mmw ☆ India, 2014-09-16 13:16 (3481 d 23:32 ago) Posting: # 13518 Views: 4,812 |
|
Dear all, I have one query regarding steady state bio equivalence study of Tramadol SR 200 mg tablets. In public assessment report of Tramadol in which post-dose 12 hours sample was taken on day 1 to 4. link: http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con140629.pdf Also a bioequivalence study done in India; 12 hours post dose sample was collected on day 1 to 4. (Comparative bioequivalence studies of tramadol hydrochloride sustained-release 200 mg tablets - Accutest, India) I want to know that what is significance of 12 hours post dose sample collection on day 1 to 4. However guidelines states that “In multiple-dose studies, the pre-dose sample should be taken immediately before (within 5 minutes) dosing and the last sample is recommended to be taken within 10 minutes of the nominal time for the dosage interval to ensure an accurate determination of AUC(0–τ).” I want to understand that why 12 hours post dose sample was collected from day 1 to 4. |
nobody nothing 2014-09-16 15:21 (3481 d 21:27 ago) @ mmw Posting: # 13521 Views: 3,847 |
|
❝ I want to understand that why 12 hours post dose sample was collected from day 1 to 4. ...to compare it to Ctau,ss from the EU MR guideline? — Kindest regards, nobody |
Helmut ★★★ Vienna, Austria, 2014-09-16 15:27 (3481 d 21:21 ago) @ mmw Posting: # 13522 Views: 3,877 |
|
Hi mmw, without knowing the studies’ protocols it is just guess-work. Sometimes studies contain a lot of exploratory stuff (mine do). The posology’s dosing interval is 12 hours (amazingly the PAR does not state the τ applied in the study). Maybe they were aware of the ongoing discussions of EMA’s MR-GL. Cτ in SD (here day 1) was suggested as a predictive metric of MD-performance. I was to lazy to check at which time-point they quantified Cmin on day 5 (I guess 24 hours post dose). C12 would be interesting as well, since this is the intended dosing interval. BTW, why they sampled >24 hours in steady state is beyond my intellectual reach. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
jag009 ★★★ NJ, 2014-09-16 18:34 (3481 d 18:14 ago) @ Helmut Posting: # 13524 Views: 3,915 |
|
Hi Helmut, ❝ BTW, why they sampled >24 hours in steady state is beyond my intellectual reach. Some sample > 24 hrs to capture the half-life, yes the half-life at steady state. I know some old timers and they like running steady state studies with the sampling time pts beyond the dosing interval so to obtain the half-life, for NDA purpose. John |