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RegisterDiscontinuations and Withdrawal [Design Issues]
Hello All
If a drug contain combination of two formulations [IR+ CR] for that drug how can justify the Discontinuation and Withdrawal criteria in case of emesis?
Generally as per guidelines
For IR fomulations we go through as subject experiences emesis within twice the median tmax of X drug after administration of IP.
For CR formulations: subject experiences emesis any time within the labelled dosing interval of the IP
Edit: Category changed. [Helmut]
If a drug contain combination of two formulations [IR+ CR] for that drug how can justify the Discontinuation and Withdrawal criteria in case of emesis?
Generally as per guidelines
For IR fomulations we go through as subject experiences emesis within twice the median tmax of X drug after administration of IP.
For CR formulations: subject experiences emesis any time within the labelled dosing interval of the IP
Edit: Category changed. [Helmut]
Complete thread:
- Discontinuations and Withdrawalkvgreddy06 2013-10-09 13:09
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- IR+CR = MR Helmut 2013-10-09 14:28
- IR+CR = MR jag009 2013-10-13 21:05
- IR+CR = MR Helmut 2013-10-09 14:28
Ing. Helmut Schütz