Achievement 研究業績

公表論文等

  • 鈴木香菜子、成川衛．新薬の薬価算定の運用改善に向けた検討：類似薬効比較方式の適用範囲の拡大の視点から．レギュラトリーサイエンス学会誌 2023(in press).
  • Inoue T, Narukawa M. Anti-tumor efficacy of anti-PD-1/PD-L1 antibodies in combination with other anticancer drugs in solid tumors: a systematic review and meta-analysis. Cancer Control 2022 (in press).
  • Oka T, Narukawa M. Emergence of new drugs for intractable diseases is associated with an increase in the number of patients diagnosed thereafter with those intractable diseases. Therapeutic Innovation & Regulatory Science 2023; 57(1): 70-78.
  • Hoshino Y, Narukawa M. A comparison of safety information in drug labeling at the initial approval of new drugs approved both in Japan and the United States. Therapeutic Innovation & Regulatory Science 2022; 56(5): 839-847.
  • 成川衛、小林江梨子．国際共同臨床試験への日本の参加状況：大手外資系製薬企業による試験の分析．レギュラトリーサイエンス学会誌 2022; 12(3): 271-276.
  • Yamaguchi S, Narukawa M. Combinations of drug candidate properties affecting development success and discontinuation for five diseases: lymphoma, non-small cell lung cancer, arthritis, depression, and Alzheimer’s disease. The Journal of Clinical Pharmacology 2022; 62(10): 1247-1256.
  • 今井優也、成川衛．日本における新薬開発遅延の背景に関する研究．レギュラトリーサイエンス学会誌 2022; 12(3): 235-245.
  • Watanabe Y, Narukawa M. Association between post-marketing safety-related regulatory actions and characteristics of new drugs approved in Japan between 2005 and 2016. YAKUGAKU ZASSHI 2022; 142(7): 761-770.
  • Kubota Y, Narukawa M. Randomized controlled trial data for new drug application for rare diseases in Japan. Therapeutic Innovation & Regulatory Science 2022; 56(4): 659-666.
  • Oda Y, Narukawa M. Response rate of anticancer drugs approved by the Food and Drug Administration based on a single-arm trial. BMC Cancer 2022; 22: 277. doi:10.1186/s12885-022-09383-w.
  • Noguchi Y, Narukawa M. Investigation of the relationship between clinical trial design of randomized controlled trials and scientific influence of the trial outcome in non-small cell lung cancer. J Pharm Health Care Sci. 2022; 48(4): 161-171.
  • Takada S, Narukawa M. Acceptability of manufacturer-proposed utility values for NICE cancer medicine appraisals: analysis of manufacturers' information sources. Int J Technol Assess Health Care. 2022; 38(1): e25. doi:10.1017/S0266462322000149.
  • Ito S, Narukawa M. Estimation of the under-reporting of suspected serious adverse drug reactions in Japan using an interrupted time series analysis. Therapeutic Innovation & Regulatory Science 2022; 56(2): 358-365.
  • 八木遥、成川衛．日本で承認された新薬におけるヒト初回投与試験の開始用量に関する研究．レギュラトリーサイエンス学会誌 2022; 12(2): 143-152.
  • Takada S, Narukawa M. Medicine characteristics affecting the time to guidance publication by National Institute for Health and Care Excellence in the single technology appraisal process. International Journal of Technology Assessment in Health Care 2022; 38(1): e11. doi:10.1017/S0266462321001677.
  • Nishiyama S, Narukawa M. Impact of the economic status of the patient's country of residence on the outcome of oncology clinical trials. The Oncologist 2022; 27(3): e244-e250.
  • Otsuka Y, Kaneko M, Narukawa M. Factors associated with successful phase III trials for solid tumors: A systematic review. Contemporary Clinical Trials Communications 2021; 24: 100855.
  • Shiragasawa C, Narukawa M. Key characteristics of database studies on drug effectiveness in the post-marketing stage: A systematic review. Pharmaceutical Medicine 2021; 35(6): 327-338.
  • Miyazaki K, Kaneko M, Narukawa M. Factors associated with high placebo response in clinical studies of hot flashers: a meta-analysis. Menopause 2022; 29(2): 239-246.
