Highly variable long half life drug parallel reference scal [Design Issues]

posted by DAHK – 2011-10-11 09:27 (5374 d 00:33 ago) – Posting: # 7465
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  1. A drug with a very long half life, gets retained in body for a very long period, thus it requires a parallel design for establishing Bioequivalence.

  2. When a drug is having a very high variability, we prefer to conduct a partial replicate or a full replicate design (RTR or RTRT).

  3. On the other hand if a drug is highly variable and with a very long half life can we go in for a parallel study design with three groups i.e. R T and R and do the reference scaled averaging.

else how do we design this study?

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