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Dear Helmut,
The rationale is not scientific, it's just paranoia. The fear is that the lab could be tempted to repeat the assay if bioequivalence is not demonstrated, particularly for Cmax, to try and get "better" results. No reason to do such a thing in BA trials when developing a new drug.
There is a lot of regulatory paranoia regarding BE trials, but one has to admit that this paranoia is fed by inspection results. Remember the results of French inspections which were presented at the EGA meeting some years ago (2007 I think): basically, critical observations in half of the dossiers inspected, including fraud or some level of data manipulation in one quarter of the dossiers inspected.
Best regards
Ohlbe
❝ But I must confess that I don't see the rationale] behind 'a ban on BE
❝ studies'.
The rationale is not scientific, it's just paranoia. The fear is that the lab could be tempted to repeat the assay if bioequivalence is not demonstrated, particularly for Cmax, to try and get "better" results. No reason to do such a thing in BA trials when developing a new drug.
There is a lot of regulatory paranoia regarding BE trials, but one has to admit that this paranoia is fed by inspection results. Remember the results of French inspections which were presented at the EGA meeting some years ago (2007 I think): basically, critical observations in half of the dossiers inspected, including fraud or some level of data manipulation in one quarter of the dossiers inspected.
Best regards
Ohlbe
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- BLQ values in Winnonlin Dr. Harish L. Rao 2009-09-10 07:53 [Software]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BLQ values in Winnonlin Ohlbe 2009-09-11 00:18
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- BLQ values in Winnonlin > Status codes tool Ohlbe 2009-09-11 22:19
- Irregular profiles Helmut 2009-09-14 17:11
- About "PK repeats" Ohlbe 2009-09-14 22:01
- About "PK repeats" Helmut 2010-10-21 15:51
- About "PK repeats" Ohlbe 2010-10-21 16:38
- About "PK repeats" Helmut 2010-10-21 17:01
- About "PK repeats"Ohlbe 2010-10-21 17:32
- slowly going off-topic Helmut 2010-10-21 18:47
- About "PK repeats"Ohlbe 2010-10-21 17:32
- About "PK repeats" Helmut 2010-10-21 17:01
- About "PK repeats" ElMaestro 2010-10-21 16:56
- About "PK repeats" Helmut 2010-10-21 18:02
- About "PK repeats" Ohlbe 2010-10-21 16:38
- About "PK repeats" Helmut 2010-10-21 15:51
- BLQ Values in Winnonlin Dr. Harish L. Rao 2009-09-15 05:45
- About "PK repeats" Ohlbe 2009-09-14 22:01
- Irregular profiles Helmut 2009-09-14 17:11
- BLQ values in Winnonlin > Status codes tool Ohlbe 2009-09-11 22:19
- BLQ values in Winnonlin > Status codes tool SDavis 2009-09-11 08:13
- BLQ values in Winnonlin Ohlbe 2009-09-11 00:18
Ing. Helmut Schütz