Guest Editor’s Note: Clinical Trials and Gcp in East Asia Kiichiro Tsutani EditorialNotes 30 December 1997 Pages: 1051 - 1055
General View of Clinical Trials and GCP in East Asia Kiichiro Tsutani OriginalPaper 30 December 1997 Pages: 1057 - 1064
Current Status of Clinical Trials and Good Clinical Practice in Japan Toshiyoshi Tominaga OriginalPaper 30 December 1997 Pages: 1071 - 1078
Current Status of Clinical Trials and GCP in the Republic of Korea Sang-Goo Shin OriginalPaper 30 December 1997 Pages: 1079 - 1087
Current Status of Clinical Trials and GCP in Taiwan Herng-Der Chern OriginalPaper 30 December 1997 Pages: 1097 - 1103
Current Status of Clinical Trials and Good Clinical Practice in Singapore and Hong Kong Robert Teoh OriginalPaper 30 December 1997 Pages: 1105 - 1108
Current Status of Clinical Trials on Drugs and GCP in China Sang Guo-Wei OriginalPaper 30 December 1997 Pages: 1109 - 1125
Panel Discussion: Clinical Trials and GCP in East Asia Kiichiro Tsutani OriginalPaper 30 December 1997 Pages: 1127 - 1143
Guest Editor’s Note: Practical and Regulatory Issues on New Drug, New Dosage Form, and Generic Drug Development Oliver Yoa-Pu HuShein-Chung Chow EditorialNotes 30 December 1997 Pages: 1145 - 1147
The Various Regulatory Clinical Development Pathways to Obtain Marketing Approval Thomas A. HayesD. P. Gangi OriginalPaper 30 December 1997 Pages: 1149 - 1153
Current Practical Issues in Phase III Clinical Trials Jacqueline De Silva BriefCommunication 30 December 1997 Pages: 1155 - 1156
Good Statistics Practice in the Drug Development and Regulatory Approval Process Shein-Chung Chow OriginalPaper 30 December 1997 Pages: 1157 - 1166
Statistical/Practical Issues in Clinical Trials Annpey PongShein-Chung Chow OriginalPaper 30 December 1997 Pages: 1167 - 1174
Limitations of Conducting Clinical Trials in Taiwan Yen-Yau Hsieh OriginalPaper 30 December 1997 Pages: 1175 - 1179
Evolution of Clinical Trial Requirements in Taiwan’s Pharmaceutical Registration Weng-Foung HuangMei-Ling Hsiao OriginalPaper 30 December 1997 Pages: 1181 - 1188
Meta-Analysis of Drug Safety Data with Logistic Regression Mei-Ling Ting LeeRoss Lazarus OriginalPaper 30 December 1997 Pages: 1189 - 1193
Pharmaceutical Validation and Process Controls in Drug Development Shein-Chung Chow OriginalPaper 30 December 1997 Pages: 1195 - 1201
Assessment of Intrasubject Variability of Pharmacokinetic Parameters in Clinical Studies Cheng-Tao ChangRobert L. Wong OriginalPaper 30 December 1997 Pages: 1203 - 1213
Exploratory and Population Pharmacodynamic Analysis of Pilot Dose-Response Data in the Bioequivalence Testing of Topical Corticosteroid Preparations Laszlo EndrenyiMin GaoYong Hao OriginalPaper 30 December 1997 Pages: 1215 - 1226
Single and Multiple Dose Pharmacokinetics of a Pharmaceutical Compound in Elderly Subjects H. JangD. BuhrmanF. Cattelin OriginalPaper 30 December 1997 Pages: 1227 - 1235
Experimental Design for Estimating Area under the Curve by Trapezoidal Approximation in Destructive Sampling Greg C. G. Wei OriginalPaper 30 December 1997 Pages: 1237 - 1242
The Utility of Steady State Trough Concentrations in Assessing Intrasubject Variability Robert A. SmithWen-Chyi ShyuWei-Chi Liao OriginalPaper 30 December 1997 Pages: 1243 - 1248
A Mixed Effects Model for Gastric Ulcer Data Donghui Zhang OriginalPaper 30 December 1997 Pages: 1249 - 1254
