Bioequivalence and Bioavailability Forum

Correction to EMA Final BE-GL [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2010-03-28 19:28 (5562 d 12:13 ago) – Posting: # 4978
Views: 4,260

Dear all,

a correction (dated 10 March 2010) was published recently. The new Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1/Corr

Changes (apart from a few typos):
p10, 4^th paragraph: 'kcal' instead of 'calories'
p15, 5^th paragraph: In specific cases of products with a narrow therapeutic range, the acceptance interval for AUC may need to be tightened (see section 4.1.9).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Correction to EMA Final BE-GLHelmut 2010-03-28 17:28 [Regulatives / Guidelines] 
  • Correction to EMA Final BE-GL yjlee168 2010-03-29 13:36
    • Correction to EMA Final BE-GL Helmut 2010-03-29 13:47
      • Correction to EMA Final BE-GL (for IR dosage forms) yjlee168 2010-03-29 13:55