Palbociclib product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of palbociclib.
Keywords: Bioequivalence, generics, palbociclib
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Overview of comments received on 'Draft palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - Revision 1' (PDF/229.54 KB)
First published: 13/09/2021
EMA/CHMP/133838/2021 -
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Draft palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - Revision 1 (PDF/165.53 KB)
Draft: consultation closed
First published: 23/11/2020
Consultation dates: 23/11/2020 to 28/02/2021
EMA/CHMP/802679/2018 Rev. 1 Corr. 1 -
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Draft palbociclib hard capsule 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - First version (PDF/124.51 KB)
Draft: consultation closed
First published: 08/02/2019
Consultation dates: 08/02/2019 to 30/06/2019
EMA/CHMP/802679/2018