|
1）Scannell JW, Blanckley A, Boldon H, et al. Diagnosing the decline in pharmaceutical R&D efficiency. Nat Rev Drug Discov. 2012; 11: 191-200
|
|
|
|
2）医薬産業政策研究所. 製薬産業の将来像. 2007
|
|
|
|
|
|
3）辰巳邦彦. 主要基礎・臨床医学論文掲載数の国際比較. 政策研ニュース. 2012; 35: 48-9
|
|
|
|
|
|
4）閣議決定. 第四次科学技術基本計画. 東京. 2011
|
|
|
|
|
|
5）Orloff J, Douglas F, Pinheiro J, et al. The future of drug development: advancing clinical trial design. Nat Rev Drug Discov. 2009; 8: 949-57
|
|
|
|
|
|
6）Frank R, Hargreaves R. Clinical biomarkers in drug discovery and development. Nat Rev Drug Discov. 2003; 2: 566-80
|
|
|
|
|
|
7）Kingsmore SF, Lindquist IE, Mudge J, et al. Genome-wide association studies: progress and potential for drug discovery and development. Nat Rev Drug Discov. 2008; 7: 221-30
|
|
|
|
|
|
8）Paul SM, Mytelka DS, Dunwiddie CT, et al. How to improve R&D productivity: the pharmaceutical industrys grand challenge. Nat Rev Drug Discov. 2010; 9: 203-14
|
|
|
|
|
|
9）Zuckerman R, Milne C-P. Market watch: Industry perspectives on personalized medicine. Nat Rev Drug Discov. 2012; 11: 178
|
|
|
|
|
|
10）Gobburu JVS. Pharmacometrics 2020. J Clin Pharmacol. 2010; 50(9 Suppl): 151-7S
|
|
|
|
|
|
11）Lee JY, Garnett CE, Gobburu JVS, et al. Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008. Clin Pharmacokinet. 2011; 50: 627-35
|
|
|
|
|
|
12）Manolis E, Herold R. Pharmacometrics for regu-latory decision making: status and perspective. Clin Pharmacokinet. 2011; 50: 625-6
|
|
|
|
|
|
13）Ando Y, Hirakawa A, Uyama Y. Adaptive clinical trials for new drug applications in Japan. Eur Neuropsychopharmacol. 2011; 21: 175-9
|
|
|
|
|
|
14）Wang S-J, James Hung HM, ONeill R. Regulatory perspectives on multiplicity in adaptive design clinical trials throughout a drug development program. J Biopharm Stat. 2011; 21: 846-59
|
|
|
|
|
|
15）US Food and Drug Administration. Guidance for Industry Adaptive Design Clinical Trials for Drugs and Biologics (DRAFT GUIDANCE). 2010
|
|
|
|
|
|
16）Krejsa C, Rogge M, Sadee W. Protein thera-peutics: new applications for pharmacogenetics. Nat Rev Drug Discov. 2006; 5: 507-21
|
|
|
|
|
|
17）Uyama Y, Ishiguro A, Nakamura H, et al. Use of biomarker in drug development-Japanese per-spectives. In: Williams JA, Lalonde R, Koup J, et al. editors. Hoboken: John Wily & Sons, Inc; 2012
|
|
|
|
|
|
18）宇山佳明. 審査する立場からみたバイオマーカー. 臨床評価. 2011; 39: 340-4
|
|
|
|
|
19）Tominaga T, Asahina Y, Uyama Y, et al. Regulatory science as a bridge between science and society. Clin Pharmacol Ther. 2011; 90: 29-31
|
|
|
|
|
|
20）（独）医薬品医療機器総合機構. 独立行政法人医薬品医療機器総合機構におけるレギュラトリーサイエンス研究に関する基本的考え方. 東京．2011
|
|
|
|
|
|
21）（独）医薬品医療機器総合機構. PMDA Regulatory Science Homepage. 2012; Available from: http://www.pmda.go.jp/regulatory2/index.html
|
|
|
|
|
|
22）Hamburg MA. Advancing regulatory science. Science. 2011; 331: 987
|
|
|
|
|
|
23）US Food and Drug Administration. Identifying CDERs science and research needs report. 2011
|
|
|
|
|
|
24）The European Medicines Agency. Benefit-Risk Methodology Project. 2009
|
|
|
|
|
|
