The Patient Labeling Program at Bristol-Myers Squibb Cathleen A. O’ConnellRebecca Skinner OriginalPaper 31 December 1999 Pages: 649 - 654
Partnering for Success—Performance Measurements for Sponsors, Contract Research Organizations, and Site Management Organizations Bruce L. Maloff OriginalPaper 31 December 1999 Pages: 655 - 661
Getting the Best from Freelance Writers Diana E. H. Barkley OriginalPaper 31 December 1999 Pages: 663 - 667
Pricing and Reimbursement Regulation in Europe: An Update on the Industry Perspective Michael L. BurstallBryan G. ReubenAnthony J. Reuben OriginalPaper 31 December 1999 Pages: 669 - 688
The Role of Evidence-Based Guidelines in Managed Care Pilot Projects in Germany Regina KunzLudger Pientka OriginalPaper 31 December 1999 Pages: 689 - 697
New and Integrated Approaches to Successful Accelerated Drug Development Anthony Clemento OriginalPaper 31 December 1999 Pages: 699 - 710
The Future of Medical and Technical Writing Stephen de Looze OriginalPaper 31 December 1999 Pages: 711 - 715
Overview of Herbal Quality Control Peter A. G. M. de Smet OriginalPaper 31 December 1999 Pages: 717 - 724
The Impact of Global Integration on Drug Development and Clinical Research Ignacio Christian Marquez OriginalPaper 31 December 1999 Pages: 725 - 728
The Human Genome Project: Benefits and Risks to Society Suvara WattanapitayakulJon C. Schommer OriginalPaper 31 December 1999 Pages: 729 - 735
Guest Editor’s Note: Fourth Symposium on Active Pharmaceutical Ingredients (APIs): “Issues at the Development, Production, Regulatory Interface” Arthur C. Fabian OriginalPaper 31 December 1999 Pages: 737 - 738
Current Good Manufacturing Practice Design Trends in Active Pharmaceutical Ingredients Facilities Louis A. Angelucci OriginalPaper 31 December 1999 Pages: 739 - 746
Principles for Effective Regulatory Active Pharmaceutical Ingredients Policy Arthur C. Fabian OriginalPaper 31 December 1999 Pages: 747 - 753
The Active Pharmaceutical Ingredients Starting Material (Apism) and other Materials in API Manufacture: Scientifically-Based Principles for the Common Technical Dossier Helgam MöllerChris Oldenhof OriginalPaper 31 December 1999 Pages: 755 - 761
Bulk Actives Post Approval Changes (BACPAC): A European Perspective Chris Oldenhof OriginalPaper 31 December 1999 Pages: 763 - 768
Product Quality Research Initiative and Bulk Actives Post Approval Change Daniel H. GoldStephen Byrn OriginalPaper 31 December 1999 Pages: 777 - 784
A Review of the Source Document Verification Process in Clinical Trials Malcolm L. SchuylThim Engel OriginalPaper 31 December 1999 Pages: 789 - 797
The Over-The-Counter Scientific/ Regulatory Paradigm R. William Soller OriginalPaper 31 December 1999 Pages: 799 - 804
OTCS, Switch, and the Impact of Dietary Supplements Eve E. Bachrach OriginalPaper 31 December 1999 Pages: 805 - 810
Statistical Models for Predicting the Duration of Vaccine-Induced Protection Joseph G. PigeonNorman R. BohidarBrian L. Wiens OriginalPaper 31 December 1999 Pages: 811 - 819
A Decision Analysis for An End of Phase II Go/Stop Decision Allan PallayScott M. Berry OriginalPaper 31 December 1999 Pages: 821 - 833
Sensitivity Analysis by Worst and Best Case Assessment: Is it Really Sensitive? Kristina UnnebrinkJürgen Windeler OriginalPaper 31 December 1999 Pages: 835 - 839
The Estimation and Use of Confidence Intervals in Economic Analysis Mohan V. BalaJosephine Mauskopf OriginalPaper 31 December 1999 Pages: 841 - 848
Using Conjoint Analysis to Evaluate Health State Preferences Sheryl L. SzeinbachJames H. BarnesRon Corey OriginalPaper 31 December 1999 Pages: 849 - 858
Use of Matrix Designs in Stability Studies: A Simulation Study Kimberly L. DeWoodyDamaraju Raghavarao OriginalPaper 31 December 1999 Pages: 859 - 868
Statistical and Operational Issues Arising in an Interim Analysis When the Study Will Continue William HusterAarti ShahRichard DiMarchi OriginalPaper 31 December 1999 Pages: 869 - 875
An Algorithmic Approach to Incorporating the Ich E2A Guidelines Into Safety Department ADR Reporting in the United States Stephen L. KlincewiczNancy A. WoolpertJohn A. Clark OriginalPaper 31 December 1999 Pages: 877 - 885
Globalization of the Safety Sections of the Periodic Safety Update Report Stephen L. KlincewiczJohn A. ClarkMark K. Blake OriginalPaper 31 December 1999 Pages: 887 - 898
New Methodologies in Computer-Based Training for Adverse Event Reporting Lionel O. BensonJanet SteinerLauren Haff OriginalPaper 31 December 1999 Pages: 899 - 906
A Model for Understanding Patient Attribution of Adverse Drug Reaction Symptoms Jane E. DeWittBernard A. Sorofman OriginalPaper 31 December 1999 Pages: 907 - 920
Impact of Geographic and Cross-Cultural Differences on Spontaneous Adverse Events Reporting Hsiao-Hui WuMan FungEdmundo Muniz OriginalPaper 31 December 1999 Pages: 921 - 931
Pharmaceutical Company Strategies for Designing Nonclinical Safety Programs for Products of Biotechnology Susan A. Griffiths OriginalPaper 31 December 1999 Pages: 933 - 938
A Task and Problem Focused Approach to the Development and Regulation of Drugs Alexander Fleming OriginalPaper 31 December 1999 Pages: 939 - 948
From Signals to Policies: Academic and Regulatory Perspectives in the Philippines Kenneth Hartigan-Go OriginalPaper 31 December 1999 Pages: 949 - 954
Bringing Information on Evolving FDA Standards to Bear on Ongoing Drug Development Programs Larry R. VersteeghLynne M. Tracey OriginalPaper 31 December 1999 Pages: 955 - 963
FDA Clinical Investigator Site Inspections: The Sponsor’s Role Richard D. Huddleston OriginalPaper 31 December 1999 Pages: 965 - 968
