Points to consider on the non-clinical safety evaluation of anticancer drugs
スポンサーリンク
概要
- 論文の詳細を見る
Since malignant tumors are life-threatening, the death rate from these diseases is high, and existing therapies have limited effectiveness, it is desired to provide new effective anticancer drugs to tumor patients sooner. However, there is no guideline regarding non-clinical safety studies on the development of anticancer drugs required for the first in human clinical trials and for the approval applications in Japan. Then, the Ministry of Health, Labour and Welfare (MHLW) established the collaboration group including regulatory, academic and industrial scientists to prepare the guideline on the non-clinical safety evaluation of anticancer drugs in 2004. As a guide for basic concept of non-clinical safety studies on anticancer drugs, the "Points to Consider" document was prepared by this group in 2007.
- 日本トキシコロジー学会の論文
- 2008-05-01
著者
-
KAI Shuichi
Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufactures A
-
SAGAMI Fumio
Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufactures A
-
Kai Shuichi
ブリストルマイヤーズスクイブ
-
Kai Shuichi
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufacturers As
-
Kai Shuichi
東京都健康安全研究センター
-
Kai Shuichi
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufacturers As
-
Sagami Fumio
第一三共安全性研究所
-
Sagami Fumio
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufacturers As
-
Sagami Fumio
Drug Safety Research Laboratories Eisai Co. Ltd.
-
Sagami Fumio
Subcommittee Of Non-clinical Evaluation Drug Evaluation Committee Japan Pharmaceutical Manufacturers
-
Sagami Fumio
Department Of Drug Safety Research Eisai Kawashima Research Laboratories Eisai Co. Ltd.
-
Nakae Dai
東京都健康安全研究センター
-
Nakae Dai
Tokyo Metropolitan Institute Of Public Health
-
Onodera Hiroshi
東京都健康安全研究センター
-
小野寺 博志
Division Of Pathology National Institute Of Health Sciences
-
Onodera Hiroshi
Pharmaceuticals And Medical Devices Agency
-
Inoue Tohru
Biological Safety Research Center, National Institute of Health Sciences
-
Shinoda Kazutoshi
Pharmaceuticals and Medical Devices Agency
-
Onodera Horoshi
Pharmaceuticals and Medical Devices Agency
-
Fueki Osamu
Pharmaceuticals and Medical Devices Agency
-
Urano Tsutomu
Pharmaceuticals and Medical Devices Agency
-
Komiyama Noriyuki
Pharmaceuticals and Medical Devices Agency
-
Nishimura Chihiro
Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers
-
Inoue Tohru
Biological Safety Res. Center National Inst. Of Health Sciences
-
Nishimura Chihiro
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufacturers As
-
Onodera H
Pharmaceuticals And Medical Devices Agency
-
Onodera Hiroshi
Dvision Of Pathology Biological Safety Research Center National Institute Of Health Sciences
-
Inoue Tohru
Biological Safety Research Center National Institute Of Health Sciences
-
Nakae Dai
Tokyo Metropolitan Inst. Of Public Health
関連論文
- The predictivity of preliminary embryo-fetal development (EFD) studies : results of a retrospective survey in Japanese pharmaceutical companies
- Comparison of enhancing effects of different goitrogen treatments in combination with β-estradiol-3-benzoate for establishing a rat two-stage thyroid carcinogenesis model to detect modifying effects of estrogenic compounds
- LACK OF MODIFYING EFFECTS OF EUGENOL ON DEVELOPMENT OF LUNG PROLIFERATIVE LESIONS INDUCED BY URETHANE IN TRANS-GENIC MICE CARRYING THE HUMAN PROTOTYPE c-Ha-ras GENE
- Lack of Modifying Effects of Cinnamaldehyde on Development of Lung Proliferative Lesions Induced by Urethane in Transgenic Mice Carrying the Human Prototype c-Ha-ras Gene
- Inhibiting Effects of Ethinylestradiol on N-ethyl-M-nitrosourea-Initiated Uterine Carcinogenesis in Transgenic Mice Carrying a Human Prototype C-Ha-ras Gene (rasH2 mice) (CARCINOGENICITY) (GENERAL SESSION BY POSTER PRESENTATION) (Proceedings of the 30th A
