Risk Assessment of Pesticides Residue by JMPR - To set ADI and ARfD-
|
|
- Denis Hoover
- 7 years ago
- Views:
Transcription
1 The FAO Regional Training Course: Strengthening Capacity of Data Collection and Generation for Food Safety Risk Analysis Support to Capacity Building and Implementation of International Safety Standards in ASEAN Countries (GCP/RAS/280/JPN) Tokyo, Japan, June 2013 Risk Assessment of Pesticides Residue by JMPR - To set ADI and ARfD- Midori Yoshida National Institute of Health Sciences
2 Contents: 1. Purpose of the evaluation by JMPR 2. Assessment process in JMPR a. Quality of toxicological data b. Assessors c. NOAEL/LOAEL d. Kinetics/MOA 3. ADI setting 4. ARfD setting
3 Today s key words : Dr. Keyword ADI ARfD Data Quality (GLP, Test guideline)
4 1. Purpose of the toxicology evaluation by JMPR
5 To set Purpose 1.Acceptable Daily Intake (ADI) : The amount of pesticide to which human can be exposed daily for a lifetime without injury 2.Acute Reference Dose (ARfD) : The amount of pesticide that can be ingested in a period 24 hours or less without injury
6 2. Assessment process in JMPR
7 Toxicology data Assessors (Expert & member) Acute toxicity Repeated toxicity TK, MOA Reproductive Genotoxicity Carcinogenicity profile profile profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Test guidelines Principles of /Accordance with GLP Monograph /Summary Chronic effects Acute effects ADI ARfD Outline of toxicological evaluation process in JMPR
8 a. Quality of toxicological data
9 Toxicology data Assessors (Expert & member) Acute toxicity Repeated toxicity TK, MOA Reproductive Genotoxicity Carcinogenicity profile profile profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Test guidelines Principles of /Accordance with GLP Monograph /Summary Chronic effects Acute effects ADI ARfD Outline of toxicological evaluation process in JMPR
10 What are qualified toxicological data? Accordance with recognized test guidelines (OECD, EPA, EFSA, APVMA, HealthCanada, MAFF) Conducted to the principles of GLP (Good Laboratory Practice)
11 Why is quality necessary in submitted toxicological data? Robusty Transparency Consistency High impact factors are not needed Quality
12 b. Assessors
13 Toxicology data Assessors (Member & temporary adviser) Acute toxicity Repeated toxicity profile Reproductive Genotoxicity Carcinogenicity profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Test guidelines Principles of /Accordance with GLP Monograph /Summary Chronic effects Acute effects ADI ARfD Outline of toxicological evaluation process in JMPR
14 JMPR Roster of Toxicological Experts Scientific experts Roles of roster Members Reviewing monograph Leading evaluation process Temporary Advisers Making draft monograph
15 Toxicology data Evaluators (Expert & member) Acute toxicity Repeated toxicity Reproductive Genotoxicity c. NOAEL/LOAEL Carcinogenicity TK, MOA profile profile profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Test guidelines Principles of /Accordance with GLP Monograph /Summary Chronic effects Acute effects ADI ARfD Outline of toxicological evaluation process in JMPR
16 Data required in toxicological evaluation Toxicological studies Acute toxicity (rats, mice) Short-term toxicity (rats, mice, dogs) Long-term toxicity/carcinogenicity (rats, mice) Genotoxicity (in vitro, in vivo) Reproductive toxicity (rats, rabbits) Special study=neurotoxicy/immuotoxicity/mechanistic(mode of action, MOA) study Biochemical aspects = Kinetics/ADME Observation in humans
17 How to set NOAEL/LOAEL No Observed Adverse Effect Level (mg/kg bw per day) Lowest Observed Adverse Effect Level (mg/kg bw per day) Set NOAEL/LOAEL in each study Rosters determine NOAEL based on endpoints at lowest dose detected toxicity/adverse effect Dose tested /adverse effect LOAEL 100 mg/kg bw 20 mg/kg bw Hepatocellular necrosis Anemia Body weight decrease Body weight decrease Endpoint to set NOAEL NOAEL 5 mg/kg bw
18 d. Kinetics/MOA
19 What is くすりの useful information 毒 性 を 理 解 for するためにまず toxicological 理 evaluation? 解 すべきこと! What is ADME? Absorption Distribution Metabolism Excretion Chemicals Absorption Metabolism Metabolism Distribution Distribution Absorption Excretion Excretion
