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RegisterDifference between actual and published PK parameters [Study Assessment]
Dear Loky do!
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
❝ 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
Complete thread:
- Difference between actual and published PK parameters Loky do 2022-02-14 16:06 [Study Assessment]
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- Difference between actual and published PK parameters Helmut 2022-02-14 17:30
- Difference between actual and published PK parameters Loky do 2022-02-15 13:20
- Difference between actual and published PK parametersdshah 2022-02-15 15:26
- Difference between actual and published PK parameters Loky do 2022-02-15 15:48
- Difference between actual and published PK parameters Helmut 2022-02-15 15:56
- Difference between actual and published PK parametersdshah 2022-02-15 15:26
- Difference between actual and published PK parameters Loky do 2022-02-15 13:20
- Difference between actual and published PK parameters dshah 2022-02-14 18:39
- Difference between actual and published PK parameters ElMaestro 2022-02-14 23:09
- Difference between actual and published PK parameters Helmut 2022-02-14 17:30
Ing. Helmut Schütz