Bioequivalence and Bioavailability Forum

EMA: Guideline on bioanalytical method validation Rev.1 [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2014-09-19 19:39 (4302 d 16:39 ago) – Posting: # 13545
Views: 5,082

Thanks Helmut.

Very important.

But I wonder how on earth are you supposed to know about this update: It is not mentioned on the EMA mainpage, it is not mentioned on the page listing guidelines which is often also listing revisions along with dates, and the document itself makes no -absolutely zero- attempt at indicating when the asterisked changes are made or when they are coming into effect. For the latter, I assume the effect is immediate, but that isn't my point.

Perhaps I was overlooking something, but how was I really supposed to figure out a change had been made?

Complete thread:

• EMA: GL on bioanalytical method validation Rev.1 Helmut 2014-09-19 17:09 
  • EMA: Guideline on bioanalytical method validation Rev.1ElMaestro 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