All Stories

  1. Important missing information in Japan's risk management plans: a cross-sectional analysis after a decade of implementation

    Article • Frontiers in Medicine, July 2026, Frontiers

    PhD Hideki Maeda

  2. Post‐Marketing Requirements for Anticancer Drugs Approved in Japan, 2001–2024: A Cross‐Sectional Analysis

    Article • CPT Pharmacometrics & Systems Pharmacology, July 2026, Wiley

    PhD Hideki Maeda

  3. Identifying Factors Associated with the Acquisition of Multiple Indications for Anticancer Drugs

    Article • Current Oncology, June 2026, MDPI AG

    PhD Hideki Maeda

  4. Dose optimization in FDA oncology drug approvals: Factors associated with observing exposure-efficacy relationships.

    Article • Journal of Clinical Oncology, June 2026, American Society of Clinical Oncology (ASCO)

    PhD Hideki Maeda

  5. Tumor‐Specific Success Probabilities and Factors Associated With Phase III Trials in Oncology Drug Development

    Article • Clinical and Translational Science, June 2026, Wiley

    PhD Hideki Maeda

  6. Adverse Event Reports and Safety Measures for Breast Implant–associated Anaplastic Large Cell Lymphoma in Japan

    Article • Plastic and Reconstructive Surgery Global Open, March 2026, Wolters Kluwer Health

    PhD Hideki Maeda

  7. Prognostic value of HER2 discordance between primary and metastatic or recurrent breast cancer: A systematic review and meta-analysis

    Article • Critical Reviews in Oncology/Hematology, January 2026, Elsevier

    PhD Hideki Maeda

  8. A landscape analysis of Japanese tolerability assessments in oncology drug development

    Article • Cancer Treatment and Research Communications, January 2026, Elsevier

    PhD Hideki Maeda

  9. Interactions Between Pharmaceutical Companies and Patient Advocacy Groups in Japan: A Qualitative and Quantitative Interview Study

    Article • Risk Management and Healthcare Policy, November 2025, Taylor & Francis

    PhD Hideki Maeda

  10. Surrogate Endpoints in Pivotal Clinical Trials for Drug Approval in Japan Compared to the United States

    Article • Clinical and Translational Science, November 2025, Wiley

    PhD Hideki Maeda

  11. A cross-sectional study on the first-in-human trials of anticancer drugs in Japan and the United States and the probability of approval

    Article • International Journal of Clinical Oncology, August 2025, Springer Science + Business Media

    PhD Hideki Maeda

  12. Retrospective Analysis of Master Protocols in Tumor‐Agnostic Drug Development: Evaluation of Application to Single‐Agent Therapies With ORR as the Endpoint for Approval of Oncology Drugs

    Article • Clinical and Translational Science, August 2025, Wiley

    PhD Hideki Maeda

  13. Consideration on Food Effect Studies for Anticancer Drugs Approved in Japan Between 2001 and 2022

    Article • Clinical and Translational Science, July 2025, Wiley

    PhD Hideki Maeda

  14. Characterization of Japanese Risk Management Plans after 10 Years of Implementation: 2013–2023

    Article • Therapeutic Innovation & Regulatory Science, June 2025, Springer Science + Business Media

    PhD Hideki Maeda

  15. Potential surrogate endpoint for B-cell hematologic malignancy: A systematic review and meta-analysis

    Article • Scientific Reports, June 2025, Springer Science + Business Media

    PhD Hideki Maeda

  16. Added Therapeutic Benefits of Top‐Selling Drugs in Japan: A Cross‐Sectional Study Using Health Technology Assessment

    Article • Clinical and Translational Science, May 2025, Wiley

    Frank Moriarty, PhD Hideki Maeda

  17. Dose Optimization in Oncology Drug Development: Risk Factors for Postmarketing Requirements and Commitments

    Article • Clinical Pharmacology & Therapeutics, May 2025, Wiley

    PhD Hideki Maeda

  18. Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval

    Article • Therapeutic Innovation & Regulatory Science, April 2025, Springer Science + Business Media

    PhD Hideki Maeda

  19. Impact of loss of HER2 positivity following neoadjuvant therapy in HER2-positive breast cancer patients on long-term prognosis: A systematic review and meta-analysis

