Science vs. regulations [Regulatives / Guidelines]

posted by qualityassurance – 2020-04-23 16:11 (1459 d 00:43 ago) – Posting: # 21345
Views: 16,149

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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