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RegisterCorrection to EMA Final BE-GL [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2010-03-28 19:28 (5920 d 00:47 ago) – Posting: # 4978
Views: 5,185
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, 4th paragraph: 'kcal' instead of 'calories'
p15, 5th paragraph: In specific cases of products with a narrow therapeutic range, the acceptance intervalfor AUC may need to be tightened (see section 4.1.9).
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, 4th paragraph: 'kcal' instead of 'calories'
p15, 5th paragraph: In specific cases of products with a narrow therapeutic range, the acceptance interval
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Correction to EMA Final BE-GLHelmut 2010-03-28 17:28 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- Correction to EMA Final BE-GL Helmut 2010-03-29 13:47
- Correction to EMA Final BE-GL yjlee168 2010-03-29 13:36
Ing. Helmut Schütz