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RegisterApproved Pilot and Failed Pivotal Study [Study Assessment]
Dear Lucas
As per my experience, this is a clear case of Scale-up gone bad (assuming that the Pilot was sone on Lab batch and Pivotal was done on Exhibit batches)
First attempt should be to do some proper in vitro studies to find out the differences between both the batches and then to take a call.
For better understanding could you confirm
a) BCS class of drug (impact of PSD)
b) type of formulation (IR /ER)
c) pH solubility and degradation profile
d) Variations in DT/dissolution observed for both the batches?
e) Any changes in pilot and pivotal study sites?
Regards
As per my experience, this is a clear case of Scale-up gone bad (assuming that the Pilot was sone on Lab batch and Pivotal was done on Exhibit batches)
First attempt should be to do some proper in vitro studies to find out the differences between both the batches and then to take a call.
For better understanding could you confirm
a) BCS class of drug (impact of PSD)
b) type of formulation (IR /ER)
c) pH solubility and degradation profile
d) Variations in DT/dissolution observed for both the batches?
e) Any changes in pilot and pivotal study sites?
Regards
—
~A happy Soul~
~A happy Soul~
Complete thread:
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 15:27
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- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 16:02
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 17:51
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 18:38
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 18:55
- Approved Pilot and Failed Pivotal Study kumarnaidu 2014-03-18 05:03
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 18:55
- Approved Pilot and Failed Pivotal Study - same test? Dr_Dan 2014-03-18 11:30
- Approved Pilot and Failed Pivotal Study - same test? Lucas 2014-03-18 13:38
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 18:38
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 17:51
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 10:28
- Approved Pilot and Failed Pivotal Study Ohlbe 2014-03-18 11:15
- Approved Pilot and Failed Pivotal Study Helmut 2014-03-18 13:06
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 13:24
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 13:31
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-18 14:03
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 15:55
- Approved Pilot and Failed Pivotal Studyluvblooms 2014-03-19 05:16
- Approved Pilot and Failed Pivotal Study kumarnaidu 2015-12-08 07:02
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-18 14:03
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 13:31
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 13:24
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 16:02
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