Justification of Drug Product Dissolution Rate and Drug Substance Particle Size Specifications Based on Absorption PBPK Modeling for Lesinurad Immediate Release Tablets
Pepin, Xavier J. H, Flanagan, Talia R, Holt, David J, Eidelman, Anna, Treacy, Don, Rowlings, Colin E
Published in Molecular pharmaceutics (06.09.2016)
Published in Molecular pharmaceutics (06.09.2016)
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Journal Article
Understanding Mechanisms of Food Effect and Developing Reliable PBPK Models Using a Middle-out Approach
Pepin, Xavier J. H., Huckle, James E., Alluri, Ravindra V., Basu, Sumit, Dodd, Stephanie, Parrott, Neil, Emami Riedmaier, Arian
Published in The AAPS journal (04.01.2021)
Published in The AAPS journal (04.01.2021)
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Journal Article
Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report
Pepin, Xavier J.H., Parrott, Neil, Dressman, Jennifer, Delvadia, Poonam, Mitra, Amitava, Zhang, Xinyuan, Babiskin, Andrew, Kolhatkar, Vidula, Suarez-Sharp, Sandra
Published in Journal of pharmaceutical sciences (01.02.2021)
Published in Journal of pharmaceutical sciences (01.02.2021)
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Journal Article
Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models
Wagner, Christian, Kesisoglou, Filippos, Pepin, Xavier J. H., Parrott, Neil, Emami Riedmaier, Arian
Published in The AAPS journal (17.06.2021)
Published in The AAPS journal (17.06.2021)
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Journal Article
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 input
Pepin, Xavier J.H., Sanderson, Natalie J., Blanazs, Alexander, Grover, Shveta, Ingallinera, Timothy G., Mann, James C.
Published in European journal of pharmaceutics and biopharmaceutics (01.09.2019)
Published in European journal of pharmaceutics and biopharmaceutics (01.09.2019)
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Journal Article
Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report
Mitra, Amitava, Suarez-Sharp, Sandra, Pepin, Xavier J.H., Flanagan, Talia, Zhao, Yang, Kotzagiorgis, Evangelos, Parrott, Neil, Sharan, Satish, Tistaert, Christophe, Heimbach, Tycho, Zolnik, Banu, Sjögren, Erik, Wu, Fang, Anand, Om, Kakar, Shefali, Li, Min, Veerasingham, Shereeni, Kijima, Shinichi, Lima Santos, Gustavo Mendes, Ning, Baoming, Raines, Kimberly, Rullo, Greg, Mandula, Haritha, Delvadia, Poonam, Dressman, Jennifer, Dickinson, Paul A., Babiskin, Andrew
Published in Journal of pharmaceutical sciences (01.02.2021)
Published in Journal of pharmaceutical sciences (01.02.2021)
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Journal Article
In Vitro Biopredictive Methods: A Workshop Summary Report
Pepin, Xavier J.H., Dressman, Jennifer, Parrott, Neil, Delvadia, Poonam, Mitra, Amitava, Zhang, Xinyuan, Babiskin, Andrew, Kolhatkar, Vidula, Seo, Paul, Taylor, Lynne S., Sjögren, Erik, Butler, James M., Kostewicz, Edmund, Tannergren, Christer, Koziolek, Mirko, Kesisoglou, Filippos, Dallmann, André, Zhao, Yang, Suarez-Sharp, Sandra
Published in Journal of pharmaceutical sciences (01.02.2021)
Published in Journal of pharmaceutical sciences (01.02.2021)
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Journal Article
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 juices
Pepin, Xavier J.H., Moir, Andrea J., Mann, James C., Sanderson, Natalie J., Barker, Richard, Meehan, Elizabeth, Plumb, Allan P., Bailey, George R., Murphy, Dean S., Krejsa, Cecile M., Andrew, Marilee A., Ingallinera, Timothy G., Slatter, J. Greg
Published in European journal of pharmaceutics and biopharmaceutics (01.09.2019)
Published in European journal of pharmaceutics and biopharmaceutics (01.09.2019)
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Journal Article
Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling
Pepin, Xavier J H, Hynes, Scott M, Zahir, Hamim, Walker, Deborah, Semmens, Lois Q, Suarez-Sharp, Sandra
Published in CPT: pharmacometrics and systems pharmacology (02.09.2024)
Published in CPT: pharmacometrics and systems pharmacology (02.09.2024)
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