Governmental and Academic Efforts to Advance the Field of Pharmacogenomics
作者： Larisa H. Cavallari , Teri E. Klein , Shiew-Mei Huang
DOI: 10.1016/B978-0-12-391918-2.00003-2
关键词: International HapMap Project 、 PharmGKB 、 Pharmacogenomics 、 Personalized medicine 、 Public relations 、 Bioinformatics 、 1000 Genomes Project 、 Drug development 、 Candidate gene 、 Human genome 、 Medicine
摘要: Abstract With the completion of Human Genome Project in 2003 came significant interest elucidating genetic contributors to drug response. Data from subsequent International HapMap allowed pharmacogenomic studies extend beyond a candidate gene focus. Genome-wide association studies, enriched with data 1000 Genomes Project, have led discoveries previously unsuspected genes linked Both National Institutes Health (NIH) and U.S. Food Drug Administration (FDA) invested resources toward further advancing field pharmacogenomics. This chapter will discuss efforts by NIH, FDA, non-U.S. regulatory agencies promote research, encourage integration development process, address scientific challenges associated clinical implementation data.
sci-hub.se 参考文章(74)
M V Relling, T E Klein, CPIC: Clinical Pharmacogenetics Implementation Consortium of the Pharmacogenomics Research Network Clinical Pharmacology & Therapeutics. ,vol. 89, pp. 464- 467 ,(2011) , 10.1038/CLPT.2010.279
Issam Zineh, Janet Woodcock, The clinical pharmacogeneticist: An emerging regulatory scientist at the US Food and Drug Administration Human Genomics. ,vol. 4, pp. 221- 225 ,(2010) , 10.1186/1479-7364-4-4-221
S G Leckband, J R Kelsoe, H M Dunnenberger, A L George, E Tran, R Berger, D J Müller, M Whirl-Carrillo, K E Caudle, M Pirmohamed, Clinical pharmacogenetics implementation consortium guidelines for HLA-B genotype and carbamazepine dosing Clinical Pharmacology & Therapeutics. ,vol. 94, pp. 324- 328 ,(2012) , 10.1038/CLPT.2013.103
Yasuto Otsubo, Yasuko Asahina, Atsushi Noguchi, Yumiko Sato, Yuki Ando, Yoshiaki Uyama, Similarities and Differences between US and Japan as to Pharmacogenomic Biomarker Information in Drug Labels Drug Metabolism and Pharmacokinetics. ,vol. 27, pp. 142- 149 ,(2012) , 10.2133/DMPK.DMPK-11-RV-082
D R Abernethy, J Woodcock, L J Lesko, Pharmacological mechanism-based drug safety assessment and prediction. Clinical Pharmacology & Therapeutics. ,vol. 89, pp. 793- 797 ,(2011) , 10.1038/CLPT.2011.55
K R Crews, A Gaedigk, H M Dunnenberger, T E Klein, D D Shen, J T Callaghan, E D Kharasch, T C Skaar, Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for Codeine Therapy in the Context of Cytochrome P450 2D6 (CYP2D6) Genotype Clinical Pharmacology & Therapeutics. ,vol. 91, pp. 321- 326 ,(2012) , 10.1038/CLPT.2011.287
Francis S. Collins, , Eric D. Green, Alan E. Guttmacher, Mark S. Guyer, A vision for the future of genomics research Nature. ,vol. 422, pp. 835- 847 ,(2003) , 10.1038/NATURE01626
Gualberto Ruaño, Jerry M Collins, Andrew J Dorner, Sue-Jane Wang, Roberto Guerciolini, Shiew-Mei Huang, Pharmacogenomic data submissions to the FDA: clinical pharmacology case studies. Pharmacogenomics. ,vol. 5, pp. 513- 517 ,(2004) , 10.1517/14622416.5.5.513
Shiew-Mei Huang, Janet Woodcock, Transporters in drug development: advancing on the Critical Path Nature Reviews Drug Discovery. ,vol. 9, pp. 175- 176 ,(2010) , 10.1038/NRD3124
L M Hinman, S-M Huang, J Hackett, W H Koch, P Y Love, G Pennello, A Torres-Cabassa, C Webster, The drug diagnostic co-development concept paper: commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop. Pharmacogenomics Journal. ,vol. 6, pp. 375- 380 ,(2006) , 10.1038/SJ.TPJ.6500392