20 Concentration in blood くすりの 毒 性 を 理 解 するためにまず 理 解 すべきこと! What is useful information for toxicological evaluation? Kinetics data =Biochemical aspects 100 C max Toxicokinetics (TK) 50 AUC T max T 1/2 Time after treatment Toxicokinetics (TK) Better understanding toxicological profiles
21 Acute toxicity Reproductive What is useful information for toxicological evaluation? Toxicology data Repeated toxicity Genotoxicity Assessors (Expert & member) TK, MOA Carcinogenicity profile profile profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Chronic effects Acute effects Test guidelines Principles of /Accordance with GLP Monograph /Summary ADI ARfD Outline of toxicological evaluation process in JMPR
22 Mechanism (Mode) of action Are the animal data sufficient for MOAs? Yes Is the animal MOA plausible in humans? Are animal kinetics/ dynamics similar to humans? Yes Yes No Species difference Relevant or Unknown Human Relevance Not Relevant in Humans MOA is Helpful information on relevance to human risk
23 3/4. ADI/ARfD setting
24 Toxicology data Assessors (Expert & member) Acute toxicity Repeated toxicity TK, MOA Reproductive Genotoxicity Carcinogenicity profile profile profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Test guidelines Principles of /Accordance with GLP Monograph /Summary Chronic effects Acute effects ADI ARfD Outline of toxicological evaluation process in JMPR
25 3. ADI setting Acceptable daily intake (ADI) : Setting on the basis of the lowest relevant NOAEL in the most sensitive species. POD UF Lowest NOAEL Default = 100 Usually chronic effects in all toxicity studies POD, point of departure; UF, uncertainty factor
26 4. ARfD setting Acute reference dose (ARfD) : POD UFs Lowest NOAEL Default = 100 ARfD>=ADI Cut-off value All indications after single exposure Clear explanation
27 Toxicology data Assessors (Expert & member) Acute toxicity Repeated toxicity TK, MOA Reproductive Genotoxicity Carcinogenicity profile profile profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Test guidelines Principles of /Accordance with GLP Monograph /Summary Chronic effects Acute effects ADI ARfD Outline of toxicological evaluation process in JMPR
28 Reference IPCS: Environmental Health Criteria 240 Principles and Methods for the Risk Assessment of Chemicals in Food Thank your attention for my presentation National Institute of Health Sciences since NIHS
Risk Assessment in Chemical Food Safety. Dept. of Food Safety and Zoonoses (FOS) http://www.who.int/foodsafety/en/
Risk Assessment in Chemical Food Safety Dept. of Food Safety and Zoonoses (FOS) http://www.who.int/foodsafety/en/ Risk Analysis Paradigm Internationally Scientific data analysis Risk Assessment WHO & FAO
More informationIMPORTANCE OF RISK PROFILE IN RISK MANAGEMENT
IMPORTANCE OF RISK PROFILE IN RISK MANAGEMENT MAFF, JAPAN RISK PROFILING AS A PRELIMINARY RISK MANAGEMENT ACTIVITY IN RISK ANALYSIS MAFF, JAPAN 1 Contents 1. Globally Agreed Framework of Risk Analysis
More informationBifenthrin 41 5.2 BIFENTHRIN (178)
Bifenthrin 41 5.2 BIFENTHRIN (178) TOXICOLOGY Bifenthrin is the International Organization for Standardization (ISO) approved name for 2-methyl-3- phenylphenyl) methyl (1RS, 3RS)-3-[(Z)-2-chloro-3, 3,
More informationChemical Name: Acetone CAS: 67-64-1 Synonyms: propanone, β-ketopropane, dimethyl ketone, dimethylformaldehyde, DMK, 2-propanone, propan-2-one
2011 Health Risk Limits for Groundwater Health Risk Assessment Unit, Environmental Health Division 651-201-4899 651-201-5797 TDD Web Publication Date: March 21, 2011 Chemical Name: Acetone CAS: 67-64-1
More informationCommunication of Uncertainty in Hazard & Risk Assessment: Panel Discussion. Lynn H. Pottenger, PhD, DABT The Dow Chemical Company
Communication of Uncertainty in Hazard & Risk Assessment: Panel Discussion Lynn H. Pottenger, PhD, DABT The Dow Chemical Company Uncertainty Workshop Focus: Focus on identification of sources & communication
More informationDocument and entity information
Company information Company information FASF member mark Document name Document and entity information Aug 2015 第 3 四 半 期 決 算 短 信 日 本 基 準 ( 連 結 ) Filing date 20150710 Company name TRANSACTION CO., Ltd.
