Table Of Content

Drug Information Journal, Vol. 26, pp. VII-XVI, 1992 0092-8615/92 $5.00 + .00 Printed in the USA. All rights reserved. Copyright © 1992 Drug Information Association Inc. Contents Volume 26, 1992 Volume 26, Number 1 January — March, 1992 CONTENTS Arnold J. Gordon Worldwide Regulations for Manufacturers on Robert J. Petrick Clinical Safety Surveillance of Drugs Phn Nelly Baudrihaye Events and Milestones on the Road to 1992: A View from 1990 Mark Moran Clinical Studies and the Price of Information Thomas E. Bradstreet et al A Statistics Appreciation Course for Clinical Research Personnel Sheila R. Shulman A Survey of Therapeutic Substitution Programs in Patricia A. Dicerbo Ten Boston Area Hospitals Marianne E. Ulcickas Louis Lasagna Gerard W. Wood Strategic Planning in the US Pharmaceutical Ashok K. Gumbhir Industry: An Introduction Johnny L. Anderson Shelly C. Anderson Gerard W. Wood Strategic Planning in the US Pharmaceutical Ashok K. Gumbhir Industry: A National Study Johnny L. Anderson Shelly C. Anderson Christy Chuang-Stein Summarizing Laboratory Data with Different Reference Ranges in Multi-Center Clinical Trials Linda Compton Current Ethical Issues Surrounding Animal Cathy Taylor Research Charles F. Curran Investigational Adverse Reaction Monitoring in a Osman Bawa Multinational Pharmaceutical Corporation Jerry D. Fry Creation and Implementation of a Computer Robert T. Drew Validation Program VIT Drug Information Journal Ping-Hwa Hsu A Method for Identifying Adverse Events Related to Andre G. Pernet New Drug Treatment J. Carl Craft Michael J. Hurley Mark E. Sale Incorporating Pharmacokinetic/ Pharmacodynamic Terrence F. Blaschke Modeling in Drug Development — Are We Ready? Frances O. Kelsey Good Clinical Practices in the US: Impact of European Guidelines Software Survey Section: “Results Master” Volume 26, Number 2 April— June, 1992 CONTENTS Judi Weissinger 133 Carcinogenicity Testing of Therapeutics Stuart L. Nightingale 141 Unlabeled Uses of Approved Drugs Rhonda B. Friedman 149 Rx to OTC Conversions: The Role of Epidemiology Kristina L. Baum Carol Brignoli Gable Gary L. Yingling The Impact of Regulatory Issues in Contract Negotiations Gerald F. Meyer The Food and Drug Administration Perspective on the Importance of Dialogue with Industry Robert Corak Removing the Mystique Surrounding Optical Disk Technology David M. Cocchetto Qualifications of Investigators for Clinical Jon R. Wallace Investigations Conducted Under an IND: A Discussion Paper Robert J. Petrick The Pfizer International Medical Management John M. Pakulski System (PIMMS): Tracking Worldwide Registration Kathleen Johnson and Commercialized Products John L. Hakes Rayanne S. Berman Format and Content of a Statistical Data Item J. K. Haseman Value of Historical Controls in the Interpretation of Rodent Tumor Data Mark Moran The Measurement of Efficiency in Clinical Research Suzanne Boots and Development Nina Resnick Carl Wallemark Harold Neal Conduct of Investigator Site Audits in Europe by Clinical Quality Assurance Personnel Elizabeth A. Chrischilles The Contribution of Epidemiology to Pharmaco- economic Research David M. Benjamin When Is a Drug Not a Drug? The L-Tryptophan Tragedy: Lessons to Be Learned Ji M. Koo North Dakota Pharmacists’ Need for Drug Informa- Donald R. Miller tion: 1990 vs 1980 Mark E. Lacy The Systems Approach as a Paradigm for Pharma- ceutical Research: A Proposal Loren L. Miller Pitfalls in the Drug Approval Process: Dose-Effect, Experimental Design, and Risk Benefit Issues Michael R. Toscani Postmarketing Studies: Methods for Implementa- Gene Resnik tion and Potential Use of Data Claude Ameline Opening Remarks — Clinical Trial Supplies Paul Blattmann Patient Product Information (PPI) — Elements for a Rational Approach Thomas H. Althuis A Therapeutic and Economic Comparison of the Top Innovative New Drugs of the 1970s and 1980s Kevin Darryl White Training and Developing of Clinical Research Per- David M. Cocchetto sonnel Through the Glaxo Professional Develop- ment Program Mark Moran The Relationship of Changes in the Headcount to Go/No Go Decisions Software Survey Section Volume 26, Number 3 July —September, 1992 CONTENTS Kenneth M. Given 311 Value the US Pharmaceutical Industry Places on Early Dialogue in the Drug Development Process Drug Information Journal Henry B. Alsobrook, Jr. An Overview of Liability for OTC Drugs Peter P. Lamy Heightened Need for Information Exchange in Geriatrics Noriaki Murao Regulatory Requirements and Practices for Clinical Studies in Japan Kenneth I. Kaitin Are Initiatives to Speed the New Drug