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RegisterFull Replicate Study Design [Two-Stage / GS Designs]
Dear All,
Currently we are working on product XYZ. The product is reported to be highly variable drug product, intra subject variability is around 36 % for Cmax as seen in pilot study (02 studies) results.
My question is that whether we can conduct pivotal BE study with full replicate design using two stage approach.
Kindly also provide the links for any published references with such designs.
Thanks and regards,
Prashant
Edit: Category changed. [Helmut]
Currently we are working on product XYZ. The product is reported to be highly variable drug product, intra subject variability is around 36 % for Cmax as seen in pilot study (02 studies) results.
My question is that whether we can conduct pivotal BE study with full replicate design using two stage approach.
Kindly also provide the links for any published references with such designs.
Thanks and regards,
Prashant
Edit: Category changed. [Helmut]
Complete thread:
- Full Replicate Study Designprashantmohite 2015-01-28 06:56
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Full Replicate Study Design – search the Forum Dr_Dan 2015-01-28 08:38
Ing. Helmut Schütz