Bioequivalence and Bioavailability Forum

Dear all,

the FDA was definitely not happy with our article. Why am I not surprised?

Sun W , Alosh M, Schuirmann DJ, Grosser S. Letter to the Editor on “Group‑by‑Treatment Interaction Effects in Comparative Bio­avail­ability Studies”. AAPS J. 2024; 26(5): 101. doi:10.1208/s12248-024-00972-0.

Disclaimer The views expressed in this article represent the opinions of the authors, and do not represent the views and/or policies of the U.S. Food and Drug Administration.

At least.

Common procedure, e.g., in ‘Science’, ‘Statistics in Medicine’, ‘Journal of the American Statistical Association’, ‘Biometrics’, ‘British Medical Journals’ (a rant):

1. An article is published.
   
2. Some don’t agree, draft a ‘Letter to the Editor’, and submit it for review.
   
3. If the editor deems it worthwhile, reviewers will be invited.
   
4. If it is accepted, the authors of the publication are notified, provided with the accepted Letter, and given the opportunity to write a Rejoinder.
   
5. The Letter is published together with the Rejoinder (not earlier).
   
6. In some journals, both have even the same DOI so that interested readers are aware of both.

• The letter was submitted on May 31^st (#2). The editor invited me to review it on June 11^th (#3) and notified me six (‼) minutes later that “we have already received sufficient commitments to review this manuscript”. #4 and #5 not followed. Was I notified that the letter was published on 9 September? Nope. I checked the website of the journal regulary…
  Is the letter Open Access like our article? Nope. The can’t afford that. Buy it for $ 39.95 or ask Wanjie for a copy.

Since Rejoinders are not possible in the AAPS J, we will submit a ‘Letter’ responding to a ’Letter’…