Dose for BE Studies [Design Issues]

posted by hiren379 – India, 2012-10-06 08:01 (5011 d 04:08 ago) – Posting: # 9327
Views: 3,113

Hello All...
Can anyone through some light on below issue

e.g A drug (Reference) is available at maximum strength of 50mg tablet. But the prescribing information says that minimum therapeutic dose is 200 mg i.e 4*50 mg tablet.

Then at what dose one should assess BE for such drug? single tablet (50 mg dose) or 4 tablets (200mg dose).
Note: Please note that there are no analytical issues. PK can be well characterised with single dose also.

OGD sometimes recommends to do BE at therapeutic dose (4 tablets)
e.g Balsalazide.
However for Mesalamine even though therapeutic dose is higher than maximum strength they have not recommended to assess BE at therapeutic dose. :confused::confused::confused:

Please guide...

Thanks

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