Drug Safety. Progress and Controversies

Content: 
Front Matter, Page III
Copyright, Page IV
LE IVe CONGRES DES MEDECINS DE L'INDUSTRIE PHARMACEUTIQUE THE 4th INTERNATIONAL MEETING OF PHARMACEUTICAL PHYSICIANS, Page VII
PREFACE, Pages XIII-XIV, R.K. RONDEL
Dedication, Page XV
ALLOCUTION DE BIENVENUE, Pages XVII-XVIII, Michel AURICHE
Introduction, Pages 1-5, M. AURICHE
The Scientific Basis of Drug Safety Regulations, Pages 9-18, F.H. GROSS
The Effects of Drug Regulation on Iatrogenic Disease, Pages 19-31, M.N.G. DUKES, I. LUNDE
Deregulation of Drug Development: If Effective, Can it be Safe?, Pages 33-40, W.M. WARDELL
Les grands médicaments d'hier auraient-ils franchi avec succès le barrage de la réglementation préclinique actuelle?, Pages 41-50, P. DUCHENE-MARULLAZ
The International Transfer of Information Regarding Drug Safety: Benefits, Difficulties and Solutions, Pages 51-53, J.F. DUNNE
Ethical Considerations in Drug Safety Evaluation, Pages 55-62, Michael P. HAMILTON
A Comparison of International Guidelines for the Clinical Evaluation of Psychotropic Drugs The Price of Safety, Pages 63-66, V. H. VAN LANDEGHEM
USA et FDA Versus CEE et CSP Une étude comparative ouverte des médicaments anti-angoreux, Pages 67-70, J.R. ESPIE
Spontaneous Notification, Pages 73-82, J.E. IDÄNPÄÄN-HEIKKILÄ
Assessment of the Cause and Effect Relationship of Suspected Adverse Drug Reactions, Pages 83-91, J. VENULET, A.G. Ciucci
Experiences of Registers in Drug Safety Assessment in Sweden, Pages 93-103, B. WESTERHOLM, B.E. WIHOLM
Méthodes actuelles pour évaluer l'innocuité des médicaments: enquêtes prospectives, Pages 105-110, C. RUMEAU-ROUQUETTE
Case-Control Studies in the Evaluation of Drug Safety, Pages 111-121, M.P. VESSEY
Hospital Surveys, Pages 123-125, H. JICK
Cost and Effectiveness of Post-marketing Surveillance, Page 127, P.E. LUCCHELLI
Scientific Obstacles to Overcome in Establishing Systematic Post-marketing Surveillance, Page 131, K.L. MELMON
Cohorts From Data Banks, Pages 133-135, H. JICK
The Drug Surveillance Research Unit (DSRU), Pages 137-142, W.H.W. INMAN
Post-marketing Safety Assessment New Zealand Experience, Pages 143-150, J.S. PHILLIPS
Post-marketing Surveillance in U. K.: A Study of Cimetidine Recipients, Page 151, P.H. LAWSON
Post-marketing Surveillance Experience Gained with an Orally Active Asthma Prophylactic Agent, Page 153, P. KRUPP, D. CROWDER
La sécurité passe par l'information sur le médicament. Role du médecin de l'industrie pharmaceutique, Pages 155-159, J.F. SCHLUMBERGER
The Liability of Manufacturers in Respect of Known Effects of Medical Products, Pages 163-167, G.C. TUCK
La responsabilité stricte des laboratoires pour tous les risques même imprévisibles, Pages 169-175, F. MARTEL
The Physician's Labeling — An American Point of View, Pages 177-182, L.G. MILLSTEIN
Drug Safety — Information Systems, Page 183, J. CROOKS
Future Systems in Providing the Prescriber with Drug Information, Pages 185-187, H. DUCROT
Rôle du prescripteur dans l'information du patient sur les effets du médicament, Pages 189-192, P. GUILLET
Pharmacist Contribution to Patient Information and Drug Safety, Pages 193-198, J.R. WUEST
The Patient Package Insert The FDA Concept and Plans, Pages 199-205, L.G. MILLSTEIN
Evaluation de l'observance, Pages 207-212, E. WEBER
Cross Culturad Problems with Regard to Product Information and Drug Safety, Pages 213-220, L.A. SALAKO
Product Information: Proposal for a Coherent Action Program, Pages 221-225, A. HERXHEIMER
A Diploma Course in Pharmaceutical Medicine, Page 229, B.T. MARSH, D.K. LUSCOMBE
Diploma in Pharmaceutical Medicine (D.P.M.): A survey of Attitudes of A.M.A.P.I. members., Page 231, R.P. BAX, D. McCULLEY
Test of Small Airways Function in Monitoring Respiratory Effects of Medicinals, Page 233, B.M. COHEN
Algorithms and the Science of Systematic Drug Development, Page 235, F.W. WOLFF
Management of Clinical Triads in Developing Countries, Pages 237-245, E.W.J. DE MAAR
The Pathologist's Role in the Interpretation of Carcinogenicity Studies on Laboratory Animals, Page 247, J.M. FACCINI
Methodological Problems in the Detection and Evaluation of Adverse Events during the Phases I, II and III of the Drug Development, Page 249, L. Bossi, J.F. HENRY, M. VADROT
Post-marketing Surveillance in Italy: A Comparison between Firm-sponsored and Independent Trials with Prazosin, Pages 251-255, V. FORTE, M. CIAMPINI
Current Concepts for Assessing the Drug Adverse event Relationship and their Problems, Pages 257-262, J. HASFORD
Methodological and Statistical Problems in the Evaluation of Data on Adverse Drug Reaction, Page 263, J. SCHERER, A. STRAUSS
Post-marketing Surveillance Methodology as Applied in a Pharmaceutical Medical Department, Pages 265-273, A. EMANUELI, G. SACCHETTI
Cimetidine as a Model for Post-marketing Safety Assessment, Page 275, A.C. FUND, D. ROWLEY-JONES
Improving Drug Compliance in a Multi-cultural Multi-linguistic Society, Page 277, P.S. TALBOT, L.D. BECKWITH
1984 and the Committee on Safety of Surgery, Page 279, D.M. BURLEY
Adverse Drug Reaction Monitoring in Psychiatric Hospitals, Pages 281-285, R. GROHMANN
A Post-marketing Surveillance Study on Bacampicillin, Pages 287-290, P.G. PRELLA, M. CIAMPINI, E. MICHELETTI
Post-marketing Surveillance: Computerized Evaluation of Side Effects, Pages 291-300, U. QUAST
CNS Safety Evaluations of New Drugs Based on Computerized Bio-electrical Potentials, Page 301, T.M. ITIL, D.M. SHAPIRO, G.N. MENON, K.Z. ITIL
ALLOCUTION DE CLOTURE, Page 303, Michel AURICHE
TABLE OF SPEAKERS, Pages 305-308
Inside Back Cover, Page 310