Φαρμακογονιδιωματική και αξιολόγηση νέων φαρμάκων
Keywords:
Εξατομικευμένη Ιατρική, φαρμακογονιδιωματική, ρυθμιστικές αρχές, ΕΜΑ, FDA, PMDA, κατευθυντήριες γραμμές
Abstract
Η φαρμακογονιδιωματική, ένας από τους ακρογωνιαίους λίθους της εξατομικευμένης ιατρικής, έχει τη δυνατότητα να αλλάξει τον τρόπο που παρέχεται η ιατρική φροντίδα ως σήμερα, κατατάσσοντας τους ασθενείς σε διάφορες κατηγορίες πριν την έναρξη της φαρμακευτικής αγωγής, δηλαδή σε ασθενείς με τάση να ανταποκριθούν στη θεραπεία, να μην ανταποκριθούν ή να εμφανίσουν ανεπιθύμητες ενέργειες. Με σκοπό την πρόοδο της διαδικασίας ανάπτυξης φαρμάκων, οι ρυθμιστικές αρχές, έχουν εκδώσει κατευθυντήριες γραμμές για τον τομέα της φαρμακογονιδιωματικής εδώ και μια δεκαετία. Στο άρθρο αυτό συνοψίζονται οι νέες κατευθυντήριες γραμμές για την εφαρμογή της φαρμακογονιδιωματικής στην ανάπτυξη νέων φαρμάκων, με μία κοινή ρυθμιστική οπτική μεταξύ της Ευρώπης, των Ηνωμένων Πολιτειών και της Ιαπωνίας, με έμφαση στη κλινική φαρμακοκινητική.
References
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Daly, A. K. (2010). Pharmacogenetics and human genetic polymorphisms. Biochem J, 429(3), 435-449. doi: 10.1042/BJ20100522
Eichelbaum, M., Ingelman-Sundberg, M., & Evans, W. E. (2006). Pharmacogenomics and individualized drug therapy. Annu Rev Med, 57, 119-137. doi: 10.1146/annurev.med.56.082103.104724
Evans, W. E., & Relling, M. V. (1999). Pharmacogenomics: translating functional genomics into rational therapeutics. Science, 286(5439), 487-491.
Frueh, F. W., Amur, S., Mummaneni, P., Epstein, R. S., Aubert, R. E., DeLuca, T. M., . . . Lesko, L. J. (2008). Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use. Pharmacotherapy, 28(8), 992-998. doi: 10.1592/phco.28.8.992
Fürst, J., Bottà, G., Saino, S., Dopinto, S., Gandini, R., Dossena, S., . . . Paulmichl, M. (2006). The ICln interactome. Acta Physiol (Oxf), 187(1-2), 43-49. doi: 10.1111/j.1748-1716.2006.01549.x
Ge, H., Liu, Z., Church, G. M., & Vidal, M. (2001). Correlation between transcriptome and interactome mapping data from Saccharomyces cerevisiae. Nat Genet, 29(4), 482-486. doi: 10.1038/ng776
Giacomini, K. M., Huang, S. M., Tweedie, D. J., Benet, L. Z., Brouwer, K. L., Chu, X., . . . Consortium, I. T. (2010). Membrane transporters in drug development. Nat Rev Drug Discov, 9(3), 215-236. doi: 10.1038/nrd3028
Goodsaid, F., & Papaluca, M. (2010). Evolution of biomarker qualification at the health authorities. Nat Biotechnol, 28(5), 441-443. doi: 10.1038/nbt0510-441
Goodsaid, F. M., Amur, S., Aubrecht, J., Burczynski, M. E., Carl, K., Catalano, J., . . . Zineh, I. (2010). Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact. Nat Rev Drug Discov, 9(6), 435-445. doi: 10.1038/nrd3116
Ho, R. H., Tirona, R. G., Leake, B. F., Glaeser, H., Lee, W., Lemke, C. J., . . . Kim, R. B. (2006). Drug and bile acid transporters in rosuvastatin hepatic uptake: function, expression, and pharmacogenetics. Gastroenterology, 130(6), 1793-1806. doi: 10.1053/j.gastro.2006.02.034
Ishiguro, A. (2008). Current japanese regulatory situations of pharmacogenomics in drug administration. In S. a. U. Toyoshima, Y. (Ed.), (Vol. 1, pp. 505-514). Expert Rev. Clin. Pharmacol.