  • Oka T, Narukawa M. Increased availability of drugs is correlated with the number of patients diagnosed thereafter: data analysis of 45 intractable diseases. Journal of Clinical Pharmacy and Therapeutics 2021;46:1319–1325.
  • 相野早紀、南部智子、大久寛晴、成川衛．アルツハイマー病発症患者の特性探索及び発症リスクへの寄与因子に関する研究．臨床精神薬理 2021; 24: 841-857.
  • Sawada T, Kaneko M, Narukawa M. Predictability of Severe Adverse Events in Phase 3 Trials from Safety Information on Phase 1 Trials in Oncology Drug Development. Therapeutic Innovation & Regulatory Science 2021; 55(4):667-675.
  • Fukazawa C, Hinomura Y, Kaneko M, Narukawa M. Factors influencing regulatory decision-making in signal management: Analysis based on the signals identified from the FAERS. Therapeutic Innovation & Regulatory Science 2021;55(4): 685-695.
  • Hoshino Y, Narukawa M. A comparison of decision and timing of safety related labeling changes for new drugs approved both in Japan and the United States. Pharmacoepidemiol Drug Saf. 2021; 30(5): 561-572.
  • 緒方映子、成川衛．臨床試験における安全性を理由とした治験薬の投与中止・減量と市販後の低用量処方の関係．YAKUGAKU ZASSHI 2021; 141(5): 743-749.
  • Yoshida Y, Kaneko M, Narukawa M. Impact of advantage in tumor response on the correlation between progression-free survival and overall survival: meta-analysis of clinical trials in patients with advanced non-small cell lung cancer. Pharmaceutical Medicine 2021; 35(3): 81-92.
  • Yamaguchi S, Kaneko M, Narukawa M. Approval success rates of drug candidates based on target, action, modality, application, and their combinations. Clinical and Translational Science 2021; 14(3): 1113-1122.
  • Tamai T, Kaneko M, Narukawa M. Comparison of efficacy outcomes of anticancer drugs between Japanese patients and the overall population. International Journal of Clinical Oncology 2021; 26(2): 296-304.
  • Kobayashi E, Matsuyama M, Suzuki K, Murakami T, Narukawa M. Characteristics of industry-sponsored drug clinical trials registered in Japan Pharmaceutical Information Center Clinical Trials Information 2010-2018. Therapeutic Innovation & Regulatory Science 2021; 55(2): 378-387.
  • Ueyama E, Kaneko M, Narukawa M. Analysis of Pediatric Drug Approval Lag in Japan. Therapeutic Innovation & Regulatory Science 2021; 55(2): 336-345.
  • 相野早紀、金子真之、成川衛．各都道府県における高齢者アルツハイマー病受療率に影響を及ぼす要因に関する研究．日本予防医学会雑誌 2020; 14(2): 19-24.
  • Irisawa K, Kaneko M, Narukawa M. Factors Related to Conversion from Accelerated to Full Approval for Drugs Approved in the United States between 2000 and 2016. Therapeutic Innovation & Regulatory Science 2021; 55(1): 82-89.
  • Noguchi Y, Kaneko M, Narukawa M. Characteristics of drug intervention clinical trials and scientific impact of the trial outcome: A bibliometric analysis using the Relative Citation Ratio in non-small cell lung cancer from 2007 to 2016. Therapeutic Innovation & Regulatory Science 2020; 54(6): 1501-1511.
  • 成川衛、山田知子．医薬品リスク管理計画（RMP）における追加のリスク最小化活動の効果の評価：患者向け情報資材の効果に関するインターネット調査－ゾフルーザを例として．レギュラトリーサイエンス学会誌 2020; 10(3): 87-98.
  • Ueyama E, Kaneko M, Narukawa M. Pediatric drug development in Japan: A comparison of the current situation and characteristics between Japan and Europe. Therapeutic Innovation & Regulatory Science 2020; 54(5): 1152-1158.
  • Yoshida Y, Kaneko M, Narukawa M. Magnitude of advantage in tumor response contributes to a better correlation between treatment effects on overall survival and progression-free survival: A literature-based meta-analysis of clinical trials in patients with metastatic colorectal cancer. International Journal of Clinical Oncology 2020; 25(5): 851-860.
