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RegisterEMA: Well done finally [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2011-11-21 19:12 (5334 d 10:07 ago) – Posting: # 7690
Views: 4,624
Hi ElMaestro,
the final version [Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.7.1] was published last Friday (see here, effective with 1 June 2012; comments). After a first look it seems to be OK now.
Some footnotes added on page 8:
4Arithmetic Means (±SD)
tmax3
3 Median (Min, Max)
4 Arithmetic Means (±SD) may be substituted by Geometric Mean (±CV%)
page 10:
Added Biological matrix <e.g. Plasma, Whole Blood, Urine>
Removed Linearity <r>
More detailed information about Matrix Factor requested
‘Plasma’ replaced by ‘Biological matrix’
the final version [Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.7.1] was published last Friday (see here, effective with 1 June 2012; comments). After a first look it seems to be OK now.
Some footnotes added on page 8:
4Arithmetic Means (±SD)
tmax3
3 Median (Min, Max)
4 Arithmetic Means (±SD) may be substituted by Geometric Mean (±CV%)
page 10:
Added Biological matrix <e.g. Plasma, Whole Blood, Urine>
Removed Linearity <r>
More detailed information about Matrix Factor requested
‘Plasma’ replaced by ‘Biological matrix’
—
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
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
Complete thread:
- EMA: Reporting arithmetic means‽ Helmut 2011-04-22 15:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: Reporting arithmetic means‽ ElMaestro 2011-04-23 00:23
- EMA: Reporting arithmetic means‽ Helmut 2011-04-24 15:43
- EMA: Well done finallyHelmut 2011-11-21 18:12
- EMA: Well done finally ElMaestro 2011-11-21 18:43
- EMA: Well done finally Helmut 2011-11-21 21:07
- EMA: Well done finally Ohlbe 2011-11-21 23:07
- yikes! ElMaestro 2011-11-22 10:11
- EMA: Well done finally ElMaestro 2011-11-21 18:43
- EMA: Reporting arithmetic means‽ ElMaestro 2011-04-23 00:23
Ing. Helmut Schütz