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SCIDIR_ocn884457497 |
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OCoLC |
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140723s1982 fr a o 100 0 eng d |
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|a 896795117
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|a 9781483140377
|q (electronic bk.)
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|a 1483140377
|q (electronic bk.)
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|z 9780080270746
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|a (OCoLC)884457497
|z (OCoLC)896795117
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|a eng
|a fre
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|a RS189
|b .I523 1981eb
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|a QV771 In82p 1981
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|a MED
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|a 615.1
|2 22
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|a International Congress of Pharmaceutical Physicians
|n (4th :
|d 1981 :
|c Paris, France)
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|a Drug safety :
|b progress and controversies : proceedings of the IVth International Congress of Pharmaceutical Physicians = S�ecurit�e et m�edicament : progr�es et controverses : comptes rendus du IVe congr�es international des m�edecins de l'industrie pharmaceutique /
|c editors, Michel Auriche, John Burke, Jacques Duchier.
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|a S�ecurite et m�edicament
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|a Paris ;
|a New York :
|b Pergamon Press,
|c [1982]
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264 |
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|c �1982
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|a 1 online resource (xviii, 308 pages) :
|b illustrations
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|a text
|b txt
|2 rdacontent
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|a computer
|b c
|2 rdamedia
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|a online resource
|b cr
|2 rdacarrier
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|a "Paris, 27/30 April 1981."
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|a "The 4th International Meeting of Pharmaceutical Physicians."--Page vii
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|a Print version record.
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|a Front Cover; Copyright Page; Drug Safety: Progress and Controversies; Table of Contents; PREFACE; ALLOCUTION DE BIENVENUE; Introduction; PART I: DRUG SAFETY: A MULTIFACETED PROBLEM DIVERSITE DES PROBLEMES POSES PAR L'EVALUATION DE LA SECURITE ENMATIERE DE MEDICAAIENTS; Chapter 1. The Scientific Basis of Drug Safety Regulations; HOW CAN DRUG SAFETY BE REGULATED?; DO DRUG SAFETY REQUIREMENTS IMPEDE DRUG INNOVATION?; WHAT IS THE SIGNIFICANCE OF THE BENEFIT-TO-RISR RATIO?; WHERE ARE THE LIMITS OF SAFETY REGULATIONS?; CAN CLINICAL TRIALS BE EXPEDITED WITHOUT NEGLECTING DRUG SAFETY?
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|a HOW CAN THE SCIENTIFIC BASIS OF DRUG SAFETY BE IMPROVED?REFERENCES; Chapter 2. The Effects of Drug Regulation on Iatrogenic Disease; Abstract; A FOLLOW-UP STUDY OF REJECTIONS; A RETROSPECTIVE STUDY OF RESTRICTIVE DECISIONS; MAJOR IATROGENIC ACCIDENTS IN RETROSPECT; EFFICIENCY OF REGULATORY ACTIVITY ON SAFETY MATTERS; OTHER TECHNIQUES; AN INVALID TECHNIQUE; CONCLUSIONS; REFERENCES; Chapter 3. Deregulation of Drug Development: If Effective, Can it be Safe?; Abstract; THE EARLY STAGES : LESS-STHINGENT CONTROL; SEQUENTIAL SUBMISSION AND REVIEW; REALISTIC STANDARDS OF EVIDENCE FOR EFFICACY.
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|a ACCEPTANCE OF FOREIGN AND IRREGULAR DATAIMPROVED ADMINISTRATIVE AND MANAGEMENT TECHNIQUES; POSTMARKETING ISSUES; CONCLUSIONS; REFERENCES; Chapter 4. Les grainds m�edicaLinents d'hier auraient-ils franchi avec succes le bairrage de la r�eglementation pr�eclinique actuelle?; Resume; LES COMMISSIONS D'AGREMENT; LE PRIX ET LA DUR�EE DES ESSAIS PR�ECLINIQUES; LES LABORATOIRES DE RECHERCHE PHARMACEUTIQUE; QUELQUES DOSSIERS DE GRANDS MEDICAMENTS ANCIENS; CONCLUSIONS; REFERENCES; Chapter 5. The Intemationad Transfer of Information Regarding Drug Saifety : Benefits, Difficulties and Solutions; Abstract.
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|a Chapter 6. Ethicad Considerations in Drug Saifety EvaduationAbstract; CONFLICT OF INTEREST IN RESEARCH; ETHICAL ISSUES IN CLINICAL DRUG TRIALS; THE MARKETING AND USE OF DRUGS; DRUGS IN T H E THIRD WORLD; THE CARE AND FEEDING OF PHARAiACEUTICAL PHYSICIANS; REFERENCES; Chapter 7. A Compairisoii of International Guidelines for the Clinicad Evaduation of Psychotropic Drugs The Price of Safety; Abstract; Chapter 8. USA et FDA Versus CEE et CSP Une etude comparative ouverte des medicaments anti-aingoreux; Resume.
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|a PART II:POST MARKETING SAFETY ASSESSMENT INTERET ET LIMITES DES METHODES D'EVALUATION CLINIQUE DES EFFETS INDESIRABLES DES MEDICAMENTS APRES MISE SUR LE MARCHE: PRESENT METHODSChapter 9. Spontaneous Notification; Abstract; DEFICIENCIES OF PRE-MARKETING TESTS; PRESCRIBING CONDITIONS; ADR REGISTERS IN PMS; ADVANTAGES AND DISADVANTAGES; SPONTANEOUS REPORTING AND IDENTIFICATION OF A NEW HAZARD; RELATIVE RISKS OF VARIOUS DRUGS; ADR'S AND IN-DEPTH STUDIES; WHEN AND WHAT TO REPORT; FEEDBACK OF INFORMATION; CONCLUDING REMARKS; REFERENCES.
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650 |
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|a Drugs
|v Congresses.
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|a Drugs
|x Side effects
|v Congresses.
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650 |
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2 |
|a Pharmaceutical Preparations
|x standards
|0 (DNLM)D004364Q000592
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650 |
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2 |
|a Drug Evaluation
|0 (DNLM)D004341
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650 |
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6 |
|a M�edicaments
|0 (CaQQLa)201-0002990
|v Congr�es.
|0 (CaQQLa)201-0378219
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650 |
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6 |
|a M�edicaments
|0 (CaQQLa)201-0002241
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|0 (CaQQLa)201-0002241
|v Congr�es.
|0 (CaQQLa)201-0378219
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|a MEDICAL
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|a Drugs
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655 |
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|a proceedings (reports)
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655 |
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|a Conference papers and proceedings
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|0 (OCoLC)fst01423772
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655 |
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|a Conference papers and proceedings.
|2 lcgft
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655 |
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|a Actes de congr�es.
|2 rvmgf
|0 (CaQQLa)RVMGF-000001049
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700 |
1 |
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|a Auriche, Michel,
|e editor.
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700 |
1 |
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|a Burke, John McDonald,
|e editor.
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700 |
1 |
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|a Duchier, Jacques,
|e editor.
|
776 |
0 |
8 |
|i Print version:
|a International Congress of Pharmaceutical Physicians (4th : 1981 : Paris, France).
|t Drug safety
|z 0080270743
|w (OCoLC)10444955
|
856 |
4 |
0 |
|u https://sciencedirect.uam.elogim.com/science/book/9780080270746
|z Texto completo
|