Issa, A. M. (2002). Ethical perspectives on pharmacogenomic profiling in the drug development process. Nat Rev Drug Discov, 1(4), 300-308. doi: 10.1038/nrd771
Katz, D. A., Murray, B., Bhathena, A., & Sahelijo, L. (2008). Defining drug disposition determinants: a pharmacogenetic-pharmacokinetic strategy. Nat Rev Drug Discov, 7(4), 293-305. doi: 10.1038/nrd2486
Kohane, I. S. (2012). (Mis)treating the pharmacogenetic incidentalome. Nat Rev Drug Discov, 11(2), 89-90. doi: 10.1038/nrd3659
Kohane, I. S., Hsing, M., & Kong, S. W. (2012). Taxonomizing, sizing, and overcoming the incidentalome. Genet Med, 14(4), 399-404. doi: 10.1038/gim.2011.68
Kohane, I. S., Mandl, K. D., Taylor, P. L., Holm, I. A., Nigrin, D. J., & Kunkel, L. M. (2007). Medicine. Reestablishing the researcher-patient compact. Science, 316(5826), 836-837. doi: 10.1126/science.1135489
Kohane, I. S., Masys, D. R., & Altman, R. B. (2006). The incidentalome: a threat to genomic medicine. JAMA, 296(2), 212-215. doi: 10.1001/jama.296.2.212
Lenzini, P., Wadelius, M., Kimmel, S., Anderson, J. L., Jorgensen, A. L., Pirmohamed, M., . . . Gage, B. F. (2010). Integration of genetic, clinical, and INR data to refine warfarin dosing. Clin Pharmacol Ther, 87(5), 572-578. doi: 10.1038/clpt.2010.13
Lesko, L. J., & Woodcock, J. (2002). Pharmacogenomic-guided drug development: regulatory perspective. Pharmacogenomics J, 2(1), 20-24.
Lesko, L. J., & Woodcock, J. (2004). Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective. Nat Rev Drug Discov, 3(9), 763-769. doi: 10.1038/nrd1499
Lim, J., Hao, T., Shaw, C., Patel, A. J., Szabó, G., Rual, J. F., . . . Zoghbi, H. Y. (2006). A protein-protein interaction network for human inherited ataxias and disorders of Purkinje cell degeneration. Cell, 125(4), 801-814. doi: 10.1016/j.cell.2006.03.032
Lindpaintner, K. (2002). The impact of pharmacogenetics and pharmacogenomics on drug discovery. Nat Rev Drug Discov, 1(6), 463-469. doi: 10.1038/nrd823
Link, E., Parish, S., Armitage, J., Bowman, L., Heath, S., Matsuda, F., . . . Group, S. C. (2008). SLCO1B1 variants and statin-induced myopathy--a genomewide study. N Engl J Med, 359(8), 789-799. doi: 10.1056/NEJMoa0801936
Ma, Q., & Lu, A. Y. (2011). Pharmacogenetics, pharmacogenomics, and individualized medicine. Pharmacol Rev, 63(2), 437-459. doi: 10.1124/pr.110.003533
Mega, J. L., Close, S. L., Wiviott, S. D., Shen, L., Walker, J. R., Simon, T., . . . Sabatine, M. S. (2010). Genetic variants in ABCB1 and CYP2C19 and cardiovascular outcomes after treatment with clopidogrel and prasugrel in the TRITON-TIMI 38 trial: a pharmacogenetic analysis. Lancet, 376(9749), 1312-1319. doi: 10.1016/S0140-6736(10)61273-1
Mega, J. L., Simon, T., Collet, J. P., Anderson, J. L., Antman, E. M., Bliden, K., . . . Sabatine, M. S. (2010). Reduced-function CYP2C19 genotype and risk of adverse clinical outcomes among patients treated with clopidogrel predominantly for PCI: a meta-analysis. JAMA, 304(16), 1821-1830. doi: 10.1001/jama.2010.1543
Mirnezami, R., Nicholson, J., & Darzi, A. (2012). Preparing for precision medicine. N Engl J Med, 366(6), 489-491. doi: 10.1056/NEJMp1114866
Moving toward precision medicine. (2011). Lancet, 378(9804), 1678. doi: 10.1016/S0140-6736(11)61725-X
Ozsolak, F. (2012). Third-generation sequencing techniques and applications to drug discovery. Expert Opin Drug Discov, 7(3), 231-243. doi: 10.1517/17460441.2012.660145
Pasanen, M. K., Neuvonen, M., Neuvonen, P. J., & Niemi, M. (2006). SLCO1B1 polymorphism markedly affects the pharmacokinetics of simvastatin acid. Pharmacogenet Genomics, 16(12), 873-879. doi: 10.1097/01.fpc.0000230416.82349.90
Paulmichl, M., Li, Y., Wickman, K., Ackerman, M., Peralta, E., & Clapham, D. (1992). New mammalian chloride channel identified by expression cloning. Nature, 356(6366), 238-241. doi: 10.1038/356238a0
Phillips, K. A., & Van Bebber, S. L. (2005). Measuring the value of pharmacogenomics. Nat Rev Drug Discov, 4(6), 500-509. doi: 10.1038/nrd1749
Rual, J. F., Venkatesan, K., Hao, T., Hirozane-Kishikawa, T., Dricot, A., Li, N., . . . Vidal, M. (2005). Towards a proteome-scale map of the human protein-protein interaction network. Nature, 437(7062), 1173-1178. doi: 10.1038/nature04209
