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Systemic Bioequivalence Is Unlikely to Equal Target Site Bioequivalence for Nanotechnology Oncologic Products

Approval of generic drugs by the US Food and Drug Administration (FDA) requires the product to be pharmaceutically equivalent to the reference listed drug (RLD) and demonstrate bioequivalence (BE) in effectiveness when administered to patients under the conditions in the RLD product labeling. Effect...

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Détails bibliographiques
Publié dans:AAPS J
Auteurs principaux: Au, Jessie L.-S., Lu, Ze, Abbiati, Roberto A., Wientjes, M. Guillaume
Format: Artigo
Langue:Inglês
Publié: 2019
Sujets:
Accès en ligne:https://ncbi.nlm.nih.gov/pmc/articles/PMC6432930/
https://ncbi.nlm.nih.gov/pubmed/30710324
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-019-0296-z
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