Bioequivalence and Bioavailability Forum

Dear Cláudia
For a pilot study you do not need to have a pilot batch. A batch in lab scale is sufficient as long as this is manufactured under GMP and as long as stability is prooven for the time of study conduct. A pilot study has to be in compliance with ICH-GCP but need not to follow any guideline (it is not a pivotal study). It is in the sponsor's decision what kind of results he expects (proof of concept, etc.) and these results have to be presented in an application dossier to authorities but solely as supportive information. A pilot study with a pilot batch would only make sense if you aim to demonstrate bioequivalence and to use this study as the pivotal BE study
Kind regards
Dan