Shah, J. (2003). Economic and regulatory considerations in pharmacogenomics for drug licensing and healthcare. Nat Biotechnol, 21(7), 747-753. doi: 10.1038/nbt0703-747
Shuldiner, A. R., O’Connell, J. R., Bliden, K. P., Gandhi, A., Ryan, K., Horenstein, R. B., . . . Gurbel, P. A. (2009). Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy. JAMA, 302(8), 849-857. doi: 10.1001/jama.2009.1232
Sim, S. C., & Ingelman-Sundberg, M. (2011). Pharmacogenomic biomarkers: new tools in current and future drug therapy. Trends Pharmacol Sci, 32(2), 72-81. doi: 10.1016/j.tips.2010.11.008
Stumpf, M. P., Thorne, T., de Silva, E., Stewart, R., An, H. J., Lappe, M., & Wiuf, C. (2008). Estimating the size of the human interactome. Proc Natl Acad Sci U S A, 105(19), 6959-6964. doi: 10.1073/pnas.0708078105
Teichert, M., Eijgelsheim, M., Rivadeneira, F., Uitterlinden, A. G., van Schaik, R. H., Hofman, A., . . . Stricker, B. H. (2009). A genome-wide association study of acenocoumarol maintenance dosage. Hum Mol Genet, 18(19), 3758-3768. doi: 10.1093/hmg/ddp309
Uyama, Y., Ishiguro, A., Nakamura, H. & Nakamura, H. (2012). Predictive approaches in drug discovery and development: biomarkers and in vitro/in vivo correlations (J. Williams, Lalonde, R., Koup, J. & DD, C. Ed. Vol. Ch. 11): John Wiley & Sons.
Venkatesan, K., Rual, J. F., Vazquez, A., Stelzl, U., Lemmens, I., Hirozane-Kishikawa, T., . . . Vidal, M. (2009). An empirical framework for binary interactome mapping. Nat Methods, 6(1), 83-90. doi: 10.1038/nmeth.1280
Vidal, M., Cusick, M. E., & Barabási, A. L. (2011). Interactome networks and human disease. Cell, 144(6), 986-998. doi: 10.1016/j.cell.2011.02.016
Wang, L., McLeod, H. L., & Weinshilboum, R. M. (2011). Genomics and drug response. N Engl J Med, 364(12), 1144-1153. doi: 10.1056/NEJMra1010600
Weinshilboum, R., & Wang, L. (2004). Pharmacogenomics: bench to bedside. Nat Rev Drug Discov, 3(9), 739-748. doi: 10.1038/nrd1497
Williams, J. A., Andersson, T., Andersson, T. B., Blanchard, R., Behm, M. O., Cohen, N., . . . Wrighton, S. A. (2008). PhRMA white paper on ADME pharmacogenomics. J Clin Pharmacol, 48(7), 849-889. doi: 10.1177/0091270008319329
Yu, H., Tardivo, L., Tam, S., Weiner, E., Gebreab, F., Fan, C., . . . Vidal, M. (2011). Next-generation sequencing to generate interactome datasets. Nat Methods, 8(6), 478-480. doi: 10.1038/nmeth.1597
Zineh, I., & Pacanowski, M. A. (2011). Pharmacogenomics in the assessment of therapeutic risks versus benefits: inside the United States Food and Drug Administration. Pharmacotherapy, 31(8), 729-735. doi: 10.1592/phco.31.8.729
Περισσότερες πληροφορίες
Committee for Medicinal Products for Human Use:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp&mid=WC0b01ac0580028c79
EMA — Qualification of novel methodologies for medicine development:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp&mid=WC0b01ac0580022bb0
EMA workshop on pharmacogenomics: from science to clinical care:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2012/04/event_detail_000559.jsp&mid=WC0b01ac058004d5c3
Innovation Task Force:
http://www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000334.jsp&mid=WC0b01ac05800ba1d9
International Conference on Harmonisation — Guidelines:
http://www.ich.org/products/guidelines.html
Pharmacogenomics Working Party:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/CHMP/people_listing_000018.jsp&mid=WC0b01ac0580028d91
Pharmacokinetics Working Party:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/CHMP/people_listing_000070.jsp&mid=WC0b01ac05802327c9
Table of Pharmacogenomic Biomarkers in Drug Labels:
http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm
Daly, A. K. (2010). Pharmacogenetics and human genetic polymorphisms. Biochem J, 429(3), 435-449. doi: 10.1042/BJ20100522
Eichelbaum, M., Ingelman-Sundberg, M., & Evans, W. E. (2006). Pharmacogenomics and individualized drug therapy. Annu Rev Med, 57, 119-137. doi: 10.1146/annurev.med.56.082103.104724
Evans, W. E., & Relling, M. V. (1999). Pharmacogenomics: translating functional genomics into rational therapeutics. Science, 286(5439), 487-491.
