Journal of Clinical Research and Drug Development 1991: Vol 5 Table of Contents PDF
Preview Journal of Clinical Research and Drug Development 1991: Vol 5 Table of Contents
Journal of Clinical Research and Pharmacoepidemiology Volume 5, Number 1, March 1991 Contents ORIGINAL ARTICLES Preparation, Packaging, and Labeling of Investigational Drug Supplies: Part I: Preparation of Investigational Drug Supplies David F. Bernstein and Frank J. Tiano 1 Linked Databases (LDs) and Epidemiology Karin B. Michels and Gerald A. Faich 11 Development of Supplemental Indications for Already-Approved Drugs by the United States Pharmaceutical Industry Joseph A. DiMasi and Louis Lasagna 19 Patient Recruitment and Enrollment into Clinical Trials: A Discussion of Specific Methods and Disease States James M. Swinehart 35 Laboratory Charges Associated with Achieving Serum Theophylline Concentrations of 10-20 ug/ml in Patients Entering Two Double-Blind Multicenter Clinical Trials J. Gregory Boyer, David M. Cocchetto, and Cristina Pilati 49 COMMENTARY Commentary on: Laboratory Charges Associated with Achieving Serum Theophylline Concentrations of 10—20 ug/ml in Patients Entering Two Double-Blind Multicenter Trials, by J. G. Boyer, D. M. Cocchetto, and C. Pilati Commentary by R. Scott Sykes 5S Commentary by R. G. McAllister 61 ABSTRACTS ACP Spring 1991 Poster Abstracts 63 BOOK REVIEW Handbook of Clinical Drug Research, Edited by Helen Glenny and Philip Nelmes Gary C. Magistrelli 77 ANNOUNCEMENTS Meetings of Interest 79 Journal of Clinical Research and Pharmacoepidemiology Volume 5, Number 2, June 1991 Contents SPECIAL SECTION The Clinical Trial in Canada, the U.S., and Nordic and EEC Countries. Part I: Ethical Aspects in Clinical Trials Chair: David J. Roy 81 Contents to Symposium 83 Preface Robert Goyer 85 Notes on Contributors 87 Basic Ethical Considerations in Clinical Trials and Their Rationale: The Canadian Perspective David J. Roy 89 The U.S. Perspective Robert J. Levine 99 The EEC and Nordic Countries’ Perspective Eigill F. Hvidberg 105 The Patient as the Ethical Reconciliating Cornerstone Between Investigators, Regulators, and the Pharmaceutical Industry: An Introduction to the Round Table Discussion Arthur H. Hayes 11% Toward a Universal Standard Code of Ethics? A Round Table Discussion 115 ORIGINAL ARTICLE Pharmacoepidemiology Continues Healthy Growth Stanley A. Edlavitch 125 ABSTRACTS Abstracts: 7th International Conference on Pharmacoepidemiology 131 ANNOUNCEMENTS Meetings of Interest 197 Journal of Clinical Research and Pharmacoepidemiology Volume 5, Number 3, September 1991 Contents SPECIAL SECTION The Clinical Trial in Canada, the U.S., and Nordic and EEC Countries Part II: Undertaking the Clinical Trial Chair: Stuart J. MacLeod 199 Contents to Symposium 201 Introduction Stuart J. MacLeod 203 Notes on Contributors 205 The U.K. Versus the U.S. Perspective John §. Patterson 207 The European Perspective Yves Champey 213 The Canadian Versus the U.S. Perspective Richard O. Davies 221 Must the FDA Guidelines Be the Golden Rules for a Universally Standardized Patient?: An Introduction to the Round Table Discussion Arthur H. Hayes 227 A Universal Clinical Procedure: A Utopia? A Round Table Discussion 231 ORIGINAL ARTICLES Geriatrics: Clinical Trials in an Aging Population Neal R. Cutler, John J. Sramek, and P.K. Narang 241 The Influence of Prior Prescription of H, Blockers on the Use of NSAIDs Alexander M. Walker, Lee L. Lanza, Nathan J. Schultz, Douglas Gause, MaryGrace Brickley, and Edward A. Bortnichak 255 Some Methodological Problems in Analyzing Quality of Life Data in Severe Congestive Heart Failure Patients Ingela Wiklund and Kary Swedburg 265 TECHNICAL NOTE Misrepresentation of a Patient’s Heart Rate and EKG Configuration by a Computer Assisted Monitoring System Mark Younger 275 ANNOUNCEMENTS Meetings of Interest 279 Journal of Clinical Research and Pharmacoepidemiology Volume 5, Number 4, December 1991 Contents EDITORIAL Proceedings from Selected Scientific Sessions at the Annual Meeting of the Associates of Clinical Pharmacology, Montreal, Quebec, May 1990 281 PROCEEDINGS Regulatory Audits at Study Sites in the United States, Canada, and Abroad 283 A Sponsor’s Perspective on Regulatory Audits of Clinical Investigators Thomas Ott 285 An Investigator’s Perspective on Regulatory Audits of Clinical Investigations Becky Deatherage 291 AIDS: Therapeutic and Educational Approaches Donna Mildvan 295 Update on Epilepsy 305 Update on Epilepsy: Diagnosis Braxton B. Wannamaker 307 Update on Epilepsy: Approaches to Prediction of Idiosyncratic Reactions to Anti-epileptic Drugs Charles E. Pippenger 313 Update on Epilepsy: Advances and Future Directions Miles Drake 319 Update on Epilepsy: Psychosocial Issues Patricia Ann Gibson 323 ORIGINAL ARTICLES Method of Examining Oral Acyclovir Use for Adverse Events Richard E. Johnson, John P. Mullooly, Barbara G. Valanis, Bentson H. McFarland, Elizabeth B. Andrews, and Hugh H. Tilson 331 The Role of the Staff Nurse in Clinical Drug Trials: A Descriptive Study Johnny A. Stanfield and Jolene M. Simon 347 ANNOUNCEMENTS Meetings of Interest 359 ACKNOWLEDGEMENTS 360 AUTHOR INDEX TO VOLUME 5 361 SUBJECT INDEX TO VOLUME 5 363 TABLE OF CONTENTS TO VOLUME 5
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