More information5.7 CHLOROTHALONIL (081)
Chlorothalonil 89 5.7 CHLOROTHALONIL (081) TOXICOLOGY Chlorothalonil is the ISO approved common name for tetrachloroisophthalonitrile. Chlorothalonil (CAS No. 1897-45-6) is a non-systemic foliar fungicide
More informationGuidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data 1
EFSA Journal 2012;10(3):2579 SCIENTIFIC OPINION Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data 1 ABSTRACT
More informationEFSA explains the carcinogenicity assessment of glyphosate
PESTICIDES UNIT EFSA explains the carcinogenicity assessment of glyphosate Background 12 November 2015 During the EFSA peer-review process for the renewal of the approval of the pesticide active substance
More informationChemical Risk Assessment in Absence of Adequate Toxicological Data
Chemical Risk Assessment in Absence of Adequate Toxicological Data Mark Cronin School of Pharmacy and Chemistry Liverpool John Moores University England m.t.cronin@ljmu.ac.uk The Problem Risk Analytical
More informationレッドハット 製 品 プライスリスト Red Hat Enterprise Linux2013 新 製 品 (ベースサブスクリプション) 更 新 :2015 年 4 22
Red Hat Enterprise Linux2013 新 製 品 (ベースサブスクリプション) 更 新 :2015 年 4 22 薄 紫 :3 年 型 番 :5 年 型 番 字 : 新 規 追 加 変 更 新 規 新 規 SKU 製 品 名 ソケット ゲストOS サポート 期 間 標 準 価 格 備 考 Server RH00001 Red Hat Enterprise Linux for Virtual
More informationBasic Overview of Preclinical Toxicology Animal Models
Basic Overview of Preclinical Toxicology Animal Models Charles D. Hebert, Ph.D., D.A.B.T. December 5, 2013 Outline Background In Vitro Toxicology In Vivo Toxicology Animal Models What is Toxicology? Background
More informationRisk Assessment Report on (3-CHLORO-2-HYDROXYPROPYL)TRIMETHYLAMMONIUM CHLORIDE (CHPTAC)
Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on (3-CHLORO-2-HYDROXYPROPYL)TRIMETHYLAMMONIUM CHLORIDE (CHPTAC) Human Health Part CAS No.: 3327-22-8 EINECS No.: 222-048-3
More informationWellmark International Dog Collar 34 g (1.2 oz) 5986 0.0051 55 15. 0.28 1000 Cat Collar 10.5 g (0.37oz)
revised risk estimates which are provided in Table 1 below. These corrections do not alter the risk conclusions as described in D371250. The Agency is also anticipating additional data from the registrants
More informationThe Science of Chemical Safety Essential Toxicology - 4. Hazard and Risk. John Duffus & Howard Worth. IUPAC Educators Resource Material IUPAC
The Science of Chemical Safety Essential Toxicology - 4 Hazard and Risk John Duffus & Howard Worth IUPAC Educators Resource Material IUPAC Hazard and Risk - 1 Hazard is the potential of a substance to
More informationEdward Odenkirchen, Ph.D. Office of Pesticide Programs US Environmental Protection Agency
Edward Odenkirchen, Ph.D. Office of Pesticide Programs US Environmental Protection Agency 1 Mission Statement Best possible regulatory decisions to protect public health and environment. Rely on all best
More informationFrequently asked questions on the procedure for the re-assessment of glyphosate within the framework of the EU active substance review
Frequently asked questions on the procedure for the re-assessment of glyphosate within the framework of the EU active substance review BfR FAQ, 12 November 2015 Active substances used in pesticides are
More informationIntroduction. MassDEP, Office of Research and Standards 1 Tetrachloroethylene
Summary of the Basis of Cancer Risk Values for Massachusetts Department of Environmental Protection (MassDEP) Office of Research and Standards January 22, 2014 Introduction In February 2012 the United
More informationINTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE S1A. Current Step 4 version
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE ON THE NEED FOR CARCINOGENICITY STUDIES
More informationPermethrin in Drinking-water: Use for Vector Control in Drinking-water Sources and Containers
WHO/SDE/WSH/05.08/111/Rev/1 Permethrin in Drinking-water: Use for Vector Control in Drinking-water Sources and Containers Background document for development of WHO Guidelines for Drinking-water Quality
More informationCost Accounting 1. B r e a k e v e n A n a l y s i s. S t r a t e g y I m p l e m e n t a t i o n B a l a n c e d S c o r e c a r d s
Cost Accounting 1 B r e a k e v e n A n a l y s i s S t r a t e g y I m p l e m e n t a t i o n B a l a n c e d S c o r e c a r d s S t r a t e g y M o n i t o r i n g R e s p o n s i b i l i t y S e g
More informationWHO/SDE/WSH/03.04/91 English only Diquat in Drinking-water
WHO/SDE/WSH/03.04/91 English only Diquat in Drinking-water Background document for development of WHO Guidelines for Drinking-water Quality World Health Organization 2004 Requests for permission to reproduce
