Kambayashi Research Lab　東京理科大学薬学部上林研究室

Reiji Negoya, Mayuki Tsueoka, Xichen Sun, Shuto Nishida, Bertil Abrahamsson¹, Naseem A. Charoo², Rodrigo Cristofoletti³, Peter Langguth⁴, Mehul Mehta⁵, Alan Parr⁶, James E. Polli⁷, Vinod P. Shah⁸, Jennifer Dressman⁹, 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), ¹AstraZeneca (Sweden); ²Wissen Healthcare (United Arab Emirates); ³University of Florida (USA); ⁴Johannes Gutenberg University Mainz (Germany); ⁵United States Food and Drug Administration, (USA); ⁶Bioceutics (USA); ⁷University of Maryland (USA); ⁸Pharmaceutical Consultant (USA); ⁹Pharmaceutical Consultant (Germany)

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 Masada¹, Toshihide Takagi¹, Makoto Kataoka¹, Hiroyuki Yoshida², Shinji Yamashita³, 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), ¹Setsunan University (Japan); ²National Institute of Health Sciences (Japan); ³Ritsumeikan University (Japan)

Kristian Beran¹, Bertil Abrahamsson², Naseem Charoo³, Rodrigo Cristofoletti⁴, René Holm⁵, Atsushi Kambayashi, Peter Langguth⁶, Alan Parr⁷, James E. Polli⁸, Vinod P. Shah⁹, Jennifer Dressman*¹.
"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), ¹Fraunhofer Institute for Translational Medicine and Pharmacology (Germany); ²AstraZeneca (Sweden); ³Aramed (UAE); ⁴University of Florida (USA); ⁵University of Southern Denmark (Denmark); ⁶Johannes Gutenberg University Mainz (Germany); ⁷BioCeutics (USA); ⁸University of Maryland (USA); ⁹Pharmaceutical Consultant (USA)

Kristian Beran¹, Bertil Abrahamsson², Naseem Charoo³, Rodrigo Cristofoletti⁴, René Holm⁵, Atsushi Kambayashi, Peter Langguth⁶, Mehul Mehta⁷, Alan Parr⁸, James E. Polli⁹, Vinod P. Shah¹⁰, Jennifer Dressman*¹.
"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), ¹Fraunhofer Institute for Translational Medicine and Pharmacology (Germany); ²AstraZeneca (Sweden); ³Aramed (UAE); ⁴University of Florida (USA); ⁵University of Southern Denmark (Denmark); ⁶Johannes Gutenberg University Mainz (Germany); ⁷United States Food and Drug Administration (USA); ⁸BioCeutics (USA); ⁹University of Maryland (USA); ¹⁰Pharmaceutical Consultant (USA)

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 Abrahamsson¹, Naseem A. Charoo², Rodrigo Cristofoletti³, Peter Langguth⁴, Mehul Mehta⁵, Alan Parr⁶, James E. Polli⁷, Vinod P. Shah⁸, Jennifer Dressman⁹.
"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), ¹AstraZeneca (Sweden); ²Adcan Pharma (United Arab Emirates); ³University of Florida (USA); ⁴Johannes Gutenberg University Mainz (Germany); ⁵United States Food and Drug Administration (USA); ⁶Bioceutics (USA); ⁷University of Maryland (USA); ⁸Pharmaceutical Consultant (USA); ⁹Fraunhofer Institute for Translational Medicine and Pharmacology (Germany)

Naseem A. Charoo¹, Selvasudha N.², Zahira Nala Kath¹, Bertil Abrahamsson³, Rodrigo Cristofoletti⁴, Atsushi Kambayashi, Peter Langguth⁵, Mehul Mehta⁶, Alan Parr⁷, James E. Polli⁸, Vinod P. Shah⁹, Jennifer Dressman*¹⁰.
"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), ¹Adcan Pharma (United Arab Emirates); ²Pondicherry University (India); ³AstraZeneca (Sweden); ⁴University of Florida (USA); ⁵Johannes Gutenberg University Mainz (Germany); ⁶United States Food and Drug Administration (USA); ⁷Bioceutics (USA); ⁸University of Maryland (USA); ⁹International Pharmaceutical Federation (Netherlands); ¹⁰Fraunhofer Institute for Translational Medicine and Pharmacology (Germany)

Kohei Nakamura¹, Atsushi Kambayashi*, Satomi Onoue².
"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), ¹Astellas Pharma (Japan); ²University of Shizuoka (Japan)

Yoshiyuki Shirasaka*¹, 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), ¹Kanazawa University (Japan)

David Plano¹, Niklas Rudolph¹, Christoph Saal², Bertil Abrahamsson³, Rodrigo Cristofoletti⁴, Atsushi Kambayashi, Peter Langguth⁵, Mehul Mehta⁶, Alan Parr⁷, James E. Polli⁸, Vinod P. Shah⁹, Naseem Charoo¹⁰, Jennifer Dressman*¹.
"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), ¹Fraunhofer Institute for Translational Medicine and Pharmacology (Germany); ²Boehringer Ingelheim (Germany); ³AstraZeneca (Sweden); ⁴University of Florida (USA); ⁵Johannes Gutenberg University Mainz (Germany); ⁶United States Food and Drug Administration (USA); ⁷BioCeutics (USA); ⁸University of Maryland (USA); ⁹International Pharmaceutical Federation (Netherlands); ¹⁰Adcan Pharma (United Arab Emirates)

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.22-00170-2

Naseem 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)