Japan Clinical Trials

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Japan PMDA (PFSB-ELD No. 0928010) : Basic Principles of Global Clinical Trials in Japan
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Ministerial Ordinance 161: Good Clinical Practice (GCP) for Drugs in Japan
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Ministerial Ordinance No. 36: Good Clinical Practice for Medical Devices
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Ministerial Ordinance No.21 – Good Laboratory Practice for Nonclinical Safety Studies of Drugs
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Ministerial Ordinance on Good Clinical Practice for Drugs
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Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices
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Notification 743/1998 : Guideline for Clinical Evaluation of Antibacterial Drugs
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PFSB-ELD No. 0404-1: Guideline on Data Monitoring Committee
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PMDA Guidelines: Clinical Study Data on Medical Devices from Foreign Clinical Studies in Japan
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PMDA: Basic Principles of Risk-based Monitoring
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PMDA: Basic Principles on Global Clinical Trials (Reference Cases)
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PMDA: Guideline Pharmacokinetic and Pharmacodynamic Analysis
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PSEHB 0608-4/2020 Guideline for Exposure-Response Analysis of Drugs
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PSEHB No. 0122-7 – Clinical Trials Conducted on Ethical Grounds
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YAKUSHOKUKIHATSU No. 0331006/2006: Good Clinical Practices for Medical Devices
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