Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report

scientific article published on 04 May 2020

Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report is …
instance of (P31):
scholarly articleQ13442814

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P356DOI10.1016/J.XPHS.2020.04.021
P698PubMed publication ID32380182

P2093author name stringXinyuan Zhang
Amitava Mitra
Jennifer Dressman
Neil Parrott
Andrew Babiskin
Poonam Delvadia
Sandra Suarez-Sharp
Vidula Kolhatkar
Xavier Jh Pepin
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Bridging in vitro dissolution and in vivo exposure for acalabrutinib. Part II. A mechanistic PBPK model for IR formulation comparison, proton pump inhibitor drug interactions, and administration with acidic juicesQ91889907
Bridging in vitro dissolution and in vivo exposure for acalabrutinib. Part I. Mechanistic modelling of drug product dissolution to derive a P-PSD for PBPK model inputQ91889930
P577publication date2020-05-04
P1433published inJournal of Pharmaceutical SciencesQ3186933
P1476titleCurrent State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report

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cites work (P2860)
Q101354662Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to support Drug Product Quality: A Workshop Summary Report
Q100568976Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report
Q99589896In Vitro Biopredictive Methods: A Workshop Summary Report

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