The Development and Adoption of Nonproprietary, Established, and Proprietary Names for Pharmaceuticals Dan Boring OriginalPaper 30 December 1997 Pages: 621 - 634
The Value of Computer-Assisted Data Review in the Clinical Development Process Kenneth BuchholzDiane Ascoli OriginalPaper 30 December 1997 Pages: 635 - 638
Development of Stereoisomers (Chiral) Drugs: A Brief Review Of Scientific and Regulatory Considerations Jonathan M. DanielsEarle R. NestmannAlex Kerr OriginalPaper 30 December 1997 Pages: 639 - 646
A Statistically-Based Process for Auditing Clinical Data Listings Ellen M. SullivanMary Ann GorkoGeorge Chao OriginalPaper 30 December 1997 Pages: 647 - 653
Standardizing Clinical Study Designs for Accelerating Drug Development Rafe M. J. DonahueStephen J. Ruberg OriginalPaper 30 December 1997 Pages: 655 - 663
A Team-Oriented Approach to the Analysis and Reporting Process Beth B. HauryPhilip M. BrownCindy Hollander OriginalPaper 30 December 1997 Pages: 665 - 670
Effect of Dose Escalation Pace on Benzodiazepine Clinical Response Hung-Ir LiPatricia L. RuppelAngie Q. Denahan OriginalPaper 30 December 1997 Pages: 671 - 677
Canda Submissions: A Retrospective Look at a Sponsor’s Experience Margaret M. MazzeoIrwin HoRegina Liao OriginalPaper 30 December 1997 Pages: 679 - 684
Clinical Trials for Antiepileptic Drugs: From Add-On to Monotherapy and Dose-Related Designs Volker Möckel OriginalPaper 30 December 1997 Pages: 685 - 695
World Class Clinical Supplies Robert A. NieuwenhuizenSharlene J. Cirillo OriginalPaper 30 December 1997 Pages: 697 - 714
Behavior of Pharmaceutical Drugs (Human and Animal Health) in the Environment Ranga Velagaleti OriginalPaper 30 December 1997 Pages: 715 - 722
The Role and Responsibilities of the Investigator in Ensuring Quality Laboratory Data Samantha Owen OriginalPaper 30 December 1997 Pages: 723 - 727
From Mouse to Man: The Early Clinical Testings Kimberly T. Perry OriginalPaper 30 December 1997 Pages: 729 - 736
Design and Analysis of Dose-Response Studies: Reality Versus Regulatory Requirements Alan Phillips OriginalPaper 30 December 1997 Pages: 737 - 744
Voluntary Standards for the Operation of Clinical Pharmacology Units Gary L. SteinmanSusana R. K. deDennisHoward Uderman OriginalPaper 30 December 1997 Pages: 751 - 757
The Use of Electronic Diaries in Respiratory Studies B. TipladyG. K. CromptonD. Brackenridge OriginalPaper 30 December 1997 Pages: 759 - 764
Quality Assurance/Quality Control Issues in GMP Regulatory Compliance Mohammed Barkat OriginalPaper 30 December 1997 Pages: 765 - 769
Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-Sponsor Conferences Joseph A. DiMasiMichael Manocchia OriginalPaper 30 December 1997 Pages: 771 - 788
Regulatory Strategies for the Development of Adjunctive Cancer Chemotherapies Suzanne K. HansenLoren L. Miller OriginalPaper 30 December 1997 Pages: 789 - 803
The Regulatory Affairs Professional in the “Hot Seat” in the Drug Development Process Loren L. MillerDavid M. Cocchetto OriginalPaper 30 December 1997 Pages: 805 - 823
Automating Surveillance for the Analysis of Adverse Event Case Reports Lionel O. BensonLinda Marc OriginalPaper 30 December 1997 Pages: 825 - 832
An Index of United States Federal Regulations and Guidelines Which Cover Safety Surveillance of Drugs Charles F. CurranCindy Engle OriginalPaper 30 December 1997 Pages: 833 - 841
An Index of United States Federal Regulations and Guidelines Which Cover Clinical Safety Surveillance of Biological Products Charles F. CurranJudith M. Sills OriginalPaper 30 December 1997 Pages: 843 - 847
From Causality Assessment to Product Labeling Myles David Buckinghasm Stephens OriginalPaper 30 December 1997 Pages: 849 - 856
