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Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the

Paul A Dickinson1, Filippos Kesisoglou2, Talia Flanagan3

  • 1Seda Pharmaceutical Development Services, The Biohub at Alderley Park, Alderley Edge, Cheshire, UK SK10 4TG.

Journal of Pharmaceutical Sciences
|September 24, 2016
PubMed

Keywords:
Biopharmaceutics Classification System (BCS)Biopharmaceutics Risk Assessment Roadmap (BioRAM)bioavailabilityclinical trial simulationsdrug deliveryin silico modelingin vitro and in vivo correlations/relationships (IVIVC/R)in vitro modelspharmokinetic/pharmacodynamic modelsquality by design (QbD)

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