Drug Information Journal 1991: Vol 25 Table of Contents

9 Pages·1991·1 MB·English

Drug Information Journal, Vol. 25, pp. V-XVI, 1991 0092-8615/91 $3.00 + .00
Printed in the USA. All rights reserved. Copyright © 1991 Drug Information Association Inc.
Contents
Volume 25, 1991
Volume 25, Number 1 1991
CONTENTS
Robert J. Temple 1 Access, Science, and Regulation
P. Blake 13. Can We Accelerate Drug Development?
M. J. Ratcliffe
Alan Gelberg 19 = Technological Developments with the FDA Adverse
George D. Armstrong Drug Reaction File System
Michael W. Dreis
Charles Anello
Tom A. Hutchinson 29 Computerized Aids for Probabilistic Assessment of
A. Philip Dawid Drug Safety I: A Spreadsheet Program
David J. Spiegelhalter
Robert G. Cowell
Sue Roden
Tom A. Hutchinson 41 Computerized Aids for Probabilistic Assessment of
A. Philip Dawid Drug Safety II: An Expert System
David J. Spiegelhalter
Robert G. Cowell
Sue Roden
Beverly M. DeVries Screening for Illicit Drug Use in Drug Development
George S. Hughes, Jr Studies
Linda S. Huyser
Chih-Wu Chang Automated Information Delivery in a Pharmaceutical
John G. Caster Company
Jed C. Morris
Roger P. Nelson
David L. Larson
Joseph A. Tangrea A Method for the Detection and Management of
Maria Elena Adrianza Adverse Events in Clinical Trials
Mary McAdams
Drug Information Journal
Gene S. Gilbert 81 A Statistical Comparison of Drug Safety in Controlled
Naitee Ting Clinical Trials: The Genie Score as an Objective
Lonni Zubkoff Measure of Lab Abnormalities
Michael C. Joseph 97 An Automated COSTART Coding Scheme
Kathy Schoeffler
Peggy A. Doi
Helen Yefko
Cindy Engle
Erika F. Nissman
Mary Ann F. Kirkpatrick 109 Factors that Motivate Healthy Adults to Participate in
Phase I Drug Trials
Mickey C. Smith 115 A Computerized Bibliography of Research on
Julie A. Fisher Medication Use Studies (MUST)
Robert M. Bell 123. Welcome and Introduction
Joyce A. Generali 125 Adverse Drug Reactions: Communications and
Report— iHosnpigta l and Home Health Care
Perspectives
G. Edward Collins 131 Adverse Drug Experience Communications and
Reporting Industry Perspective: Regulations and
Practice
Karen Overstreet Price 139 Fee-for-Service and Cost Justification Activities of
Jack M. Rosenberg Pharmacist-manned Drug Information Centers in the
Martha M. Rumore United States
J. Anne Milochik Information Technologies—Challenges of the 1990s:
A Company View
Erratum
Software Survey Section:
BBAC—Blood and Breath Alcohol Concentrations :
Volume 25, Number 2
CONTENTS
The Management of Adverse Experience Information:
Phase 1 Through Epidemiology
Raymond L. Herman 163 Opening Remarks
A. D. Dayan 165 The Limitations of Animal Studies: What Can and
Cannot Be Predicted for Man
Michael L’E. Orme 171 The Safety of Phase I Studies: A Study of Healthy
Philip A. Routledge Volunteer Studies in Great Britain Over a 12-Month
John D. Harry Period
Judith Kramer LittleJohn Adverse Experience Collection: Perspective from a
Deborah Otcasek Lucas Biological Development Program
Gail Batson-Fowler
Suzanne Edwards
Patrick C. Waller Postmarketing Surveillance: The Viewpoint of a
Newcomer to Pharmacoepidemiology
M. J. S. Langman Postmarketing Surveillance: The Problems of
Confounded Conclusions
Susan M. Wood Postmarketing Surveillance: Viewpoint from a
Regulatory Authority
Margaret M. Westland Coding: The Mortar in the Bricks of Data Analysis
Charles Matsumoto Implementation and Use of the COSTART Dictionary
at Lilly: Would We Do It Again?
Paul A. Litka Labeling Development: Incorporation of Safety
Information
Garth K. Graham Labeling: What Should It Say, and How Should It
Say It?
Jeffrey B. Margulies Epidemiologic Causation in the Courtroom: Square
Pegs in Round Holes?