Statistical Evaluation of Similarity Factor f2 as a Criterion for Assessment of Similarity Between Dissolution Profiles Jen-Pei LiuMi-Chia MaShein-Chung Chow OriginalPaper 30 December 1997 Pages: 1255 - 1271
On The Assessment of Similarity of Drug Dissolution Profiles—A Simulation Study Huey Lin JuShu-Jean Liaw OriginalPaper 30 December 1997 Pages: 1273 - 1289
A Comparative Study of Some Statistical Procedures in Establishing Therapeutic Equivalence of Nonsystemic Drugs with Binary Endpoints Dongsheng Tu OriginalPaper 30 December 1997 Pages: 1291 - 1300
Immunotoxicity of Pharmaceuticals: Current Knowledge, Testing Strategies, Risk Evaluation & Consequences for Human Health Jan Willem van der LaanHenk van LoverenKenneth L. Hastings OriginalPaper 30 December 1997 Pages: 1301 - 1305
Drug-Induced Autoimmunity and Autoimmune Disease Norman TalalHoward Dang OriginalPaper 30 December 1997 Pages: 1307 - 1309
Drug Eruptions: Allergic Reactions? Derk P. Prof. dr. Bruynzeel OriginalPaper 30 December 1997 Pages: 1311 - 1316
Practice of Tiered Testing for Immunosuppression in Rodents E. J. de WaalH. van LoverenJ. G. Vos OriginalPaper 30 December 1997 Pages: 1317 - 1323
The Practice of Preclinical Immunotoxicity Testing in Japan Eiji Maki OriginalPaper 30 December 1997 Pages: 1325 - 1329
Evaluation of the Immunotoxic Potential of Pharmaceuticals: Functional Aspects M. PallardyC. BlotP. Rieu OriginalPaper 30 December 1997 Pages: 1331 - 1336
Suitability of the Popliteal Lymph Node Assay as a Predictive Immunotoxicological Test Ruud AlbersWillem SeinenRaymond Pieters OriginalPaper 30 December 1997 Pages: 1337 - 1340
Models for Preclinical Testing of Allergy Klaus Ejner Andersen OriginalPaper 30 December 1997 Pages: 1341 - 1345
Integration of Immunotoxicology Evaluation in Drug Development Jack H. DeanBernard Remandet OriginalPaper 30 December 1997 Pages: 1347 - 1356
Considerations in Assessing the Immunotoxic Potential of Investigational Drugs Kenneth L. HastingsChang-Ho AhnJames L. Weaver OriginalPaper 30 December 1997 Pages: 1357 - 1361
Risk Assessment and Immunotoxicity Henk van LoverenJohan GarssenJoseph G. Vos OriginalPaper 30 December 1997 Pages: 1363 - 1367
Using Cytokines to Assess Immunotoxicity of Drugs: Bridging the Gap from Preclinical to Clinical Studies Robert V. House OriginalPaper 30 December 1997 Pages: 1369 - 1372
Clinical Approach to Immunotoxicology and Autoimmunity K. Whaley OriginalPaper 30 December 1997 Pages: 1373 - 1378
Hapten-Specific Lymphocytes: Biomarkers of Allergy in Man Vera D. M. Stejskal OriginalPaper 30 December 1997 Pages: 1379 - 1382
Issues and Concerns for the Registration of Biological Products in ASIA Pacific: An Introduction to the Session Irene W. Wei OriginalPaper 30 December 1997 Pages: 1383 - 1384
The Approval System for Biological Products in Japan Masanobu Yamada OriginalPaper 30 December 1997 Pages: 1385 - 1393
Issues and Concerns for the Registration of Biological Products in Australia Brian L. Hillcoat OriginalPaper 30 December 1997 Pages: 1395 - 1400
Registration of Biological Products in China Zhou Haijun OriginalPaper 30 December 1997 Pages: 1401 - 1403
Introduction: Quality of Life Abstracts from the Dia Fourth Annual Symposium of Contributed Papers on Quality of Life Evaluation Faye A. LuscombeRobert S. EpsteinEva Lydick BriefCommunication 30 December 1997 Pages: 1405 - 1405
A Tribute to Sol Levine, PhD: 1922–1996 William R. Lenderking OriginalPaper 30 December 1997 Pages: 1443 - 1448
