Science vs. regulations [Regulatives / Guidelines]

posted by qualityassurance – Jordan, 2020-04-23 14:11 (388 d 09:34 ago) – Posting: # 21345
Views: 10,586

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:

Activity
 Admin contact
21,462 posts in 4,487 threads, 1,514 registered users;
online 7 (0 registered, 7 guests [including 2 identified bots]).
Forum time: Sunday 23:46 CEST (Europe/Vienna)

Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body.    Leslie Z. Benet

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