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Application of Absorption Modeling to Predict Bioequivalence Outcome of Two Batches of Etoricoxib Tablets

As part of the overall product development and manufacturing strategy, pharmaceutical companies routinely change formulation and manufacturing site. Depending on the type and level of change and the BCS class of the molecule, dissolution data and/or bioequivalence (BE) may be needed to support the c...

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Détails bibliographiques
Publié dans:AAPS PharmSciTech
Auteurs principaux: Mitra, Amitava, Kesisoglou, Filippos, Dogterom, Peter
Format: Artigo
Langue:Inglês
Publié: Springer US 2014
Sujets:
Accès en ligne:https://ncbi.nlm.nih.gov/pmc/articles/PMC4309824/
https://ncbi.nlm.nih.gov/pubmed/25182387
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-014-0194-8
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