Guest Editor’s Note: Aids Drug Development: Shifting the Regulatory Paradigm Lynn Smiley EditorialNotes 30 December 1999 Pages: 335 - 335
FDA approval of Antiretroviral Agents: An Evolving Paradigm Rachel E. Behrman OriginalPaper 30 December 1999 Pages: 337 - 341
Changes to the European Regulatory Guidelines for the Approval of Antiretroviral Agents Kjell E. Strandberg OriginalPaper 30 December 1999 Pages: 343 - 345
Use of Surrogate Versus Clinical Markers in Trials for HIV Infection Scott Hammer OriginalPaper 30 December 1999 Pages: 347 - 352
Designing Global Development Programs Jeffrey Chodakewitz OriginalPaper 30 December 1999 Pages: 353 - 356
The Evolving Paradigm for Clinical Development and Regulatory Approval of Antiretroviral Drugs in the United States David M. CocchettoLynn Smiley OriginalPaper 30 December 1999 Pages: 357 - 372
Guest Editor’s Note: Pediatric Drug Development: Successes and New Solutions Gregory L. Kearns EditorialNotes 30 December 1999 Pages: 373 - 374
Questions and Answers on Labeling of Drugs for Children John T. Wilson OriginalPaper 30 December 1999 Pages: 375 - 383
The Pediatric Pharmacology Research Unit Network of the National Institute of Child Health and Human Development Duane Alexander OriginalPaper 30 December 1999 Pages: 385 - 391
Pediatric Drug Formulations: A Rate-Limiting Step Milap C. Nahata OriginalPaper 30 December 1999 Pages: 393 - 396
De Novo Pediatric Development of an Antiviral Drug Product: A Perspective from Industry Jon M. Rogers OriginalPaper 30 December 1999 Pages: 397 - 405
Qualified Statisticians in the European Pharmaceutical Industry: Report of a European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) Working Group EFSPI Working Group OriginalPaper 30 December 1999 Pages: 407 - 415
Sequential Designs for Monitoring Two Endpoints in a Clinical Trial Susan Todd OriginalPaper 30 December 1999 Pages: 417 - 426
Guidelines for Assessing the Performance of Statisticians Involved in Clinical Research in the Pharmaceutical Industry Alan Phillips OriginalPaper 30 December 1999 Pages: 427 - 433
Individual Bioequivalence—A Review of the FDA Draft Guidance Shein-Chung Chow OriginalPaper 30 December 1999 Pages: 435 - 444
What Does It Mean?: Anchoring Psychosocial Quality of Life Scale Score Changes with Reference to Concurrent Changes in Reported Symptom Distress Richard B. Anderson OriginalPaper 30 December 1999 Pages: 445 - 453
Exact Comparisons of Means and Within-Subject Variances in 2 × 2 Crossover Trials Olivier Guilbaud OriginalPaper 30 December 1999 Pages: 455 - 469
The Evaluation of Multiple Clinical Endpoints, with Application to Asthma Markus NeuhäuserVolker W. SteinijansFrank Bretz OriginalPaper 30 December 1999 Pages: 471 - 477
Group Sequential Monitoring of Multi-Armed Clinical Trials Nancy L. GellerMichael A. ProschanDean A. Follmann OriginalPaper 30 December 1999 Pages: 479 - 486
American and Japanese Drug Distribution and Information Systems in 1994 and a Proposed System for Improved Pharmaceutical Care Eiichi AkahoHowell I. RunionKaoru Inoue OriginalPaper 30 December 1999 Pages: 487 - 508
An Ethical Basis to Advertising Medicines Asunción Alvarez OriginalPaper 30 December 1999 Pages: 509 - 514
Globalizing Medical Information Services at Eli Lilly and Company Jennifer L. RigginsKevin J. FergusonElaine Gorham OriginalPaper 30 December 1999 Pages: 515 - 524
Hoffmann-La Roche Ltd. Drug Information & Safety Department Survey of Customer Needs and Satisfaction Patricia Rawn OriginalPaper 30 December 1999 Pages: 525 - 539
Pharmaceutical Recalls: Strategies for Minimizing the Damage Bruce R. ParkerJ. Gregory Lahr OriginalPaper 30 December 1999 Pages: 541 - 556
Using the Readability Assessment Instrument to Evaluate Patient Medication Leaflets Mary Ann F. KirkpatrickCherri P. Mohler OriginalPaper 30 December 1999 Pages: 557 - 563
Orphan Drugs: The United States Experience Marlene E. Haffner OriginalPaper 30 December 1999 Pages: 565 - 568
Quality of Life Evaluation in Chronic Lichen Sclerosus for Improved Medical Care Rukmini RajagopalanRoger T. AndersonLibby Edwards OriginalPaper 30 December 1999 Pages: 577 - 584
Proceedings of the 34th Dia Annual Meeting: “Thinking Globally: Product Development, Registration, and Marketing in the New Millennium,” June 7–11, 1998, Boston, Massachusetts Françoise de Crémiers OriginalPaper 30 December 1999 Pages: 585 - 600
ICH M4/The Common Technical Document (CTD): Comparison of Clinical Documents and Summaries Assessment Practices in the United States, Europe, and Japan Françoise de Crémiers OriginalPaper 30 December 1999 Pages: 601 - 614
A Suggested Postgraduate Curriculum for Education and Training for the Biopharmaceutical Industry D. Brendan MurphyGary Walsh OriginalPaper 30 December 1999 Pages: 615 - 626
Clinical Research after Drug Approval: What is Needed and What is Not Genevieve DecosterMarc Buyse OriginalPaper 30 December 1999 Pages: 627 - 634
Role of X-Ray Imaging in the Development of Drugs Sanjay SainiRaju Sharma OriginalPaper 30 December 1999 Pages: 635 - 640
Creation of a Knowledge-Based System to Accelerate Drug Development Martin D. Hynes IIIScott A. GetzinRebecca R. Field-Perez OriginalPaper 30 December 1999 Pages: 641 - 648