25）Brinkmann V, Billich A, Baumruker T, et al. Fingolimod (FTY720): discovery and develop-ment of an oral drug to treat multiple sclerosis. Nat Rev Drug Discov. 2010; 9: 883-97
|
|
|
|
|
|
26）Huynh T. The multiple sclerosis market. Nat Rev Drug Discov. 2010; 9: 759-60
|
|
|
|
|
|
27）Brinkmann V, Davis MD, Heise CE, et al. The immune modulator FTY720 targets sphingosine 1-phosphate receptors. J Biol Chem. 2002; 277: 21453-7
|
|
|
|
|
|
28）Mandala S, Hajdu R, Bergstrom J, et al. Altera-tion of lymphocyte trafficking by sphingosine-1-phosphate receptor agonists. Science. 2002; 296: 346-9
|
|
|
|
|
|
29）Bloomgren G, Richman S, Hotermans C, et al. Risk of natalizumab-associated progressive multifocal leukoencephalopathy. N Engl J Med. 2012; 366: 1870-80
|
|
|
|
|
|
30）厚生労働省医薬食品局審査管理課長, 厚生労働省医薬食品局安全対策課長. （通知）ゲノム薬理学における用語集について．2008
|
|
|
|
|
|
31）（独）医薬品医療機器総合機構. クリゾチニブ添付文書. Available from: http://www.info.pmda.go.jp/downfiles/ph/PDF/671450_4291026M1023_1_01.pdf
|
|
|
|
|
|
32）Chung WH, Hung SI, Hong HS, et al. Medical genetics: a marker for Stevens-Johnson syn-drome. Nature. 2004; 428: 486
|
|
|
|
|
|
33）Chen P, Lin JJ, Lu CS, et al. Carbamazepine-induced toxic effects and HLA-B*1502 screening in Taiwan. N Engl J Med. 2011; 364: 1126-33
|
|
|
|
|
|
34）Kaniwa N, Saito Y, Aihara M, et al. HLA-B locus in Japanese patients with anti-epileptics and allopurinol-related Stevens-Johnson syndrome and toxic epidermal necrolysis. Pharmaco-genomics. 2008; 9: 1617-22
|
|
|
|
|
|
35）Ozeki T, Mushiroda T, Yowang A, et al. Genome-wide association study identifies HLA-A*3101 allele as a genetic risk factor for carbamazepine-induced cutaneous adverse drug reactions in Japanese population. Hum Mol Genet. 2011; 20: 1034-41
|
|
|
|
|
|
36）厚生労働省医薬食品局審査管理課長，厚生労働省医薬食品局安全対策課長．（通知）医薬品またはバイオテクノロジー応用医薬品の開発におけるバイオマーカー: 適格性確認のための資料における用法の記載要領，資料の構成及び様式．東京．2011
|
|
|
|
|
|
37）（独）医薬品医療機器総合機構．ファーマコゲノミクス・バイオマーカー相談に関する記録．Available from: http://www.pmda.go.jp/operations/shonin/info/consult/m03_pharma_kekka.html
|
|
|
|
|
|
38）Hampel H, Frank R, Broich K, et al. Biomarkers for Alzheimers disease: academic, industry and regulatory perspectives. Nat Rev Drug Discov. 2010; 9: 560-74
|
|
|
|
|
|
39）中村治雅, 宇山佳明. 神経疾患における創薬研究・開発展望. Brain Nerve. 2012; 64: 229-35
|
|
|
|
|
40）Yokota T, Takeda S, Lu QL, et al. A renaissance for antisense oligonucleotide drugs in neurology exon skipping breaks new ground. Arch Neurol. 2009; 66: 32-8
|
|
|
|
|
|
41）Katsuno M, Banno H, Suzuki K, et al. Molecular pathophysiology and disease-modifying therapies for spinal and bulbar muscular atrophy. Arch Neurol. 2012; 69: 436-40
|
|
|
|
|
|
42）桑原 聡．Crow-Fukase症候群の新規治療展望．臨床神経．2010; 50: 794-6
|
|
|
|
|
43）Ichimaru K, Toyoshima S, Uyama Y. Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors. Clin Pharmacol Ther. 2010; 87: 362-6
|
|
|
|
|
|
44）Tambuyzer E. Rare diseases, orphan drugs and their regulation: questions and misconceptions. Nat Rev Drug Discov. 2010; 9: 921-9
|
|
|
|
|
|
45）Kneller R. The importance of new companies for drug discovery: origins of a decade of new drugs. Nat Rev Drug Discov. 2010; 9: 867-82
|
|
|
|
|