Log in
RegisterDissolution Testing Requirement - ANDA [Dissolution / BCS / IVIVC]
Guys and gals,
Appreciate your input on this...
For ANDA comparative (T vs R) dissolution testings (Method as per BE guidance + release testing):
1) Do we need to do all the testings on all 3 batches?
2) If not, which testing requires for all 3 batches?
Reason I asked is because my old RA group said comp disso tests (Guidance reqt + release testing) should be done on all 3 batches. But my new RA group said only release test is required on all 3 batches.
Thx
J
Appreciate your input on this...
For ANDA comparative (T vs R) dissolution testings (Method as per BE guidance + release testing):
1) Do we need to do all the testings on all 3 batches?
2) If not, which testing requires for all 3 batches?
Reason I asked is because my old RA group said comp disso tests (Guidance reqt + release testing) should be done on all 3 batches. But my new RA group said only release test is required on all 3 batches.
Thx
J
Complete thread:
- Dissolution Testing Requirement - ANDAjag009 2019-10-30 02:29 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
Ing. Helmut Schütz