Bioequivalence and Bioavailability Forum

prashantmohite
☆

India,
2015-01-28 07:56
(3731 d 16:30 ago)

Posting: # 14326
Views: 4,604

Full 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]

Dr_Dan ★★ Germany, 2015-01-28 09:38 (3731 d 14:48 ago) @ prashantmohite Posting: # 14327 Views: 3,559	Full Replicate Study Design – search the Forum Post reply
	Dear Prashant Please search the Forum before entering a question. Less than a week ago ElMaestro states that no method is published yet and Helmut explained that it would take several years if you want to explore RSABE in a two stage design with current hard-/software finding and validating an adjusted α. (see this link) Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan

Full Replicate Study Design [Two-Stage / GS Designs]

Full Replicate Study Design – search the Forum