From Russia (with love?) [RSABE / ABEL]

posted by PharmCat  – Russia, 2019-12-04 15:16 (220 d 22:33 ago) – Posting: # 20924
Views: 2,209

Hello Helmut!

IMHO, main points:

1. Basic words. Review article.
2. ABEL/RSABE - all have TIE inflation.
3. Biggest inflation when CVintra = 25—30%.
4. EMA aproach better than FDA.

Conclusion:

When you are planning bioequivalence trial better look at EMA guidelines, rather than FDA. We know that all approaches have TIE inflation.

I think this is primarily a message to regulatory experts.

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