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Dear Mayur,
The draft guidances for diclofenac capsules and diclofenac potassium capsules both recommend to do fasting and fed studies. Only doing a fasting study for your powder for oral solution could be risky. I would suggest to initiate a controlled correspondence with the FDA.
❝ As per these statements we are going for only fasting BE study. Please provide opinion on this topic.
The draft guidances for diclofenac capsules and diclofenac potassium capsules both recommend to do fasting and fed studies. Only doing a fasting study for your powder for oral solution could be risky. I would suggest to initiate a controlled correspondence with the FDA.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Diclofenac Potassium Powder for Oral Solution Ahmed Al Habashi 2014-08-16 07:08 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Diclofenac Potassium Powder for Oral Solution Dr_Dan 2014-08-16 09:47
- Diclofenac Potassium Powder for Oral Solution Helmut 2014-08-16 13:00
- Diclofenac Potassium Powder for Oral Solution mayur661 2018-11-16 09:02
- Diclofenac Potassium Powder for Oral Solution Ohlbe 2018-11-16 10:01
- Diclofenac Potassium Powder for Oral Solution mayur661 2018-11-16 10:08
- Fasting and fedOhlbe 2018-11-16 12:09
- Fasting and fed mayur661 2018-11-16 12:27
- Fasting and fedOhlbe 2018-11-16 12:09
- Diclofenac Potassium Powder for Oral Solution mayur661 2018-11-16 10:08
- Diclofenac Potassium Powder for Oral Solution Ohlbe 2018-11-16 10:01
- Diclofenac Potassium Powder for Oral Solution mayur661 2018-11-16 09:02
- Diclofenac Potassium Powder for Oral Solution Helmut 2014-08-16 13:00
- Diclofenac Potassium Powder for Oral Solution Dr_Dan 2014-08-16 09:47
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