投稿者: Masayoshi Takezawa List of articles

ELIQUENT Japan > Articles by: Masayoshi Takezawa

2026.06.08

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Considerations for Determining the Need for Comparative Efficacy Studies in Biosimilar Development in Japan

Introduction to PMDA’s Early Consideration on Comparative Efficacy Studies for Biosimilars According to the Ea […]

2026.05.27

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Q&A on Japan’s Conditional Approval Policies for Pharmaceuticals: Key Clarifications for Global Drug Developers

Introduction to Japan’s Conditional Approval Q&A According to the Q&A document issued by Japan’s Minis […]

2026.05.13

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Early Consideration on Clinical Development of In Vivo Diagnostic Drugs in Japan

Introduction to Early Consideration on In Vivo Diagnostic Drug DevelopmentAccording to the Early Consideration […]

2026.04.27

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Early Consideration on Food Effect Evaluation for Oral Drug Products in Japan

Introduction to Early Consideration on Food Effect Evaluation According to the notification issued by Pharmace […]

2026.04.13

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PMDA Early Consideration on Clinical Trials with a Limited Number of Subjects: Key Considerations for Drug Development in Japan

Introduction to Small Sample Clinical TrialsAccording to the notification issued by the Pharmaceuticals and Me […]

2026.03.31

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Points to Consider for Clinical Development of PSMA-PET Radiopharmaceuticals in Japan

Introduction to Regulatory Considerations According to the document issued by the Pharmaceuticals and Medical […]

2026.03.11

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Revision of Q&A for preparing Pediatric Investigation Plans During Development of Adult Drug in Japan

Introduction to the Regulatory Update According to a notification issued by Japan’s Ministry of Health, Labour […]

2026.02.26

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Japan Enhances Global Clinical Trial Access Through One-Stop Window and PMDA Collaboration

Introduction to the New Clinical Trial Initiative According to the official notification issued by Japan’s Min […]

2026.02.17

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Points to Consider for the Development of Drugs for Hypertrophic Cardiomyopathy (Early Consideration)

Introduction Hypertrophic cardiomyopathy (HCM) is a condition marked by abnormal thickening of the ventricular […]

2026.02.04

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Points to Consider for the Efficacy Evaluation of Drugs for IgA Nephropathy (Early Consideration)

Introduction to Regulatory Considerations According to the document “Points to Consider for the Efficacy Evalu […]

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