Bio-waiver for Pregabalin Capsules [Dissolution / BCS / IVIVC]

posted by Anand – India, 2015-03-11 12:38 (3327 d 04:03 ago) – Posting: # 14559
Views: 13,595

Dear All,

We are developing Pregabalin Capsules,

We are going to file BCS based Bio-waiver approach by below data,

Drug Solubility:
  1. API Solubility(pH 1.2 to 7.2).
  2. Dissolution(API + Finished Product)
  3. Composition & Process similarity
Permeability:
  1. We are going to file Literature support for Pregabalin high Permeable (Class I) whether USFDA will accept our ANDA or not?
Regards,
A.Anand
Bio-PK

Edit: Category changed. [Helmut]

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