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Hi All,
Imagine a clinical trial where we need to continue the study to evaluate efficacy for 200 patients
and will have pharmacokinetics (PK) stoppage at 100 patients. The study is a double blind study. We
need to prepare a PK report to evaluate bioequivalance.
Wanted to know from all of you what could be the best possible way to maintain blinding and get a
meaningful bio equivalence PK report. What are the challenges we may face if we submit this study to
regulatory agencies.
Regards,
Sudipta Basu, Ph.D
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Hi Sudipta,
I assume the trial will compare the efficacy of the test and reference formulations.
If I am correct do you really need to show pharmacokinetic bioequivalence when you will be able to
compare the safety and efficacy endpoints?
If you want to have a formal bioequivalence study you can maintain blinding conditions using a
double dummy study medication for the first 100 patients (i.e. Test plus placebo of Reference and
Reference plus placebo of Test in this way all patient will take two tablets one tablet of Test and
one tablet of Reference) but you will have to solve the problem of crossing over the patients which
I think will be you real problem.
The other problem that you might have is that depending on the clinical endpoint/s, blood collection
might affect the efficacy of the two study formulations in the first half of the patients.
Alternatively, compare the PK of the two formulations by sparse sampling and Population PK analysis
using all the (200) patients.
Best
Stefano
--
STEFANO PERSIANI, Ph.D.
Director
Translational Sciences and Pharmacokinetics Department
ROTTAPHARM BIOTECH
Rottapharm Biotech S.r.l.
Via Valosa di Sopra, 9
20900 Monza - ITALY
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Dear Stefano,
Yes, you are right its a test vs reference study comparison. However, this is a biosilimar clinical
trial. This trial is having two components PK similarity and PD similarity. We have to club these
two together in this study and need to maintain double blind as well. PK stoppage will be at 100
patients and PD stoppage will be at 200 patients. We need to prepare a full PK report immediately
after PK stoppage and need to continue the study for PD and need to maintain double blind as well,
that's the challenge.
Regards,
Sudipta Basu, Ph.D
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Have unblinded PK and stats folks generate report for bioequivalency at cohort level. No need to
show subject IDs. That should do it?
N
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