Frueh, F. W., Amur, S., Mummaneni, P., Epstein, R. S., Aubert, R. E., DeLuca, T. M., . . . Lesko, L. J. (2008). Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use. Pharmacotherapy, 28(8), 992-998. doi: 10.1592/phco.28.8.992
Fürst, J., Bottà, G., Saino, S., Dopinto, S., Gandini, R., Dossena, S., . . . Paulmichl, M. (2006). The ICln interactome. Acta Physiol (Oxf), 187(1-2), 43-49. doi: 10.1111/j.1748-1716.2006.01549.x
Ge, H., Liu, Z., Church, G. M., & Vidal, M. (2001). Correlation between transcriptome and interactome mapping data from Saccharomyces cerevisiae. Nat Genet, 29(4), 482-486. doi: 10.1038/ng776
Giacomini, K. M., Huang, S. M., Tweedie, D. J., Benet, L. Z., Brouwer, K. L., Chu, X., . . . Consortium, I. T. (2010). Membrane transporters in drug development. Nat Rev Drug Discov, 9(3), 215-236. doi: 10.1038/nrd3028
Goodsaid, F., & Papaluca, M. (2010). Evolution of biomarker qualification at the health authorities. Nat Biotechnol, 28(5), 441-443. doi: 10.1038/nbt0510-441
Goodsaid, F. M., Amur, S., Aubrecht, J., Burczynski, M. E., Carl, K., Catalano, J., . . . Zineh, I. (2010). Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact. Nat Rev Drug Discov, 9(6), 435-445. doi: 10.1038/nrd3116
Ho, R. H., Tirona, R. G., Leake, B. F., Glaeser, H., Lee, W., Lemke, C. J., . . . Kim, R. B. (2006). Drug and bile acid transporters in rosuvastatin hepatic uptake: function, expression, and pharmacogenetics. Gastroenterology, 130(6), 1793-1806. doi: 10.1053/j.gastro.2006.02.034
Ishiguro, A. (2008). Current japanese regulatory situations of pharmacogenomics in drug administration. In S. a. U. Toyoshima, Y. (Ed.), (Vol. 1, pp. 505-514). Expert Rev. Clin. Pharmacol.
Issa, A. M. (2002). Ethical perspectives on pharmacogenomic profiling in the drug development process. Nat Rev Drug Discov, 1(4), 300-308. doi: 10.1038/nrd771
Katz, D. A., Murray, B., Bhathena, A., & Sahelijo, L. (2008). Defining drug disposition determinants: a pharmacogenetic-pharmacokinetic strategy. Nat Rev Drug Discov, 7(4), 293-305. doi: 10.1038/nrd2486
Kohane, I. S. (2012). (Mis)treating the pharmacogenetic incidentalome. Nat Rev Drug Discov, 11(2), 89-90. doi: 10.1038/nrd3659
Kohane, I. S., Hsing, M., & Kong, S. W. (2012). Taxonomizing, sizing, and overcoming the incidentalome. Genet Med, 14(4), 399-404. doi: 10.1038/gim.2011.68
Kohane, I. S., Mandl, K. D., Taylor, P. L., Holm, I. A., Nigrin, D. J., & Kunkel, L. M. (2007). Medicine. Reestablishing the researcher-patient compact. Science, 316(5826), 836-837. doi: 10.1126/science.1135489
Kohane, I. S., Masys, D. R., & Altman, R. B. (2006). The incidentalome: a threat to genomic medicine. JAMA, 296(2), 212-215. doi: 10.1001/jama.296.2.212
Lenzini, P., Wadelius, M., Kimmel, S., Anderson, J. L., Jorgensen, A. L., Pirmohamed, M., . . . Gage, B. F. (2010). Integration of genetic, clinical, and INR data to refine warfarin dosing. Clin Pharmacol Ther, 87(5), 572-578. doi: 10.1038/clpt.2010.13
Lesko, L. J., & Woodcock, J. (2002). Pharmacogenomic-guided drug development: regulatory perspective. Pharmacogenomics J, 2(1), 20-24.
