Strategic inclusion of regions in multiregional clinical trials

The evolution of clinical trials: Can we address the challenges of the future?

(2018) Hans-Georg Eichler et al.   Clinical Trials

Japanese Guideline on Global Clinical Trials: Statistical Implications and Alternative Criteria for Assessing Consistency

(2015) Kevin J. Carroll et al.   DRUG INFORMATION JOURNAL

Impact of Different Regulatory Requirements for Trial Endpoints in Multiregional Clinical Trials

(2015) Cynthia J. Girman et al.   DRUG INFORMATION JOURNAL

Comparison of global versus Asian clinical trial strategies supportive of registration of drugs in Japan

(2014) Mari Shirotani et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Regulatory Challenges in the Review of Data from Global Clinical Trials: The PMDA Perspective

(2013) K Asano et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Regulatory and Scientific Issues Regarding Use of Foreign Data in Support of New Drug Applications in the United States: An FDA Perspective

(2013) N A Khin et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

An Approach to Rationalize Partitioning Sample Size into Individual Regions in a Multiregional Trial

(2012) Norisuke Kawai et al.   DRUG INFORMATION JOURNAL

Potential Factors Influencing Regional Differences and Similarities in Multiregional Clinical Trials

(2012) Masahiko Ohishi   DRUG INFORMATION JOURNAL

Design and Analysis Issues of Multiregional Clinical Trials with Different Regional Primary Endpoints

(2012) Hsiao-Hui Tsou et al.   Journal of Biopharmaceutical Statistics

Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective

(2010) Yuki Ando et al.   PHARMACEUTICAL STATISTICS

Challenges in the Clinical Development Requirements for the Marketing Authorization of New Medicines in Southeast Asia

(2009) Alex Kudrin   JOURNAL OF CLINICAL PHARMACOLOGY