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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 General Principles for the Education and Training of GCP Inspectors: The Outcome of Discussions by International Regulatory Experts in the Discussion Group on ICH E6 guideline. new Uyama Y, Yamazaki E, Osawa T. et al. Ther Innov Regul Sci. DOI: 10.1177/2168479014551646 2014
Clinical development and trial design of biosimilar products: A japanese perspective new Nagasaki M, Ando Y J Biopharm Stat, 24: 1165-1172 2014
Relationship between drug lag and factors associated with clinical trials in Japan new Ohwaki K, Nakabayashi T J Clin Pharm Ther. 39(6):649-52 2014
Regulatory activities to address the needs of older patients. Cerreta F, Temple R, Asahina Y, Connaire C J Nutr Health Aging. 10.1007/s12603-014-0494-4, 2014 2014
Assessing the prediction accuracy of cure in the Cox proportional hazards cure model: an application to breast cancer data Asano J, Hirakawa A, Hamada C, Pharmaceut Statist. DOI: 10.1002/pst.1630 2014
Moving Beyond the Hazard Ratio in Quantifying the Between-Group Difference in Survival Analysis Uno H, Claggett B, Tian L, Inoue E, Gallo P, Miyata T, Schrag D, Takeuchi M, Uyama Y, Zhao L, Skali H, Solomon S, Jacobus S, Hughes M, Packer M, Wei L J Clin Oncol. DOI: 10.1200/JCO.2014.55.2208 2014
Comparison of Statistical Analysis Plans in Randomize-All Phase Ⅲ Trials with a Predictive Biomaker Matsui S, Choai Y, Nonaka T Clin Cancer Res. DOI: 10.1158/1078-0432.CCR-13-2698 2014
Drug discovery in renal disease-towards a more efficient framework Ando T, Hiragi H, Watanabe K, Yamamoto F Nat Rev nephrology. 10, 290-296 2014
Representation of older patients in clinical trials for drug approval in Japan Asahina Y, Sugano H, Sugiyama E, Uyama Y J Nutr Health Aging 2014;18(5):520-23. 2014
Significant Differences in Drug Lag in Clinical Development Among Various Strategies Used for Regulatory Submissions in Japan 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 Ogura T, Morita S, Yonemori K, NonakaT, Urano T Therapeutic Innovation & Regulatory Science: published online 3 March
DOI: 10.1177/2168479014524582
2014
A stepwise variable selection for a Cox proportional hazards cure model with application to breast cancer data Asano J, Hirakawa A, Hamada C Jpn J Biomet. 34(1): 21-34 2013
Recent trends and special topics in new drug review in PMDA Sugita T GaBiJournal. 2(2)99-100. DOI:10.5639/gabij.2013.0202.024 2013
Regulatory Experience at the FDA, EMA, and PMDA. -Regulatory Experience at PMDA. - Ishiguro A, Otsubo Y, Uyama Y Biomarker Qualification. 41-44 2013
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. 93(4): 342-4 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
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 Considerations for non-clinical safety studies of therapeutic peptide Vaccines Matsumoto M, Komatsu S, Tsuchimoto M, Matsui H, Watanabe K, Nakamura K, Amakasu K, Ito K, Fueki O, Sawada JI, Maki K, Onodera H. Regul Toxicol Pharmacol. 70(1); 254-260 2014
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
Medical Devices The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety Mori K, Watanabe M, Horiuchi N, Tamura A, Kutsumi H Clin J Gastroenterol. DOI 10.1007/s12328-014-0474-6 2014
Safety Analysis of the Factors Influencing the Spontaneous Reporting Frequency of Drug Safety Issues Addressed in the FDA's Drug Safety Communications, Using FAERS Data Ishiguro C, Hinomura Y, Uehara K, Matsuda T Pharm Med. 28(1):7-19 2014
Post-approval appending of CSARs to drug package inserts: an analysis of the types of adverse reactions and time to addition Tamura N, Ishiguro C, Matsuda T Pharmacoepidemiol Drug Saf. 2014; doi: 10.1002/pds.3629. 2014
Assessment of Postmarketing Safety-Related Regulatory Actions in Japan Ogami T, Imaizumi T, Ishiguro C, Matsuda T Pharm Med. 26(6):395-403 2012
Regulatory Science 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