Egypt: Strange requirements [🇷 for BE/BA]
we have to wait for Yung-jin passing by when it comes to bear.
I have some questions / remarks.
❝ […] new requirements issued by the Bioequivalence committee at the central administration of pharmaceutical affairs (CAPA) at the ministry of health and population in egypt.
Are these requirements available on the net? The latest version I know is of January 2010, which states:
For tmax descriptive statistics should be given. If tmax is to be subjected to a statistical analysis this should be based on non-parametric methods and should be applied to untransformed data.
For parameters describing the elimination phase (t1/2) only descriptive statistics should be given.
❝ […] ANOVA for K (1st order elimination rate constant), t1/2 and tmax for test and reference products;
- Identical clearance after T and R is one of the assumptions in bioequivalence. Think about the basic equation of PK: AUC = F × D / CL.
For two treatments we have a set of two equations with six unknown variables (FT, FR, DT, DR, CLT, CLR) and two constants (AUCT, AUCR). Only if we assume [sic] that DT = DR and CLT = CLR we can eliminate these variables from the equations and end up with a comparison of Fs based on the ratio of observed AUCs. To ask for a comparison of clearances (expressed as k or t½) is strange. Furthermore, CL is a property of the drug not the formulation. In BE we are not interested in that.
BTW, asking for a comparison of both k and t½ demonstrates a lack of understanding of statistics. They differ only by a factor of ln(2). Any comparison will give identical variance, CI, etc.
- ANOVA for tmax doesn’t make sense. Contradicts the next point.
❝ […] also can it perform Kruskal Wallis analysis for tmax…
Kruskal Wallis makes only sense for more than two treatments and will give only a global comparison. IMHO, not very helpful since post-hoc tests for pairwise comparisons with a Bonferroni-adjustment are needed.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- ANOVA for lambdaz, half life and tmax in bear 2.7.7 mahmoud-teaima 2016-07-20 11:03 [🇷 for BE/BA]
- Egypt: Strange requirementsHelmut 2016-07-20 12:25
- Egypt: Strange requirements mahmoud-teaima 2016-07-20 14:12
- Output is not from Phoenix/Winnonlin mittyri 2016-07-20 17:00
- ke versus t1/2 d_labes 2016-07-20 16:05
- ke versus t1/2 Helmut 2016-07-20 16:31
- ke versus t1/2 d_labes 2016-07-21 14:42
- “double“ testing Helmut 2016-07-21 14:54
- ke versus t1/2 d_labes 2016-07-21 14:42
- ke versus t1/2 Helmut 2016-07-20 16:31
- Egypt: Strange requirements mahmoud-teaima 2016-07-20 14:12
- tmax in bear 2.7.7 yjlee168 2016-07-20 21:10
- tmax in bear 2.7.7 mahmoud-teaima 2016-07-20 22:40
- tmax in bear 2.7.7 yjlee168 2016-07-21 11:11
- tmax results in R 3.3.1 and spss 20 on macos 10.11.6 mahmoud-teaima 2016-07-27 12:13
- tmax in bear 2.7.7 yjlee168 2016-07-21 11:11
- tmax in bear 2.7.7 mahmoud-teaima 2016-07-20 22:40
- Egypt: Strange requirementsHelmut 2016-07-20 12:25