LEADER 04448nam 2200649Ia 450 001 9910459673503321 005 20200520144314.0 010 $a1-282-76077-7 010 $a9786612760778 010 $a92-4-068530-8 035 $a(CKB)2670000000067994 035 $a(EBL)579101 035 $a(OCoLC)700687957 035 $a(SSID)ssj0000437502 035 $a(PQKBManifestationID)12211577 035 $a(PQKBTitleCode)TC0000437502 035 $a(PQKBWorkID)10432401 035 $a(PQKB)11345330 035 $a(MiAaPQ)EBC579101 035 $a(Au-PeEL)EBL579101 035 $a(CaPaEBR)ebr10411806 035 $a(CaONFJC)MIL276077 035 $a(EXLCZ)992670000000067994 100 $a20101008d2009 uf 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aQuality practices for regulated non-clinical research and development$b[electronic resource] /$fUNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases 205 $a2nd ed. 210 $aGeneva $cWHO on behalf of the Special Programme for Research and Training in Tropical Diseases$dc2009 215 $a1 online resource (327 p.) 300 $aHandbook : Good Laboratory Practice (GLP). 311 $a92-4-154755-3 320 $aIncludes bibliographical references. 327 $aCONTENTS; 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 327 $aII. 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 327 $aIX . 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 327 $aXV . ESTABLISHMENT AND CONTROL OF ARCHIVES THAT OPERATE IN COMPLIANCE WITH THE PRINCIPLES OF GLP 330 $aGood 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 517 3 $aGood Laboratory Practice (GLP) 606 $aLaboratories$xStandards$vHandbooks, manuals, etc 606 $aLaboratories$xTechnique$vHandbooks, manuals, etc 608 $aElectronic books. 615 0$aLaboratories$xStandards 615 0$aLaboratories$xTechnique 676 $a344.7304 712 02$aSpecial Programme for Research and Training in Tropical Diseases. 712 02$aWorld Health Organization. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910459673503321 996 $aQuality practices for regulated non-clinical research and development$92099284 997 $aUNINA LEADER 03033nam1 22006133i 450 001 LO10014037 005 20251003044204.0 100 $a20160627d1984 ||||0itac50 ba 101 | $aita 102 $ait 181 1$6z01$ai $bxxxe 182 1$6z01$an 183 1$6z01$anc$2RDAcarrier 200 1 $aScritti economici$fAntonio Genovesi$ga cura di Maria Luisa Perna 210 $aNapoli$cIstituto italiano per gli studi filosofici$d1984 215 $a2 volumi$d25 cm 225 | $aEconomisti meridionali 410 0$1001LO10014051$12001 $aEconomisti meridionali 463 1$1001LO10014059$12000 $aVol. 1$fAntonio Genovesi$v1 463 1$1001TO00302357$12000 $aVol. 2$fAntonio Genovesi$v2 606 $aECONOMIA$xSAGGI$2FIR$3MILC005425$9E 606 $aGENOVESI, ANTONIO$xOpere$2FIR$3NAPC030895$9I 676 $a330$9SCIENZE ECONOMICHE$v19 676 $a330.092$9ECONOMIA. 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La consegna del doc. é effettuata dall'Uff. Distribuzione. 901 $bNAP LS$cLS $n$ 901 $bNAP GV$cF.MARTANO $n$ 901 $bNAP 17$cPUBBL.IST.$n$ 901 $bNAP BE$cBIBLIOTECA$n$ 901 $bNAP DP$cCAU $nDonazione della famiglia Causa 901 $bNAP SP$cNF. $nNUOVO FONDO 901 $bNAP 01$cPOZZO LIB.$nVi sono collocati fondi di economia, periodici di ingegneria e scienze, periodici di economia e statistica e altri fondi comprendenti documenti di economia pervenuti in dono. 901 $bNAP AV$cMANCINO $n$ 901 $bNAP FT$cFIL. $n$ 912 $aLO10014037 950 1$aBiblioteca Centralizzata di Ateneo$bv. 1-2$cv. 1-2$d 01POZZO LIB.ECON MON 6236 977 $a 01$a 17$a AN$a AV$a BE$a BN$a BU$a DP$a FC$a FT$a GV$a LS$a SP 996 $aScritti economici$9453711 997 $aUNISANNIO