Group-by-Treatment Interaction: FDA [General Statistics]
Dear all,
the FDA was definitely not happy with our article. Why am I not surprised?
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):
Edit: Rejoinder submitted on 6 October.
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):
- An article is published.
- Some don’t agree, draft a ‘Letter to the Editor’, and submit it for review.
- If the editor deems it worthwhile, reviewers will be invited.
- If it is accepted, the authors of the publication are notified, provided with the accepted Letter, and given the opportunity to write a Rejoinder.
- The Letter is published together with the Rejoinder (not earlier).
- In some journals, both have even the same DOI so that interested readers are aware of both.
- The letter was submitted on May 31st (#2). The editor invited me to review it on June 11th (#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.
Edit: Rejoinder submitted on 6 October.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Group-by-Treatment Interaction: the final word? Helmut 2024-04-19 01:26 [General Statistics]
- Group-by-Treatment Interaction: FDAHelmut 2024-09-20 13:30
- Group-by-Treatment Interaction: the final word? BEQool 2024-10-03 15:09
- ANOVA of Model 1 Helmut 2024-10-03 15:33
- ANOVA of Model 1 BEQool 2024-10-03 16:08
- ANOVA of Model 1 Helmut 2024-10-04 10:11
- Between vs Within mittyri 2024-10-05 00:08
- Between vs Within BEQool 2024-10-06 20:06
- Treatment-by-Group in PROC MIXED and PROC GLM? mittyri 2024-10-06 22:00
- Treatment-by-Group in PROC MIXED and PROC GLM? BEQool 2024-10-07 10:27
- Treatment-by-Group in PROC MIXED and PROC GLM? mittyri 2024-10-07 13:11
- Treatment-by-Group in PROC MIXED and PROC GLM? BEQool 2024-10-14 11:01
- Treatment-by-Group in PROC MIXED and PROC GLM? mittyri 2024-10-07 13:11
- Treatment-by-Group in PROC MIXED and PROC GLM? BEQool 2024-10-07 10:27
- Treatment-by-Group in PROC MIXED and PROC GLM? mittyri 2024-10-06 22:00
- Between vs Within BEQool 2024-10-06 20:06
- Between vs Within mittyri 2024-10-05 00:08
- ANOVA of Model 1 Helmut 2024-10-04 10:11
- ANOVA of Model 1 BEQool 2024-10-03 16:08
- ANOVA of Model 1 Helmut 2024-10-03 15:33