Return on Investment and Minimizing Risk in Partnering with Preclinical CROs Bruce L. MaloffKaren L. ValentinoBrian R. Broxup OriginalPaper 30 December 1997 Pages: 857 - 863
Choosing the Right Balance of Health Economics Expertise: Internal Capabilities Versus External Contract Research Organizations Michael E. Minshall OriginalPaper 30 December 1997 Pages: 865 - 871
The Central Register of Clinical Trials: Current Status of Clinical Research in Poland Andrzej Czarnecki OriginalPaper 30 December 1997 Pages: 873 - 877
Documentation Handling within the Polish Registration System Andrzej Czarnecki OriginalPaper 30 December 1997 Pages: 879 - 881
A New International Perspective—the Application of the Principles of GLP to Computerized Systems (OECD 1995) J. Bryan Doherty OriginalPaper 30 December 1997 Pages: 883 - 888
Organization of Spanish Pharmacovigilance in the Multinational Situation: An Overview Dolores MonteroMariano MadurgaFrancisco J. de Abajo OriginalPaper 30 December 1997 Pages: 889 - 893
Globalization and Harmonization of Regulatory Issues: The Who Perspective of Developing Countries’ Needs and Perspectives A. Wehrli OriginalPaper 30 December 1997 Pages: 895 - 898
The Who Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce A. Wehrli OriginalPaper 30 December 1997 Pages: 899 - 902
Use of a Trinomial Distribution Probability Model in Development of a Tier-Testing Scheme for Content Uniformity Testing Charles PanaccioneAmy L. TaylorSusan P. Duke OriginalPaper 30 December 1997 Pages: 903 - 909
A Formula for Determining Sample Sizes to Study Dose-Response Gil D. Fine OriginalPaper 30 December 1997 Pages: 911 - 916
The Abecedarian Risk Manager—Alpha, Beta, and Cash Mark Moran OriginalPaper 30 December 1997 Pages: 917 - 922
Digit Preference and Sample Size Alain SprietThérèse Dupin-Spriet OriginalPaper 30 December 1997 Pages: 923 - 925
Treatment-By-Center Interaction: What is The Issue? Anders Källén OriginalPaper 30 December 1997 Pages: 927 - 936
Consumer Comprehension of Efficacy Data in Four Experimental Over-The-Counter Label Conditions Douglas B. GrisaffeSusan Shellabarger OriginalPaper 30 December 1997 Pages: 937 - 961
The Influence of Pictorials on Evaluations of Prescription Medication Instructions Russell J. SojournerMichael S. Wogalter OriginalPaper 30 December 1997 Pages: 963 - 972
The Preferred Order of Over-the-Counter (OTC) Pharmaceutical Label Components J. William JrS. Michael OriginalPaper 30 December 1997 Pages: 973 - 988
Guest Editor’s Note: Positron Emission Tomography (PET): A Revolutionary New Approach to Drug Discovery and Development? Bruce CampbellDominique Comar OriginalPaper 30 December 1997 Pages: 989 - 990
New Opportunities in Molecular Imaging Using Pet Terry Jones OriginalPaper 30 December 1997 Pages: 991 - 995
The Status of Pet Radiochemistry for Drug Development and Evaluation Victor William Pike OriginalPaper 30 December 1997 Pages: 997 - 1013
Preclinical Pharmacokinetic Pet Studies with Radiolabeled Potential new Drugs in Man Willem Vaalburg OriginalPaper 30 December 1997 Pages: 1015 - 1018
The in Vivo Quantification of the Receptor Site Concentration Using Ligand-Receptor Interaction Modeling Jacques Delforge OriginalPaper 30 December 1997 Pages: 1019 - 1027
Cardiovascular Positron Emission Tomography: A Possible Tool for Assessment of New Pharmaceuticals M. SchwaigerI. Kosa OriginalPaper 30 December 1997 Pages: 1029 - 1034
Pet Evaluation of Drugs in Alzheimer’s and Parkinson’s Diseases Karl Herholz OriginalPaper 30 December 1997 Pages: 1035 - 1044
The Potential of Tracer Kinetic Studies in Drug Development Programs: A New Investigational Area for Cancer Research P. PriceR. HarteT. Jones OriginalPaper 30 December 1997 Pages: 1045 - 1049
