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

Reiji Negoya¹, Mayuki Tsueoka¹, Xichen Sun¹, Shuto Nishida¹, Bertil Abrahamsson², Naseem A. Charoo³, Rodrigo Cristofoletti⁴, Peter Langguth⁵, Mehul Mehta⁶, Alan Parr⁷, James E. Polli⁸, Vinod P. Shah⁹, Jennifer Dressman¹⁰, Atsushi Kambayashi¹*.
"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
Affiliations: ¹Tokyo University of Science (Japan); ²AstraZeneca (Sweden); ³Wissen Healthcare (United Arab Emirates); ⁴University of Florida (USA); ⁵Johannes Gutenberg University Mainz (Germany); ⁶United States Food and Drug Administration (USA); ⁷Bioceutics (USA); ⁸University of Maryland (USA); ⁹Pharmaceutical Consultant (USA); ¹⁰Pharmaceutical Consultant (Germany)
Impact Factor: 3.8, JIF Percentile: 74.0 (JCR 2024)

Makoto Ishihara¹, Atsushi Kambayashi¹*.
"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
Affiliations: ¹Tokyo University of Science (Japan)
Impact Factor: 4.9, JIF Percentile: 86.5 (JCR 2024)

Takuto Niino¹, Takato Masada², Toshihide Takagi², Makoto Kataoka², Hiroyuki Yoshida³, Shinji Yamashita⁴, Atsushi Kambayashi¹*.
"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
Affiliations: ¹Tokyo University of Science (Japan); ²Setsunan University (Japan); ³National Institute of Health Sciences (Japan); ⁴Ritsumeikan University (Japan)
Impact Factor: 5.5, JIF Percentile: 90.5 (JCR 2024)

Kristian Beran¹, Bertil Abrahamsson², Naseem Charoo³, Rodrigo Cristofoletti⁴, René Holm⁵, Atsushi Kambayashi⁶, Peter Langguth⁷, Alan Parr⁸, James E. Polli⁹, Vinod P. Shah¹⁰, Jennifer Dressman¹*.
"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
Affiliations: ¹Fraunhofer Institute for Translational Medicine and Pharmacology (Germany); ²AstraZeneca (Sweden); ³Aramed (UAE); ⁴University of Florida (USA); ⁵University of Southern Denmark (Denmark); ⁶Tokyo University of Science (Japan);⁷Johannes Gutenberg University Mainz (Germany); ⁸BioCeutics (USA); ⁹University of Maryland (USA); ¹⁰Pharmaceutical Consultant (USA)
Impact Factor: 3.7, JIF Percentile: 74.7 (JCR 2023)

Kristian Beran¹, Bertil Abrahamsson², Naseem Charoo³, Rodrigo Cristofoletti⁴, René Holm⁵, Atsushi Kambayashi⁶, Peter Langguth⁷, Mehul Mehta⁸, Alan Parr⁹, James E. Polli¹⁰, Vinod P. Shah¹¹, Jennifer Dressman¹*.
"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
Affiliations: ¹Fraunhofer Institute for Translational Medicine and Pharmacology (Germany); ²AstraZeneca (Sweden); ³Aramed (UAE); ⁴University of Florida (USA); ⁵University of Southern Denmark (Denmark); ⁶Tokyo University of Science (Japan);⁷Johannes Gutenberg University Mainz (Germany); ⁸United States Food and Drug Administration (USA); ⁹BioCeutics (USA); ¹⁰University of Maryland (USA); ¹¹Pharmaceutical Consultant (USA)
Impact Factor: 3.7, JIF Percentile: 74.7 (JCR 2023),

Yoshinori Takahashi¹, Atsushi Kambayashi¹*.
"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
Affiliations: ¹Tokyo University of Science (Japan)
Impact Factor: 4.4, JIF Percentile: 81.8 (JCR 2023)

Atsushi Kambayashi¹*, Masaki Iida¹, Makoto Ishihara¹, Yoshinori Takahashi¹, Bertil Abrahamsson², Naseem A. Charoo³, Rodrigo Cristofoletti⁴, Peter Langguth⁵, Mehul Mehta⁶, Alan Parr⁷, James E. Polli⁸, Vinod P. Shah⁹, Jennifer Dressman¹⁰.
"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
Affiliations: ¹Tokyo University of Science (Japan); ²AstraZeneca (Sweden); ³Adcan Pharma (United Arab Emirates); ⁴University of Florida (USA); ⁵Johannes Gutenberg University Mainz (Germany); ⁶United States Food and Drug Administration (USA); ⁷Bioceutics (USA); ⁸University of Maryland (USA); ⁹Pharmaceutical Consultant (USA); ¹⁰Fraunhofer Institute for Translational Medicine and Pharmacology (Germany)
Impact Factor: 3.7, JIF Percentile: 74.7 (JCR 2023)

Naseem A. Charoo¹, Selvasudha N.², Zahira Nala Kath¹, Bertil Abrahamsson³, Rodrigo Cristofoletti⁴, Atsushi Kambayashi⁵, Peter Langguth⁶, Mehul Mehta⁷, Alan Parr⁸, James E. Polli⁹, Vinod P. Shah¹⁰, Jennifer Dressman¹¹*.
"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
Affiliations: ¹Adcan Pharma (United Arab Emirates); ²Pondicherry University (India); ³AstraZeneca (Sweden); ⁴University of Florida (USA); ⁵Tokyo University of Science (Japan); ⁶Johannes Gutenberg University Mainz (Germany); ⁷United States Food and Drug Administration (USA); ⁸Bioceutics (USA); ⁹University of Maryland (USA); ¹⁰International Pharmaceutical Federation (Netherlands); ¹¹Fraunhofer Institute for Translational Medicine and Pharmacology (Germany)
Impact Factor: 3.7, JIF Percentile: 74.7 (JCR 2023)

Kohei Nakamura^1,2, Atsushi Kambayashi³*, 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
Affiliations: ¹Astellas Pharma (Japan); ²University of Shizuoka (Japan); ³Tokyo University of Science (Japan)
Impact Factor: 3.7, JIF Percentile: 60.3 (JCR 2022)

Yoshiyuki Shirasaka¹*, Atsushi Kambayashi².
"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
Affiliations: ¹Kanazawa University (Japan); ²Tokyo University of Science (Japan)
Impact Factor: 2.1, JIF Percentile: 23.9 (JCR 2022)

David Plano¹, Niklas Rudolph¹, Christoph Saal², Bertil Abrahamsson³, Rodrigo Cristofoletti⁴, Atsushi Kambayashi⁵, Peter Langguth⁶, Mehul Mehta⁷, Alan Parr⁸, James E. Polli⁹, Vinod P. Shah¹⁰, Naseem Charoo¹¹, Jennifer Dressman¹*.
"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
Affiliations: ¹Fraunhofer Institute for Translational Medicine and Pharmacology (Germany); ²Boehringer Ingelheim (Germany); ³AstraZeneca (Sweden); ⁴University of Florida (USA); ⁵Tokyo University of Science (Japan); ⁶Johannes Gutenberg University Mainz (Germany); ⁷United States Food and Drug Administration (USA); ⁸BioCeutics (USA); ⁹University of Maryland (USA); ¹⁰International Pharmaceutical Federation (Netherlands); ¹¹Adcan Pharma (United Arab Emirates)
Impact Factor: 3.8, JIF Percentile: 62.4 (JCR 2022)

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)