  • Ikeda J, Kaneko M, Narukawa M. Postmarketing Safety-related Regulatory Actions on First-in-class drugs: a double-cohort study. Jounal of Clinical Pharmacy and Therapeutics 2020;45(3):496-502.
  • Kobayashi T, Kaneko M, Narukawa M. Influence of prevalent vertebral fracture on the correlation between change in lumbar spine bone mineral density and risk of new vertebral fracture: a meta-analysis of randomized clinical trials. Clinical Drug Investigation 2020; 40(1): 15-23.
  • Kobayashi T, Kaneko M, Narukawa M. Investigation of the influencing factors on the incidence of vertebral fracture: a meta-analysis based on placebo data of randomized clinical trials. Therapeutic Innovation & Regulatory Science 2020;54(1):240-245.
  • Yasuoka Y, Kaneko M, Narukawa M. Evaluation of the implementation of additional risk minimization activities in Europe, the United States, and Japan. Pharmaceutical Medicine 2019; 33(5): 417-424.
  • Watanabe-Uchida M, Watanabe T, Narukawa M. The current state and future prospects of population pharmacokinetic research in post-marketing clinical studies in Japan. Yakugaku-Zasshi 2019; 139(10): 1297-1303.
  • Ogata A, Kaneko M, Narukawa M. Lower-dose prescriptions in the post-marketing situation and the influencing factors thereon. PLOS ONE 14(6):e0218534.https://doi.org/10.1371/ journal.pone.0218534.
  • Matsusaki A, Kaneko M, Narukawa M. Meta-analysis of dropout rates in placebo-controlled randomized clinical trials of atypical antipsychotics assessed by PANSS. Clinical Drug Investigation 2019; 39(10): 917-926.
  • Yamashita K, Kaneko M, Narukawa M. Regulatory characteristics and pivotal study design of United States Food and Drug Administration approval of drugs for major vs. minor cancer. Eur J Clin Pharmacol 2019; 75(9): 1193-1200.
  • Kaneko M, Narukawa M. Time-matched evaluation of cardiovascular risks associated with drugs for type 2 diabetes mellitus. Clinical Drug Investigation 2019; 39(5): 469-476.
  • Kaneko M, Narukawa M. Effects of sodium-glucose cotransporter 2 inhibitors on amputation, bone fracture, and cardiovascular outcomes in patients with type 2 diabetes mellitus using an alternative measure to the hazard ratio. Clinical Drug Investigation 2019; 39(2): 179-186.
  • Yamashita K, Kaneko M, Narukawa M. A significant anti-cancer drug approval lag between Japan and the US still exists for minor cancers. Clinical Pharmacology & Therapeutics 2019; 105(1): 153-160.
  • Kohara N, Kaneko M, Narukawa M. Investigation of the study characteristics affecting clinical trial quality using the protocol deviations leading to exclusion of subjects from the Per Protocol Set data in studies for new drug application: a retrospective analysis. Therapeutic Innovation & Regulatory Science 2019; 53(1): 45-51.
  • 榊原由紀子、金子真之、成川衛．日本における医師主導治験の実施状況の分析とその求められる役割の検討．Jpn Pharmacol Ther. 2018; 46(s2): s114-20.
  • Tomotsugu N, Kaneko M, Takayama A, Narukawa M. Is the total review time of new medical devices related to the size of the company?: Medical devices development and its related factors in Japan. Journal of Regulatory Science 2018; 6(2): 24-34.
  • Hyogo A, Kaneko M, Narukawa M. FDA’s Decisions in Oncology Drug Product Approvals from 2006 to 2016. Health Policy and Technology 2018; 7(4): 341-346.
  • Fukazawa C, Hinomura Y, Kaneko M, Narukawa M. Significance of data mining in routine signal detection: Analysis based on the safety signals identified by the FDA. Pharmacoepidemiol Drug Saf. 2018; 27(12): 1402-1408.
  • Ikeda J, Kaneko M, Narukawa M. Analysis of factors related to the occurrence of important drug-specific postmarketing safety-related regulatory actions: a cohort study focused on first-in-class drug. Pharmacoepidemiol Drug Saf. 2018; 27(12): 1393-1401.
