Science vs. regulations [Regulatives / Guidelines]

posted by qualityassurance – 2020-04-23 16:11 (1864 d 09:12 ago) – Posting: # 21345
Views: 22,485

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.

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,676 registered users;
46 visitors (0 registered, 46 guests [including 37 identified bots]).
Forum time: 01:24 CEST (Europe/Vienna)

Nerds don’t just happen to dress informally.
They do it too consistently.
Consciously or not, they dress informally
as a prophylactic measure against stupidity.    Paul Graham

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5