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RegisterAdd on study design acceptability by the reg authorities [Regulatives / Guidelines]
Dear All,
Greetings!
This is a very informative forum.
I wish to congratulate everyone who are sharing their knowledge and expertise using this forum.
I have came across an approved ANDA of Labetalol tablets submitted by Watson lab for US submission. Watson lab had used a study design in which 30 volunteers were enrolled (ANDA application No is 75133. Information is available on CDER)
The study conducted was crossover, two treatment, two period in which volunteers (N =30) were divided in two groups with subject 1 to 20 in group I and 21 to 30 in group II.
The dosing was done in a cross over fashion to one group first and then to second group.
As add on dsign is not acceptable in US, I am confused with this type of design.
Kindly elaborate on this.
My second query is:
In add on study design, if the result of the first group is passing, then is it necessary to carry out the dosing for the second group?
Can we divide the number of volunteers in 2:1 proportion in add on design?
Thanks and best regards
Rahul Dixit
Unichem Laboratories Ltd
India
Greetings!
This is a very informative forum.
I wish to congratulate everyone who are sharing their knowledge and expertise using this forum.
I have came across an approved ANDA of Labetalol tablets submitted by Watson lab for US submission. Watson lab had used a study design in which 30 volunteers were enrolled (ANDA application No is 75133. Information is available on CDER)
The study conducted was crossover, two treatment, two period in which volunteers (N =30) were divided in two groups with subject 1 to 20 in group I and 21 to 30 in group II.
The dosing was done in a cross over fashion to one group first and then to second group.
As add on dsign is not acceptable in US, I am confused with this type of design.
Kindly elaborate on this.
My second query is:
In add on study design, if the result of the first group is passing, then is it necessary to carry out the dosing for the second group?
Can we divide the number of volunteers in 2:1 proportion in add on design?
Thanks and best regards
Rahul Dixit
Unichem Laboratories Ltd
India
Complete thread:
- Add on study design acceptability by the reg authoritiesrahul dixit 2010-10-26 07:08
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Add on study design acceptable with FDA/EMA Helmut 2010-10-26 14:00
- Add on study design acceptable with FDA/EMA rahul dixit 2010-10-26 14:55
- Add on study design acceptable with FDA/EMA rahul dixit 2010-10-27 09:49
- Add on design in US rahul dixit 2010-10-30 08:52
- Patience... Helmut 2010-10-30 15:12
- Patience... rahul dixit 2010-11-09 11:30
- About add-ons Helmut 2010-11-09 14:50
- Patience... rahul dixit 2010-11-09 11:30
- Patience... Helmut 2010-10-30 15:12
- Add on study design acceptable with FDA/EMA Helmut 2010-10-26 14:00
Ing. Helmut Schütz