Science vs. regulations [Regulatives / Guidelines]

posted by qualityassurance – Jordan, 2020-04-23 14:11  – Posting: # 21345
Views: 3,598

Dear Helmut and all,

Hope everyone is good and safe.

The same query raised by MoH and i want to answer. Could you help me?

» IR or MR formulation? If MR, DR or CR?
IR

» Pilot studies performed? If yes, outcome?
No

» Sampling planned based on average t½ from the literature? If yes, please give x±SD and sample size in your study.
The last two time point was 24.00 & 48.00. It was planned based on PARs (12.00 & 24.00 was the last time point in two PARs). 36 subjects

» Observed t½ (x±SD, range)?
For reference (10.03 ±4.09, 3.5-19.0)
For test (9.2 ±2.96, 3.22-17.0)

» tmax, tlast?
For reference: Tmax: 0.67, Tlast: 28.25
For test: Tmax: 0.50, Tlast: 23.91

Forgive me for the formatting. I tried my best.
Regards.

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