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Back to the forum  Query: 2017-09-26 02:16 CEST (UTC+2h)
 
ElMaestro
Hero

Denmark,
2017-09-08 17:24

Posting: # 17795
Views: 568
 

 Sample size for FDA's in vitro population BE [Power / Sample Size]

Hi all,

here's the pretty solution to a terrible challenge, originating from this guidance and which is now applied to about 40 different products.

It basically involves the application of an idea that is 40 years old and which was totally impractical at the time it was invented, and using it on FDA's pop BE approach. No-one has been able to deal with it analytically because the math gets too complicated (in fact, FDA's way to calculate the confidence limit for Eta is in itself an approximation).

:-):-)

A good weekend to all of you.

I could be wrong, but…


Best regards,
ElMaestro

- since June 2017 having an affair with the bootstrap.
Helmut
Hero
Homepage
Vienna, Austria,
2017-09-08 18:05

@ ElMaestro
Posting: # 17796
Views: 498
 

 Extra-marital cohabitation

Hi ElMaestro,

nice. Can’t say that I understand much (if anything at all). The fruit of your love-affair looks impressive.

What I like:

Received on August 2, 2017
in final form, August 2, 2017


No peer-review of letters to the editor? Detlew and I were not so lucky in the past…

[image]All the best,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
ElMaestro
Hero

Denmark,
2017-09-08 18:42

@ Helmut
Posting: # 17797
Views: 490
 

 The hidden details

Hi Hötzi,

» What I like:
»    Received on August 2, 2017
»    in final form, August 2, 2017
» No peer-review of letters to the editor? Detlew and I were not so lucky in the past…

This paper was subjected to all kinds of events as far as I understand from my discussion with the author :-D:-D:
  1. The author contacted the editor in advance and said more or less "Hey, I've got this wonderful idea, but I can't submit as a full paper, and I do not see a category like 'regulatory note' like they have in the AAPS J, please suggest a solution because I think this would be the proper journal for such a publication."
  2. The editor responded back that it would fit the journal's scope and could be submitted as an "unsolicited review" even though it wasn't a review.
  3. The ms was submitted in that manuscript category.
  4. The paper was reviewed by two peers. One was very positive, the other was negative. Editor asked for a major revision.
  5. The author submitted a revision and the reviews were repeated; the negative reviewer and the author were clearly not sending and receiving on the same frequencies ('it is questionable whether this paper deserves to be published as full paper' - which the author never intended it to be, hence the initial contact to the editor).
  6. Editor rejected the submission but said the author could boil it down to 500 words and then it would be accepted as a letter with one figure.
  7. The author did that on Aug 2, and the letter was accepted the same day it was submitted with one figure and the other original tables and figures as online supplementary material. Technically, the submission of the letter was a new manuscript, hence you don't see info on the review cycle. Trust me, there was ample peer reviewing here. :lookaround:
The author had to strip some info about sensitivity to alterations in MSWR, MSWT, MSBT, MSBR and more in order to get it down to 500 words.

Even though the author does perhaps not agree 100% with the negative reviewer, the author is firmly of the opinion that editor handled this in a quite OK fashion.

I heard in my local supermarket that the author is currently looking for flighs to Prague on Sept 20. If you know the BioBridges people, ask them if there are any speaker dropouts then he could perhaps jump in and volunteer a talk about GCP/GLP findings in BE trials, Bootstrapping and how it relates to BE, or something else.

I could be wrong, but…


Best regards,
ElMaestro

- since June 2017 having an affair with the bootstrap.
Helmut
Hero
Homepage
Vienna, Austria,
2017-09-09 12:29

@ ElMaestro
Posting: # 17798
Views: 414
 

 The hidden details

Hi ElMaestro,

amazing story. THX for sounding the unfathomable depths of the publication process.

PS: You have Mehl in your Mehlschachtel.

[image]All the best,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
mahmoud-teaima
Regular

Cairo, Egypt,
2017-09-10 16:12

@ ElMaestro
Posting: # 17799
Views: 364
 

 Sample size for FDA's in vitro population BE

Thanks for ElMaestro, for this valuable post.
Please find attached the published letter as an image (sorry for the poor quality).
I have the file as pdf, so if anyone is interested to get it, just let me know and i will send it via private email.

Greetings.


Edit: Images removed. [Helmut]

Mahmoud Teaima, PhD.
Assistant Professor at Department of Pharmaceutics and Industrial Pharmacy.
Vice-director at Center of Applied Research and Advanced Studies (CARAS).
Faculty of Pharmacy, Cairo University, Cairo, Egypt.
ElMaestro
Hero

Denmark,
2017-09-10 16:23

@ mahmoud-teaima
Posting: # 17800
Views: 359
 

 Sample size for FDA's in vitro population BE

Dear Mahmoud Teaima,

» Please find attached the published letter as an image (sorry for the poor quality).

The publication is copyrighted and currently behind a paywall; no-one except the publisher can OK its publication elsewhere like here.
The Bebac forum administrator can get in quite some legal trouble if the paper is published on his forum without permission. I recommend to be careful and state explicitly if permission has been granted from the publisher.

I could be wrong, but…


Best regards,
ElMaestro

- since June 2017 having an affair with the bootstrap.
mahmoud-teaima
Regular

Cairo, Egypt,
2017-09-11 13:26

@ ElMaestro
Posting: # 17801
Views: 308
 

 Sample size for FDA's in vitro population BE

Dear ElMaestro,
Thanks for the advice. Sorry for publishing it on the forum.
I can use it personally.
Greetings.

Mahmoud Teaima, PhD.
Assistant Professor at Department of Pharmaceutics and Industrial Pharmacy.
Vice-director at Center of Applied Research and Advanced Studies (CARAS).
Faculty of Pharmacy, Cairo University, Cairo, Egypt.
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