  • Matsusaki A, Kaneko M, Narukawa M. Meta-analysis of placebo response in randomized clinical trials for antipsychotic drugs using PANSS focusing on different approaches to the handling of missing data. Clinical Drug Investigation 2018; 38(8): 751-761.
  • Matsuoka Y, Kaneko M, Narukawa M. Investigation into the impact of aging on serious adverse events associated with anti-rheumatic agents using the Japanese Adverse Drug Event Report database. Pharmaceutical Medicine. 2018; 32(3): 209-217.
  • Iino S, Kaneko M, Narukawa M. Factors influencing efficacy endpoints in clinical trials for new oral medicinal treatments for overactive bladder: a systematic literature review and meta-analysis. International Urology and Nephrology 2018; 50(6): 1021-1030.
  • Kaneko M, Narukawa M. Assessment of Cardiovascular Risk With Glucagon-Like Peptide 1 Receptor Agonists in Patients With Type 2 Diabetes Using an Alternative Measure to the Hazard Ratio. The Annals of Pharmacotherapy 2018; 52(7): 632-638.
  • 岩崎麻美、金子真之、成川衛. 日本と欧州の医薬品リスク管理計画における安全性監視活動の比較. 臨床薬理 2018; 49(1): 23-34.
  • Hyogo A, Kaneko M, Narukawa M. Factors Influencing FDA’s Decisions for Postmarketing Requirements and Commitments during Their Review of Oncology Products. Journal of Oncology Practice 2018; 14(1): e34-e41.
  • Matsuoka Y, Narukawa M. Comparison of serious adverse event profiles among anti-rheumatic agents using Japanese Adverse Drug Event Report database. Therapeutic Innovation & Regulatory Science 2018; 52(3): 339-347.
  • Sato M, Narukawa M. Investigation of predictive factors for effect of acid-reducing agents on drug exposure. Int. Journal of Clinical Pharmacology and Therapeutics 2017; 55(10): 798-806.
  • 還田悠平、高山茜、成川衛．高齢者を考慮した新薬開発および情報提供に係る研究．レギュラトリーサイエンス学会誌 2017; 7(3): 163-172.
  • 盛岡一輝、高山茜、成川衛．日本におけるロングセラー医薬品の特性に係る研究．レギュラトリーサイエンス学会誌 2017; 7(3): 151-162.
  • Takayama A, Narukawa M. Comparison of new drug accessibility and price between Japan and major European countries. Therapeutic Innovation & Regulatory Science 2017; 51(5): 604-611.
  • Takayama A, Kobayashi E, Nakamura T, Narukawa M. Quantitative assessment of premium rates for clinical usefulness in new drug price calculation in Japan. Therapeutic Innovation & Regulatory Science 2017; 51(5): 582-588.
  • Kaneko M, Narukawa M. Assessment of the risk of hospitalization for heart failure with dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes using an alternative measure to the hazard ratio. The Annals of Pharmacotherapy 2017; 51(7): 570-576.
  • 成川衛．リスク最小化策の効果の評価．薬剤疫学 2017; 22(1): 3-7. 　　　
  • Fujita K, Kaneko M, Narukawa M. Factors related to glucose-lowering efficacy of dipeptidyl peptidase-4 inhibitors: a systematic review and meta-analysis focusing on ethnicity and study regions. Clinical Drug Investigation 2017; 37(3): 219–232.
  • Iwasaki M, Kaneko M, Narukawa M. Characterization of the recent postmarketing safety measures in Europe focusing on additional pharmacovigilance activities. Pharmaceutical Medicine 2017; 31(1): 31-39.
  • 還田悠平、髙山茜、成川衛．世界初承認医薬品の開発経緯及びリスクの特定状況に関する研究．臨床薬理 2017; 48(1): 9-14.
  • 成川衛．医薬品の市販直後調査の実施状況及び意義に関する調査研究（アンケート調査に基づく考察）．レギュラトリーサイエンス学会誌 2017; 7(1): 17-24.
  • Watanabe-Uchida M, Narukawa M. Utilization of Population Pharmacokinetics in Drug Development and Provision of the Results to Healthcare Professionals. Int. Journal of Clinical Pharmacology and Therapeutics 2017; 55(1): 25-31.
  • 高山茜、成川衛．公定薬価と市場での取引価格の差に影響を与える因子の検討．レギュラトリーサイエンス学会誌 2016; 6(3): 295-305.
