2026
Porfirio de la Cruz-Cruz, Mauricio A. García, José Trinidad Pérez-Urizar, Bertil Abrahamsson, Rodrigo Cristofoletti, Atsushi Kambayashi, Mehul Mehta, Alan Parr, James E. Polli, Vinod P. Shah, Naseem Charoo, Jennifer Dressman, Peter Langguth*.
"Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amlodipine Besylate."
Journal of Pharmaceutical Sciences (2026) 115:104108 https://doi.org/10.1016/j.xphs.2025.104108
Impact Factor: 3.8, JIF Percentile: 74.0 (JCR 2024)
2025
Reiji Negoya, Mayuki Tsueoka, Xichen Sun, Shuto Nishida, Bertil Abrahamsson, Naseem A. Charoo, Rodrigo Cristofoletti, Peter Langguth, Mehul Mehta, Alan Parr, James E. Polli, Vinod P. Shah, Jennifer Dressman, Atsushi Kambayashi*.
"Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Empagliflozin."
Journal of Pharmaceutical Sciences (2025) 114:104023 https://doi.org/10.1016/j.xphs.2025.104023
Impact Factor: 3.8, JIF Percentile: 74.0 (JCR 2024)Makoto Ishihara, Atsushi Kambayashi*.
"Physiologically based biopharmaceutics modeling to predict bioequivalence of rivaroxaban formulated as conventional tablets, OD tablets, and fine granules."
Journal of Drug Delivery Science and Technology (2025) 114:107631 https://doi.org/10.1016/j.jddst.2025.107631
Impact Factor: 4.9, JIF Percentile: 86.5 (JCR 2024)Takuto Niino, Takato Masada, Toshihide Takagi, Makoto Kataoka, Hiroyuki Yoshida, Shinji Yamashita, Atsushi Kambayashi*.
"Integrating In Vitro BE Checker with In Silico Physiologically Based Biopharmaceutics Modeling to Predict the Pharmacokinetic Profiles of Oral Drug Products."
Pharmaceutics (2025) 17:1222 https://doi.org/10.3390/pharmaceutics17091222
Impact Factor: 5.5, JIF Percentile: 90.5 (JCR 2024)Kristian Beran, Bertil Abrahamsson, Naseem Charoo, Rodrigo Cristofoletti, René Holm, Atsushi Kambayashi, Peter Langguth, Alan Parr, James E. Polli, Vinod P. Shah, Jennifer Dressman*.
"Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Voriconazole."
Journal of Pharmaceutical Sciences (2025) 114:660-680 https://doi.org/10.1016/j.xphs.2024.10.055
Impact Factor: 3.7, JIF Percentile: 74.7 (JCR 2023)Kristian Beran, Bertil Abrahamsson, Naseem Charoo, Rodrigo Cristofoletti, René Holm, Atsushi Kambayashi, Peter Langguth, Mehul Mehta, Alan Parr, James E. Polli, Vinod P. Shah, Jennifer Dressman*.
"Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Lemborexant."
Journal of Pharmaceutical Sciences (2025) 114:644-659 https://doi.org/10.1016/j.xphs.2024.10.030
Impact Factor: 3.7, JIF Percentile: 74.7 (JCR 2023)
2024
Yoshinori Takahashi, Atsushi Kambayashi*.
"Physiologically based in vitro – in vivo correlation of modified release oral formulations with non-linear intestinal absorption: a case study using mirabegron."
European Journal of Pharmaceutics and Biopharmaceutics (2024) 204:114479 https://doi.org/10.1016/j.ejpb.2024.114479
Impact Factor: 4.4, JIF Percentile: 81.8 (JCR 2023)Atsushi Kambayashi*, Masaki Iida, Makoto Ishihara, Yoshinori Takahashi, Bertil Abrahamsson, Naseem A. Charoo, Rodrigo Cristofoletti, Peter Langguth, Mehul Mehta, Alan Parr, James E. Polli, Vinod P. Shah, Jennifer Dressman.
"Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Raltegravir Potassium."
Journal of Pharmaceutical Sciences (2024) 113:3137-3144 https://doi.org/10.1016/j.xphs.2024.08.006
Impact Factor: 3.7, JIF Percentile: 74.7 (JCR 2023)Naseem A. Charoo, Selvasudha N., Zahira Nala Kath, Bertil Abrahamsson, Rodrigo Cristofoletti, Atsushi Kambayashi, Peter Langguth, Mehul Mehta, Alan Parr, James E. Polli, Vinod P. Shah, Jennifer Dressman*.
"Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fexofenadine."
Journal of Pharmaceutical Sciences (2024) 113:2981-2993 https://doi.org/10.1016/j.xphs.2024.06.002
Impact Factor: 3.7, JIF Percentile: 74.7 (JCR 2023)Kohei Nakamura, Atsushi Kambayashi*, Satomi Onoue.
