Bioequivalence and Bioavailability Forum

Merhaba Erkin!

❝ We're using subject (sequence) as Random Effects in our statistical calculations for 2x2 cross-over design. We've done the calculations with two methods of ANOVA, and the results are the same.

Results should be identical if you have a balanced design (equal number of subjects in both sequences). Depending on the degree of imbalance you might get increasingly different results from both models.

❝ The calculations with random effects are acceptable from EMA?

IMHO, it is not worth the efforts trying. I received one deficiency letter last year from the Spanish agency.

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PS: I switched off the e-mail notification in your post because they bounced. Same story as during your registration. I have no idea what I could do from my side. Maybe you talk to your IT-guys. The error I received in all its glory:

This message was created automatically by mail delivery software.

A message that you sent could not be delivered to one or more of its
recipients. This is a permanent error. The following address(es) failed:

  {your email-address}
    SMTP error from remote mail server after end of data:
    host {your mail-server} {your IP}: 552 Mail with no Date header not accepted here

Of course the timestamp was given in the header. See below:

------ This is a copy of the message, including all the headers. ------

Return-path: <[email protected]>
Received: from {my server} ({my server’s IP})
   by {server gateway} with smtp (Exim 4.69)
   (envelope-from <[email protected]>)
   id 1W5dJz-0007ZV-Cs
   for {your e-mail address}; Tue, 21 Jan 2014 16:34:55 +0100
X-SIL: 0a1b0f9a0001b51829758069000041b5
To: Erkin <{your e-mail address}>
Subject: Reply to your post
From: Bioequivalence and Bioavailability Forum <[email protected]>
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Hi Erkin,
Helmut has written a reply to this post:

Subject: EMA: fixed

… followed by the text of my post. Strange.