Helmut
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2004-10-05 13:31
(edited by HS on 2004-12-09 21:32)

Posting: # 9
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 Volume of Fluid at Administration [Design Issues]

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
'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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dr_ilesh
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2004-12-12 13:21

@ Helmut
Posting: # 12
Views: 9,758
 

 Volume of Fluid at Administration

Dear Sir

This is very good information regarding water volume for different regulatory agencies. I request to all members/viewer pls. inform this to others and inform to be a member of this forum.

Dr.ILESH
H_Rotter
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Germany,
2004-12-13 11:56

@ Helmut
Posting: # 14
Views: 9,726
 

 Water Consumption in Study

Dear colleagues,

are there also specific guidelines for water 'consumption' in BE studies around?

Thank you,
H. Rotter
Helmut
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2004-12-13 12:46

@ H_Rotter
Posting: # 15
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 some national Guidelines

» […] specific guidelines for water 'consumption' in BE studies

Yes, but only in some guidelines. Moreover, different recommendations for standardization are given.

EU, Australia, and Malaysia:
[…] standardisation of […] fluid intake […] is recommended. Subjects should preferably be fasting at least during the night prior to administration of the products.
All […] fluids taken after the treatment should also be standardised in regard to composition and time of administration during the sampling period. The subjects should abstain from […] drinks, which may interact with circulatory, gastrointestinal, liver or renal function (e.g. alcoholic or xanthine-containing beverages or certain fruit juices).

http://www.fda.gov/cder/guidance/5356fnl.pdf FDA:
Before and during each study phase, we recommend that subjects be allowed water as desired except for 1 hour before and after drug administration […]

Canada:
The administration of […] fluid should be controlled carefully. Normally, subjects should fast for 10 hours before drug administration. A fast means that no food or solids are to be consumed, although alcohol-free and xanthine-free clear fluids are permissible the night prior to the study. On the morning of the study, up to 250 ml of water may be permitted up to two hours before drug administration. […] Two hours after drug administration, 250 ml of xanthine-free fluids are permitted.

New Zealand:
For medicines taken orally, gastrointestinal conditions should be standardised. Subjects should be fasted for at least 10 hours before and 2-4 hours after dosing, or (if more appropriate for the medicine concerned) the dose should be given with or before/after a standardised meal. […] Any fluids taken with the dose should be the same for all subjects.

South Africa:
In fasted studies the period of fasting prior to dosing should be standardised and supervised. All […] fluids taken after dosing should also be standardised in regard to composition and time of administration and in accordance with any specific requirements for each study.

WHO:
Standardization ([…] fluid intake, […], restriction of the intake of alcohol, caffeine, certain fruit juices […] in the time period before and during the study) is important to minimize the magnitude of variability other than in the pharmaceutical products.


Edit: Link corrected for FDA’s new site. [Helmut]

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Helmut
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2005-12-29 14:36

@ Helmut
Posting: # 49
Views: 9,444
 

 Supplement: India

India:
4.1.3. Study Conditions
Standardisation of […] fluid intake […] is important in all studies. Compliance to these standardisations should be stated in the protocol and reported at the end of the study, in order to reassure that all variability factors involved, except that of the products being tested, have been minimised.

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Helmut
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2006-08-11 13:41

@ Helmut
Posting: # 205
Views: 9,319
 

 Update

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)

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Helmut Schütz
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Helmut
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2006-09-22 12:29

@ Helmut
Posting: # 255
Views: 9,337
 

 Update (MZ)

Malaysia
at least 150 ml fluid
http://www.bpfk.gov.my/pdfworddownload/MSIA%20BEguide.pdf (2000)

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Helmut
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2007-07-09 13:58

@ Helmut
Posting: # 873
Views: 8,786
 

 Update

Different volumes (between 100 ml and 250 ml) are recommended in some national guidelines.
An overwiew of updated guidelines is given below:

Japan
water between 100 and 200 ml (normally 150 ml)
http://www.nihs.go.jp/drug/be-guide/GL061124_ganryo.pdf (2006, in Japanese)

Argentina
200-250 ml water
http://www.anmat.gov.ar/normativa/Normativa/Medicamentos/Disposicion_ANMAT_1746-2007.pdf (2007, in Spanish)

South Africa
e.g. 200 ml fluid
http://www.mccza.com/documents/2.06%20Biostudies%20Jun07%20v2.zip (2007)

Cheers,
Helmut Schütz
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