Cancer Drug Development Problems and Opportunities Maurie Markman OriginalPaper 30 December 1998 Pages: 1 - 5
Technologies for Automating Randomized Treatment Assignment in Clinical Trials Uwe Haag OriginalPaper 30 December 1998 Pages: 7 - 11
The Need for and Design of Combination Vaccines William P. Hausdorff OriginalPaper 30 December 1998 Pages: 13 - 17
Transfer of Processes from Development to Manufacturing Donald F. GersonVaughn HimesSusan Sciotto-Brown OriginalPaper 30 December 1998 Pages: 19 - 26
Faster Access to Drugs for Serious or Life-Threatening Illnesses Through use of the Accelerated Approval Regulation in the United States David M. CocchettoDouglas R. Jones OriginalPaper 30 December 1998 Pages: 27 - 35
Understanding the Interfaces Among Multiple Technical Disciplines: An Increasing Challenge for Regulatory Affairs David M. Cocchetto OriginalPaper 30 December 1998 Pages: 37 - 41
CDER/FDA Formats for Submission of Animal Carcinogenicity Study Data Karl K. Lin OriginalPaper 30 December 1998 Pages: 43 - 52
Preparing an Integrated Summary of Safety: A Writer’s Perspective Sharie MyersBeth BaronMary Alice Miller OriginalPaper 30 December 1998 Pages: 53 - 63
An Analysis of Class I Recalls: 1982–1996 Martha M. Rumore OriginalPaper 30 December 1998 Pages: 65 - 71
Development of ADR Monitoring Activities in Poland Subsequent to Changes in the Pharmaceutical Market Andrzej Czarnecki OriginalPaper 30 December 1998 Pages: 73 - 77
Adverse Drug Reactions: The Great Masqueraders P. A. RoutledgeM. C. BialasF. Woods OriginalPaper 30 December 1998 Pages: 79 - 84
Working Methods for the Adverse Drug Reaction Monitoring Program in the Philippines Kenneth Hartigan-Go OriginalPaper 30 December 1998 Pages: 85 - 92
Orphan Drug Development—International Program and Study Design Issues Marlene E. Haffner OriginalPaper 30 December 1998 Pages: 93 - 99
Quality Criteria and Standardization of Phytopharmaceuticals: Can Acceptable Drug Standards Be Achieved? Rudolf Bauer OriginalPaper 30 December 1998 Pages: 101 - 110
Changing the Review Process: The View of the Japanese Ministry of Health and Welfare Yoshinobu Hirayama OriginalPaper 30 December 1998 Pages: 111 - 117
An Historical Perspective of the Successful Development of Sevoflurane Clair CallanLeticia Delgado-HerreraSevoflurane Venture Team OriginalPaper 30 December 1998 Pages: 119 - 127
Clinical Trials in Central/Eastern Europe: Industry Viewpoint Benona Lillian Natorff OriginalPaper 30 December 1998 Pages: 129 - 133
Expectations for an International Harmonized Guideline Tosiya SatoIsao Yoshimura OriginalPaper 30 December 1998 Pages: 135 - 139
Impact of the Ich Guideline on Ethnic Differences Helene Dumitriu OriginalPaper 30 December 1998 Pages: 141 - 144
Assessment of Generic Drugs in the Caribbean Lexley M. Pinto PereiraHenry FraserFrancis Burnett OriginalPaper 30 December 1998 Pages: 145 - 150
The Emerging Role of Herbal Medicine in Health Care in Europe Joerg Gruenwald OriginalPaper 30 December 1998 Pages: 151 - 153
A Systems Infrastructure for Sponsor/CRO Collaboration on International Clinical Trials Sandor SchoichetGareth CreaseySteve Kasay OriginalPaper 30 December 1998 Pages: 155 - 161
Drug Metabolism in Drug Development: A DIA Tutorial for Regulatory Affairs Specialists Peter K. HonigLouis R. CantilenaKenneth S. Santone OriginalPaper 30 December 1998 Pages: 163 - 167
Pharmacoeconomic Evaluation in Japanese Pharmaceutical Companies Shunya IkedaAdam James OliverNaoki Ikegami OriginalPaper 30 December 1998 Pages: 169 - 174
Accelerating Availability of New Vaccines: The Role of the International Community Julie B. MilstienAmie Batson OriginalPaper 30 December 1998 Pages: 175 - 182
Proposed Statistical Methods for Signal Detection of Adverse Medical Device Events Chang S. LaoLarry G. KesslerThomas P. Gross OriginalPaper 30 December 1998 Pages: 183 - 191
Sample Size Estimation when Comparing More than Two Treatment Groups Alan Phillips OriginalPaper 30 December 1998 Pages: 193 - 199
Detection of an Outlier and Evaluation of its Influence in Chronic Toxicity Studies Chikuma HamadaKei YoshinoIsao Yoshimura OriginalPaper 30 December 1998 Pages: 201 - 212
Interpretation of Subgroup Analyses in Medical Device Clinical Trials Pamela E. ScottGregory Campbell OriginalPaper 30 December 1998 Pages: 213 - 220
Project Management in Pharmaceutical Biometry and Data Management: Conception, Implementation, and Operations Martin Wilhelm OriginalPaper 30 December 1998 Pages: 221 - 228
A Statistical Evaluation of the Chemical Composition of Heroin Samples with the View to Discriminating Between Their Possible Sources A. EkangakiJ. SkopecR. J. Wells OriginalPaper 30 December 1998 Pages: 229 - 241
Statistics and Statisticians in European Drug Regulatory Agencies Wolfgang KöpckeDavid R. JonesKarsten Schmidt OriginalPaper 30 December 1998 Pages: 243 - 251
Further Statistical Issues in Project Prioritization in the Pharmaceutical Industry Stephen Senn OriginalPaper 30 December 1998 Pages: 253 - 259
Using Tolerance Limits to Evaluate Laboratory Data Dana J. Nickens OriginalPaper 30 December 1998 Pages: 261 - 269
What Does the Over-the-Counter Industry in Europe Need? Hubertus Cranz OriginalPaper 30 December 1998 Pages: 271 - 275
Eli Lilly and Company Global Medical Information: Pharmacy Student Clerkships in Industry Jennifer L. RigginsJeffrey L. Winn OriginalPaper 30 December 1998 Pages: 283 - 288
Medical Information on Demand Mary GaspicLorenzo BiondiTeresa Flowers OriginalPaper 30 December 1998 Pages: 289 - 292
The Drug Information Service at a University Hospital in Malaysia: Characteristics of Drug Inquiries Ab Fatah Ab RahmanNoor Aini Abu Samah OriginalPaper 30 December 1998 Pages: 293 - 298
Labeling of Drug and Biologic Products for Pediatric Use Emily ShacterPatricia L. DeSantis OriginalPaper 30 December 1998 Pages: 299 - 303
Drug Information Clerkships in the Pharmaceutical Industry Andrea F. Fus OriginalPaper 30 December 1998 Pages: 305 - 311