Jan Venulet APWI: Past and Present
Drug Information Journal
Tom A. Hutchinson 235 Computerized Bayesian ADE Assessment
Claudio A. Naranjo 243 Microcomputer-Assisted Bayesian Differential
Krista L. Lanctét Diagnosis of Severe Adverse Reactions to New
Drugs: A 4-Year Experience
Christian Benichou 251 Experts’ Opinion in Causality Assessment: Results of
Gaby Danan Consensus Meetings
Additional Articles
of Significant Interest
J. M. Antonello 257 An Automated System for the Statistical Evaluation
J. F. Heyse of Developmental Toxicology
D. J. Verbinski
J. L. Ebbenga
J. A. Trojnar
R. L. Clark
Ross H. Weaver 269 The Role of Information Technology in ICI
KT Porter Pharmaceuticals Group Medical Information
Department
Robert M. Sturm 275 Strategic Uses of Information Technology in Clinical
Research
Harvey Gurien 285 . A Module System for the Preparation of International
Dossiers, Manufacturing, and Controls (New
Chemical Entities)
Jack Faricelli 289 Analysis and Reporting Windows for Clinical Trial
Gregory L. Lazarev Information
Frank A. Adornato 295 Worldwide Drug Planning System: An Automated
Stephan J. Bachmann System of Registration Requirements and Its
Lyse DeMontigny Application for Regulatory Planning and Strategies
Pamela Corsentino
Gail Lowden
Terry Jamieson
Linda G. Brown
Software Survey Section:
PREACC
Volume 25, Number 3 July-September, 1991
CONTENTS
Part I
Articles Developed From the DIA Workshop on Statistical Issues in the Pharmaceutical
Industry: Analysis of Reporting of Phase III Clinical Trials Including Kinetic/Dynamic
Analysis and Bayesian Analysis
W. A. T. Archambault 305 Introduction
Lilly P. Sanathanan 307 Random Effects Modeling in Population:
Kinetic/Dynamic Analysis
Lewis B. Sheiner Population PK/PD Analysis
Raymond J. Lipicky
P. I. Feder Statistical Analysis of Dose-Response Experiments by
C. T. Olson Maximum Likelihood Analysis and Iteratively
D. W. Hobson Reweighted Nonlinear Least Squares Regression
M. C. Matthews Techniques
R. L. Joiner
James F. Ward Using Early Drug Development Data to Design Phase
Ronald V. Nardi III Trials
Donald A. Berry Bayesian Methods in Phase III Trials
A. Lawrence Gould Using Prior Findings to Augment Active-Controlled
Trials and Trials With Small Placebo Groups
Michael D. Hughes Practical Reporting of Bayesian Analyses of Clinical
Trials
Jonathan B. Skinner On Combining Studies
William H. Stewart Statistical Analysis of Trough/Peak Ratios
Kerry B. Hafner
Drug Information Journal
Dennis Gillings The Application of the Principle of Intention-To-Treat
Gary Koch to the Analysis of Clinical Trials
Lilly P. Sanathanan 425 Randomization, PK-Controlled Dosing, and Titration:
Carl Peck An Integrated Approach for Designing Clinical Trials
Robert Temple
Ron Lieberman
Gordon Pledger
Gary G. Koch 433 Summary and Discussion
Part Il
Statistics in the Analysis of Safety Data
Gregory G. Enas) 439 Making Decisions About Safety in Clinical Trials —
The Case for Inferentiai Statistics
William J. Huster 447 Clinical Trial Adverse Events: The Case for
Descriptive Techniques
W. James Alexander 457 Adverse Events: A Classification System for Use in
Clinical Trials
Gary G. Koch 461 _ Discussion: Statistical Perspective
| Software Survey Section:
e ‘N’ ’
Volume 25, Number 4 October—December, 1991
CONTENTS
David A. Kessler 465 Remarks—1991 Annual DIA Meeting
A. C. Cartwright et al 471 — International Harmonization and Consensus DIA
Meeting on Bioavailability and Bioequivalence
Testing Requirements and Standards
Index
Articles Developed from the DIA Workshop on Integrated Safety Summary
David M. Cocchetto 483 Preface: Preparation of an Integrated Safety Summary
Cheryl F. Graham for a New Drug Application
Robert J. Temple 485 The Regulatory Evolution of the Integrated Safety
Summary
Charles Lineberry 493 Approaches to Describing Common Adverse Events
in the Integrated Safety Summary
Thomas Q. Garvey III 501 Can There Really Be an Integrated Safety Summary?
Additional Articles of Significant Interest
Charles F. Curran 513 A Multidrug Patient Assistance Program
Diane Chen 523 ~~ All You Ever Wanted to Know About a CPMP
Hearin—gA DRA Professional’s Guide into the
Unknown
Gerald A. Faich 531 Postmarketing Surveillance: Lessons Learned
John L. Turner 537 ~~ The Implementation of European Community
Directives Concerning GMP
Ronald D. Mann 545 Monitoring Safety with Particular Reference to the
European Community
Léon Gauci 551 Meeting Summary Report: Biotechnology and Drug
Development
C. Benichou 565 Guidelines for the Management of Adverse Events
G. Danan Occurring During Clinical Trials
Charles F. Curran 573 A System for Managing Medical and Technical
Larry M. Hagerman Information
Betty R. Kuhnert 579 International Approval Process for Clinical
Documents
Drug Information Journal
Harold K. Pickering 585 In-House Mechanisms for Handling Products Liability
Litigation
Yves Juillet 591 Industry Health Authorities Relationships in
Pharmacovigilance (PMS): The French Situation
James D.Cope 595 Self-Care/Self-Medication: Where Are We Headed?
Annie L. Britt 599 Completeness of Adverse Drug Experience Reporting
Deanne E. Knapp by Manufacturers to the FDA
Charles Anello
Zollie A. Perry
Albert Weissman 607 Inferring Drug Efficacy Based on Data from One
Subject
Software Survey Section
Volume 25 Contents and Author Index