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RegisterFed-fasted BE studies using different polymorphs [Regulatives / Guidelines]
Dear London and Helmut,
Independently of the guideline, for EU submissions Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, requires that all clinical trials conducted on the product be submitted, whether positive or negative.
A lot of fuss has been made about this paragraph in the draft EU guideline. There was nothing new in it: this requirement is in place since at least 1975 (Annex to Directive 75/318/EC).
Regards
Ohlbe
❝ ❝ [...] the fasted study will be repeated.
❝
❝ Danger! I would say that the part about mandatory submission of all studies from the 2008 BE drafted guideline will survive and make it to the final version.
Independently of the guideline, for EU submissions Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, requires that all clinical trials conducted on the product be submitted, whether positive or negative.
A lot of fuss has been made about this paragraph in the draft EU guideline. There was nothing new in it: this requirement is in place since at least 1975 (Annex to Directive 75/318/EC).
Regards
Ohlbe
Complete thread:
- Fed-fasted BE studies using different polymorphs london12 2009-08-25 14:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fed-fasted BE studies using different polymorphs Helmut 2009-08-27 00:44
- Fed-fasted BE studies using different polymorphsOhlbe 2009-08-31 01:34
- Submission of 'failed' studies Helmut 2009-08-31 15:36
- Submission of 'failed' studies Ohlbe 2009-08-31 23:01
- Submission of 'failed' studies Helmut 2009-08-31 15:36
- Fed-fasted BE studies using different polymorphs qualityassurance 2023-08-03 10:44
- Fed-fasted BE studies using different polymorphsOhlbe 2009-08-31 01:34
- Fed-fasted BE studies using different polymorphs Helmut 2009-08-27 00:44
Ing. Helmut Schütz