| no |
title |
author |
magazine |
year |
volume |
issue |
page(s) |
type |
| 1 |
A Noninferiority Test for Treatment-by-Factor Interaction with Application to Bridging Studies and Global Trials
|
Liu, Jen-pei
|
|
|
43 |
1 |
p. 11-16
|
article
|
| 2 |
A Review of Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials
|
Cocchetto, David M.
|
|
|
43 |
1 |
p. 109-110
|
article
|
| 3 |
Bridging Studies in Japan and Taiwan: A Dynamic Evolution in Regulating Ethnic Differences
|
Kuo, Wen-Hua
|
|
|
43 |
1 |
p. 3-10
|
article
|
| 4 |
Bridging Study versus Prespecified Regions Nested in Global Trials
|
Wang, Sue-Jane
|
|
|
43 |
1 |
p. 27-34
|
article
|
| 5 |
Clinical Trials in Southeast Asia: An Update
|
Wong, Ellick
|
|
|
43 |
1 |
p. 57-61
|
article
|
| 6 |
Collaboration between Japan and Other Asian Countries in New Drug Development: Japanese Industry Perspective
|
Wada, Kohei
|
|
|
43 |
1 |
p. 21-26
|
article
|
| 7 |
Current Drug Regulatory Status of Advanced Drug Evaluation System in Korea
|
Pork, In-Sook
|
|
|
43 |
1 |
p. 41-46
|
article
|
| 8 |
Editor’s Note
|
Chern, Herng-Der
|
|
|
43 |
1 |
p. 1-2
|
article
|
| 9 |
Nonclinical Testing of Vaccines: Report from a Workshop
|
van der Laan, Jan Willem
|
|
|
43 |
1 |
p. 97-107
|
article
|
| 10 |
Recent Approaches by the PMDA to Promoting New Drug Development: Change in the Status of the PMDA in Relation to New Drug Development over the Last Five Years
|
Mori, Kazuhiko
|
|
|
43 |
1 |
p. 47-55
|
article
|
| 11 |
Standard Operating Procedures (SOPs): Why Companies Must Have Them, and Why They Need Them
|
Gough, Janet
|
|
|
43 |
1 |
p. 69-74
|
article
|
| 12 |
Statistical Validation of Traditional Chinese Diagnostic Procedures
|
Hsiao, Chin-Fu
|
|
|
43 |
1 |
p. 83-95
|
article
|
| 13 |
Stringent Laws and Regulations for Dietary Supplements
|
Jiang, Tao
|
|
|
43 |
1 |
p. 75-81
|
article
|
| 14 |
The Australian Medicines Regulatory System: A Risk-Based Approach to Regulation
|
Hammett, Rohan
|
|
|
43 |
1 |
p. 17-20
|
article
|
| 15 |
The Role of the Asia-Pacific Region in Global Drug Development Strategy
|
Tsuei, S. Edmund
|
|
|
43 |
1 |
p. 35-40
|
article
|
| 16 |
Updates on IND Process and Clinical Trials Status in Taiwan
|
Lido, Jon-Jih
|
|
|
43 |
1 |
p. 63-68
|
article
|
Journal description