Journal of Clinical Research and Drug Development Volume 7, Number 1, March 1993 Contents EDITORIAL To All Our Readers Gilles Cloutier 1 ORIGINAL ARTICLES Untangling a Safety Controversy: Pressor Effects of Phenylpropanolamine Frank R. Funderburk, John P. Morgan, Ann Summerfelt, and Linda L. Weinhold 3 Candida Vaginitis: Signs and Symptoms Aid Women’s Self-Recognition Robert J. Chaponis, Philip A. Bresnick, Robert R. Weiss, and Lionel D. Edwards 17 RESEARCH REPORT Reversal of Effects of Morphine by Nalmefene R. Nagarajan, S. Jeyashree, M. Shanmugam, V. Bala Subramanian, R. R. Tuttle, and R. W. Caldwell 25 EDUCATION AND TRAINING Lessons Learned From Coordinating a Pivotal Clinical Trial Dianne B. Johnston 31 ABSTRACTS ACP Spring 1992 Poster Abstracts 41 ANNOUNCEMENTS Meetings of Interest 57 PROGRAM ACP’s 17th Annual Meeting, San Francisco, California 59 Journal of Clinical Research and Drug Development Volume 7, Number 2, June 1993 Contents ORIGINAL ARTICLE Behavioral Evaluation of Drugs: A Comparison of the Behavioral Effects of Adinazolam and Lorazepam Frank R. Funderburk, Alisdair Mackenzie, Linda Felch, George E. Bigelow, Ira A. Liebson, and Roland R. Griffiths 65 EDUCATION AND TRAINING The PF (Pitfalls) of B (Brevity) Anne Papke 77 ACP Continuing Education Curriculums 87 ABSTRACTS ACP Spring 1993 Poster Abstracts 99 THE LIGHTER SIDE Phone Tag: The People’s Sport for the 90s David M. Cocchetto 121 BOOK REVIEW Presentation of Clinical Data, by B. Spilker and J. Schoenfelder John A. Lubina 123 ANNOUNCEMENTS Meetings of Interest 125 Journal of Clinical Research and Drug Development Volume 7, Number 3, September 1993 Contents SPECIAL SECTION The Impact of European Common Market Regulations on the World Pharmaceutical Industry Preface Chairs: James Parmentier, Adelbert Stagg, and James Swarbrick 127 Symposium Contributors 129 United States Trade Perspectives on European Community Developments Mary Saunders 130 Harmonization and Registration Procedures Within the E.C.: A European Perspective David Birtwistle 139 A Comparison of U.S. and E.C. Preclinical Requirements as Addressed at the First International Conference on Harmonization (ICH1) Patricia P. Edgar 147 FDA-EC Harmonization Effects in the Area of GMPs Nicholas Buhay 154 Impact of the E.C. Regulations on the World Pharmaceutical Industr—yA Japanese Perspective Margaret Martin 161 Round Table Summary Discussion David Cocchetto 174 COMMENTARY Peggy Berry 181 INTRODUCING MEDWatch A New Approach to Reporting Medication and Device Adverse Effects and Product Problems David A. Kessler for the Working Group 183 ANNOUNCEMENTS Meetings of Interest 191 Journal of Clinical Research and Drug Development Volume 7, Number 4, December 1993 Contents BIBLIOGRAPHY Quality of Life Bibliography and Indexes: 1992 Update Richard A. Berzon, George P. Simeon, Rolly L. Simpson, Jr., and Hugh H. Tilson 193 ORIGINAL ARTICLE A Paradigm for Interim Analyses in Controlled Clinical Trials Gregory G. Enas and Robert L. Zerbe 233 EDUCATION AND TRAINING The Role of the Coordinating Center Project Manager in a Multicenter Clinical Trial Susan Elizabeth Margiti¢é 243 ACKNOWLEDGEMENTS 1993 Reviewers 253 ANNOUNCEMENTS Meetings of Interest 255 INDICES Author 257 Subject 259 oF SYS OER agR AE GSES ASSERTA I Et”88 tr se — yas