FDA's RSABE on NTIDs in R [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2018-03-02 00:39 (2304 d 13:31 ago) – Posting: # 18492
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Dear CECIF,

❝ Now, If I understand correctly this is bioequivalent because:


❝ 1. 95% CI of RSABE criterion= -0.009828289 <0


Correct.

❝ 2. Conventional ABE test: 0.9 < 0.9429483, 1.11>1.029172 (or is it also with conventional limits 0.8 and 1.25?).


As Detlew already pointed out: 80–125%. See the guidance:

Use the unscaled average bioequivalence procedure to determine BE for individual PK parameter(s). […] should pass […] also regular unscaled bioequivalence limits of 80.00-125.00%.


❝ 3. Upper 90% CI of the ratio swT/swR: 0.6842668<=2.5


Correct.

❝ In addition to this, do I still have to demonstrate conventional bioequivalence for:

❝ ❝ 1. Period 1 vs period 2 (regular bioequivalence study)

❝ ❝ 2. Period 3 vs period 4 (replicated study)

❝ ❝ 3. Pooled analysis (Average periods 1 and 3 vs average period 2 and 4)

❝ ?

❝ as they do here? https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40301_Warfarin%20Sodium_Approv.pdf


Again, as Detlew wrote: No.
BTW, I don’t see such a (strange) requirement in the ANDA of 1999 (!) you linked.

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