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Drug Epidemiology and Post-Marketing Surveillance : NATO Science Series A - Brian L. Strom

Drug Epidemiology and Post-Marketing Surveillance

NATO Science Series A

By: Brian L. Strom (Editor), G. P. Velo (Editor)

Hardcover Published: 31st August 1992
ISBN: 9780306440991
Number Of Pages: 172

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This volume is a summary of material presented in the course given in the International School of Phannacology on "Drug Epidemiology and Post-Marketing Surveillance" between September 27 and October 8, 1990, at the "Ettore Majorana Center for Scientific Culture" in Erice, Sicily. The course, which was a NATO Advanced Study Institute, included lectures and workshops presented by experts in the new field of phannacoepidemiology. The material covered includes various approaches to spontaneous reporting of adverse drug reactions, including aggregate approaches, such as those used in France, and detailed analyses of individual reports, such as that done in The Netherlands and in Sweden. Also, included are studies using traditional epidemiology methods. In addition, modern pharmacoepidemiology makes considerable use of automated databases. As such, information is presented on their use as well. Phannacoepidemiology started in hospitals and some of the newest work in the field is returning to the hospital as a site for studies. Material on these topics was presented as well. Finally, selected new methodologic developments were outlined in specific examples presented that were of regulatory and commercial importance. This new field of phannacoepidemiology is exploding in interest internationally. Evidence of this is the increasing development of pharmacoepidemiology programs in industry, medical schools, pharmacy schools, and schools of public health. Also, there is a new International Society ofPhannacoepidemiology. Practitioners in this field tend to specialize in either analyses of spontaneous reporting or the use of formal epidemiologic techniques.

Spontaneous Reporting
The Analysis of Postmarketing Drug Surveillance Data at the U.S. Food and Drug Administrationp. 1
Postmarketing Surveillance of ADRs by Spontaneous Reporting and Register Data: The Swedish Approachp. 9
Spontaneous Monitoring of Adverse Reactions to Drugs, Procedures, and Experiences in The Netherlandsp. 21
Pharmacovigilance in France: A Decentralized Approachp. 39
Traditional Clinical Epidemiology Methods as Applied to Pharmacoepidemiology
The Use of Vital and Morbidity Statistics for the Detection of Adverse Drug Reactions and for Monitoring of Drug Safetyp. 43
The Use of Case-Control Studies in Pharmacoepidemiologyp. 49
The Use of Cohort Studies in Pharmacoepidemiologyp. 53
Using Randomized Trials in Pharmacoepidemiologyp. 59
Use of Automated Databases for Pharmacoepidemiology
Pharmacoepidemiology Studies Using Large Databasesp. 65
Screening for Unknown Effects of Newly Marketed Drugsp. 73
Hospital Pharmacoepidemiology
Hospital Data Sourcesp. 83
Hospital-Based Intensive Cohort Studiesp. 91
Hospital-Based Adverse Reaction and Drug Utilization Review in the United Statesp. 99
New Methodologic Developments
Approaches to Evaluating Causation of Suspected Drug Reactionsp. 103
Pharmacoeconomics: Principles and Basic Techniques of Economic Analysisp. 115
N of 1 Randomized Trials for Investigating New Drugsp. 125
Measuring Health-Related Quality of Life in Clinical Trialsp. 135
Selected Examples of Regulatory and Commercial Importance
Evaluation of Bias and Validation of Survival Estimates in a Large Cohort of AIDS Patients Treated with Zidovudinep. 143
The Triazolam Experience in 1979 in The Netherlands, a Problem of Signal Generation and Verificationp. 159
Contributorsp. 169
Indexp. 171
Table of Contents provided by Blackwell. All Rights Reserved.

ISBN: 9780306440991
ISBN-10: 0306440997
Series: NATO Science Series A
Audience: Professional
Format: Hardcover
Language: English
Number Of Pages: 172
Published: 31st August 1992
Publisher: Springer Science+Business Media
Country of Publication: US
Dimensions (cm): 23.4 x 15.6  x 1.91
Weight (kg): 0.97