    Article • Cancer Treatment Reviews, April 2025, Elsevier

    PhD Hideki Maeda

  20. Cross-sectional Study on Sex Disparities among Japanese and Korean University School of Pharmacy Professors

    Article • January 2025, openRxiv

    PhD Hideki Maeda

  21. Gender differences in pharmacy professors in Japan and Korea

    Article • The Lancet Regional Health - Western Pacific, January 2025, Elsevier

    PhD Hideki Maeda

  22. Comparison of National Lists of Essential Medicine among Japan, the United States of America, the European Union, the World Health Organization, Thailand, and China

    Article • Asian Pacific Journal of Health Economics and Policy, January 2025, The Japanese Association of Counseling Science

    PhD Hideki Maeda

  23. Has risk management plan system influenced the speed of package insert revisions in Japan?

    Article • Frontiers in Medicine, October 2024, Frontiers

    PhD Hideki Maeda

  24. Comparison of regulatory approval system for medicines in emergency among Japan, the United States, the United Kingdom, Europe, and China

    Article • PLOS One, September 2024, PLOS

    PhD Hideki Maeda

  25. Trends in the market for drug delivery devices categorized as combination drugs and medical devices and regulatory challenges for autoinjectors in Japan

    Article • Frontiers in Medical Technology, August 2024, Frontiers

    PhD Hideki Maeda

  26. A Qualitative Interview Study on Expanded Access Clinical Trials for Compassionate Use in Japan

    Article • Patient Preference and Adherence, July 2024, Taylor & Francis

    PhD Hideki Maeda

  27. Current situation and issues regarding termination of risk management plans in Japan

    Article • Frontiers in Medicine, May 2024, Frontiers

    PhD Hideki Maeda

  28. Adult and pediatric relapsing multiple sclerosis phase II and phase III trial design and their primary end points: A systematic review

    Article • Clinical and Translational Science, May 2024, Wiley

    PhD Hideki Maeda

  29. Trends in oncology drug lags in Japan from 2001–2020

    Article • Clinical and Translational Science, October 2023, Wiley

    PhD Hideki Maeda

  30. Patient enrollment speed for clinical trials in Japan

    Article • Biological and Pharmaceutical Bulletin, September 2023, Pharmaceutical Society of Japan

    PhD Hideki Maeda

  31. Comparing cancer drug approval systems in the United States and Japan

    Article • Health Science Reports, May 2023, Wiley

    PhD Hideki Maeda

  32. Assessment of Surrogate End Point Trends in Clinical Trials to Approve Oncology Drugs From 2001 to 2020 in Japan

    Article • JAMA Network Open, April 2023, American Medical Association (AMA)

    PhD Hideki Maeda

  33. Correlation of Anticancer Drug Prices with Outcomes of Overall Survival and Progression-Free Survival in Clinical Trials in Japan

    Article • February 2023, MDPI AG

    PhD Hideki Maeda

  34. Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999–2019

    Article • International Journal of Clinical Pharmacy, November 2022, Springer Science + Business Media

    PhD Hideki Maeda

  35. O16-6 Consideration for the trends on drug lag in oncology drugs during the last two decades in Japan; 2001-2020

    Article • Annals of Oncology, July 2022, Elsevier

    PhD Hideki Maeda

  36. Characteristics of the Compassionate Use Program in Japan: An Analysis of Expanded Access Clinical Trials from 2016 to 2021

    Article • Clinical Pharmacology & Therapeutics, June 2022, Wiley

    PhD Hideki Maeda

  37. Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan

    Article • Frontiers in Medicine, April 2022, Frontiers

    PhD Hideki Maeda

  38. Lag Time for New Innovative, First-in-Class, Drug Approval in Japan

    Article • Biological and Pharmaceutical Bulletin, April 2022, Pharmaceutical Society of Japan

    PhD Hideki Maeda

  39. The Current Status and Future Direction of Clinical Research in Japan From a Regulatory Perspective

    Article • Frontiers in Medicine, January 2022, Frontiers

    PhD Hideki Maeda

  40. Relationships between developmental strategies for additional indications and price revisions for anticancer drugs in Japan

    Article • BMC Health Services Research, December 2021, Springer Science + Business Media

    PhD Hideki Maeda

  41. Study of the compatibility of oral magnesium oxide preparations sold in Japan with the ICH-Q3D guideline for elemental impurities

    Article • Drug Discoveries & Therapeutics, October 2021, International Research and Cooperation Association for Bio & Socio-Sciences Advancement (IRCA-BSSA)

    PhD Hideki Maeda

  42. Relationships between Developmental Strategies for Additional Indications and Price Revisions for Anticancer Drugs in Japan

