From the Editor-in-Chief: “Regulatory Reform at a Crossroads” Kenneth I. Kaitin EditorialNotes 31 December 2002 Pages: 245 - 246
Guest Editor’s Note: Regulatory Affairs Thomas L. Copmann EditorialNotes 31 December 2002 Pages: 247 - 248
Ethical Concerns in Placebo-Controlled Studies: An Analytical Approach Nora CavazosD. ForsterA. J. Bowen OriginalPaper 31 December 2002 Pages: 249 - 259
A Review of Current Events in Human Subjects Protection Laura ColemanStacy Holdsworth ReviewPaper 31 December 2002 Pages: 261 - 267
Analysis of The QT Interval in Clinical Trials Alex DmitrienkoBrian P. Smith OriginalPaper 31 December 2002 Pages: 269 - 279
Which Factors Shape and Limit the Role of the Center for Drug Evaluation and Research’s Advisory Committees? Sara SchulmanMary K. OlsonRobert W. Makuch OriginalPaper 31 December 2002 Pages: 281 - 289
The Single Controlled Trial: Industry Survey Indicates that Implementation is Still a Work in Progress Christopher-Paul Milne OriginalPaper 31 December 2002 Pages: 291 - 302
Evaluation of Published Case Reports’ Standards and Notification Jeffrey A. FergusonCollen MockbeeEdmundo Muniz OriginalPaper 31 December 2002 Pages: 303 - 307
Prescription-to-over-the-Counter Switch Criteria R. William Soller OriginalPaper 31 December 2002 Pages: 309 - 317
505(b)(2) Applications: History, Science, and Experience Gordon JohnstonRoger L. Williams OriginalPaper 31 December 2002 Pages: 319 - 323
Managing a Crisis Effectively: A Blueprint for Pharmaceutical Companies Jennifer L. StotkaMary Alice Miller OriginalPaper 31 December 2002 Pages: 325 - 331
The United States Food and Drug Administration’s Risk Management Framework Gina SteidleShawn E. Hodges OriginalPaper 31 December 2002 Pages: 333 - 341
Aggregate Analysis of the Export Petition and Waiver Process: A Pharmaceutical Industry Perspective Travis S. FisherThomas L. Copmann OriginalPaper 31 December 2002 Pages: 343 - 348
Bridging Data between Two Ethnic Populations. A New Application of Matched Case-Control Methodology Somnath SarkarSteven WattsChuck Rivera OriginalPaper 31 December 2002 Pages: 349 - 356
A Database Quality Review Process with Interim Checks Rocco BrunelleRobert Kleyle OriginalPaper 31 December 2002 Pages: 357 - 367
Standard Operating Procedures for Clinical Research Coordinators Ruth Ann Fries OriginalPaper 31 December 2002 Pages: 369 - 377
Comparison of Additional Regulatory Requirements for Conducting Clinical Trials on Genetically-Modified Microorganisms and Recombinant DNA in Europe, the United States, and Canada King C. Lee OriginalPaper 31 December 2002 Pages: 379 - 386
Clinical Trials: Focus on Italy Walter BianchiPia FurlaniLuisella Majori OriginalPaper 31 December 2002 Pages: 387 - 394
A Nonparametric Method for Combining Multilaboratory Data Jie HuangRocco Brunelle OriginalPaper 31 December 2002 Pages: 395 - 406
Japanese Perspectives on Pharmaceutical Product Release Rate Testing Nahoko Kaniwa OriginalPaper 31 December 2002 Pages: 407 - 415
Assessment of the Immunotoxic Potential of Human Pharmaceuticals: A Workshop Report Esther PutmanHenk van LoverenJan-Willem Van Der Laan OriginalPaper 31 December 2002 Pages: 417 - 427
Taking the Package Insert into the Electronic Age Neil V. SmithKathryn E. Ramseyer OriginalPaper 31 December 2002 Pages: 429 - 434
Deceptive Inquiries Made to Drug Information Departments Charles F. Curran OriginalPaper 31 December 2002 Pages: 435 - 438
Adverse Event Reporting and Standardized Medical Terminologies: Strengths and Limitations Stephen A. Goldman OriginalPaper 31 December 2002 Pages: 439 - 444
Are Commercial Disease Managers Willing and Prepared to Enter the Medicare Market? Joshua Cohen OriginalPaper 31 December 2002 Pages: 445 - 452
Pricing Policies in the Pharmaceutical Sector Stefano CapriRosella Levaggi OriginalPaper 31 December 2002 Pages: 453 - 464
Will Data Privacy Impact Health Research? Lisbeth Ehlert KnudsenMette Due TheiladeRudolf Bruppacher OriginalPaper 31 December 2002 Pages: 465 - 480
