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RegisterUpdate [Design Issues]
posted by Helmut 
– Vienna, Austria, 2006-08-11 15:41 (7263 d 12:27 ago) – Posting: # 205
Views: 17,245
Different volumes (between 100 ml and 250 ml) are recommended in national and international guidelines.
An overwiew of updated guidelines is given below:
Brazil
200 ml liquid (generally water)
http://e-legis.anvisa.gov.br/leisref/public/showAct.php?id=21746 (2006)
South Africa
e.g. 200 ml fluid
http://www.mccza.com/documents/2.06%20Biostudies%20Jun06%20v2.zip (2006)
WHO
150-250 ml water
http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf (2006)
Saudi Arabia
sufficient fluid
http://www.sfda.gov.sa/NR/rdonlyres/6A114B70-4201-46EF-B4C7-127FD66D3314/0/BioequivalenceRequirementGuidelines.pdf (2005)
PAHO-States
240 ml (8 fluid ounces) water
http://www.paho.org/Spanish/AD/THS/EV/BE-EDITEDVERSION-AUG2004.pdf (2004)
ASEAN-States
at least 150 ml fluid
http://www.bpfk.gov.my/pdfworddownload/drug/ASEAN%20GUIDELINES%20FOR.pdf (2004)
Thailand
at least 150 ml fluid
http://wwwapp1.fda.moph.go.th/be/guideline/Thailand%20BABE%20guideline.doc (2004)
An overwiew of updated guidelines is given below:
Brazil
200 ml liquid (generally water)
http://e-legis.anvisa.gov.br/leisref/public/showAct.php?id=21746 (2006)
South Africa
e.g. 200 ml fluid
http://www.mccza.com/documents/2.06%20Biostudies%20Jun06%20v2.zip (2006)
WHO
150-250 ml water
http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf (2006)
Saudi Arabia
sufficient fluid
http://www.sfda.gov.sa/NR/rdonlyres/6A114B70-4201-46EF-B4C7-127FD66D3314/0/BioequivalenceRequirementGuidelines.pdf (2005)
PAHO-States
240 ml (8 fluid ounces) water
http://www.paho.org/Spanish/AD/THS/EV/BE-EDITEDVERSION-AUG2004.pdf (2004)
ASEAN-States
at least 150 ml fluid
http://www.bpfk.gov.my/pdfworddownload/drug/ASEAN%20GUIDELINES%20FOR.pdf (2004)
Thailand
at least 150 ml fluid
http://wwwapp1.fda.moph.go.th/be/guideline/Thailand%20BABE%20guideline.doc (2004)
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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 Administration Helmut 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
- UpdateHelmut 2006-08-11 13:41
- Update (MZ) Helmut 2006-09-22 12:29
- Update Helmut 2007-07-09 13:58
Ing. Helmut Schütz