Bioequivalence and Bioavailability Forum • Bioequivalence study of Pyridostigmine Bromide

Bioequivalence study of Pyridostigmine Bromide [Design Issues]

posted by Helmut – Vienna, Austria, 2015-01-05 15:21 (4192 d 15:20 ago) – Posting: # 14219
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Hi Falisa,

Not me.
Yes.
⇐ click
In MHRA’s EPAR the CI for C_max in the fasting study was 89.60–125.85% (n 24).
“[…] the C_max 90% upper limit is exceeded, albeit only slightly. The fasting environment is potentially a more sensitive test for bioequivalence than the fed study. The applicant has provided a suitable argument to justify why the upper limit for C_max may not be of clinical relevance and should have no safety or efficacy consequences.”
With a CV_intra of 35.3% of C_max that’s a candidate for reference-scaling, otherwise you have to increase the sample size. Below some ideas for different designs & 80% power (the replicate designs for reference-scaling approaches). For a HVD I would suggest to assume a T/R-ratio of 90%.
design regulator n treatments (~costs) 2×2 (conventional ABE) all 108 216 2×2×3 full replicate FDA 26 78 EMA 28 84 2×3×3 partial replicate FDA 27 81 EMA 28 84 2×2×4 full replicate FDA 18 72 EMA 20 80

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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Science Quotes

Bioequivalence study of Pyridostigmine Bromide Falisa_Mustafa 2015-01-05 09:01
- Bioequivalence study of Pyridostigmine BromideHelmut 2015-01-05 14:21
  - Bioequivalence study of Pyridostigmine Bromide nobody 2015-01-06 18:16