Table Of Content

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