19th Annual meeting of the Japanese Society for the Study of Xenobiotics
Session ID : F1-8
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Host: The Japanese Society for the Study of Xenobiotics
F1: OPENING REMARKS, OVERVIEW.
F2: SECUREMENT OF SAFETY IN EARLY CLINICAL TRIALS - IN LINE WITH ICH-M3 AND THE RECENT EMEA POSITION PAPER.
F3: PRECLINICAL STUDIES REQUIRED FOR SINGLE MICRODOSE CLINICAL TRIALS AND CONCEPT OF SECURING SAFETY.
F4: "REGULATORY SUBMISSION WORK" (RSW). A PACKAGE DESIGNED BY GE HEALTHCARE TO SERVE THE CARBON-14 HUMAN ADME STUDY MARKET.
F5: MICRODOSING TECHNIQUES IN EXPLORATORY DEVELOPMENT.
F6: HUMAN RADIOLABLED STUDY IN EARLY STAGE OF DRUG DEVELOPMENT -APPLICATION OF ACCELERATOR MASS SPECTROMETRY(AMS) IN PHARMACOKINETIC STUDY OF [14C]Y-700, A NOVEL XANTHINE OXIDASE INHIBITOR-.
F7: DRUG EVALUATION IN THE LIVING HUMAN BODY USING POSITRON EMISSION TOMOGRAPHY.
F8: REFORMATION OF ETHICS COMMITTEE SYSTEM IN EU AND UK AND PROPOSAL FOR JAPAN.
F2: SECUREMENT OF SAFETY IN EARLY CLINICAL TRIALS - IN LINE WITH ICH-M3 AND THE RECENT EMEA POSITION PAPER.
F3: PRECLINICAL STUDIES REQUIRED FOR SINGLE MICRODOSE CLINICAL TRIALS AND CONCEPT OF SECURING SAFETY.
F4: "REGULATORY SUBMISSION WORK" (RSW). A PACKAGE DESIGNED BY GE HEALTHCARE TO SERVE THE CARBON-14 HUMAN ADME STUDY MARKET.
F5: MICRODOSING TECHNIQUES IN EXPLORATORY DEVELOPMENT.
F6: HUMAN RADIOLABLED STUDY IN EARLY STAGE OF DRUG DEVELOPMENT -APPLICATION OF ACCELERATOR MASS SPECTROMETRY(AMS) IN PHARMACOKINETIC STUDY OF [14C]Y-700, A NOVEL XANTHINE OXIDASE INHIBITOR-.
F7: DRUG EVALUATION IN THE LIVING HUMAN BODY USING POSITRON EMISSION TOMOGRAPHY.
F8: REFORMATION OF ETHICS COMMITTEE SYSTEM IN EU AND UK AND PROPOSAL FOR JAPAN.
*Yasuo Ohno†, *Hiroshi Mayahara†, *Mamoru Nomura†, *Philip Wilde†, *Colin W. Vose†, *Ichimaro Yamada†, *Tetsuya Suhara†, *Chieko Kurihara†
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