PharmPK Discussion - Saquinavir assay

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On 17 Feb 2004 at 11:00:03, "Daniel Rossi de Campos" (Daniel.Campos.at.anvisa.gov.br) sent the message


Dear All,
  Has anyone been experience in bioequivalence assays with saquinavir
(single dose) ?
  Some guidelines (FDA, ANVISA) suggest the blood collecting period of 3
x t1/2 to pk profile in BE studies.  I could see in literature that
elimination half-life of saquinavir is 13 hrs (micromedex). So, a
adequate collecting time would be around 40 hrs. However, some pk
studies have only 8 hrs of collecting time points (ex: Merry, C et al.
AIDS 1997; 11(4):F29-33)
  Could anyone explain, why ?
  Thanks,
  Daniel

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On 17 Feb 2004 at 19:44:14, Varun_Garg.aaa.vrtx.com sent the message


Dear Daniel,
The paper you cite had steady-state pharmacokinetics of saquinavir three
times daily with or without ritonavir bid, hence the collection up to 8
h.
  Also, I think the half-life of saquinavir is lower when it is given
alone
- ritonavir increase the half-life.
Hope this helps,
Varun

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