Guest Editor’s Note: Special Series on Global Drug Development Issues Kenneth I. Kaitin EditorialNotes 31 December 2001 Pages: 319 - 319
Preclinical Testing Strategies Klaus OlejniczakPeter GünzelRolf Bass OriginalPaper 31 December 2001 Pages: 321 - 336
Clinical Development of Therapeutic Medicines: A Biopharmaceutical Versus Pharmaceutical Product Comparison Janice M. Reichert OriginalPaper 31 December 2001 Pages: 337 - 346
A Review and Analysis of Key Regulations and Guidelines Concerning the Safety Sections of the Investigator’s Brochure Stephen L. KlincewiczJohn A. ClarkNorman D. LaFrance ReviewPaper 31 December 2001 Pages: 347 - 355
Main Deficiencies Concerning the European Marketing Authorization: Part II Yvonne Legras OriginalPaper 31 December 2001 Pages: 357 - 367
International Conference on Harmonization-Keeping International Drug Development in Harmony? Craig McCarthy OriginalPaper 31 December 2001 Pages: 369 - 376
Recent Advancements in the Analysis and Presentation of Safety Data Christy Chuang-SteinVu LeWilliam Chen OriginalPaper 31 December 2001 Pages: 377 - 397
Internal Pilot Studies for Determining the Sample Size without Unblinding Dietmar ZellnerGünter E. ZellnerFrieder Keller OriginalPaper 31 December 2001 Pages: 399 - 405
A Permutation Test for Nonindependent Matched Pair Data Seung-Ho KangHyung W. KimChul W. Ahn OriginalPaper 31 December 2001 Pages: 407 - 411
How to Assess Simple Screening Strategies Dhammika Amaratunga OriginalPaper 31 December 2001 Pages: 413 - 418
The Practical Use of Different Strategies to Handle Dropout in Longitudinal Studies Geert VerbekeEmmanuel LesaffreBart Spiessens OriginalPaper 31 December 2001 Pages: 419 - 434
Statistical Methods for Comparison to Placebo in Active-Control Trials Vic HasselbladDavid F. Kong OriginalPaper 31 December 2001 Pages: 435 - 449
Emerging Roles of Project Management in Clinical Research Organizations Olalekan E. OdeleyeMilan KovacevicCarl R. Torchio OriginalPaper 31 December 2001 Pages: 451 - 460
Introducing a System for the Assessment of Quality, Safety, and Efficacy of Herbal Medicinal Products in the Netherlands Willem K. ScholtenS. Bart A. Halkes OriginalPaper 31 December 2001 Pages: 461 - 468
System Audit of a Megatrial Kristel Van de VoordeKarin Reygaert OriginalPaper 31 December 2001 Pages: 469 - 473
The Contract Research Organization Perspective: Audits in Central and Eastern European Countries Harold Neal OriginalPaper 31 December 2001 Pages: 475 - 480
Dutch Measures to Control Medical Grade Marijuana: Facilitating Clinical Trials Willem K. Scholten OriginalPaper 31 December 2001 Pages: 481 - 484
Some Best Practices for Supplying Clinical Drug Products Internationally Charles F. Carney OriginalPaper 31 December 2001 Pages: 485 - 491
Critical Changes in Clinical Trials in Japan Shuichi IchikawaMasatake Tamaki OriginalPaper 31 December 2001 Pages: 493 - 495
A Digital Network for Clinical Trials Involving Multiple Private Clinics in Japan Aizan HiraiYoshimi ItoToshio Ito OriginalPaper 31 December 2001 Pages: 497 - 500
Should Global Clinical Studies be Conducted Under the United States Investigational New Drug Application? Thomas J. KirschGraham Burton OriginalPaper 31 December 2001 Pages: 501 - 508
The “Pharmacokinetics” of Patient Communications Louis A. MorrisKathryn J. Aikin OriginalPaper 31 December 2001 Pages: 509 - 527
Issues in the Regulation of Dietary Supplements Quinton BryanLaura K. ColemanThomas Copmann OriginalPaper 31 December 2001 Pages: 529 - 538
Sources of Drug Information Available to Consumers Charles F. CurranKathleen E. Oh OriginalPaper 31 December 2001 Pages: 539 - 546
The Emerging Role of Medical Affairs within the Modern Pharmaceutical Company Maurice J. WolinPriscilla M. AyersElaine K. Chan OriginalPaper 31 December 2001 Pages: 547 - 555
Distribution of Off-Label Information By Pharmaceutical Manufacturers? Meryl Weiss RobinsonBarry GrobmanDavid Graves OriginalPaper 31 December 2001 Pages: 557 - 560
Development and Implementation of Drug Information Web Site for Health Care Professionals Andrew M. KennedyRobert P. BakerKaren H. Song OriginalPaper 31 December 2001 Pages: 561 - 568
Pharmacy Benefit Managers and Medicare Beneficiary Access to Prescription Drugs Joshua CohenJennifer Chee OriginalPaper 31 December 2001 Pages: 569 - 576
Evaluation of Diagnostic Tests: Measuring Degree of Agreement and Beyond T. S. Weng OriginalPaper 31 December 2001 Pages: 577 - 588
Outlook for the Development of Fixed Combination Antihypertensive Agents in Japan Masao Ishii OriginalPaper 31 December 2001 Pages: 589 - 598
Similarities and Differences between the United States and Europe in the Development of Fixed Combination Products for the Treatment of Hypertension John AlexanderKurt Püchler OriginalPaper 31 December 2001 Pages: 599 - 605
Managing Medical Manager Meetings in Europe Ivor CowlrickManfred Bauleser OriginalPaper 31 December 2001 Pages: 607 - 610
Pharmaceutical Starting Materials: Safe Trade Pieter H. Vree OriginalPaper 31 December 2001 Pages: 611 - 616
Considerations in Animal-Based Preclinical Safety Testing: The United Kingdom Perspective Jon Richmond OriginalPaper 31 December 2001 Pages: 617 - 621
Evaluation of Indian Traditional Medicine Pulok K. Mukherjee OriginalPaper 31 December 2001 Pages: 623 - 632
The Primrose Path—Errors in Prescribing and Giving Medicines Robin Esmond Ferner OriginalPaper 31 December 2001 Pages: 633 - 638
