Kel Calculation in ANVISA Regulatory [Regulatives / Guidelines]

posted by MGR  – India, 2022-03-21 07:30 (56 d 12:11 ago) – Posting: # 22850
Views: 629

Hi Everyone,

I have done the pharmacokinetic analysis using Phoenix WinNonlin 8.3 (as per ANVISA data published in Manual for Good Bioavailability and Bioequivalence Practices (Vol. 1 Module 3 : Statistical step)). But the calculated kel (Elimination Rate constant) values were not matching with the presented guideline values (Result values were reported in Page No. 12 (Table 1.3 and Table 1.4))

[image]

For further information I have used best fit option in Winnonlin for kel calculation.

The Raw Data is available in Page No. 11 (Table 1.1 and Table 1.2)

[image]

Could anybody help me how to calculate/formula/logic of Kel Value calculations as per ANVISA Regulatory?


Edit: I deleted a later post – you can edit your posts for 24 hours; see also the FAQ #3[Helmut]

Regards,
MGR

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