Art

J-GLOBAL ID：201702267855929925   Reference number：17A0870774

Current and Future Issues of Companion Diagnostics

コンパニオン診断薬の現状と今後の課題

Author (3)： TSUKUMO YOSHINORI (国立医薬品食品衛生研究所 遺伝子医薬部) ,  SUZUKI TAKAYOSHI (国立医薬品食品衛生研究所 遺伝子医薬部) ,  NAITO MIKIHIKO (国立医薬品食品衛生研究所 遺伝子医薬部)
Material： レギュラトリーサイエンス学会誌  (RSMP)
Volume： 7  Issue： 2  Page： 71-80(J-STAGE)  Publication year： 2017 
JST Material Number： F1425A  ISSN： 2185-7113  Document type： Article
Article type： 解説  Country of issue： Japan (JPN)  Language： JAPANESE (JA)

Thesaurus term： *diagnostic drug ,...
Semi thesaurus term： genetic variation ,...

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Author keywords (10)： companion diagnostics (CoDx) ,  molecular targeted drugs ,  next generation sequence (NGS) ,  precision medicine ,  cancer ,  companion diagnostics (CoDx) ,  molecular targeted drugs ,  next generation sequence (NGS) ,  precision medicine ,  cancer

JST classification (3)： Clinical application of diagnostic drugs  (GW20020A) ,  Diagnosis of tumors(=neoplasms)  (GE03020J) ,  Research methods in genetics  (EC01020N)

Reference (32)：

• 1) Trastuzumab, Genentech Herceptin approval letter. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm091360.pdf
• 2) Gleevec approval letter. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-335_Gleevec_Approv.pdf
• 3) Druker BJ, Talpaz M, Resta DJ, Peng B, Buchdunger E, Ford JM et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med. 2001; 344: 1031-1037.
• 4) Druker BJ, Sawyers CL, Kantarjian H, Resta DJ, Reese SF, Ford JM et al. Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronic myeloid leukemia and acute lymphoblastic leukemia with the Philadelphia chromosome. N Engl J Med. 2001; 344: 1038-1042.
• 5) Paez JG, Jänne PA, Lee JC, Tracy S, Greulich H, Gabriel S et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science. 2004; 304: 1497-1500.

Terms in the title (2)： コンパニオン診断薬 ,  現状