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)
スポンサーリンク
概要
- 論文の詳細を見る
- 日本トキシコロジー学会の論文
- 2004-10-29
著者
-
Sagami Fumio
Japan Pharmaceutical Manufacturers Association (jpma) Qt Prodact
-
SAITO Mamoru
Japan Pharmaceutical Manufacturers Association (JPMA) QT PRODACT
-
HASHIMOTO Munehiro
Japan Pharmaceutical Manufacturers Association (JPMA) QT PRODACT
-
Saito Mamoru
Drug Safety Research Laboratories Eisai Co. Ltd.
-
OKAYACHI HIROSHI
Japan Pharmaceutical Manufacturers Association
-
KUBOTA KUNITSUGU
Japan Pharmaceutical Manufacturers Association
-
KADOTA TOSHIHITO
Japan Pharmaceutical Manufacturers Association
-
MORI Tatsuya
Japan Farriers Association
-
Ikeda Takanori
Japan Pharmaceutical Manufactures Association (JPMA), Basic Research A1 group GLP requirement subtea
-
Okutsu Hiroshi
Japan Pharmaceutical Manufactures Association (JPMA), Basic Research A1 group GLP requirement subtea
-
Ochi Seishi
Japan Pharmaceutical Manufactures Association (JPMA), Basic Research A1 group GLP requirement subtea
-
Sato Noriyuki
Japan Pharmaceutical Manufactures Association (JPMA), Basic Research A1 group GLP requirement subtea
-
Nomura Shunji
Japan Pharmaceutical Manufactures Association (JPMA), Basic Research A1 group GLP requirement subtea
-
Muraki Yukiko
Japan Pharmaceutical Manufactures Association (JPMA), Basic Research A1 group GLP requirement subtea
-
Kadota Toshihito
Japan Pharmaceutical Manufactures Association (jpma) Basic Research A1 Group Glp Requirement Subteam
-
Kadota Toshihito
Non-clinical Evaluation Subcommittee Drug Evaluation Japan Pharmaceutical Manufacturers Association
-
Ikeda Takanori
Japan Pharmaceutical Manufactures Association (jpma) Basic Research A1 Group Glp Requirement Subteam
-
Ochi Seishi
Japan Pharmaceutical Manufactures Association (jpma) Basic Research A1 Group Glp Requirement Subteam
-
Muraki Yukiko
Japan Pharmaceutical Manufactures Association (jpma) Basic Research A1 Group Glp Requirement Subteam
-
Nakamura Shouhei
Japan Pharmaceutical Manufactures Association (jpma) Basic Research A1 Group Glp Requirement Subteam
-
Kubota Kunitsugu
Japan Pharmaceutical Manufactures Association (jpma) Basic Research A1 Group Glp Requirement Subteam
-
Okayachi Hiroshi
Japan Pharmaceutical Manufactures Association (jpma) Basic Research A1 Group Glp Requirement Subteam
-
Hashimoto Munehiro
Nonclinical Regulatory Sciences Worldwide Safety Sciences Global Research & Development Nagoya L
-
Saito Mamoru
Japan Pharmaceutical Manufactures Association (jpma) Basic Research A1 Group Glp Requirement Subteam
-
Sato Noriyuki
Japan Pharmaceutical Manufactures Association (jpma) Basic Research A1 Group Glp Requirement Subteam
-
Mori Tatsuya
Japan Pharmaceutical Manufactures Association (jpma) Basic Research A1 Group Glp Requirement Subteam
関連論文
- 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
- CURRENT OPINION : SAFETY EVALUATION OF DRUG METABOLITES IN DEVELOPMENT OF PHARMACEUTICALS
- 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)
- MMR-MS Imaging Analysis of Moisture Pattern in the Hoof Wall
- QT PRODACT : Comparison of Non-clinical Studies for Drug-Induced Delay in Ventricular Repolarization and Their Role in Safety Evaluation in Humans
- QT PRODACT : Evaluation of the Potential of Compounds to Cause QT Interval Prolongation by Action Potential Assays Using Guinea-Pig Papillary Muscles
- QT PRODACT : A Multi-site Study of In Vitro Action Potential Assays on 21 Compounds in Isolated Guinea-Pig Papillary Muscles
- 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))
- Point to Consider in Non-Clinical Studies on Each Category of Biotechnology-Derived Pharmaceuticals.(GENERAL SESSION BY ORAL PRESENTATION)(MINI SYMPOSIUM : CONSIDERATION OF NON-CLINICAL STUDIES ON BIO-PHARMACEUTICALS(CURENT 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
- 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)
- Evaluation of cardiovascular safety pharmacology study using new data acquisition and real time data analyzing system (HEM).
- 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))