Bioequivalence and Bioavailability Forum

Hi John(s),

❝ I'm looking for the inter-subject variability of the Cmax of oral hydroxychloroquine.

I guess you mean CV_total? CV_inter is only accessible in a crossover study. BE studies of hydroxy­chloro­quine are performed in a parallel design due to its long half-life.
In the future please first.
If the CV was not given, I calculated it from the CIs and sample sizes:

Ref.  n   PK metric   PE      90% CI     CVtotal
 1   72   Cmax        97.1%  86.4–109.2%  29.8%
          AUClast*    94.3%  84.2–105.7%  29.0%
 2   72   Cmax        90.8%  79.3–104%    35.6%
          AUC0-72     99.5%  87.4–113%    33.6%
 3   54   Cmax        99.3%  98.1–102.1%   4.4%
          AUC0-24     99.7%  98.9–101.4%   2.7%

Liu’s CVs are simply bizarre. Unbelievable that such a paper passed the peer-review.

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• Blood was harvested for 11 weeks.

1. Midha KK, Rawson MJ, Hubbard JW. Bioequivalence: Issues and Options. J Pharmacokin Biopharm. 1997;25(6):743–52.
   
2. MHRA. Public Assessment Report: Hydroxychloroquine Sulphate 200mg Film-Coated Tablets. PL 17907/0017 (2007)
   online
   
3. Liu YM et al. A Parallel Design Study to Assess the Bioequivalence of Generic and Branded Hydroxychloroquine Sulfate Tablets in Healthy Volunteers. Arzneim Forsch / Drug Res. 2012;62(12):644–9. doi:10.1055/s-0032-1329962.