Bioequivalence study of Pyridostigmine Bromide [Design Issues]

posted by Falisa_Mustafa – Malaysia, 2015-01-05 10:01 (4195 d 11:50 ago) – Posting: # 14216
Views: 6,980

Good day.

Hello Everyone,

Basically I have four questions particularly on the above subject :-)
  1. Has anybody got any experience in conducting BE study for immediate release tablets containing Pyridostigmine Bromide?

  2. Is BE possible to be achieved if the reference product used in BE study is sugar-coated, whereas the test product is film-coated?

  3. Where can I get documented references on bioequivalence/bioavailability of the active ingredient Pyridostigmine Bromide and its formulations?

  4. Has anybody got any experience in submitting BE study reports of Pyridostigmine Tablets to drug control authority which is found not to be BE in either the AUC or Cmax?
Appreciate feedback from all the experts!
Thank you in advance.

Kind regards,
Falisa

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