A New and Fast Drug Approval System in Europe Fernand Sauer OriginalPaper 30 December 1997 Pages: 1 - 6
The CDER Labeling and Nomenclature Committee: Structure, Function, and Process Daniel L. Boring OriginalPaper 30 December 1997 Pages: 7 - 11
Specialized Anti-HIV Testing: Expediting Preclinical Drug Development Robert W. Buckheit Jr. OriginalPaper 30 December 1997 Pages: 13 - 22
The United States Orphan Drug Act: Challenges and Success Marlene E. Haffner OriginalPaper 30 December 1997 Pages: 23 - 25
FDA Reform: Setting the Stage for Efforts to Reform the Agency Kenneth I. Kaitin OriginalPaper 30 December 1997 Pages: 27 - 33
Preparing for An FDA Advisory Committee Meeting Wayne L. PinesMary Ann N. Cotton OriginalPaper 30 December 1997 Pages: 35 - 41
The Global Registration of Zyprexa™ (Olanzapine) Sue T. WorthenJeffrey S. KasherJeffrey T. Ramsey OriginalPaper 30 December 1997 Pages: 49 - 55
An Index of United States Regulations Pertaining to Labeling of Prescription Drugs Charles F. Curran OriginalPaper 30 December 1997 Pages: 57 - 62
Clinical Trial Safety Surveillance in the New Regulatory and Harmonization Environment: Lessons Learned from the “Fialuridine Crisis” James Nickas OriginalPaper 30 December 1997 Pages: 63 - 70
Patient Compliance of Women Taking Estrogen Replacement Therapy Rayanne S. Berman OriginalPaper 30 December 1997 Pages: 71 - 83
How to Improve the Medical Quality of the Coding Reports Based on Who-Art and Costart Use Christian Fizames OriginalPaper 30 December 1997 Pages: 85 - 92
The Challenge of Managing Quality Control/Quality Assurance for Loosely Structured and Virtual Biopharmaceutical Companies John Geigert OriginalPaper 30 December 1997 Pages: 97 - 100
Orphan Drugs: The Current Situation in the United States, Europe, and Asia Abbey S. Meyers OriginalPaper 30 December 1997 Pages: 101 - 104
A Matrix Method for the Evaluation of Therapeutic Agents: A Framework Based on Disease Process-Oriented Mechanisms of Drug Action and Their Effectiveness Thorir D. Bjornsson OriginalPaper 30 December 1997 Pages: 105 - 110
Outsourcing Management in the Pharmaceutical Industry: The Early Stages at Four United States Companies Debbie A. DanielNanette Nanjo-JonesSue A. Stempien OriginalPaper 30 December 1997 Pages: 111 - 118
An Innovative Concept in Pharmaceutical Drug Development Rolf F. TiggemannHermann Sabel OriginalPaper 30 December 1997 Pages: 119 - 124
“Aboutness” and Other Problems of Text Retrieval in the Pharmaceutical Industry Robert Abbott OriginalPaper 30 December 1997 Pages: 125 - 135
Three Principles That Govern FDA Advertising and Promotion Regulation Wayne L. Pines OriginalPaper 30 December 1997 Pages: 137 - 142
Postapproval Changes in the United States—Is Life Getting Easier For Industry? Helened Umitriup OriginalPaper 30 December 1997 Pages: 143 - 149
Recent Changes in Clinical Trial Authorization in Eastern Europe Tamás L. Paál OriginalPaper 30 December 1997 Pages: 151 - 155
Accounting for Noncompliance in the Design of Clinical Trials Jeffrey M. Albert OriginalPaper 30 December 1997 Pages: 157 - 165
A Simple Three-Step Procedure for Parametric and Nonparametric Assessment of Bioequivalence Jouni VuorinenJari Turunen OriginalPaper 30 December 1997 Pages: 167 - 180