More informationGeneral Principles for the Safety Assessment of Excipients
General Principles for the Safety Assessment of Excipients General Characteristics of the Pharmaceutical Excipients Classification of excipients The Safety Assessment of Pharmaceutical Excipients : how
More informationICH Topic S 1 A The Need for Carcinogenicity Studies of Pharmaceuticals. Step 5
European Medicines Agency July 1996 CPMP/ICH/140/95 ICH Topic S 1 A The Need for Carcinogenicity Studies of Pharmaceuticals Step 5 NOTE FOR GUIDANCE ON THE NEED FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS
More information医 学 生 物 学 一 般 問 題 ( 問 題 用 紙 1 枚 解 答 用 紙 2 枚 )
平 成 26 年 度 大 学 院 医 学 研 究 科 博 士 課 程 入 学 試 験 (1 回 目 ) 医 学 生 物 学 一 般 問 題 ( 問 題 用 紙 1 枚 解 答 用 紙 2 枚 ) 以 下 の 問 題 1 問 題 4のうち 二 つの 問 題 を 選 択 して 解 答 しなさい 一 つの 問 題 につき1 枚 の 解 答 用 紙 を 使 用 しなさい 紙 面 不 足 の 場 合 は 裏
More informationGUIDANCE ON A CONSUMER PRODUCT RISK ASSESSMENT FOR GHS LABELLING
GUIDANCE ON A CONSUMER PRODUCT RISK ASSESSMENT FOR GHS LABELLING April, 2008 National Institute of Technology and Evaluation Chemical Management Center Introduction This document provides guidance on
More informationICH M3 (R2) Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
ICH M3 (R2) Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals International Conference on Harmonisation of Technical Requirements
More informationPART B: METHODS FOR THE DETERMINATION OF TOXICITY AND OTHER HEALTH EFFECTS GENERAL INTRODUCTION: PART B
PART B: METHODS FOR THE DETERMINATION OF TOXICITY AND OTHER HEALTH EFFECTS GENERAL INTRODUCTION: PART B A. EXPLANATORY NOTE For the purpose of this General Introduction the following nymbering applies:
More informationFluoride. Introduction
Fluoride Introduction Most fluoride in the body is found in bones and teeth, due to its high affinity for calcium and calcium phosphate. Ingestion of and topical treatment with fluoride is effective in
More informationChapter 12: SPECIFIC TARGET ORGAN SYSTEMIC TOXICITY (TOST) FOLLOWING A SINGLE EXPOSURE
Chapter 12: SPECIFIC TARGET ORGAN SYSTEMIC TOXICITY (TOST) FOLLOWING A SINGLE EXPOSURE DEFINITIONS 1. Classification identifies the chemical substance as being a specific target organ/systemic toxicant
More informationAUTOMOBILE LIABILITY SECURITY ACT
AUTOMOBILE LIABILITY SECURITY ACT & RELATED CABINET ORDER, MINISTERIAL ORDINANCE AND NOTIFICATION Including: Policy Conditions for Automobile Liability Insurance As of May 2, 2011 Translated and published
More informationRegulatory Risk Assessment
Regulatory Risk Assessment Richard B. Belzer PhD Regulatory Checkbook Mt. Vernon, VA Belzer@RegulatoryCheckbook.Org What is the Purpose of Risk Assessment? For regulatory analysis [A] risk assessment should
More informationUncertainty factors:
The Interdepartmental Group on Health Risks from Chemicals Uncertainty factors: Their use in human health risk assessment by UK Government cr9 The Interdepartmental Group on Health Risks from Chemicals
More informationBiological importance of metabolites. Safety and efficacy aspects
Biological importance of metabolites Safety and efficacy aspects Bernard Walther Technologie Servier Biological importance of metabolites Safety testing of drug metabolites Bioanalytical strategy Structural
More informationGuidance for Industry Safety Testing of Drug Metabolites
Guidance for Industry Safety Testing of Drug Metabolites U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) February 2008 Pharmacology
More informationTeacher Training and Certificate System
Teacher Training and Certificate System 1. Teacher Training Teacher training in Japan started with the establishment of normal schools (schools for teacher training) in 1872. In 1886, a higher normal school
More informationNONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS
More informationPanasonic AC-DC Power Supply Design Support Service
Panasonic AC-DC Power Supply Design Support Service The best solution to design your AC-DC power supply (how to design a switching power supply, order a transformer, prevent EMI, etc.) Panasonic s IPD
More informationPest Management Regulatory Agency
Pest Management Regulatory Agency Overview Document Introduction The Pest Management Regulatory Agency (PMRA) was established in April 1995 in response to the recommendations of the Pesticide Registration
More informationSeptember 19, 1984 FOOD PRODUCTION AND DIRECTION GÉNÉRALE, SECTION INSPECTION BRANCH PRODUCTION ET INSPECTION PESTICIDES DES ALIMENTS TRADE MEMORANDUM
