Neeraj
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2009-01-16 07:56
(6371 d 23:54 ago)

Posting: # 3040
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 Labeled dosing interval [Design Issues]

Dear All

Please let me know what is labelled dosing interval in BA/BE studies.

Best Regards
Neeraj

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Category changed. [Helmut]
Helmut
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Vienna, Austria,
2009-01-16 18:01
(6371 d 13:49 ago)

@ Neeraj
Posting: # 3048
Views: 5,818
 

 Labeled dosing interval

Dear Neeraj

❝ 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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