"Importance of Considering Fed-State Gastrointestinal Physiology in Predicting the Reabsorption of Enterohepatic Circulation of Drugs."
Pharmaceutical Research (2024) 41:673-685 https://doi.org/10.1007/s11095-024-03669-3
Impact Factor: 3.7, JIF Percentile: 60.3 (JCR 2022)Yoshiyuki Shirasaka*, Atsushi Kambayashi.
"Food effects on oral drug absorption: Recent advances in understanding mechanisms and quantitative prediction."
Drug Metabolism and Pharmacokinetics (2024) 54:100533 https://doi.org/10.1016/j.dmpk.2023.100533
Impact Factor: 2.1, JIF Percentile: 23.9 (JCR 2022)David Plano, Niklas Rudolph, Christoph Saal, Bertil Abrahamsson, Rodrigo Cristofoletti, Atsushi Kambayashi, Peter Langguth, Mehul Mehta, Alan Parr, James E. Polli, Vinod P. Shah, Naseem Charoo, Jennifer Dressman*.
"Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Isavuconazonium Sulfate."
Journal of Pharmaceutical Sciences (2024) 113:386-395 https://doi.org/10.1016/j.xphs.2023.11.005
Impact Factor: 3.8, JIF Percentile: 62.4 (JCR 2022)
2023
Keisuke Makino, Ryota Tsukada, Atsushi Kambayashi, Kohei Yamada, Hideyuki Sato, Satomi Onoue*.
"Self‐micellizing solid dispersion of tacrolimus: Physicochemical and pharmacokinetic characterization."
Biopharmaceutics and Drug Disposition (2023) 44:387-395 https://doi.org/10.1002/bdd.2373
Impact Factor: 2.1, JIF Percentile: 23.9 (JCR 2022)Atsushi Kambayashi*.
"In Silico Modeling Approaches Coupled with In Vitro Characterization in Predicting In Vivo Performance of Drug Delivery System Formulations."
Molecular Pharmaceutics (2023) 20:4344-4353 https://doi.org/10.1021/acs.molpharmaceut.3c00184
Impact Factor: 4.9, JIF Percentile: 78.2 (JCR 2022)Kohei Yamada, Atsushi Kambayashi, Hideyuki Sato, Satomi Onoue*.
"Control and Prediction of Drug Absorption at Mucosal Tissues."
YAKUGAKU ZASSHI (2023) 143:349-352 https://doi.org/10.1248/yakushi.22-00170-2Naseem A. Charoo, Daud B. Abdallah, Daoud T. Ahmed, Bertil Abrahamsson, Rodrigo Cristofoletti, Peter Langguth, Mehul Mehta, Alan Parr, James E. Polli, Vinod P. Shah, Atsushi Kambayashi, Jennifer Dressman*.
"Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride."
Journal of Pharmaceutical Sciences (2023) 112:893-903 https://doi.org/10.1016/j.xphs.2022.12.021
Impact Factor: 3.784, JIF Percentile: 55.38 (JCR 2021)Atsushi Kambayashi*, Mariska de Meijer, Kim Wegman, Cees van Veldhuizen, Bertil Abrahamsson, Rodrigo Cristofoletti, Peter Langguth, Mehul Mehta, Alan Parr, James E. Polli, Vinod P. Shah, Jennifer Dressman.
"Biowaiver Monograph for Immediate-Release Dosage Forms: Levamisole Hydrochloride."
Journal of Pharmaceutical Sciences (2023) 112:634-639 https://doi.org/10.1016/j.xphs.2022.12.014
Impact Factor: 3.784, JIF Percentile: 55.38 (JCR 2021)Atsushi Kambayashi, Yoshiyuki Shirasaka*.
"Food effects on gastrointestinal physiology and drug absorption."
Drug Metabolism and Pharmacokinetics (2023) 48:100488 https://doi.org/10.1016/j.dmpk.2022.100488
Impact Factor: 2.041, JIF Percentile: 17.74 (JCR 2021)Tsuyoshi Kiyota, Yuki Ando, Atsushi Kambayashi*.
"Dynamic Changes in Gastrointestinal Fluid Characteristics after Food Ingestion Are Important for Quantitatively Predicting the In Vivo Performance of Oral Solid Dosage Forms in Humans in the Fed State."
Molecular Pharmaceutics (2023) 20:357-369 https://doi.org/10.1021/acs.molpharmaceut.2c00666
Impact Factor: 5.364, JIF Percentile: 76.88 (JCR 2021)
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Kambayashi lab members are underlined. The corresponding author has an asterisk in his/her name.