Lesko, L. J., & Woodcock, J. (2004). Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective. Nat Rev Drug Discov, 3(9), 763-769. doi: 10.1038/nrd1499
Lim, J., Hao, T., Shaw, C., Patel, A. J., Szabó, G., Rual, J. F., . . . Zoghbi, H. Y. (2006). A protein-protein interaction network for human inherited ataxias and disorders of Purkinje cell degeneration. Cell, 125(4), 801-814. doi: 10.1016/j.cell.2006.03.032
Lindpaintner, K. (2002). The impact of pharmacogenetics and pharmacogenomics on drug discovery. Nat Rev Drug Discov, 1(6), 463-469. doi: 10.1038/nrd823
Link, E., Parish, S., Armitage, J., Bowman, L., Heath, S., Matsuda, F., . . . Group, S. C. (2008). SLCO1B1 variants and statin-induced myopathy--a genomewide study. N Engl J Med, 359(8), 789-799. doi: 10.1056/NEJMoa0801936
Ma, Q., & Lu, A. Y. (2011). Pharmacogenetics, pharmacogenomics, and individualized medicine. Pharmacol Rev, 63(2), 437-459. doi: 10.1124/pr.110.003533
Mega, J. L., Close, S. L., Wiviott, S. D., Shen, L., Walker, J. R., Simon, T., . . . Sabatine, M. S. (2010). Genetic variants in ABCB1 and CYP2C19 and cardiovascular outcomes after treatment with clopidogrel and prasugrel in the TRITON-TIMI 38 trial: a pharmacogenetic analysis. Lancet, 376(9749), 1312-1319. doi: 10.1016/S0140-6736(10)61273-1
Mega, J. L., Simon, T., Collet, J. P., Anderson, J. L., Antman, E. M., Bliden, K., . . . Sabatine, M. S. (2010). Reduced-function CYP2C19 genotype and risk of adverse clinical outcomes among patients treated with clopidogrel predominantly for PCI: a meta-analysis. JAMA, 304(16), 1821-1830. doi: 10.1001/jama.2010.1543
Mirnezami, R., Nicholson, J., & Darzi, A. (2012). Preparing for precision medicine. N Engl J Med, 366(6), 489-491. doi: 10.1056/NEJMp1114866
Moving toward precision medicine. (2011). Lancet, 378(9804), 1678. doi: 10.1016/S0140-6736(11)61725-X
Ozsolak, F. (2012). Third-generation sequencing techniques and applications to drug discovery. Expert Opin Drug Discov, 7(3), 231-243. doi: 10.1517/17460441.2012.660145
Pasanen, M. K., Neuvonen, M., Neuvonen, P. J., & Niemi, M. (2006). SLCO1B1 polymorphism markedly affects the pharmacokinetics of simvastatin acid. Pharmacogenet Genomics, 16(12), 873-879. doi: 10.1097/01.fpc.0000230416.82349.90
Paulmichl, M., Li, Y., Wickman, K., Ackerman, M., Peralta, E., & Clapham, D. (1992). New mammalian chloride channel identified by expression cloning. Nature, 356(6366), 238-241. doi: 10.1038/356238a0
Phillips, K. A., & Van Bebber, S. L. (2005). Measuring the value of pharmacogenomics. Nat Rev Drug Discov, 4(6), 500-509. doi: 10.1038/nrd1749
Rual, J. F., Venkatesan, K., Hao, T., Hirozane-Kishikawa, T., Dricot, A., Li, N., . . . Vidal, M. (2005). Towards a proteome-scale map of the human protein-protein interaction network. Nature, 437(7062), 1173-1178. doi: 10.1038/nature04209
Shah, J. (2003). Economic and regulatory considerations in pharmacogenomics for drug licensing and healthcare. Nat Biotechnol, 21(7), 747-753. doi: 10.1038/nbt0703-747
Shuldiner, A. R., O’Connell, J. R., Bliden, K. P., Gandhi, A., Ryan, K., Horenstein, R. B., . . . Gurbel, P. A. (2009). Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy. JAMA, 302(8), 849-857. doi: 10.1001/jama.2009.1232
