Drug safety : 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 /

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: International Congress of Pharmaceutical Physicians Paris, France
Otros Autores: Auriche, Michel (Editor ), Burke, John McDonald (Editor ), Duchier, Jacques (Editor )
Formato: Electrónico Congresos, conferencias eBook
Idioma:Inglés
Francés
Publicado: Paris ; New York : Pergamon Press, [1982]
Temas:
Drugs > Congresses.
Drugs > Side effects > Congresses.
Pharmaceutical Preparations > standards
Drug Evaluation
M�edicaments > Congr�es.
M�edicaments > Effets secondaires > Congr�es.
MEDICAL > Pharmacology.
Drugs
Drugs > Side effects
Congress
proceedings (reports)
Conference papers and proceedings
Conference papers and proceedings.
Actes de congr�es.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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?
  • 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.
  • 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.
  • 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.
  • 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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