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RegisterBSC approach at each strength? [Dissolution / BCS / IVIVC]
Hi,
Yes! For example: three strenght of 80 mg, 40 mg and 20 mg and the drug is class 1. I understand that BCS in three pHs (1,2; 4,5 and 6,8) is requeried to strenght 80 mg (Test 80 mg vs Reference 80 mg)
But, I do not understand why is necessary to perform a BSC approach to others strength (Test 40 mg vs Reference 40 mg and Test 20 mg vs Reference 20 mg).
If, there is a biowaiver for strenght of 80 mg, I could make compare Test 80 mg vs Test 40 mg and Test 80 mg vs Test 20 mg, in an only pH condiction (for example: 4,5)?
BR
❝ You mean what is the tech reason to perform disso testing (T vs R) at each strength?❝
Yes! For example: three strenght of 80 mg, 40 mg and 20 mg and the drug is class 1. I understand that BCS in three pHs (1,2; 4,5 and 6,8) is requeried to strenght 80 mg (Test 80 mg vs Reference 80 mg)
But, I do not understand why is necessary to perform a BSC approach to others strength (Test 40 mg vs Reference 40 mg and Test 20 mg vs Reference 20 mg).
If, there is a biowaiver for strenght of 80 mg, I could make compare Test 80 mg vs Test 40 mg and Test 80 mg vs Test 20 mg, in an only pH condiction (for example: 4,5)?
BR
Complete thread:
- BSC approach at each strength? Mauricio Sampaio 2019-07-19 22:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BSC approach at each strength? jag009 2019-07-22 19:56
- BSC approach at each strength?Mauricio Sampaio 2019-07-22 21:43
- BSC approach at each strength? Ohlbe 2019-07-22 23:58
- BSC approach at each strength? Mauricio Sampaio 2019-07-23 04:48
- BCS approach at each strength? Mauricio Sampaio 2019-07-26 15:32
- BSC approach at each strength? Mauricio Sampaio 2019-07-23 04:48
- BSC approach at each strength? Ohlbe 2019-07-22 23:58
- BSC approach at each strength?Mauricio Sampaio 2019-07-22 21:43
- BSC approach at each strength? jag009 2019-07-22 19:56
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