Bioequivalence and Bioavailability Forum • FDA: RSABE for NTID

FDA: RSABE for NTID [RSABE / ABEL]

posted by Jay – India, 2018-03-26 15:31 (2216 d 06:36 ago) – Posting: # 18595
Views: 9,528

Dear all,

In one of the full replicate study of NTID the results are as per below,

 Parameters   Swr    95%CI

LnCmax       0.04   0.0001

LnAUC0-t     0.07   -0.003

LnAUC0-inf   0.07   -0.004

The ABE results are as below,

 Parameters   T/R    90%CI-L    90%CI-U

LnCmax       97     95         99

LnAUC0-t     99     97         101

LnAUC0-inf   99     97         101

The point estimate is near to 100 and ABE is also within 80% to 125%.

But in SABE, the Cmax criteria is more than 0 i.e. 0.0001 which leads to bioinequivalence.

So can it be scientifically justified the 95%CI of Cmax value as its very borderline to 0 and T/R shows less difference between test and reference.

Thanks

-Jay

Edit: Category and subject line changed; see also this post #1 and #2. [Helmut]

Complete thread:

FDA: RSABE for NTIDJay 2018-03-26 13:31 [RSABE / ABEL]
- FDA: RSABE for NTID jag009 2018-03-26 17:57
  - FDA: RSABE for NTID Jay 2018-04-02 06:28
    - FDA: RSABE for NTID pjs 2018-04-02 15:07
      - FDA: RSABE for NTID Jay 2018-04-04 14:24
        
        β = 1 – π Helmut 2018-04-04 15:03
        
        Warfarin Sodium 95% Upper bound criteria Nirali 2019-01-30 15:38
        
        Upper bound in RSABE ≤0 Helmut 2019-02-02 14:15
        
        Upper bound in RSABE ≤0 Nirali 2019-02-12 07:10