Orphan Drug Programs/Policies in Australia, Japan, and Canada Drusilla L. ScottSusan AlderKarolyn Lui OriginalPaper 31 December 2001 Pages: 1 - 16
From Local Information Technology Support to a Global Information Management Organization in Pharmaceutical Research and Development Martin Wilhelm OriginalPaper 31 December 2001 Pages: 17 - 26
Good Clinical Practices (GCP) in Latin America: Prospects for Regional Harmonization: A Challenge for the Twenty-First Century Nanci BergamoVivian de TrespalaciosEric Vander Elst OriginalPaper 31 December 2001 Pages: 27 - 34
Enhancing Electronic Communications between Team Members by Establishing Best Practices: A Communications Specialist’s Perspective Thomas J. Purcell OriginalPaper 31 December 2001 Pages: 35 - 40
The Impact of Technological Advances on Drug Discovery Today Esther F. SchmidKeith JamesDennis A. Smith OriginalPaper 31 December 2001 Pages: 41 - 45
Cardiac Positron Emission Tomography (PET) for Beginners Briton Shell OriginalPaper 31 December 2001 Pages: 47 - 60
Planning for a Successful Safety Data Conversion Janet SteinerChristina CauterucciAlan R. Muirhead OriginalPaper 31 December 2001 Pages: 61 - 69
Fast Track Product Designation under the Food and Drug Administration Modernization Act: The Industry Experience Christopher-Paul MilneElaine Bergman OriginalPaper 31 December 2001 Pages: 71 - 83
The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines Janice M. ReichertJennifer CheeClaire S. Kotzampaltiris OriginalPaper 31 December 2001 Pages: 85 - 94
Migrating, Archiving, and Reconstructing Electronic Records in a Regulatory Environment Tammala D. Woodrum OriginalPaper 31 December 2001 Pages: 95 - 98
Preclinical Considerations For Regulatory Submissions Paul Baldrick OriginalPaper 31 December 2001 Pages: 99 - 105
Electronic Issues for IRBS: Administrative And Regulatory Matthew D. WhalenRebecca KushFelix A. Khin-Maung-Gyi OriginalPaper 31 December 2001 Pages: 107 - 113
The Role of an Independent Statistical Analysis Center in the Institutes of Health Model Marian R. FisherEllen B. RoeckerDavid L. DeMets OriginalPaper 31 December 2001 Pages: 115 - 129
Model-Based Drug Evaluation in Chronic Disease: Promise, Pitfalls, and Positioning A. David Paltiel OriginalPaper 31 December 2001 Pages: 131 - 139
Testing for Superiority or Inferiority after Concluding Equivalence? Christy Chuang-Stein OriginalPaper 31 December 2001 Pages: 141 - 143
A Baseline Covariate Adjusted Chi-Square Test for Binary and Categorical Data Bernard Sebastien OriginalPaper 31 December 2001 Pages: 145 - 151
Some Issues Concerning the Normalization of Laboratory Data Based on Reference Ranges Christy Chuang-Stein OriginalPaper 31 December 2001 Pages: 153 - 156
Descriptive Analysis of the Drug Name Lexicon Bruce L. LambertKen-Yu ChangSwu-Jane Lin OriginalPaper 31 December 2001 Pages: 163 - 172
Health Outcomes Data Gathering in Clinical Trials: Economic and Humanistic Assessments Josephine M. WongShilpa S. Mehta OriginalPaper 31 December 2001 Pages: 173 - 179
The Establishment of the National Institute for Clinical Excellence: Its Importance and Implications for the Pharmaceutical Industry Peter Littlejohns OriginalPaper 31 December 2001 Pages: 181 - 188
Guidelines for Economic Evaluations in Italy: Recommendations from The Italian Group of Pharmacoeconomic Studies Stefano CapriAdriana CeciThe Members of the Italian Group for Pharmacoeconomic Studies OriginalPaper 31 December 2001 Pages: 189 - 201
Changes in Clinical Trial Practice and The Working Environment in The Korean Pharmaceutical Industry Since The Implementation of Good Clinical Practice Howard LeeCharles J. KimSang-Goo Shin OriginalPaper 31 December 2001 Pages: 203 - 210
Prevention of Medication Errors Through Labeling and Packaging Elements—The Program at Bristol-Myers Squibb Cathleen O’ConnellEvan Korzin OriginalPaper 31 December 2001 Pages: 211 - 217
Planning for Variations in Level of Inquiries Received by Drug Information Departments Charles F. Curran OriginalPaper 31 December 2001 Pages: 219 - 224
Making Markets and the Global Medical Information Imperative: The Heat is On! Robert J. HoltPaul W. FinneganJohn C. Alexander OriginalPaper 31 December 2001 Pages: 225 - 230
Criteria to Request Pharmacoeconomic Data and Data Sources for Hospital Formulary Decisions Vithaya KulsomboonFrancis B. PalumboC. Daniel Mullins OriginalPaper 31 December 2001 Pages: 231 - 240
Something for Nothing in Noninferiority/Superiority Testing: A Caution Brian L. Wiens OriginalPaper 31 December 2001 Pages: 241 - 245
Training Medical Writers in Today’s Environment 1: The Integrated Medical Writer Virginia Watson OriginalPaper 31 December 2001 Pages: 247 - 251
Training Medical Writers In Today’s Environment 2: Competencies as a Tool to Assess Medical Writers Jean Soul-Lawton OriginalPaper 31 December 2001 Pages: 253 - 257
Training Medical Writers in Today’S Environment 3: How to Please a Medical Writer Paul WoolleyWalther Seiler OriginalPaper 31 December 2001 Pages: 259 - 268
Is that Adverse Experience Really Expected? Guidelines for Interpreting and Formatting Adverse Experience Information in the United States Kristina BrownR. Scott SykesGeorge Phillips OriginalPaper 31 December 2001 Pages: 269 - 284
Safety Evaluation for New Drug Approval in Korea Young-Ok KimKwang-Won HaKwang-Sik Choi OriginalPaper 31 December 2001 Pages: 285 - 291
Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999 Man FungAnna ThorntonEdmundo Muniz OriginalPaper 31 December 2001 Pages: 293 - 317
