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RegisterVolume of Fluid at Administration [Design Issues]
posted by Helmut 
– Vienna, Austria, 2004-10-05 15:31 (7935 d 21:31 ago) – Posting: # 9
Views: 20,830
(edited on 2004-12-09 21:32)
Different volumes (between 100 ml and 250 ml) are recommended in national guidelines.
An overwiew is given below:
European Union
150 ml water
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003008.pdf
Australia (EU Guideline adopted)
150 ml water
http://www.tga.gov.au/docs/pdf/euguide/ewp/140198entga.pdf
Canada
150 ml water
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/bio-a_e.pdf
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/bio-b_e.pdf
WHO
150 ml fluid
http://www.who.int/medicines/library/qsm/manual-on-marketing/who-dmp-rgs-985.doc
Japan
100–200 ml water (normally 150 ml)
http://www.nihs.go.jp/drug/be-guide(e)/Generic/be97E.pdf
Malaysia
at least 150 ml fluid
http://www.bpfk.gov.my/pdfworddownload/MSIA%20BEguide_part1.pdf
Brazil
200 ml liquid (generally water)
http://www.anvisa.gov.br/hotsite/genericos/legis/resolucoes/478_02re_e.htm
South Africa
200 ml fluid
http://www.mccza.com/documents/2.06%20Biostudies%20Dec%2003%20v1.zip
USA
8 fl ounces (237 ml) water
http://www.fda.gov/cder/guidance/5356fnl.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf
http://web.archive.org/web/20150226060249/http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf
http://www.fda.gov/cder/guidance/5194fnl.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf
Korea
240 ml water
Minimum Requirements for BE Test
Mexico
250 ml water
http://www.farmacopea.org.mx/legisla/legal28.asp
New Zealand
standardized (no volume stated)
http://www.medsafe.govt.nz/downloads/vol1.doc
A short discussion of this topic took place in a thread at David Bourne's PK/PD-List in 2004. If the direct link does not work due to changes in the file structure, try a search at http://www.google.com/search?&q=site:www.boomer.org/pkin/ with the keywords
'
Edit: Links corrected for FDA’s new site; EMA's GL removed from the website - download link added. [Helmut]
An overwiew is given below:
European Union
150 ml water
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003008.pdf
Australia (EU Guideline adopted)
150 ml water
http://www.tga.gov.au/docs/pdf/euguide/ewp/140198entga.pdf
Canada
150 ml water
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/bio-a_e.pdf
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/bio-b_e.pdf
WHO
150 ml fluid
http://www.who.int/medicines/library/qsm/manual-on-marketing/who-dmp-rgs-985.doc
Japan
100–200 ml water (normally 150 ml)
http://www.nihs.go.jp/drug/be-guide(e)/Generic/be97E.pdf
Malaysia
at least 150 ml fluid
http://www.bpfk.gov.my/pdfworddownload/MSIA%20BEguide_part1.pdf
Brazil
200 ml liquid (generally water)
http://www.anvisa.gov.br/hotsite/genericos/legis/resolucoes/478_02re_e.htm
South Africa
200 ml fluid
http://www.mccza.com/documents/2.06%20Biostudies%20Dec%2003%20v1.zip
USA
8 fl ounces (237 ml) water
http://web.archive.org/web/20150226060249/http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf
Korea
240 ml water
Minimum Requirements for BE Test
Mexico
250 ml water
http://www.farmacopea.org.mx/legisla/legal28.asp
New Zealand
standardized (no volume stated)
http://www.medsafe.govt.nz/downloads/vol1.doc
A short discussion of this topic took place in a thread at David Bourne's PK/PD-List in 2004. If the direct link does not work due to changes in the file structure, try a search at http://www.google.com/search?&q=site:www.boomer.org/pkin/ with the keywords
'
bioequivalence volume european guideline'.Edit: Links corrected for FDA’s new site; EMA's GL removed from the website - download link added. [Helmut]
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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:
- Volume of Fluid at AdministrationHelmut 2004-10-05 13:31 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Volume of Fluid at Administration dr_ilesh 2004-12-12 13:21
- Water Consumption in Study H_Rotter 2004-12-13 11:56
- some national Guidelines Helmut 2004-12-13 12:46
- Supplement: India Helmut 2005-12-29 14:36
- some national Guidelines Helmut 2004-12-13 12:46
- Update Helmut 2006-08-11 13:41
- Update (MZ) Helmut 2006-09-22 12:29
- Update Helmut 2007-07-09 13:58
Ing. Helmut Schütz