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
スポンサーリンク
概要
著者
-
Sagami Fumio
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufacturers As
-
Sagami Fumio
Japan Pharmaceutical Manufacturers Association (jpma) Qt Prodact
-
SAITO AKEMI
Japan Pharmaceutical Manufacturers Association
-
HAYASHI Mariko
Japan Pharmaceutical Manufactures Association
-
MATSUZAWA TOSHIAKI
Japan Pharmaceutical Manufacturers Association
-
Saito Akemi
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufacturers As
-
Taniguchi Katsuhiko
Japan Pharmaceutical Manufacturers Association
-
Hayashi Mariko
Japan Pharmaceutical Manufacturers Association:department Of Preclinical Science Nippon Roche Resear
-
Hayashi Mariko
Japan Pharmaceutical Manufacturers Association
-
Matsuzawa Toshiaki
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufacturers As
-
Matsuzawa Toshiaki
Non-clinical Evaluation Subcommittee Drug Evaluation Japan Pharmaceutical Manufacturers Association
-
Matsuzawa Toshiaki
Non-clinical Evaluation Subcommittee Drug Evaluation Japan Pharmaceutical Manufacturers Association
-
Taniguchi Katsuhiko
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufacturers As
-
Matsuzawa Toshiaki
Non-clinical Evaluation Subcommittee Drug Evaluation Japan Pharmaceutical Manufacturers Association
関連論文
- The predictivity of preliminary embryo-fetal development (EFD) studies : results of a retrospective survey in Japanese pharmaceutical companies
- Practical use of ICH guidelines for special toxicology studies : Questionnaire survey by JPMA.(GENERAL SESSION BY ORAL PRESENTATION)(GENOTOXICITY)
- P-59 Current Status of Clinical Chemistry in General Toxicology Studies for Pharmaceuticals.(Proceedings of the 27th Annual Meeting)
- P8-20 QT Interval Prolongation : Project for Database Construction, 14) Safety Margins of Drug-Induced QT Interval Prolongation: Comparison of Non-Clinical Animal Models and Clinical Data(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER PRESE
- Safety assessment of biopharmaceuticals : Japanese perspective on ICH S6 guideline maintenance
- Points to consider on the non-clinical safety evaluation of anticancer drugs
- CURRENT OPINION : SAFETY EVALUATION OF DRUG METABOLITES IN DEVELOPMENT OF PHARMACEUTICALS
- "POINTS TO CONSIDER" REGARDING SAFETY ASSESSMENT OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS IN NON-CLINICAL STUDIES (ENGLISH TRANSLATION)
- S3-6 Problems and Meanings of Genome-based Drug Discovery in Japanese Pharmaceutical Companies(SYMPOSIUM 3: BENEFITS OF PHARMACOGENOMICS/PHARMACOGENETICS IN PHARMACEUTICAL DEVELOPMENT)(Proceedings of the 31st Annual Meeting)
- 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)
- Survey of Carcinogenicity Studies of the Pharmaceuticals in Rodents
- A Comparision of the Results of Rat and Mouse Carcinogenicity Studies Conducted on Pharmaceuticals
- 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)
- P8-19 QT Interval Prolongation : Project for Database Construction, 13) Species-Difference in Dose-Response Relationship of Drug-Induced QT Interval Prolongation(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER PRESENTATION)(Proceedings of th
- P8-18 QT Interval Prolongation : Project for Database Construction, 12) QT prolongation: Comparison of the sensitivity between canine telemetry assay and isoflurane-anesthetized model(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER PRESENTAT
- P8-17 QT Interval Prolongation : Project for Database Construction, 11) Evaluation of the drug-induced QT interval change using the individual QT-RR interval relationship in telemetered dogs(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER PR
- P8-16 QT Interval Prolongation : Project for Database Construction, 10) Sensitivity to detect drug-induced changes in QT interval for monkey telemetry assay with individual QT-RR correction(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER PRE
- P8-15 QT prolongation : Project for Database Construction, 9) Individual QT-RR correction and sensitivity to detect drug-induced changes in QT interval for canine telemetry assay(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER PRESENTATION)(
- P8-14 QT Interval Prolongation : Project for Database Construction, 8) Dose (concentration) response analysis of drug-induced QT interval prolongation in anesthetized dogs(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER PRESENTATION)(Proceed
- P8-13 QT interval prolongation : Project for Database Construction, 7) Dose (concentration)-response analysis of drug-induced QT interval prolongation in conscious monkeys(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER PRESENTATION)(Proceed
- P8-12 QT Interval Prolongation : Project for Database Construction, 6) Dose (concentration)-response analysis of drug-induced QT interval prolongation in conscious dogs(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER PRESENTATION)(Proceeding
- P8-11 QT Interval Prolongation : Project for Database Construction, 5) Standard protocol and inter-facility differences in electrocardiographic determination in anesthetized dogs(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER PRESENTATION)(
- P8-10 QT Interval Prolongation : Project for Database Construction, 4) Inter-facility Differences in Electrocardiographic and Hemodynamic Parameters in Telemetered Monkeys(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER PRESENTATION)(Proceed
- P8-09 QT Interval Prolongation : Project for Database Construction, 3) Inter-facility Differences in Electrocardiograhic and Hemodynamic Parameters in Telemetered Dogs(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER PRESENTATION)(Proceedings
- 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)
- P8-21 QT Interval Prolongation : Project for Database Construction, 15) Relationship of pharmacokinetics and QT prolongation by various therapeutic agents: Telemetry study in dogs and monkeys(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION BY POSTER P
- P8-08 QT Interval Prolongation : Project for Database Construction, 2) The Usefulness of APD Study in Isolated Guinea Pig Papillary Muscles-Comparison with hERG study and canine Purkinje fiber APD study(CIRCULATORY SYSTEM-2/ACTIVE OXYGEN)(GENERAL SESSION
- Summary of Questionnaire Surveys of Toxicokinetics in Pharmaceutical Industries in Japan.(GENERAL SESSION BY ORAL PRESENTATION)(MINI SYMPOSIUM : STRATEGIC TOXICOKINETICS ON DRUG DISCOVERY(CURRENT SURVEY))
- Responsibility of Monitor for Quality Assurance of Outsourcing Non-clinical Studies.(GENERAL SESSION BY ORAL PRESENTATION)(MINI SYMPOSIUM : CONSIDERATION OF OUTSOURCINGS AND MONITORING IN NON-CLINICAL STUDY(CURRENT SURVEY))
- Questionnaire survey of methodologies on respiration systems in safety pharmacological studies (TEST METHODS) (GENERAL SESSION BY POSTER PRESENTATION) (Proceedings of the 30th Annual Meeting)
- P11-13 Questionnaire Survey of Functional Observational Battery in Domestic and Foreign Non-clinical Contract Research Organization.
- O10-18 Questionnaire Survey of Functional Observational Battery in Domestic and Foreign Non-clinical Contract Research Organization.
- Practical use of ICH guidelines for carcinogenicity studies : Questionnaire survey by JPMA.(GENERAL SESSION BY POSTER PRESENTATION)(CARCINOGENICITY)
- Construction of a data base on correlation between clinical laboratory data and histopathological findings.
- The Ideal Vision for the Single Dose Toxicity Study in Non-rodents.(GENERAL SESSION BY ORAL PRESENTATION)(CONSIDERATION OF SINGLE DOSE TOXICITY STUDY IN NON-RODENTS(CURRENT SURVEY))