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Japanese Pharmacopoeia

Publications

In this page, information regarding scientific articles to which PMDA members contributed is provided. Please note that it may include views of the author and does not necessarily reflect the official views of PMDA. PMDA encourages the regulatory science research by its staff with various expertise and perspectives for improving the quality of PMDA' s services and operations.

Topics Title Authors Journal Publication Year
PMDA Policy International Vision and strategy for Drug Regulatory authority: The PMDA's International Vision Tominaga T, Ando Y, Kondo T Clin Pharmacol Ther. 92(3): 349-51 2012
New Drug Significant Differences in Drug Lag in Clinical Development Among Various Strategies Used for Regulatory Submissions in Japan new Ueno T, Asahina Y, Tanaka A, Yamada H, Nakamura M, Uyama Y Clinical Pharmacology & Therapeutics advance online publication 8 January 2014; doi: 10.1038/clpt.2013.223 2014
Exploring Ethnic Differences in Toxicity in Early-Phase Clinical Trials for Oncology Drugs new Ogura T, Morita S, Yonemori K, NonakaT, Urano T Therapeutic Innovation & Regulatory Science: published online 3 March
DOI: 10.1177/2168479014524582
2014
Regulatory Challenges in the Review of Data from Global Clinical Trials: The PMDA Perspective Asano K, Tanaka A, Sato T, Uyama Y Clin Pharmacol Ther. 94(2): 195-198 2013
The Roles of Regulatory Science Research in Drug Development at the Pharmaceuticals and Medical Devices Agency of Japan Asahina Y, Tanaka A, Uyama Y, Kuramochi K, Maruyama H Therapeutic Innovation & Regulatory Science, 47(1): 19-22 2013
Good Laboratory Practice Inspections in Japan Between Fiscal Years 2009-2011 Anahara R Therapeutic Innovation & Regulatory Science. 47(4): 424-429 2013
Characteristics of pharmacogenomics / biomarker-guided clinical trials for regulatory approval of anti-cancer drugs in Japan Ishiguro A, Yagi S, Uyama Y Journal of Human Genetics: 1-4 2013
Balancing Societal Needs and Regulatory Certainty: The Case Study of Peramivir in Japan Tominaga T, Ando Y, Nagai N, Sato J, Kondo T Clin Pharmacol Ther. advance online publication 2013
Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective Maliepaard M, Nofziger C, Papaluca M, Zineh I, Uyama Y, Prasad K, Grimstein C, Pacanowski M, Ehmann F, Dossena S, Paulmichl M. Nat Rev Drug Discov.12(2): 103-115 2013
Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments Otsubo Y, Ishiguro A, Uyama Y Pharmacogenomics. 14(2):195-203 2013
Improving clinical trial sampling for future research - an international approach: outcomes and next steps from the DIA future use sampling workshop 2011 Warner AW, Bienfait KL, Bledsoe M, Burckart G, Flamion B, Knoppers B, Nelsen AJ, Rudman A, Sieffert NJ, Uyama Y Pharmacogenomics. 14(1):103-112 2013
Perspectives on non-clinical safety evaluation of drug metabolites through the JSOT workshop Minagawa T, Nakano K, Furuta S, Iwasa T, Takekawa K, Minato K, Koga T, Sato T, Kawashima K, Kurahashi Y, Onodera H, Naito S, Nakamura K J Toxicol Sci. 37(4): 667-673 2012
Multiregional Clinical Trials: Japanese Perspective on Drug Development Strategy and Sample Size for Japanese Subjects Ando Y, Uyama Y J Biopharm Stat 22(5): 977-987 2012
Similarities and differences between US and Japan as to Pharmacogenomic Biomarker information in drug labels Otsubo Y, Asahina Y, Noguchi A, Sato Y, Ando Y, Uyama Y Drug Metab. Pharmacokinet. 27(1): 142-149 2012
Regulatory Science as a Bridge Between Science and Society Tominaga T, Asahina Y, Uyama Y, Kondo T Clin Pharmacol Ther. 90(1): 29-31 2011
The value and benefits of the international conference on harmonisation to drug regulatory authorities: advancing harmonization for better public health Molzon JA, Giaquinto A, Lindstrom L, Tominaga T, Ward M, Doerr P, Hunt L, Rago L. Clin Pharmacol Ther. 89(4): 503-12 2011
Adaptive clinical trials for new drug applications in Japan Ando Y, Hirakawa A, Uyama Y Eur Neuropsychopharmacol. 21: 175-179 2011
Biologics Overview of global regulatory toxicology requirements for vaccines and adjuvants Sun Y, Gruber M, Matsumoto M. J Pharmacol Toxicol Methods. 65(2): 49-57 2012
A comparative study of monosaccharide composition analysis as a carbohydrate test for biopharmaceuticals Harazono A, Kobayashi T, Kawasaki N, Itoh S, Tada M, Hashii N, Ishii A, Arato T et al Biologicals. 39: 171-180 2011
Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan Arato T, Yamaguchi T Biologicals. 39: 289-292 2011
Quality, safety and efficacy of follow-on biologics in Japan Yamaguchi T, Arato T Biologicals. 39: 328-332 2011