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RegisterRetention of IPs for BE studies for Transdermal Systems [Regulatives / Guidelines]
Dear All,
I have doubt regarding the sample retention as per the FDA guidance. In the trasdermal formulations, there are many tests to be performed for generation of the complete release profile for which it will cross the limit of 300 (for solid oral formulation) as mentioned in the guidance.
My query is that should i have to consider upper limit of 300 units as or i have to retain 5 times of the complete release profile??
Thanks in advance!!
I have doubt regarding the sample retention as per the FDA guidance. In the trasdermal formulations, there are many tests to be performed for generation of the complete release profile for which it will cross the limit of 300 (for solid oral formulation) as mentioned in the guidance.
My query is that should i have to consider upper limit of 300 units as or i have to retain 5 times of the complete release profile??
Thanks in advance!!
Complete thread:
- Retention of IPs for BE studies for Transdermal SystemsKeath 2014-03-18 12:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Retention of IPs for BE studies for Transdermal Systems Dr_Dan 2014-03-19 11:43
- Retention of IPs for BE studies for Transdermal Systems Keath 2014-03-24 09:47
- Retention of IPs for BE studies for Transdermal Systems Dr_Dan 2014-03-19 11:43
Ing. Helmut Schütz