Diclofenac Potassium Powder for Oral Solution [Regulatives / Guidelines]
Dear Ohlbe,
We are intending to submit data to USA.
Dear Members,
In Package insert of diclofenac potassium for Oral solution it mentioned that
''High fat food had no significant effect on the extent of diclofenac absorption, but there was a reduction in peak plasma levels of approximately 70% after a high fat meal. Decreased Cmax may be associated to decreased effectiveness''. ''Taking CAMBIA with food may cause a reduction in effectiveness compared to taking CAMBIA on an empty stomach'' As per these statements we are going for only fasting BE study. Please provide opinion on this topic.
Thanks lot
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post!
Two successive posts merged. You can edit your messages within 24 hours from posting a message [Ohlbe]
❝ In which country do you intend to submit your data ? Guidelines and requirements vary from one region to the next.
We are intending to submit data to USA.
Dear Members,
In Package insert of diclofenac potassium for Oral solution it mentioned that
''High fat food had no significant effect on the extent of diclofenac absorption, but there was a reduction in peak plasma levels of approximately 70% after a high fat meal. Decreased Cmax may be associated to decreased effectiveness''. ''Taking CAMBIA with food may cause a reduction in effectiveness compared to taking CAMBIA on an empty stomach'' As per these statements we are going for only fasting BE study. Please provide opinion on this topic.
Thanks lot
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post!
Two successive posts merged. You can edit your messages within 24 hours from posting a message [Ohlbe]
Complete thread:
- Diclofenac Potassium Powder for Oral Solution Ahmed Al Habashi 2014-08-16 07:08 [Regulatives / Guidelines]
- 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 Solutionmayur661 2018-11-16 10:08
- Fasting and fed Ohlbe 2018-11-16 12:09
- Fasting and fed mayur661 2018-11-16 12:27
- Fasting and fed Ohlbe 2018-11-16 12:09
- Diclofenac Potassium Powder for Oral Solutionmayur661 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