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Registerbioequivalence range [Design Issues]
Hi there
There are regulations for ranges that differ from country to country. Mostly everyone has channelised the range to be 80-125% for normal drugs as per USFDA, but yes HVDs tend to have a different range in which it has to be analysed. It can be found in all the guidelines.
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Edit: Full quote removed. Please see this post! [HS]
There are regulations for ranges that differ from country to country. Mostly everyone has channelised the range to be 80-125% for normal drugs as per USFDA, but yes HVDs tend to have a different range in which it has to be analysed. It can be found in all the guidelines.
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Edit: Full quote removed. Please see this post! [HS]
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Best regards
Rajdeep Mukherjee
Protocol Developer
Best regards
Rajdeep Mukherjee
Protocol Developer
Complete thread:
- bioequivalence range venkatmph 2008-01-10 13:03
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- bioequivalence range Helmut 2008-01-10 13:22
- bioequivalence rangeRajdeep 2008-01-14 07:44
- bioequivalence range ShankarCL 2008-02-29 12:40
Ing. Helmut Schütz