  • 成川衛．医薬品リスク管理における薬剤疫学研究への期待．レギュラトリーサイエンス学会誌 2016; 6(3): 335-343.
  • Watanabe T, Narukawa M. Characteristics of safety information obtained from postmarketing observational studies for re-examination in Japan.SpringerPlus 2016; 5: 905, DOI 10.1186/s40064-016-2365-4.
  • Iino S, Kaneko M, Narukawa M. Potential primary endpoint for exploratory clinical trial in patients with overactive bladder: A systematic literature review. Lower Urinary Tract Symptoms 2016; DOI: 10.1111/luts.12141.
  • Kaneko M, Narukawa M. Meta-analysis of dipeptidyl peptidase-4 inhibitors useand cardiovascular risk in patients with type 2 diabetes mellitus. Diabetes Research and Clinical Practice 2016; 116: 171-182.
  • 高山茜、成川衛．新薬の薬価算定における有用性加算及び営業利益率の加算的補正の予見性．レギュラトリーサイエンス学会誌 2016; 6(2): 1-8.
  • Takayama A, Narukawa M. Pharmaceutical pricing and reimbursement in Japan:For faster, more complete access to new drugs. Therapeutic Innovation & Regulatory Science 2016; 50(3): 361-367.
  • Murakami M, Narukawa M. Matched analysis on orphan drug designations and approvals: cross regional analysis in the United States, the European Union,and Japan. Drug Discovery Today 2016; 21(4): 544-549.
  • 渡邉達也、成川衛．副作用情報に焦点を当てた添付文書利用に関する調査．臨床薬理 2016; 47(1): 3-10.
  • Sato M, Narukawa M. Factors affecting intra-subject variability of PK exposure: Absolute oral bioavailability and acidic nature of drugs. Int.Journal of Clinical Pharmacology and Therapeutics 2015; 53(11): 955-962.
  • 森恵里奈、金子真之、成川衛．全例調査に係る承認条件の現状とその付与に影響を与える因子についての検討．臨床薬理 2015; 46(4): 185-189.
  • Komuro M, Kaneko M, Narukawa M. Investigation of prognostic factors affecting efficacy in carboplatin and paclitaxel-based first-line chemotherapies for advanced non-small cell lung cancer. Tumori 2015; 101(4):424-432.
  • Hanada K, Kaneko M, Narukawa M. Comparison of approved dosages for pediatric and adult populations based on US labeling information. Therapeutic Innovation & Regulatory Science 2015; 49(4): 576-583.
  • 佐藤彰秀、成川衛．ヒト初回投与試験の開始用量に関するレトロスペクティブ研究.臨床薬理 2015; 46(2): 65-70.
  • 成川衛、高山茜ほか．新薬の薬価算定における有用性加算等の加算率の定量的評価．医薬品医療機器レギュラトリーサイエンス 2015; 46(3): 131-135.
  • 渡邉達也、成川衛．医薬情報担当者（MR）から見た医療機関における使用成績調査の実態に関するアンケート調査．医療薬学 2015; 41(2): 57-65.
  • Arakawa A, Kaneko M, Narukawa M. An Investigation of Factors Contributing to Higher Levels of Placebo Response in Clinical Trials in Neuropathic Pain: A Systematic Review and Meta-Analysis. Clinical Drug Investigation 2015;35(2): 67-81.
  • 成川衛．希少疾病用医薬品の開発経験に関するアンケート調査に基づくその開発促進策に関する検討．医薬品医療機器レギュラトリーサイエンス 2015; 46(1): 60-65.
  • 成川衛．RMP制度の着実かつ効果的な実施に向けて．薬剤疫学 2014; 19(2):109-114.
  • 成川衛．医薬品の使用成績調査の現状と今後．医薬品医療機器レギュラトリーサイエンス 2014; 45(11): 886-890.
  • Sato A, Narukawa M. Investigation of the relationship between a starting dose in first-in-human studies and no observed adverse effect level in nonclinical studies. Int. Journal of Clinical Pharmacology and Therapeutics 2014; 52(9): 770-775.
  • 渡邉達也、成川衛．医療機関の薬剤部門における使用成績調査業務への関与に関するアンケート調査．医療薬学 2014; 40(9): 507-514.