Agriculture Canada September 19, 1984 T-1-245 FOOD PRODUCTION AND DIRECTION GÉNÉRALE, SECTION INSPECTION BRANCH PRODUCTION ET INSPECTION PESTICIDES DES ALIMENTS TRADE MEMORANDUM RE: Guidelines for Developing
More informationHarmonization Project Document No. 2
This report contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization, the International
More informationHuman Risk Assessment
UNEP/IPCS Training Module No. 3 Section A Human Risk Assessment Prepared by The Edinburgh Centre for Toxicology UNEP/IPCS TRAINING MODULE SECTION A Human Risk Assessment TABLE OF CONTENTS PAGE EDUCATIONAL
More informationName of Chemical: Tebufenpyrad Reason for Issuance: Unconditional Registration Date Issued: August 26, 2002
United States Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances (7501C) Pesticide Fact Sheet Name of Chemical: Tebufenpyrad Reason for Issuance: Unconditional Registration
More informationRochester BioVenture Center November 14th
Rochester BioVenture Center November 14th Calvert Holdings, Inc. Established in 1996 Parent company for several subsidiaries Focus: health care services and investments Corporate HQ located in Cary, NC
More informationGuidance for Industry
Guidance for Industry S9 Nonclinical Evaluation for Anticancer Pharmaceuticals U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center
More informationChemical safety and big data: the industry s demands
Chemical safety and big data: the industry s demands Richard CURRIE Senior Technical Expert; Group Leader & Global Predictive and Computational Toxicology Lead Valid results Useful results Credit Money/Grants
More informationPublic Financial Assistance for Formal Education in Japan
Public Financial Assistance for Formal Education in Japan In Japan, households bear a particularly high proportion of the costs of pre-primary and tertiary education compared with other OECD countries
More information育 デジ (Iku-Digi) Promoting further evolution of digital promotion
育 デジ (Iku-Digi) Promoting further evolution of digital promotion Abstract Digital promotion has established its presence and become a commodity in the pharmaceutical industry. In the last few years, use
More informationCONCLUSION ON PESTICIDE PEER REVIEW. Peer review of the pesticide risk assessment of the active substance captan. re-issued on 4 June 2009
EFSA Scientific Report (2009) 296, 190 Conclusion on the peer review of captan CONCLUSION ON PESTICIDE PEER REVIEW Peer review of the pesticide risk assessment of the active substance captan (Question
More informationModule Three. Risk Assessment
Module Three Risk Assessment 136 Module Three Introduction to Risk Assessment Time Allotted: 90 Minutes Objectives: Upon completion of this module, the learner will be able to # Define and understand the
More informationAdvanced Training Program for Teachers of the Japanese-Language Application Instructions For FY 2016
Advanced Training Program for Teachers of the Japanese-Language Application Instructions For FY 2016 1. Objectives The Advanced Training Program at the Japan Foundation Japanese-Language Institute, Urawa
More informationレッドハット 製 品 プライスリスト Red Hat Enterprise Linux 製 品 (RHEL for HPC) 更 新 :2015 年 4 22
レッドハット 製 品 プライスリスト Red Hat Enterprise Linux 製 品 (RHEL for HPC) 更 新 :2015 年 4 22 薄 紫 :3 年 型 番 :5 年 型 番 字 : 新 規 追 加 変 更 当 価 格 表 は 予 告 なしに 変 更 する 場 合 がございますので ご 了 承 ください 価 格 は 全 て 税 抜 きでの 掲 載 となっております 新 規
More informationGENERIC RISK ASSESSMENT MODEL FOR INDOOR RESIDUAL SPRAYING OF INSECTICIDES
GENERIC RISK ASSESSMENT MODEL FOR INDOOR RESIDUAL SPRAYING OF INSECTICIDES Department of Control of Neglected Tropical Diseases HIV/AIDS, Tuberculosis, Malaria and Neglected Tropical Diseases & Department
More informationINTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE M3(R2)
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GUIDANCE ON NONCLINICAL SAFETY STUDIES FOR THE
More informationA Systematic Review of Potential Human Health Risks of Aluminum
A Systematic Review of Potential Human Health Risks of Aluminum Daniel Krewski, PhD, MHA Professor and Director McLaughlin Centre for Population Health Risk Assessment & Risk Sciences International 15
More informationTS-3GB-S.R0125-505-0v1.0 VoIP Supplementary Services Descriptions: Call Forwarding - Unconditional
TS-GB-S.R0--0v.0 VoIP Supplementary Services Descriptions: Call Forwarding - Unconditional 0 年 月 日 制 定 社 団 法 人 情 報 通 信 技 術 委 員 会 THE TELECOMMUNICATION TECHNOLOGY COMMITTEE 本 書 は ( 社 ) 情 報 通 信 技 術 委 員 会
More informationRegulatory Expectations for GMP: What s Happening. Patricia Weideman, PhD Director, Product Quality & Occupational Toxicology Genentech, Inc.
