for Elimination rate constant [NCA / SHAM]

posted by ryraman2661 – India, 2023-12-23 09:41 (212 d 17:57 ago) – Posting: # 23802
Views: 1,777

Dear All,

Kindly clarify following point.

For AUC(0 to inf) for determination of Kel (elimination rate constant), shall we include Tmax point also for lambda _z lower.

Is there any specific guidance is there to fix lambda z lower or not to take Tmax point

If Tmax point is included for 20 % subjects, will there be any query from regulators.

Both Cmax and AUC(0 to t) are passed.

Subject experts in this forum can kindly give their opinion / advise.

Thanks for your support

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