Difference between actual and published PK parameters [Study As­sess­ment]

posted by dshah  – India/United Kingdom, 2022-02-15 16:26 (789 d 20:36 ago) – Posting: # 22784
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Dear Loky do!

❝ does this biphasic nature affect the practical obtained half life of the drug? and is this nature could affect the drug variability?


The biphasic nature (compartmental analysis) would not affect your outcome for BE as NCA is recommended by regulatory bodies. Although as per AusPAR- there is no significant impact of age and Race, your half-life is different than the reported one. Kindly refer pg 27-34 of AusPAR.

Regards,
Dshah

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