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RegisterLabeled dosing interval [Design Issues]
posted by Helmut 
– Vienna, Austria, 2009-01-16 18:01 (6372 d 04:16 ago) – Posting: # 3048
Views: 5,819
Dear Neeraj
The one which is given in the reference product's label.
If nothing is specified in the label, ask a specialist in field about the common practice in the clinical situation.
There's no consensus how b.i.d. (bis in diem = twice a day) or 'three times a day' should be interpreted in terms of dosage intervals. Only for OAD (once a day) it's clear: tau = 24 h.
Most people would go with 12 h / 12 h for b.i.d. (morning/evening) and 6 h / 6 h / 12 h for 'three times a day' (morning/noon/evening) instead of 8 h / 8 h / 8 h (morning/afternoon/late evening).
❝ Please let me know what is labelled dosing interval in BA/BE studies.
The one which is given in the reference product's label.
If nothing is specified in the label, ask a specialist in field about the common practice in the clinical situation.
There's no consensus how b.i.d. (bis in diem = twice a day) or 'three times a day' should be interpreted in terms of dosage intervals. Only for OAD (once a day) it's clear: tau = 24 h.
Most people would go with 12 h / 12 h for b.i.d. (morning/evening) and 6 h / 6 h / 12 h for 'three times a day' (morning/noon/evening) instead of 8 h / 8 h / 8 h (morning/afternoon/late evening).
—
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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:
- Labeled dosing interval Neeraj 2009-01-16 06:56
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Labeled dosing intervalHelmut 2009-01-16 17:01
Ing. Helmut Schütz