1.

Record Nr.

UNINA9910785666403321

Titolo

Quality practices for regulated non-clinical research and development [[electronic resource] /] / UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases

Pubbl/distr/stampa

Geneva, : WHO on behalf of the Special Programme for Research and Training in Tropical Diseases, c2009

ISBN

1-282-76077-7

9786612760778

92-4-068530-8

Edizione

[2nd ed.]

Descrizione fisica

1 online resource (327 p.)

Disciplina

344.7304

Soggetti

Laboratories - Standards

Laboratories - Technique

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Handbook : Good Laboratory Practice (GLP).

Nota di bibliografia

Includes bibliographical references.

Nota di contenuto

CONTENTS; 1. INTRODUCTION TO THE WHO/TDR HANDBOOK ON GLP; GENERAL INTRODUCTION; INTRODUCTION TO GLP AND ITS APPLICATION; 2. GOOD LABORATORY PRACTICE TRAINING; INTRODUCTION; THE FUNDAMENTAL POINTS OF GLP; RESOURCES; CHARACTERISATION; RULES FOR PERFORMING STUDIES; RESULTS - RAW DATA AND DATA COLLECTION; QUALITY ASSURANCE UNIT; 3. STEPWISE IMPLEMENTATION OF GLP; INTRODUCTION; IMPLEMENTATION AS A PROJECT; STEPWISE IMPLEMENTATION OF GLP REQUIREMENTS; ANNEXES: OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING; I. OECD PRINCIPLES ON GOOD LABORATORY PRACTICE

II. GUIDANCE FOR GLP MONITORING AUTHORITIES: REVISED GUIDES FOR COMPLIANCE MONITORING PROCEDURES FOR GOOD LABORATORY PRACTICEIII. GUIDANCE FOR GLP MONITORING AUTHORITIES: REVISED GUIDANCE FOR THE CONDUCT OF LABORATORY INSPECTIONS AND STUDY AUDITS; IV . QUALITY ASSURANCE AND GLP; V . COMPLIANCE OF LABORATORY SUPPLIERS WITH GLP PRINCIPLES; VI . THE APPLICATION OF THE GLP PRINCIPLES TO FIELD STUDIES; VII . THE APPLICATION OF THE GLP PRINCIPLES TO SHORT TERM STUDIES; VIII . THE ROLE AND



RESPONSIBILITIES OF THE STUDY DIRECTOR IN GLP STUDIES

IX . GUIDANCE FOR GLP MONITORING AUTHORITIES: GUIDANCE FOR THE PREPARATION OF GLP INSPECTION REPORTSX . THE APPLICATION OF THE PRINCIPLES OF GLP TO COMPUTERISED SYSTEMS; XI . THE ROLE AND RESPONSIBILITIES OF THE SPONSOR IN THE APPLICATION OF THE PRINCIPLES OF GLP; XII . REQUESTING AND CARRYING OUT INSPECTIONS AND STUDY AUDITS IN ANOTHER COUNTRY; XIII . THE APPLICATION OF THE OECD PRINCIPLES OF GLP TO THE ORGANISATION AND MANAGEMENT OF MULTI-SITE STUDIES; XIV . THE APPLICATION OF THE PRINCIPLES OF GLP TO IN-VITRO STUDIES

XV . ESTABLISHMENT AND CONTROL OF ARCHIVES THAT OPERATE IN COMPLIANCE WITH THE PRINCIPLES OF GLP

Sommario/riassunto

Good laboratory practices (GLP) are the recognized rules governing the conduct of non-clinical safety studies. They ensure the quality, integrity and reliability of the study data. This handbook is designed as an aid for those countries wishing to upgrade their laboratories to GLP status. Based on the Organisation for Economic Cooperation and Development (OECD) principles of GLP, the handbook provides laboratories and trainers in disease endemic countries with the necessary technical information for implementing GLP programs. The material in the handbook is presented in a clear and informative



2.

Record Nr.

UNINA9910960266703321

Titolo

Substance abuse prevention in multicultural communities / / Jeanette Valentine, Judith A. De Jong, Nancy J. Kennedy, editors

Pubbl/distr/stampa

Abingdon, Oxon : , : Routledge, , 2013

ISBN

1-317-79063-4

1-138-00233-X

1-315-80980-X

1-317-79064-2

Edizione

[1st ed.]

Descrizione fisica

1 online resource (188 p.)

Altri autori (Persone)

De JongJudith Ann

KennedyNancy J <1952-> (Nancy Jean)

ValentineJeanette

Disciplina

362.29/17/0973

362.29170973

Soggetti

Substance abuse - United States - Prevention

Children of minorities - Substance use - United States

Minorities - Substance use - United States

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

"Substance abuse prevention in multicultural communities has been co-published simultaneously as Drugs & society, volume 12, numbers 1/2 1998."--T.p.

First published 1998 by the Haworth Press, Inc.

Nota di bibliografia

Includes bibliographical references and index at the end of each chapters.

Nota di contenuto

""Cover ""; ""Half Title ""; ""Title Page ""; ""Copyright Page ""; ""Table of Contents ""; ""Preface""; ""Implementation and Evaluation of Substance Abuse Prevention Programs in Culturally Diverse Communities: An Introduction""; ""Friendly PEERsuasionSM Against Substance Use: The Girls IncorporatedSM Model and Evaluation""; ""The Nee-kon Project: Designing and Implementing Prevention Strategies for Young Native American Children""; ""Evolution of a Substance Abuse Prevention Program with Inner City African-American Families""

""Alcohol and Drug Prevention Among American Indian Families: The Family Circles Program""""Impact of a Family and School Based Prevention Program on Protective Factors for High Risk Youth"";



""Effectiveness of the Logan Square Prevention Project: Interim Results""; ""Dosage-Related Changes in a Culturally-Responsive Prevention Program for Asian American Youth""; ""Strengthening Causal Inference in Adolescent Drug Prevention Studies: Methods and Findings from a Controlled Study of the Urban Youth Connection Program""; ""Prevention Through Empowerment in a Native American Community""

""Index""

Sommario/riassunto

This insightful volume describes a sample of prevention demonstration projects of the Center for Substance Abuse Prevention (CSAP). Substance Abuse Prevention in Multicultural Communities illuminates various aspects of prevention theory, practice, and research with a focus on the design, implementation, adaptation, and outcome of specific demonstration programs. Researchers work with prevention professionals to describe, measure, and intensify effects of interventions upon both intermediate problems and the ultimate long-term goal of decreasing substance abuse. Chapters in Substance Abuse Prev