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Therapeutic Innovation & Regulatory Science|September 27, 2024
Paediatric Drug Development in Japan: Current Status and Future ChallengesRieko Inagaki, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|February 25, 2026
Estimand Framework Development for eGFR Slope Estimation and Comparative Analyses Across Various Estimation MethodsTuo Wang, Yu DuTherapeutic Innovation & Regulatory Science|November 13, 2024
An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for MAGnetic Expansion Control Spinal RodsJack Filan, Andrew Bowey, Thomas JoyceTherapeutic Innovation & Regulatory Science|October 31, 2024
Expert Consensus Recommendations on a Biosimilars Value Framework for the Gulf Cooperation Council CountriesKhalid A Alnaqbi, Ahmed Al-Jedai, Mohamed Farghaly, et al.Therapeutic Innovation & Regulatory Science|October 28, 2024
Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody DrugsHiromu Yoshiura, Yayoi Kawata, Shintaro SengokuTherapeutic Innovation & Regulatory Science|October 28, 2024
Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research on the Effect of Risk Reduction Activities in a Risk-Based ApproachHidenobu Kondo, Shih-Wei Chiu, Yukikazu Hayashi, et al.Therapeutic Innovation & Regulatory Science|May 13, 2026
Evaluation of Ease of Use for Pediatric Medications Requiring Decapsulation, Dissolution, or Partial Dosing: A Questionnaire-Based Study in JapanJumpei Saito, Akimasa Yamatani, Hidefumi Nakamura, et al.Therapeutic Innovation & Regulatory Science|March 15, 2026
Statistical Guardrails for Hybrid-Controlled Trials: Robust to Confounding and Between-Study HeterogeneityDi Ran, Fanni Zhang, Kristine Broglio, et al.Therapeutic Innovation & Regulatory Science|March 18, 2026
Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from U.S. FDA ApprovalsKaku Saito, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|March 2, 2026
Metformin as an Adjunct in Periodontal Therapy: Mechanistic Insights, Research Evidence and Current ChallengesHamza Alasbily, Muna Saad ElburkiPageof 165