A Tribute to Dr. Louis C. Lasagna: 1923–2003 Kenneth I. Kaitin From the Editor-in-Chief 01 October 2003 Pages: 353 - 354
The European Regulatory Issues on Quality of Life Assessment Group Guidance: Some Critical Comments The Health-Related Subjective Measurements Working Group of the Société Française de Statistique/Biopharmacie R&D SantéStéphanie Garcia-Arosta Letter to the Editor 01 October 2003 Pages: 355 - 356
The New Drug Approvals of 1999, 2000, and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992 Kenneth I. KaitinCatherine Cairns Drug Regulation 01 October 2003 Pages: 357 - 371
The Current Environment in Orphan Drug Development Marlene E. Haffner Drug Regulation 01 October 2003 Pages: 373 - 379
Impact of the ICH E9 Guideline Statistical Principles for Clinical Trials on the Conduct of Clinical Trials in Japan Chihiro HirotsuLudwig A. Hothorn Drug Regulation 01 October 2003 Pages: 381 - 395
Legal and Scientific Considerations in Nonclinical Assessment of Biotechnology Products Lincoln TsangDonald Beers R & D Strategy and Management 01 October 2003 Pages: 397 - 406
Analytical Support for Drug Manufacturing in the United States’From Active Pharmaceutical Ingredient Synthesis to Drug Product Shelf Life Ranga VelagaletiPhilip K. BurnsMichael Gill R & D Strategy and Management 01 October 2003 Pages: 407 - 438
Erratum to: An Example of an Unblinded, Third-Party Interim Analysis for Sample Size Re-estimation Simon KirbyScott McBrideLohita Puvanarajan Erratum 01 October 2003 Pages: 438 - 438
The Evolving Role of United States Industry-Based Drug Information Departments Charles F. Curran Drug Information 01 October 2003 Pages: 439 - 443
Evaluation of Wyeth Medical Communications Written Responses and the Impact on Prescribing Arlene SanthouseDominick Albano Drug Information 01 October 2003 Pages: 445 - 450