- Promoting Effects of Ethinylestradiol but not Atrazine on N-ethyl-N-nitrosourea-induced Uterine Carcinogenesis in ICR Mice
- Difference in the Types of Uterine Tumors between Heterozygous p53-deficient and Wild Type CBA Mice Treated with Ethinylestradiol after N-ethyl-N-nitrosourea Initiation
- Modifying effect of atrazine on DMBA-induced mammary carcinogenesis in ovariectomized rats.(GENERAL SESSION BY POSTER PRESENTATION)(CARCINOGENICITY)
- A Preliminary Study of the Effect of Plantago Ovata Forsk on the Development of 7, 12-Dimethylbenz[a]anthracene-initiated Rat Mammary Tumors under the Influence of Hypercholesterolemia
- Modifying Effects of Genistein, 4-Nonylphenol and Methoxychlor on N-ethyl-N-nitrosourea-induced Uterine Carcinogenesis in RasH2 Transgenic Mice Harboring a Human Prototype C-Ha-ras Gene
- Enhancing Effects β-Estradiol 3-Benzoate but Not Methoxychlor on the Promotion/Progression Stage of Chemically-induced Mammary Carcinogenesis in Ovariectomized Rats
- GONADAL TOXICITY OF AN ETHANOL EXTRACT OF PSORALEA CORYLIFOLIA IN A RAT 90-DAY REPEATED DOSE STUDY
- The Utility of N-nitrosamines as Initiators for a 26-Week Rat Two-Stage Nasal Carcinogenesis Model
- Significance of Cyclin D1 Overexpression and K-ras Point Mutations in Lung Tumors Induced by N-methyl-N-nitrosourethane in Hamsters
- Effects of Simultaneous Treatment with Excess Amounts of Vitamin A and Goitrogens on Thyroid Tumorigenesis in Rats
- EFFECT OF SIMULTANEOUS TREATMENT OF LARGE AMOUNTS OF VITAMIN A AND THIOUREA ON THYROIDAL IODINE UPTAKE AND ORGANIFICATION IN RATS
- RELATIONSHIP BETWEEN PULMONARY FIBROSIS AND LUNG PROLIFERATIVE LESIONS INDUCED BY DIFFERENT DOSES OF N-METHYL-N-NITROSOURETHANE IN SYRIAN GOLDEN HAMSTERS
- "C-6 Evaluation of Rat Hepatotoxicity on Benzimidazole Compounds Using Gap Junctional Intercellular Communication Protein, Connexin 32.
- Collaborative work on evaluation of ovarian toxicity by repeated-dose and fertility studies in female rats
- Induction of Squamous Cell Carcinomas in the Salivary Glands of Rats by Potassium Iodide
- Possible enhancing effects of atrazine on growth of 7, 12-dimethylbenz(a) anthracene-induced mammary tumors in ovariectomized Sprague-Dawley rats
- α-Naphthylisothiocyanate Induces Intrahepatic Bile Duct with Greater Proliferation in Female Rats than in Males
- Effects of phenyl N-tert-butyl nitrone and its derivatives on the early phase of hepatocarcinogenesis in rats fed a choline-deficient, L-amino acid-defined diet
- Development of Hepatocellular Adenomas and Carcinomas Associated with Fibrosis in C57BL/6J Male Mice Given a Choline-deficient, L-Amino Acid-defined Diet
- Systemic mast cell disease with splenic infarction : A case report
- Increased Telomerase Activity in Hyperplastic Nodules and Hepatocellular Carcinomas Induced by a Choline-deficient L-Amino Acid-defined Diet in Rats
- Prevention by Methionine of Enhancement of Hepatocarcinogenesis by Coadministration of a Choline-deficient L-Amino Acid-defined Diet and Ethionine in Rats
- 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)
- Enhancement of lung carcinogenesis initiated with 4-(N-hydroxymethylnitrosamino)-1-(3-pyridyl)-1-butanone by Ogg1 gene deficiency in female, but not male, mice
- Preliminary Evaluation of Toxicologic and Carcinogenic Risks of Copper Gluconate in Rats Given Multiple Carcinogens
- Methylation of neutral endopeptidase 24.11 promoter in rat hepatocellular carcinoma
- Expression of profiles of cytochrome P450 enzymes in the uterus and liver of female rats treated with indole-3-carbinol(Liver, Alimentary system, Proceedings of the 32nd Annual Meeting)
- Exercise Training Enhances Tumor Necrosis Factor-α-Induced Expressions of Anti-Apoptotic Genes without Alterations in Caspase-3 Activity in Rat Epididymal Adipocytes
- α-Smooth Muscle Actin-positive Stromal Cells Reactive to Estrogens Surround Endometrial Glands in Rats but not Mice
