Bio-waiver for Pregabalin Capsules [Dissolution / BCS / IVIVC]
Dear All,
We are developing Pregabalin Capsules,
We are going to file BCS based Bio-waiver approach by below data,
Drug Solubility:
A.Anand
Bio-PK
Edit: Category changed. [Helmut]
We are developing Pregabalin Capsules,
We are going to file BCS based Bio-waiver approach by below data,
Drug Solubility:
- API Solubility(pH 1.2 to 7.2).
- Dissolution(API + Finished Product)
- Composition & Process similarity
- We are going to file Literature support for Pregabalin high Permeable (Class I) whether USFDA will accept our ANDA or not?
A.Anand
Bio-PK
Edit: Category changed. [Helmut]
Complete thread:
- Bio-waiver for Pregabalin CapsulesAnand 2015-03-11 11:38 [Dissolution / BCS / IVIVC]
- Bio-waiver for Pregabalin Capsules Tina 2015-03-11 17:27
- Bio-waiver for Pregabalin Capsules Samaya B 2015-03-12 13:15
- Bio-waiver for Pregabalin Capsules luvblooms 2015-03-13 09:18
- Bio-waiver for Pregabalin Capsules Maitri 2017-11-16 11:41
- Bio-waiver for Pregabalin Capsules luvblooms 2015-03-13 09:18
- Bio-waiver for Pregabalin Capsules Samaya B 2015-03-12 13:15
- Bio-waiver for Pregabalin Capsules Dr_Dan 2015-03-12 13:49
- Bio-waiver for Pregabalin Capsules Tina 2015-03-11 17:27