1)Warner S : Diagnostics+Therapy=Theranostics. Scientist 18:38-39,2004
2)New directions in diagnostics. Med Device Technol 11:33,2000
3)Del Vecchio S, Zannetti A, Fronti R, et al : Nuclear imaging in cancer theranostics. Q J Nucl Med Mol Imaging 51:152-163,2007
4)Papadopoulos N, Kinzler KW, Vogelstein B : The role of companion diagnostics in the development and use of mutation-targeted cancer therapies. Nat Biotechnol 24:985-995,2006
5)Draft guidance for industry and Food and Drug Administration staff - In vitro companion diagnostic devices. (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidance Documents/UCM262327.pdf)(accessed 2012-09-20)
6)Atkinson Jr AJ, Colburn WA, DeGruttola VG, et al : Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 69:89-95,2001
7)ゲノム薬理学における用語集(ICH E15ガイドライン)(http://www.pmda.go.jp/ich/e/e15_08_01_09.pdf)(accessed 2012-09-20)
8)Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels (http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm)(accessed 2012-09-20)
9)Phillips KA, Van Bebber S, Issa AM : Diagnostics and biomarker development: priming the pipeline. Nat Rev Drug Discov 5:463-469,2006
10)FDA DRAFT concept paper: Drug-Diagnostic Co-Development, April 2005 (http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/UCM116689.pdf)(accessed 2012-09-20)
11)Schubert C : Cancer drugs find a companion with new diagnostic tests. Nat Med 17:1157,2011
12)Poste G, Carbone DP, Parkinson DR, et al : Leveling the playing field: bringing development of biomarkers and molecular diagnostics up to the standards for drug development. Clin Cancer Res 18:1515-1523,2012
13)Pickl M, Ruge E, Venturi M : Predictive markers in early research and companion diagnostic developments in oncology. New Biotechnol 29:651-655,2012
14)Huang SM, Goodsaid F, Rahman A, et al : Application of pharmacogenomics in clinical pharmacology. Toxicol Mech Methods 16:89-99,2006
15)Reflection paper on co-development of pharmacogenomics biomarkers and assays in the context of drug development. (http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/07/WC500094445.pdf)(accessed 2012-09-20)
16)Schmidt C : Challenges ahead for companion diagnostics. J Natl Cancer Inst 104:14-15,2012
17)Moore MW, Babu D, Cotter PD : Challenges in the codevelopment of companion diagnostics. Pers Med 9:485-496,2012
18)Cheng S, Koch WH, Wu L : Co-development of a companion diagnostic for targeted cancer therapy. New Biotechnol 29:682-688,2012