A Review of the European Community Regulatory Requirements for Expedited and Periodic ADR Reporting Barry D. C. Arnold OriginalPaper 30 December 1997 Pages: 181 - 186
FDA Inspection of Investigator Sites in Italy N. BrunettiM. RoncolatoS. Zancan OriginalPaper 30 December 1997 Pages: 187 - 191
Results of a Data Imaging Pilot Project Marie E. LawsonPhilip M. BrownLinda Shostak OriginalPaper 30 December 1997 Pages: 193 - 196
The Challenge of Auditing Clinical Laboratories Marian DesmetSheila N. Linder OriginalPaper 30 December 1997 Pages: 197 - 205
Appropriate Endpoints for Renal Transplantation Clinical Trials Claudio PonticelliMariarosaria Campise OriginalPaper 30 December 1997 Pages: 207 - 212
A Proactive Approach to Clinical Trial Material Preparation: The Manufacturing, Packaging, and Labeling Protocol Jan A. Ehrich OriginalPaper 30 December 1997 Pages: 213 - 220
General Medical Practitioners’ Approaches to Accessing Animate Sources of Drug Information David GerrettJ. C. Clark OriginalPaper 30 December 1997 Pages: 221 - 227
Bar Coding During Clinical Trials: A Feasibility Study Gerhard GroenewoudHans Karl Ludwig HundtPetrus John Bell OriginalPaper 30 December 1997 Pages: 229 - 235
An Integrated Approach to the Preparation of Global CMC Dossiers Peter C. KarltonDavid Johnston OriginalPaper 30 December 1997 Pages: 237 - 242
Validation of Clinical Laboratory Results: Discussion of Essential Validation Elements Jean-Claude Libeer OriginalPaper 30 December 1997 Pages: 243 - 250
Pricing and Reimbursement Issues in the European Economic Area Christopher J. S. Hodges OriginalPaper 30 December 1997 Pages: 251 - 258
Opportunities in Downsizing and Reengineering for the Quality Assurance Unit Allen F. Hirschp OriginalPaper 30 December 1997 Pages: 259 - 263
Guest Editor’s Note: First Annual Symposium on Curriculum Development in Osteoporosis Albert J. Giovenella OriginalPaper 30 December 1997 Pages: 265 - 267
Educating Young Women About Calcium Marybeth McMurray OriginalPaper 30 December 1997 Pages: 269 - 271
Fibrodysplasia Ossificans Progressiva (FOP): The Value of Studying a Rare Disorder Eileen M. ShoreFrederick S. Kaplan OriginalPaper 30 December 1997 Pages: 273 - 277
Curriculum Development: Training Primary Care Doctors to Diagnose and Treat Osteoporosis Steven E. Lipton OriginalPaper 30 December 1997 Pages: 279 - 286
A Model for Osteoporosis Education of Students and Health Professionals Alexandra PapaioannouJonathan D. AdachiTish Butson OriginalPaper 30 December 1997 Pages: 287 - 291
A Translational Approach to Education of Women on Bone Health Issues Susan M. Digiorgio-PollHazel DeanSusan F. Silverton OriginalPaper 30 December 1997 Pages: 293 - 294
Student Internships: Mutual Benefits in Osteoporosis Health Care and Research Albert J. GiovenellaSusan M. RepmannJohn A. Abruzzo OriginalPaper 30 December 1997 Pages: 295 - 300
Fears, Knowledge, and Perceptions Of Osteoporosis Among Women Allison R. MartinRichard HolmesEva Lydick OriginalPaper 30 December 1997 Pages: 301 - 306
Physical Rehabilitation of the Osteoporotic Patient Amy Fitzsimmons OriginalPaper 30 December 1997 Pages: 307 - 309
Development of a Human Growth and Osteoporosis Prevention Curriculum and Computer Program Lawrence S. SternJeanne C. HubaVelimir Matkovic OriginalPaper 30 December 1997 Pages: 311 - 317
