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The following message was posted to: PharmPK
Dear Group
Kindly provide me of any FDA guideline that describes the retesting
procedure in case of outliers in BA-BE studies. Any literature
related to
this issue may also help
Thanks in advance
Isra' Admour, M.Sc Pharm
Regualtory Affairs Director
International Pharmaceutical Research Center (IPRC)
Tel: +962-6-5627651/52/48 (ext. 225)
PO Box 963166, Amman11196, Jordan
www.iprc.com.jo
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The following message was posted to: PharmPK
Dear Isra,
aside from rumours spreading at numerous BA/BE conferences
about retesting of outlying subjects (including a 'reasonable'
number of subjects who showed 'normal' values in the main study),
I don't think there is an official guideline issued by the FDA
covering this topic.
If you don't have rules specified in the protocol a-priori,
your chances are low - it may look like data-mining.
Some further reading from Canada:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/bio/
sacbb_rop_ccsbb_crd_2001-11-15_e.html
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/bio/
sacbb_rop_ccsbb_crd_2004-06-03_e.html
best regards
Helmut
--
Helmut Schuetz
BEBAC
Consultancy Services for Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna/Austria
tel/fax +43 1 2311746
http://BEBAC.at
Bioequivalence/Bioavailability Forum at http://forum.bebac.at http://
www.goldmark.org/netrants/no-word/attach.html
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