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Non-clinical Evaluation Subcommittee Drug Evaluation Japan Pharmaceutical Manufacturers Association | 論文
- Questionnaire survey of application in S7A Safety Pharmacology Guideline (Part 2) : Point of GLP (STATISTICAL METHODS) (GENERAL SESSION BY POSTER PRESENTATION) (Proceedings of the 30th Annual Meeting)
- Questionnaire survey of application in S7A Safety Pharmacology Guideline (Part 1) : Point of experimental items (STATISTICAL METHODS) (GENERAL SESSION BY POSTER PRESENTATION) (Proceedings of the 30th Annual Meeting)
- Questionnaire survey on cardiac electrophysiology examination in safety pharmacology studies.(GENERAL SESSION BY POSTER PRESENTATION)(SAFETY PHARMACOLOGY)
- P8-49 Questionnaire Survey of GLP Operation for S7A Safety Pharmacology Study in Japanese and Foreign CROs(BLOOD/TOXICOKINETICS/OTHERS-2)(GENERAL SESSION BY POSTER PRESENTATION)(Proceedings of the 31st Annual Meeting)
- O-09 No-Observed Adverse Effect Level(NOAEL) : Judging Criteria and Purpose in Safety Assessment of Pharmaceuticals(STATISTICAL AND TEST METHODS/GENERAL TOXICITY)(GENERAL SESSION BY ORAL PRESENTATION)(Proceedings of the 31st Annual Meeting)
- O-08 Questionnaire Survey on No Observed Adverse Effect Level(2) : Regulatory Comments and Company(STATISTICAL AND TEST METHODS/GENERAL TOXICITY)(GENERAL SESSION BY ORAL PRESENTATION)(Proceedings of the 31st Annual Meeting)
- O-07 Questionnaire Survey on No Observed Adverse Effect Level(1) : Concept of NOAEL(STATISTICAL AND TEST METHODS/GENERAL TOXICITY)(GENERAL SESSION BY ORAL PRESENTATION)(Proceedings of the 31st Annual Meeting)
- Survey of pharmacology study conduct using outside sources in pharmaceutical companies in Japan.(GENERAL SESSION BY ORAL PRESENTATION)(MINI SYMPOSIUM : CONSIDERATION OF OUTSOURCINGS AND MONITORING IN NON-CLINICAL STUDY(CURRENT SURVEY))
- Study Monitor : The Surveillance of Outsourced Non-Clinical Studies : Draft Report, Final Report, Archives, and Quality Assurance(GENERAL SESSION BY ORAL PRESENTATION)(MINI SYMPOSIUM : CONSIDERATION OF OUTSOURCINGS AND MONITORING IN NON-CLINICAL STUDY(CUR
- Study monitor : the Surveillance of Outsourced Non-Clinical Studies (Reproductive Studies,Pathology and Toxicokinetics).(GENERAL SESSION BY ORAL PRESENTATION)(MINI SYMPOSIUM : CONSIDERATION OF OUTSOURCINGS AND MONITORING IN NON-CLINICAL STUDY(CURRENT SURV
- Study Monitor. The Surveillance of Outsourced Non-Clinical Studies : Testing facility checking, Protocol, Formulation and In-life phase(GENERAL SESSION BY ORAL PRESENTATION)(MINI SYMPOSIUM : CONSIDERATION OF OUTSOURCINGS AND MONITORING IN NON-CLINICAL STU
- Study Monitor. Introduction of the Surveillance for Outsourcing Non-Clinical Studies and Summary of Toxicology.(GENERAL SESSION BY ORAL PRESENTATION)(MINI SYMPOSIUM : CONSIDERATION OF OUTSOURCINGS AND MONITORING IN NON-CLINICAL STUDY(CURRENT SURVEY))
- P8-48 Questionnaire Survey about GLP Requirements for Safety Pharmacology(BLOOD/TOXICOKINETICS/OTHERS-2)(GENERAL SESSION BY POSTER PRESENTATION)(Proceedings of the 31st Annual Meeting)
- Questionnaire survey of methodologies on respiration systems in safety pharmacological studies (TEST METHODS) (GENERAL SESSION BY POSTER PRESENTATION) (Proceedings of the 30th Annual Meeting)