VSL
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India,
2013-01-15 04:13
(4902 d 16:21 ago)

Posting: # 9845
Views: 3,979
 

 Types of Bioequivalence assessment [General Sta­tis­tics]

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Dear All,

I am new in the BA/BE field and therefore I have some general questions.
  1. Currently, for bio-equivalence assessment Comparative Bio-availability Study is performed in which Test formulation(T)is compared Vs. Reference formulation(R). If such study is passed (T Vs. R comparative study), Does it mean that R Vs. T comparative study would pass?

  2. If any formulation is population bio-equivalent, would it be considered average bio-equivalent ?

  3. If any formulation is individual bio-equivalent, would it be considered average bio-equivalent or population bio-equivalent?

Regards,
VSL
 
Helmut
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Vienna, Austria,
2013-01-15 17:17
(4902 d 03:17 ago)

@ VSL
Posting: # 9850
Views: 3,355
 

 ABE/PBE/IBE

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Dear VSL!
  1. Yes, since the acceptance range is based on the reference and symmetric in log-scale or backtransformed ALhi=ALlo-1 (1.25=0.8-1). The 2×2 cross-over model uses a common variance for test and reference. If you change T with R in the analysis, you will get the reciprocals of the point estimate and confidence interval; the residual error will stay the same. Passing T/R will also pass R/T. Try it.
  2. Likely but not necessarily.
  3. Likely but not necessarily.
Why are you interested in PBE/IBE? This concept was abandoned almost twenty years ago and no regulatory agency would accept a study based solely on PBE/IBE.
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