  • 成川 衛．医薬品製造販売後の全例調査の実施状況及び意義に関する調査研究（アンケート調査に基づく考察）．レギュラトリーサイエンス学会誌 2014; 4(3):199-206.
  • Kayama M, Narukawa M. Consideration of Factors Affecting the Safety Index in Early Clinical Drug Development. Therapeutic Innovation & Regulatory Science 2014; 48(4): 436-443.
  • Kanmuri K, Narukawa M. Investigation of the Safety Profiles of Japanese Clinical Trials. Therapeutic Innovation & Regulatory Science 2014; 48(3):308-315.
  • Aboshi M, Kaneko M, Narukawa M. Factors Affecting the Association between Overall Survival and Progression Free Survival in Clinical Trials of First-Line Treatment for Patients with Advanced Non-Small-Cell-Lung Cancer.Journal of Cancer Research and Clinical Oncology 2014; 140(5): 839-848.
  • Kanmuri K, Narukawa M. Characteristics of post-marketing studies and their contribution to post-marketing safety measures in Japan. Pharmaceutical Medicine 2014; 28(2): 67-73.
  • 古川衣登、成川衛．公知申請に基づく効能追加等承認の状況分析とその有効活用策の検討．臨床薬理 2014; 45(2): 59-62.
  • 成川 衛．医薬品の使用成績調査の実施状況及び意義に関する調査研究（アンケート調査に基づく考察）．レギュラトリーサイエンス学会誌 2014; 4(1): 11-19.
  • 渡邉達也、岩崎麻美、氏原淳、成川 衛．添付文書からみた承認時と再審査終了時における副作用発現率の比較．臨床薬理 2013; 44(6): 463-468.
  • Kanmuri K, Narukawa M. Investigation of characteristics of Japanese clinical trials in terms of data variability.Therapeutic Innovation & Regulatory Science 2013;47(4):430-437.
  • 成川 衛．対照群をおいた前向きコホート研究による医薬品使用成績調査の実施事例に基づく考察． レギュラトリーサイエンス学会誌 2013; 3(2): 105-110.
  • Tachibana Y, Narukawa M. Investigation of influencing factors on higher placebo response in East Asian versus Western clinical trials for partial epilepsy: a meta-analysis. Clinical Drug Investigation 2013;33:315-324
  • Tsukamoto A, Kaneko M, Narukawa M. Factors Related to Regulatory Approval of Late-Stage Development Compounds: Analysis of Japanese Pharmaceutical Company Activities, 1995-2007.　Therapeutic Innovation & Regulatory Science 2013; 47(2): 261-267.
  • Sugita Y, Inoue E, Narukawa M. Impact of clinical response on different approved doses between Japan and the United States.　Clinical Pharmacology in Drug Development 2012; 1(4): 158-169.
  • 岩崎麻美、渡邉達也、氏原淳、成川衛．医薬品の製造販売後調査の現状と今後の課題．臨床薬理 2012; 43(5): 345-351.
  • Inoue K, Narukawa M, Takeuchi M. Factors affecting efficacy and safety of add-on combination chemotherapy for non-small-cell lung cancer: a literature-based pooled analysis of randomized controlled trials.Lung 2012;190: 355-364.
  • Nakashima K, Narukawa M, Takeuchi M. Approaches to Japanese Dose Evaluation in Global Drug Development: Factors That Generate Different Dosages Between Japan and the United States.　Clinical Pharmacology and Therapeutics 2011;90(6): 836-843.
  • Nakashima K, Narukawa M, Kanazu Y, Takeuchi M. Differences between Japan and the United States in dosages of drugs recently approved in Japan.　Journal of Clinical Pharmacology 2011; 51(4): 549-560.
  • Muroyama S, Narukawa M, Takeuchi M. Analysis of the current state of industry-sponsored global clinical trials in Asia: Discussion in terms of study designs and target diseases. Pharmaceutical Medicine 2010; 24: 93-103.
  • Terada M, Narukawa M, Takeuchi M. Key performance indicators of clinical Trials in Japan: Implications for reducing the drug lag.　Pharmaceutical Medicine 2009; 23: 305-308.
