Bioequivalence and Bioavailability Forum • THX!

THX! [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-09-22 18:34 (4295 d 11:26 ago) – Posting: # 13556
Views: 4,731

Hi Ohlbe,

❝ The text actually changed from

❝ :blahblah:

❝ to

❝ :blahblah:

❝

❝ which may be a bit clearer. The initial wording could be interpreted as allowing a 40 % deviation (20 % below the mean, 20 % above it).

Thanks for pointing that out. I missed that. Definitely clearer now.

❝ ❝ 3. Section 7.1.1.11. ‘Stability of the samples’

❝

❝ This is only for large molecules (section 7 of the guideline), not small molecules.

I missed that one as well…

❝ If I remember correctly the discussions in Brussels in 2010, this was due to possible problems with the structural conformation of proteins, right ?

Possibly yes. These discussions were on the second day in the afternoon when by brain was already in idle state – I don’t remember and I didn’t take any notes.

—
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Helmut Schütz

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Science Quotes

Complete thread:

EMA: GL on bioanalytical method validation Rev.1 Helmut 2014-09-19 17:09
- EMA: Guideline on bioanalytical method validation Rev.1 ElMaestro 2014-09-19 17:39
  - EMA: NSA-approach Helmut 2014-09-19 18:02
    - EMA: NSA-approach ElMaestro 2014-09-19 19:28
      - EMA: NSA-approach nobody 2014-09-19 19:41
        
        EMA: NSA-approach ElMaestro 2014-09-20 21:41
        
        EMA: NSA-approach nobody 2014-09-21 16:59
- EMA: GL on bioanalytical method validation Rev.1 Ohlbe 2014-09-19 19:20
  - THX!Helmut 2014-09-22 16:34
  - EMA: GL on bioanalytical method validation Rev.1 Roberto 2014-09-23 17:52