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Registerless than proportional increase [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2013-02-14 13:58 (4881 d 05:19 ago) – Posting: # 10022
Views: 3,416
Dear ABE,
Correct: 1500 – 2500 h×ng/mL. Since 1300 < 1500 Dan’s case D) applies.
❝ How to calculate the dose-adjusted AUC? Does it mean that if AUC for 80 mg strength AUC is 4000 hr*ng/ml. Then for 40 mg it should be 2000 hr*ng/ml. however, we got it around 1300 hr*ng/ml. Then we will set limit as 2000 hr*ng/ml ± 25%.
Correct: 1500 – 2500 h×ng/mL. Since 1300 < 1500 Dan’s case D) applies.
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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:
- new strength olacy 2012-11-07 10:46
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- new strength Dr_Dan 2012-11-08 10:22
- new strength ABE1580 2013-02-14 07:11
- less than proportional increaseHelmut 2013-02-14 12:58
- less than proportional increase ABE1580 2013-02-16 11:21
- less than proportional increaseHelmut 2013-02-14 12:58
- new strength ABE1580 2013-02-14 07:11
- new strength Dr_Dan 2012-11-08 10:22
Ing. Helmut Schütz