Helmut ★★★ ![]() ![]() Vienna, Austria, 2004-10-05 15:31 (7508 d 08:13 ago) (edited on 2004-12-09 21:32) Posting: # 9 Views: 17,443 |
|
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://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] — 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 |
dr_ilesh ● 2004-12-12 14:21 (7440 d 08:23 ago) @ Helmut Posting: # 12 Views: 14,504 |
|
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 ★ Germany, 2004-12-13 12:56 (7439 d 09:48 ago) @ Helmut Posting: # 14 Views: 14,418 |
|
Dear colleagues, are there also specific guidelines for water 'consumption' in BE studies around? Thank you, H. Rotter |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2004-12-13 13:46 (7439 d 08:58 ago) @ H_Rotter Posting: # 15 Views: 14,767 |
|
❝ […] 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). 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] — 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 |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2005-12-29 15:36 (7058 d 07:09 ago) @ Helmut Posting: # 49 Views: 14,078 |
|
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. — 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 |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2006-08-11 15:41 (6833 d 08:03 ago) @ Helmut Posting: # 205 Views: 14,370 |
|
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) — 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 |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2006-09-22 14:29 (6791 d 09:16 ago) @ Helmut Posting: # 255 Views: 14,025 |
|
— 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 |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2007-07-09 15:58 (6501 d 07:46 ago) @ Helmut Posting: # 873 Views: 13,450 |
|
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) — 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 |