Log in
RegisterRLD strength for BE study [Design Issues]
Dear Colleagues,
We are developing a generic of an RLD with two strengths (100 mg and 50 mg).
But viewing the dosage regimen of reference drug product, it would make sense to develop a 150 mg strength even though the reference product does not have it. So, our generic drug product will have 3 strengths (150, 100 and 50 mg).
What dose should the BE study be done with? (PK linearity has been demonstrated in the range of that doses).
Should RLD 100mg VS Generic 100mg be done or RLD 100mg + RLD 50mg VS generic 150mg?
Best regards,
We are developing a generic of an RLD with two strengths (100 mg and 50 mg).
But viewing the dosage regimen of reference drug product, it would make sense to develop a 150 mg strength even though the reference product does not have it. So, our generic drug product will have 3 strengths (150, 100 and 50 mg).
What dose should the BE study be done with? (PK linearity has been demonstrated in the range of that doses).
Should RLD 100mg VS Generic 100mg be done or RLD 100mg + RLD 50mg VS generic 150mg?
Best regards,
Complete thread:
- RLD strength for BE studyBrus 2021-01-21 14:24
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ Helmut 2021-01-21 14:37
- 505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ Brus 2021-01-25 16:56
- Directive 2001/83/EC, Article 10(3) = hybrid Helmut 2021-01-25 17:39
- 505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ Brus 2021-01-25 16:56
- 505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ Helmut 2021-01-21 14:37
Ing. Helmut Schütz