- O-11 Dietary indole-3-carbinol promotes endometrial adenocarcinoma development in rats by increase of cytochrome P450 activities and modulation of estrogen metabolism in the liver(CARCINOGENICITY)(GENERAL SESSION BY ORAL PRESENTATION)(Proceedings of the 3
- Effects of Maternal Exposure to Nonylphenol on Growth and Development of the Female Reproductive System and Uterine Carcinogenesis in Rats
- Effect of neonatal exposure of high dose p-tert octylphenol on the ovary in rats (ENDOCRINE SYSTEM) (GENERAL SESSION BY POSTER PRESENTATION) (Proceedings of the 30th Annual Meeting)
- Carcinogenic risks in the high-risk groups (SYMPOSIUM3: RECENT TOPICS ON THE RISK ASSESSMENT OF CHEMICAL CARCINOGENS) (Proceedings of the 30th Annual Meeting)
- Nitric Oxide and Cancer Development
- Current status of pharmaceutical industries in Japan on pharmacogenomics and toxicogenomics in 2005(Toxicogenomics, Toxicoproteomics, Proceedings of the 32nd Annual Meeting)
- 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)
- MECHANISTIC STUDY ON INHIBITION OF SERUM THYROID HORMONE PRODUCTION BY THIOUREA
- TIME COURSE OBSERVATION OF THYROID PROLIFERATIVE LESIONS AND SERUM LEVELS OF RELATED HORMONES IN RATS TREATED WITH KOJIC ACID AFTER DHPN INITIATION
- IMMUNOHISTOCHEMICAL STUDIES OF TSH-PRODUCING CELLS IN THE PITUITARY AND EXPRESSION OF GROWTH FACTORS IN THYROIDAL PROLIF-ERATIVE LESIONS IN RATS TREATED WITH THIOUREA AND EXCESS VITAMIN A
- "P-42 Protective Effect of Lecithinization-Superoxide Dismutase Against Monocrotaline Induced Lung Injuries
- "P-41 A Morphometric study on the time course change of thyrotroph hypertrophy in the pituitary of rats treated with a goitrogen.
- Decreased Expression of Bcl-x Protein during Hepatocarcinogenesis Induced Exogenously and Endogenously in Rats
- Lack of Modifying Effects of NNK on Lung Tumorigenesis in Hamsters with Pulmonary Fibrosis Induced by MNUR
- 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))
- DOSE-THRESHOLD FOR THYROID TUMOR-PROMOTING EFFECTS OF ORALLY AMINISTERED KOJIC ACID IN RATS AFTER INITIATION WITH N-bis(2-HYDROXYPROPYL) NITROSAMINE
- P7-39 Current Analysis and Prospects of New Toxicological Biomarker : Biomarkers of Hepatotoxicity(GENERAL TOXICITY)(GENERAL SESSION BY POSTER PRESENTATION)(Proceedings of the 31st Annual Meeting)
- P7-38 Current analysis and prospects of new toxicological biomarker : biomarkers of cardiotoxicity(GENERAL TOXICITY)(GENERAL SESSION BY POSTER PRESENTATION)(Proceedings of the 31st Annual Meeting)
- P7-37 Current Analysis and Prospects of New Toxicological Biomarker : Biomarkers of Nephrotoxicity(GENERAL TOXICITY)(GENERAL SESSION BY POSTER PRESENTATION)(Proceedings of the 31st Annual Meeting)
- S13-1 Current analysis and prospects of new toxicological biomarkers : with central focus on heart, liver and kidney(SYMPOSIUM 13: CURRENT STATUS AND FUTURE ASPECTS OF NEW TOXICOLOGICALLY RESPONSIBLE BIOMARKERS)(Proceedings of the 31st Annual Meeting)
- P-39 Effect of t-buthylhydroquinone and sodium nitrite alone or in combination on the forestomach of rasH2 mice.(Proceedings of the 27th Annual Meeting)
- P-38 Carcinogenic susceptibility of phenolphthalein in heterozygous p53 deficient C57BL/6 and CBA mice.(Proceedings of the 27th Annual Meeting)
- TOXICITY AND BLOOD CONCENTRATIONS OF XYLAZINE AND ITS METABOLITE, 2, 6-DIMETHYLANILINE, IN RATS AFTER SINGLE OR CONTINUOUS ORAL ADMINISTRATIONS
- 21C-11-2 Modifying Effects of Xylazine on Rat Nasal Carcinogenesis.
- 21WA-01-4 Modifying Effects of Endocrine Disrupting Chemicals to Thyroid Proliferative Lesions in Ovariectomized Rats.
- Absence of Tumor Promoting Activity of Xylazine in a Two-stage Nasal Carcinogenesis Model in N-bis(2-hydroxypropyl)nitrosamine-treated Rats
- O11-12 Modifying effects of endocrine disrupting chemicals on ENU-induced uterine carcinogenesis in heterozygous p53 deficient CBA mice.
