Bioequivalence and Bioavailability Forum • In-vitro Dissolution complementary to BE

In-vitro Dissolution complementary to BE [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-12-16 15:50 (4578 d 02:35 ago) – Posting: # 12062
Views: 10,814

Dear Dan,

❝ Test and reference should show similar in vitro dissolution under physiologically relevant experimental pH conditions

Should? OK, it has to be done (Appendix I.i – Testing on product quality), but the similarity testing (I.ii) is only relevant if a biowaiver is intended.

❝ In the event that the results of comparative in vitro dissolution of the biobatches do not reflect bioequivalence as demonstrated in vivo the latter prevails.

Exactly.

❝ However, possible reasons for the discrepancy should be addressed and justified.

Addressed? Maybe – though I don’t see its necessity according to the GL. IMHO, reporting is sufficient.
Why justified? The dissolution media might not be biorelevant, or dissolution is simply not the driving force for absorption at all (BCS classes II and IV).

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Complete thread:

In-vitro Dissolution complementary to BE sireen 2013-12-14 12:27 [Regulatives / Guidelines]
- In-vitro Dissolution complementary to BE Dr_Dan 2013-12-16 12:58
  - In-vitro Dissolution complementary to BEHelmut 2013-12-16 14:50
    - In-vitro Dissolution: Order and questions mittyri 2014-01-22 19:39
      - In-vitro Dissolution: Order and questions Dr_Dan 2014-01-23 11:50
      - In-vitro Dissolution: Order and questions Erkin 2015-09-16 11:24
        
        In vivo ≫ in vitro Helmut 2015-09-16 15:37
        
        In vivo ≫ in vitro Erkin 2015-09-17 08:39
        
        In vivo ≫ in vitro Helmut 2015-09-17 12:41
        
        In vivo ≫ in vitro Shuanghe 2015-09-18 10:11
        
        What about BCS II, (III), IV? Helmut 2015-09-18 12:25