  • Hashimoto J, Ueda E, Narukawa M. The current situation of oncology drug lag in Japan and strategic approaches for pharmaceutical companies.　Drug Information Journal 2009; 43: 757-765.
  • Kanazu S, Horie Y, Narukawa M, Nonaka K, Taniguchi T, Arjona Ferreira JC,Takeuchi M. Predicting steady-state HbA1c responses to sitagliptin in patients with type 2 diabetes mellitus. Diabetes, Obesity and Metabolism 2009; 11: 813-818.
  • 室山総一郎、成川衛、竹内正弘. アジア地域における国際共同試験の現状分析と日本の開発戦略. 臨床薬理 2008; 39: 261-268.

著書・翻訳等

  • 成川 衛．わが国の創薬研究の規制：歴史・現実・展望．製薬と日本社会－創薬研究の倫理と法－．2020 東京：上智大学出版．pp.9-11
  • 成川 衛．がん治療薬の承認審査．進化するがん創薬－がん科学と薬物療法の最前線．2019 京都：化学同人．pp.297-303
  • 成川 衛．SBO 3, 4. スタンダード薬学シリーズⅡ6 医療薬学 Ⅴ．薬物治療に役立つ情報．2017 東京：東京化学同人．pp.9-17.
  • 成川 衛．臨床試験データからみる医薬品評価学－高血圧症に対する医薬品の臨床評価．病態と薬理を理解して薬学的ケアを実践する・高血圧症．2017 東京：公益財団法人 日本薬剤師研修センター．pp.35-46.
  • 成川 衛．臨床試験データからみる医薬品評価学－心不全に対する医薬品の臨床評価．病態と薬理を理解して薬学的ケアを実践する・心不全．2016 東京：公益財団法人 日本薬剤師研修センター．pp.29-39.
  • 成川 衛．SBO 33.薬価基準制度について概説できる．スタンダード薬学シリーズⅡ1薬学総論Ⅱ．薬学と社会．2016 東京：東京化学同人．pp.235-240.
  • 成川 衛．医薬品の研究開発の流れと情報．医薬品情報学［第4版］．2016 東京：東京大学出版会．pp.8-19.
  • 成川 衛．革新的医薬品審査のポイント．2015 東京：日経BP社
  • 成川 衛．臨床試験データからみる医薬品評価学－虚血性心疾患に対する医薬品の臨床評価．病態と薬理を理解して薬学的ケアを実践する・虚血性心疾患．2015 東京：公益財団法人 日本薬剤師研修センター．pp.41-51.
  • 成川 衛．臨床試験データからみる医薬品比較評価学－最近の糖尿病治療薬：DPP-4阻害薬、GLP-1受容体作動薬、SGLT2阻害薬などを例として．病態と薬理を理解して薬学的ケアを実践する糖尿病．2014 東京：公益財団法人 日本薬剤師研修センター．pp.35-46.
  • 成川 衛．モニタリング業務の効率化．GCPハンドブック第5版．2014 東京：じほう．pp.62-68.
  • 成川 衛．製造販売の承認審査．医薬品のレギュラトリーサイエンス．2014 東京：南山堂．pp.10-12.
  • 成川 衛．治験相談と承認審査．がん臨床試験テキストブック－考え方から実践まで．2013 東京：医学書院．pp.119-122.
  • 成川 衛．医薬品開発入門．2013 東京：じほう．pp.103-115, pp.156-168.
  • 成川 衛．第Ⅱ部 社会保障制度と医薬経済 他（分担執筆）．中村健，白神誠，木村和子（編）．薬事法規・規制マニュアル改訂11版．2013 東京：南山堂．pp.108-132,pp.148-156, pp.162-169. 他
  • 成川 衛．ドイツにおける薬剤給付の動向．諸外国の薬剤給付制度と動向 改訂版．2013 東京：薬事日報社．pp.128-158.
  • 成川 衛．新しい薬学辞典．2012 東京：朝倉書店．pp.357-365.
  • 成川 衛，竹内正弘．臨床試験の統計学．がん化学療法・分子標的治療update．2009 東京：中外医学社．pp.442-445.
  • 成川 衛．医薬品の国際共同開発の現状と課題．国際共同治験－各国治験環境とアジアへの展開に向けて 2008 東京: 情報機構. pp.3-11.
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