Approval Helen L. Walsh Process Working? Albert Weissman Two Demographic Dichotomies: “Black vs White,” “Left vs Right” Gerald Hajian The Whys and Wherefores of Statistics in Carcinogenicity Testing Iain J. McGilveray Bioavailability Testing of Medicinal Products and Harmonization of International Testing Requirements and Standards: The Canadian Perspective Dirk Suwelack Practical Issues in Design and Management of Thomas R. Weihrauch Multinational Trials R. Desgouilles A Quantified Internal Audit System Allowing J. M. Auger Quality Rating of Clinical Research B. Tisserand L. Stéru Alan Bergelson Clinical Packaging: Adhesives and Inks James L. Wilder The Strategic Approach to Imaging Alain Spriet Good Biometric Practice Proposals for a Set of Thérése Dupin-Spriet Procedures Kevin C. Farmer A Historical Perspective of Mergers in the US Ashok K. Gumbhir Pharmaceutical Industry Barbara A. Edge Padbury When Murphy’s Law Runs Rampant Martin W. Edwards Logistics-Based Approaches to Reducing Clinical Stig Jorgenson Development Times Ivan Jensen Lauren D. Harrison Reducing Barriers to the Utilization of Literature at Leocadio V. Lacerna Hoffmann-La Roche L. F. Chasseaud The Importance of Pharmacokinetic/Toxicokinetic and Metabolic Information in Carcinogenicity Study Design Gustavo Acosta 457 NDA Day Strategy and Success for ICI Nanette E. Holston Pharmaceuticals Group’s DIPRIVAN® (Propofol) Karl E. Peace 463 The Impact of Investigator Heterogeneity in Clinical Trials on Detecting Treatment Differences Software Survey Section Volume 26, Number 4 October — December, 1992 CONTENTS Managing Adverse Drug Experience Information Raymond L. Herman 471 Guest Editor’s Note Christian Bénichou 473 EEC Pharmacovigilance and the Pharmaceutical Gaby Danan Industry: Common Market, Common Rules? I. Ralph Edwards The WHO Database —I I. Ralph Edwards The WHO Database — II Marie Lindquist James P. Hickey An Expert System for Prediction of Chemical Andrew J. Aldridge IV Toxicity Dora R. Passino-Reader Anthony M. Frank Steven S. Rinsler Predicting Anaphylactoid Reactions Based on Richard A. Stein COSTART Terms John A. Harter Michael E. Mabry Computer-Aided Assessment of the Adverse Effects of Antiepileptic Drugs Max W. Talbott Clinical Trial Adverse Drug Experience Reporting Ellen Kelso Requirements in the Major Countries and a Simplified Approach Toward Meeting These Requirements George Phillips The Glaxo International Postmarketing Surveillance System: Present and Future Elizabeth J. Klinger ARMOR: ICI’s Automated Tracking System for Joel A. Riloff Adverse Events from Clinical Trials Raymond L. Herman Gustavo Acosta Drug Information Journal Judith A. Sromovsky WAES* Net — Merck’s International AE Reporting System Fred Schneiweiss Issues with Causality Assessment: A Personal Perspective Joyce M. Johnson Reasonable Possibility: Causality and Postmarket- ing Surveillance Leroy C. Knodel Did My Drug Cause This? An Academic Perspective Mark S. Von Tress Did My Drug Cause This? A Biostatistical Perspective Arnold J. Gordon An Industry Perspective on the State of Confusion in International ADR Reporting: Current Require- ments and Attempts at Standardization Ronald D. Mann Managing Adverse Reaction Information Christian Bénichou Causality Assessment in the European Pharmaceuti- Gaby Danan cal Industry: Presentation of the Preliminary Results of a New Method Claudio A. Naranjo A Consultant’s View on the Role of Bayesian Differ- Krista L. Lanctét ential Diagnosis in the Safety Assessment of Pharmaceuticals Jan Venulet The Pharmaceutical Industry on the Continent —A 10-Year Perspective Since Morges Additional Articles of Significant Interest David B. Jefferys 609 Good Clinical Practice: EC Expectations Educa- tion, Self-Regulation, or Imposition? Giovanni B. Cassano The Italian Multicenter Trial on Prevention and Cristina Borghi Treatment of Benzodiazepine Withdrawal: Method- Alberto Petracca ology and Pretrial Bruno M. Cesana Martine Garreau Ermanno Buratti Paolo L. Morselli Per Helboe New Designs for Stability Testing Programs: Matrix or Factorial Designs. Authorities’ Viewpoint on the Predictive Value of Such Studies Jirgen Drews Strategies for Successfully Managing Pharmaceuti- cal Research and Development in the 1990s Thomas J. Hoerger 647 Market Failure, Information Imperfections, and Cost-Effectiveness Analysis C. A. Teijgeler 655 The Passport to Drug Approval Ronald Carlisle Hudson 659 Data Management Team-Driven Approach to Han- dling International Clinical Data Software Survey Section: “Predictor: Laboratory Management System” Volume 26 Contents and Author Index