Regulatory Expectations for GMP: What s Happening Patricia Weideman, PhD Director, Product Quality & Occupational Toxicology Genentech, Inc. Topics Background for changes and expectations of regulatory
More informationHuman health risk assessment from combined exposure in the framework of plant protection products and biocidal products
J. Verbr. Lebensm. (2014) 9:367 376 DOI 10.1007/s00003-014-0915-7 Journal für Verbraucherschutz und Lebensmittelsicherheit Journal of Consumer Protection and Food Safety ANNOUNCEMENTS AND REPORTS Human
More informationConclusion on the peer review of the pesticide risk assessment of the active substance metam 1
CONCLUSION ON PESTICIDE PEER REVIEW Conclusion on the peer review of the pesticide risk assessment of the active substance metam 1 SUMMARY European Food Safety Authority 2 European Food Safety Authority
More informationData Mining for Risk Management in Hospital Information Systems
Data Mining for Risk Management in Hospital Information Systems Shusaku Tsumoto and Shoji Hirano Department of Medical Informatics, Shimane University, School of Medicine, 89-1 Enya-cho, Izumo 693-8501
More informationCurrent Situation of Research Nurse Education and Future Perspectives in Japan
Current Situation of Research Nurse Education and Future Perspectives in Japan Eriko Aotani Clinical Trials Coordinating Center The Kitasato Institute 1 Who are involved in Clinical Trials? Patients. Others
More informationCurrent version dated 5 March 2012
M3(R2) Implementation Working Group M3(R2) Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals Questions & Answers
More information3 Food Standards Agency, London, UK
Chapter six From Hazard to Risk e Assessing the Risk Charlotte Bernhard Madsen 1, Geert Houben 2, Sue Hattersley 3, Rene W.R. Crevel 4, Ben C. Remington 5, Joseph L. Baumert 5 1 DVM Research Leader Division
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 5 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationREGULATIONS FOR THE DEGREES OF MASTER OF SCIENCE
REGULATIONS FOR THE DEGREES OF MASTER OF SCIENCE (MSc) AND MASTER OF SCIENCE IN ENVIRONMENTAL MANAGEMENT (MSc[Env Man]) For students admitted in 2016-2017 and thereafter (See also General Regulations)
More informationGuidance for Industry
Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals U.S. Department of Health and Human Services Food and Drug
More informationResearch on Support for Persons with Mental Disability to Make Transition to Regular Employment
Research on Support for Persons with Mental Disability to Make Transition to Regular Employment (Research Report No.108) Summary Key Words Persons with Mental Disabilities, Step-Up Employment Program for
More informationRe: GRAS Notice No. AGRN 000-009
May 4, 2012 Dr. Hardy Edwards III Vitamin Derivatives, Inc. 625 Lem Edwards Road Winterville, Georgia 30683 Re: GRAS Notice No. AGRN 000-009 Dear Dr. Edwards: The Food and Drug Administration (FDA) is
More informationAmidosulfuron SANCO/1101/08 rev. 1 20 January 2008. EU Limited
EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate E Safety of the food chain Unit E.3 - Chemicals, contaminants, pesticides Amidosulfuron SANCO/1101/08 rev. 1 20 January
More informationGENERIC RISK ASSESSMENT MODEL FOR INSECTICIDES USED FOR LARVICIDING
GENERIC RISK ASSESSMENT MODEL FOR INSECTICIDES USED FOR LARVICIDING Department of Control of Neglected Tropical Diseases HIV/AIDS, Tuberculosis, Malaria and Neglected Tropical Diseases & Department of
More informationAn Evidence-Based Approach to Reviewing the Science on the Safety of Chemicals in Foods
An Evidence-Based Approach to Reviewing the Science on the Safety of Chemicals in Foods In considering the safety of chemicals added to foods, or present in foods due to environmental circumstances, we
More information8. REGULATIONS AND ADVISORIES