- P-67 Early changes of thyroid and in rats given a single administration of diisopropanolnitrosamine.(Proceedings of the 27th Annual Meeting)
- O-14 Mechanistic studies on testicular toxicity of Psoralea corylifolia extract in rats.(Proceedings of the 27th Annual Meeting)
- 21C-10-3 Susceptibility of p53 heterozygous knockout CBA mice to carcinogenic substances.
- 3A-19 A Mechanistic Study on Ovarian Carcinogenesis of Nitrofurazone in Mice
- 3A-16 Toxicological significance of the metabolite, 2,6-xylidine, in rats treated with a parent drug, xylazine
- 3A-06 Study on the Thyroid Tumor Promotion Effect of Kojic Acid
- Prevention of Stroke by a Japanese Traditional Medicine, Shichimotsu-koka-to, in Stroke-Prone Spontaneously Hypertensive Rats-a Histopathological Study
- Preventive Effects of Shinchimotsu-koka-to on Renal Lesions in Stroke-Prone Spontaneously Hypertensive Rats
- STUDIES ON EXPERIMENTAL IODINE ALLERGY : 3. LOW MOLECULAR WEIGHT ELICITOGENIC ANTIGENS OF IODINE ALLERGY
- STUDIES ON EXPERIMENTAL IODINE ALLERGY : 2. IODINATED PROTEIN ANTIGENS AND THEIR GENERATION FROM INORGANIC AND ORGANIC IODINE-CONTAINING CHEMICALS
- STUDIES ON EXPERIMENTAL IODINE ALLERGY : 1. ANTIGEN RECOGNITION OF GUINEA PIG ANTI-IODINE ANTIBODY
- MORPHOLOGICAL EVALUATION OF CYCLOPHOSPHAMIDE TESTICULAR TOXICITY IN RATS USING QUANTITATIVE MORPHOMETRY OF SPERMATOGENIC CYCLE STAGES
- P-11 Application of hepatocytes cultured in a sandwich configuration to toxicity assessment.(Proceedings of the 27th Annual Meeting)
- A 90-day Feeding Toxicity Study of L-Serine in Male and Female Fischer 344 Rats
- Mechanism for benzothiazole derivative-induced hepatotoxicity in rats(SYMPOSIUM 1 : MECHANISMS OF HEPATOTOXIC EFFECTS)
- P-90 Collaborative Work to Evaluate Toxicity on Male Reproductive Organs with 2 Weeks Repeated Daily Dosing in Rats : Testicular Toxicity of E7010, A Sulfonamide Tubulin Polymerlzation Inhibitor(Proceedings of the 27th Annual Meeting)
- COLLABORATIVE WORK TO EVALUATE TOXICITY ON MALE REPRODUCTIVE ORGANS BY REPEATED DOSE STUDIES IN RATS : 17)TESTICULAR TOXICITY OF E7010, A SULFONAMIDE TUBULIN POLYMERIZATION INHIBITOR
- TOXICOLOGICAL RESPONSE OF RATS TO A NOVEL MONOAMINE OXIDASE TYPE-A INHIBITOR, (5R)-3-[2-((1S)-3-CYANO-1-HYDROX-YPROPYL)BENZOTHIAZOL-6-YL]-5-METHOXYMETHYL-2-OXAZOLIDI-NONE (E2011), ORALLY ADMINISTERED FOR 13 WEEKS
- "B-5 Modification of Drug Conjugation Pathway by Repeated Administration of Conjugating Enzyme Inhibitors in Rats.
- 21C-02-4 Hepatic Drug Metabolizing Enzymes in CB6F1-TgrasH2 Mice.
- TOXICOKINETICS:ITS SIGNIFICANCE AND PRACTICAL PROBLEMS
- Lack of chronic toxicity and carcinogenicity of dietary administrated catechin mixture in Wistar Hannover GALAS rats
- DETERMINATION OF THE TIME AT WHICH CONGENITAL HYDROCEPHALUS IS INDUCED WITH HIGHER INCIDENCE DURING THE EARLY GESTATIONAL PERIOD IN RATS
- Lack of chronic toxicity and carcinogenicity of dietary administrated catechin mixture in Wistar Hannover GALAS rats
- Prevention of Stroke by a Japanese Traditional Medicine, Shichimotsu-koka-to, in Stroke-Prone Spontaneously Hypertensive Rats : a Histopathological Study
- Perspectives on non-clinical safety evaluation of drug metabolites through the JSOT workshop
- Susceptibility of Heterozygous p53 Deficient CBA Mice to Induction of Liver Proliferative Lesions by Phenobarbital after Dimethylnitrosamine Initiation
- Modifying Effects of Flumequine on Dimethylnitrosamine-Induced Hepatocarcinogenesis in Heterozygous p53 Deficient CBA Mice