Sim, S. C., & Ingelman-Sundberg, M. (2011). Pharmacogenomic biomarkers: new tools in current and future drug therapy. Trends Pharmacol Sci, 32(2), 72-81. doi: 10.1016/j.tips.2010.11.008
Stumpf, M. P., Thorne, T., de Silva, E., Stewart, R., An, H. J., Lappe, M., & Wiuf, C. (2008). Estimating the size of the human interactome. Proc Natl Acad Sci U S A, 105(19), 6959-6964. doi: 10.1073/pnas.0708078105
Teichert, M., Eijgelsheim, M., Rivadeneira, F., Uitterlinden, A. G., van Schaik, R. H., Hofman, A., . . . Stricker, B. H. (2009). A genome-wide association study of acenocoumarol maintenance dosage. Hum Mol Genet, 18(19), 3758-3768. doi: 10.1093/hmg/ddp309
Uyama, Y., Ishiguro, A., Nakamura, H. & Nakamura, H. (2012). Predictive approaches in drug discovery and development: biomarkers and in vitro/in vivo correlations (J. Williams, Lalonde, R., Koup, J. & DD, C. Ed. Vol. Ch. 11): John Wiley & Sons.
Venkatesan, K., Rual, J. F., Vazquez, A., Stelzl, U., Lemmens, I., Hirozane-Kishikawa, T., . . . Vidal, M. (2009). An empirical framework for binary interactome mapping. Nat Methods, 6(1), 83-90. doi: 10.1038/nmeth.1280
Vidal, M., Cusick, M. E., & Barabási, A. L. (2011). Interactome networks and human disease. Cell, 144(6), 986-998. doi: 10.1016/j.cell.2011.02.016
Wang, L., McLeod, H. L., & Weinshilboum, R. M. (2011). Genomics and drug response. N Engl J Med, 364(12), 1144-1153. doi: 10.1056/NEJMra1010600
Weinshilboum, R., & Wang, L. (2004). Pharmacogenomics: bench to bedside. Nat Rev Drug Discov, 3(9), 739-748. doi: 10.1038/nrd1497
Williams, J. A., Andersson, T., Andersson, T. B., Blanchard, R., Behm, M. O., Cohen, N., . . . Wrighton, S. A. (2008). PhRMA white paper on ADME pharmacogenomics. J Clin Pharmacol, 48(7), 849-889. doi: 10.1177/0091270008319329
Yu, H., Tardivo, L., Tam, S., Weiner, E., Gebreab, F., Fan, C., . . . Vidal, M. (2011). Next-generation sequencing to generate interactome datasets. Nat Methods, 8(6), 478-480. doi: 10.1038/nmeth.1597
Zineh, I., & Pacanowski, M. A. (2011). Pharmacogenomics in the assessment of therapeutic risks versus benefits: inside the United States Food and Drug Administration. Pharmacotherapy, 31(8), 729-735. doi: 10.1592/phco.31.8.729
Περισσότερες πληροφορίες
Committee for Medicinal Products for Human Use:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp&mid=WC0b01ac0580028c79
EMA — Qualification of novel methodologies for medicine development:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp&mid=WC0b01ac0580022bb0
EMA workshop on pharmacogenomics: from science to clinical care:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2012/04/event_detail_000559.jsp&mid=WC0b01ac058004d5c3
Innovation Task Force:
http://www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000334.jsp&mid=WC0b01ac05800ba1d9
International Conference on Harmonisation — Guidelines:
http://www.ich.org/products/guidelines.html
Pharmacogenomics Working Party:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/CHMP/people_listing_000018.jsp&mid=WC0b01ac0580028d91
Pharmacokinetics Working Party:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/CHMP/people_listing_000070.jsp&mid=WC0b01ac05802327c9
Table of Pharmacogenomic Biomarkers in Drug Labels:
http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm
Published
2023-05-31
Section
Πρωτότυπα ερευνητικά άρθρα