    Article • September 2021, Research Square

    PhD Hideki Maeda

  43. Medical Affairs in Pharmaceutical Companies and Related Pharmaceutical Regulations in Japan

    Article • Frontiers in Medicine, August 2021, Frontiers

    PhD Hideki Maeda

  44. Assessment of Drugs Approved by Public Knowledge‐Based Applications ( Kouchi‐shinsei ) During the Last Two Decades in Japan

    Article • Clinical Pharmacology & Therapeutics, July 2021, Wiley

    PhD Hideki Maeda

  45. Japan’s Special Approval for Emergency System During the COVID‐19 Pandemic

    Article • Clinical Pharmacology & Therapeutics, June 2021, Wiley

    PhD Hideki Maeda

  46. Surrogate endpoint for prostate cancer

    Article • Cancer Reports, January 2021, Wiley

    PhD Hideki Maeda

  47. 医薬品開発におけるリアルワールドデータの利活用（Regulatory approval with real world data from regulatory science perspective）

    Article • Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku, January 2021, Japanese Society for Pharmacoepidemiology

    PhD Hideki Maeda

  48. プログラム

    Article • Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku, January 2021, Japanese Society for Pharmacoepidemiology

    PhD Hideki Maeda

  49. 演者紹介

    Article • Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku, January 2021, Japanese Society for Pharmacoepidemiology

    PhD Hideki Maeda

  50. Efficacy and safety of a 3-month dosing regimen of degarelix in Japanese patients with prostate cancer: a phase II maintenance-dose-finding study

    Article • Japanese Journal of Clinical Oncology, February 2017, Oxford University Press (OUP)

    PhD Hideki Maeda

  51. A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer

    Article • International Journal of Clinical Oncology, January 2016, Springer Science + Business Media

    PhD Hideki Maeda

  52. Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?

    Article • International Journal of Clinical Oncology, April 2015, Springer Science + Business Media

    PhD Hideki Maeda

  53. Reply to the letter to the editor ‘Surrogate end points for overall survival.Festina lente (more haste, less speed)’ by Braillon

    Article • Annals of Oncology, April 2015, Elsevier

    PhD Hideki Maeda

  54. Regulatory review time for approval of oncology drugs in Japan between 2001 and 2014. Considerations of changes, factors that affect review time, and difference with the United States

    Article • The Journal of Clinical Pharmacology, February 2015, Wiley

    PhD Hideki Maeda

  55. Acceptance of surrogate end points in clinical trials supporting approval of drugs for cancer treatment by the Japanese regulatory agency

    Article • Annals of Oncology, January 2015, Elsevier

    PhD Hideki Maeda

  56. Differences in maximum tolerated doses and approval doses of molecularly targeted oncology drug between Japan and Western countries

    Article • Investigational New Drugs, March 2014, Springer Science + Business Media

    PhD Hideki Maeda

  57. Involvement of Anticancer Drugs in the Relief System for Adverse Drug Reactions in Japan

    Article • Japanese Journal of Clinical Oncology, September 2013, Oxford University Press (OUP)

    PhD Hideki Maeda

  58. The Efficacy and Safety of Degarelix, a GnRH Antagonist: A 12-month, Multicentre, Randomized, Maintenance Dose-finding Phase II Study in Japanese Patients with Prostate Cancer

    Article • Japanese Journal of Clinical Oncology, March 2012, Oxford University Press (OUP)

    PhD Hideki Maeda

  59. The efficacy and safety of degarelix, a GnRH receptor antagonist: A multicenter, randomized, maintenance dose-finding phase II study with Japanese prostate cancer patients.

    Article • Journal of Clinical Oncology, March 2011, American Society of Clinical Oncology (ASCO)

    PhD Hideki Maeda

  60. Modulation of Glutathione S-Transferase Activity by a Thiol/Disulfide Exchange Reaction and Involvement of Thioltransferase

    Article • Archives of Biochemistry and Biophysics, January 1993, Elsevier

    PhD Hideki Maeda

  61. Study on Human Erythrocyte Thioltransferase: Comparative Characterization with Bovine Enzyme and Its Physiological Role under Oxidative Stress

    Article • The Journal of Biochemistry, May 1992, Oxford University Press (OUP)

    PhD Hideki Maeda

  62. Inactivation of human placenta glutathione S-transferase by SHSS exchange reaction with biological disulfides

    Article • Biochemical and Biophysical Research Communications, January 1991, Elsevier

    PhD Hideki Maeda