ARSENIC 395 The international and national regulations and guidelines pertaining to arsenic and its metabolites in air, water, and other media are summarized in Table 8-1. ATSDR has not derived inhalation
More informationBuprofezin 101 5.4 BUPROFEZIN (173)
Buprofezin 101 5.4 BUPROFEZIN (173) TOXICOLOGY Buprofezin is the ISO approved name for (EZ)-2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5- thiadiazinan-4-one (IUPAC), CAS No. 69327-76-0. Buprofezin is an
More informationこの 外 国 弁 護 士 による 法 律 事 務 の 取 扱 いに 関 する 特 別 措 置 法 施 行 規 則 の 翻 訳 は 平
この 外 国 弁 護 士 による 法 律 事 務 の 取 扱 いに 関 する 特 別 措 置 法 施 行 規 則 の 翻 訳 は 平 成 十 六 年 法 務 省 令 第 6 号 までの 改 正 ( 平 成 16 年 4 月 1 日 施 行 )について 法 令 用 語 日 英 標 準 対 訳 辞 書 ( 平 成 18 年 3 月 版 )に 準 拠 して 作 成 したものです なお この 法 令 の 翻
More informationGrant Request Form. Request Form. (For continued projects)
Grant Request Form Request Form (For continued projects) NOTE: Check list of the needed documents Following documents should be prepared in Japanese. Continuing grant projects from FY2015(or FY2014) don
More informationHow To Teach English At Kumon
English Education at Kumon 1 Running Head: ENGLISH EDUCATION AT KUMON English Education at KUMON ~ A Case Study of Two Children and their Mothers ~ by Yukiko Kawabata A graduation thesis submitted to the
More informationGUIDELINES FOR THE REGISTRATION OF BIOLOGICAL PEST CONTROL AGENTS FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS
GUIDELINES FOR THE REGISTRATION OF BIOLOGICAL PEST CONTROL AGENTS FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS -ii- GUIDELINES ON THE REGISTRATION OF BIOLOGICAL PEST CONTROL AGENTS FOOD AND
More informationCOMMITTEE FOR VETERINARY MEDICINAL PRODUCTS
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Veterinary Use EMEA/MRL/717/99-FINAL December 1999 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS TOLDIMFOS SUMMARY
More informationGuidance on applications for technical equivalence
1 guidance Guidance on applications for technical equivalence Guidance on Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products Version 1.0 August 2013
More informationA FDA Perspective on Nanomedicine Current Initiatives in the US
A FDA Perspective on Nanomedicine Current Initiatives in the US Carlos Peña, PhD Office of the Commissioner FDA September 3, 2010 Outline Context Nanotechnology Task Force report summary Identification
More informationAct on Special Measures Concerning Nuclear Emergency Preparedness (Act No. 156 of December 17, 1999)
この 原 子 力 災 害 対 策 特 別 措 置 法 の 翻 訳 は 平 成 18 年 法 律 第 118 号 までの 改 正 ( 平 成 19 年 1 月 9 日 施 行 )について 法 令 用 語 日 英 標 準 対 訳 辞 書 ( 平 成 19 年 3 月 版 )に 準 拠 して 作 成 したものです なお この 法 令 の 翻 訳 は 公 定 訳 ではありません 法 的 効 力 を 有 するのは
More informationConclusion on the peer review of the pesticide risk assessment of the active substance lenacil 1
EFSA Journal 2009; 7(10):1326 CONCLUSION ON PESTICIDE PEER REVIEW Conclusion on the peer review of the pesticide risk assessment of the active substance lenacil 1 European Food Safety Authority 2 European
More informationGRAS Notice (GRN) No. 585 http://www.fda.gov/food/ingredientspackaginglabeling/gras/noticeinventory/default.htm ORIGINAL SUBMISSION
GRAS Notice (GRN) No. 585 http://www.fda.gov/food/ingredientspackaginglabeling/gras/noticeinventory/default.htm ORIGINAL SUBMISSION GR 1111111 111111 111111 0 0 0 0 0 1 ERIC F. GREENBERG, P.C. A professional
More informationUpper Secondary Education in Japan
Upper Secondary Education in Japan The role of upper secondary education in Japan is to provide higher general education and specialized education according to students mental and physical development
More information5.19 PROPYLENE OXIDE (250)
197 5.19 PROPYLENE OXIDE (250) TOXICOLOGY is the International Organization for Standardization (ISO) approved name for methyloxirane (International Union of Pure and Applied Chemistry) (Chemical Abstracts
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 6 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationSession 6 Clinical Trial Assessment Phase I Clinical Trial
L1 Session 6 Clinical Trial Assessment Phase I Clinical Trial Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office
More information- A9/1 - Format for the listing of end points to be included in the Tier III overall summary and assessments
- A9/1 - - A9/1 - APPENDIX 9 FORMAT FOR THE LISTING OF END POINTS TO BE INCLUDED IN THE REASONED STATEMENT OF THE OVERALL CONCLUSIONS DRAWN BY THE REGULATORY AUTHORITY (LEVEL 2)8 General remark: Testing
More informationEDB-Report. 最 新 Web 脆 弱 性 トレンドレポート(2014.11) 2014.11.01~2014.11.30 Exploit-DB(http://exploit-db.com)より 公 開 されている 内 容 に 基 づいた 脆 弱 性 トレンド 情 報 です
04. 最 新 Web トレンドレポート(04.) 04..0~04..30 Exploit-DB(http://exploit-db.com)より 公 開 されている 内 容 に 基 づいた トレンド 情 報 です サマリー ペンタセキュリティシステムズ 株 式 会 社 R&Dセンター データセキュリティチーム 04 年 月 は Exploit-DBより 公 開 されている の 中 SQLインジェクション(SQL
More informationWaiving von Datenanforderungen und Optionen zum. Daten-Waiving bei Bioziden. Gegenbeispiele aus der Praxis
Waiving von Datenanforderungen und Optionen zum Daten-Waiving bei Bioziden Gegenbeispiele aus der Praxis Advanced Course AK Reg Tox, DGPT FJT, 09. März 2015, Kiel Dr. Michael Werner, SCC GmbH, Bad Kreuznach
More informationDC DC φ φ DC φ φ AC φ φ φ φ φ φ φ 24V DC Class2 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1 ) this device may not cause harmful interference,and
More informationCHAPTER 7 ESTIMATING DIETARY INTAKE OF PESTICIDE RESIDUES
CHAPTER 7 ESTIMATING DIETARY INTAKE OF PESTICIDE RESIDUES CONTENTS Background Long-term dietary intake Short-term dietary intake Handling of cases where JMPR estimates of dietary intake exceed the ADI
More informationRisk assessment and regulation of tattoo inks in the EU
Risk assessment and regulation of tattoo inks in the EU Paul Janssen Current situation: Tattoo application in a regulatory vacuum : Is not a medical treatment Is not a cosmetic treatment No EU-regulation
More informationInitial Risk Assessment Report of Chemical Substances (Extract) Ver.1.0 No. 56. Decabromodiphenyl ether
Initial Risk Assessment Report of Chemical Substances (Extract) Ver.1.0 No. 56 Decabromodiphenyl ether Government Ordinance Number in the PRTR Law: 1-197 CAS Registry Number: 1163-19-5 July 2005 New Energy
More informationGraduate Program in Japanese Language and Culture (Master s Program) Application Instructions
Graduate Program in Japanese Language and Culture (Master s Program) Application Instructions For FY 2016 1. Objectives This program is designed to provide teachers of the Japanese-language working abroad
More informationChapter 13: SPECIFIC TARGET ORGAN SYSTEMIC TOXICITY (TOST) FOLLOWING REPEATED EXPOSURE
Chapter 13: SPECIFIC TARGET ORGAN SYSTEMIC TOXICITY (TOST) FOLLOWING REPEATED EXPOSURE DEFINITIONS 1. Classification identifies the chemical substance as being a specific target organ/systemic toxicant
More informationBushido: Way of the Samurai. Golden Screens. Chokuo TAMURA Hawks with pine and plum blossom 163.6 x 376.0 cm each
Bushido: Way of the Samurai Golden Screens Chokuo TAMURA Hawks with pine and plum blossom 163.6 x 376.0 cm each 金 Noh 屏 Theatre 風 robes teacher s notes Kin Byōbu Golden Screen teacher s notes Decorative
More informationAnnex. DRAFT Guidance Document on the Planning and Implementation of Joint Reviews of Pesticides. Revision 8 September 2010
Annex DRAFT Guidance Document on the Planning and Implementation of Joint Reviews of Pesticides Revision 8 September 2010 Table of Contents SECTION 1 BACKGROUND AND OVERVIEW OF THE JOINT REVIEW PROCESS...
More information1) Aug 2005 In Vitro Chromosomal Aberration Study Cytotoxicity (File: TS39) Conclusion No cytotoxicity can be detected at concentrations up to 100%.
Endotoxicity and Cytotoxicity Studies 1) Aug 2005 In Vitro Chromosomal Aberration Study Cytotoxicity (File: TS39) Chinese Hamster Ovary (CHO) cells were grown in monolayer with and without metabolic activation.
More information