Chan D. S., Lau R., Aune D., Vieira R., Greenwood D. C., Kampman E., Norat T. Red and processed meat and colorectal cancer incidence: meta-analysis of prospective studies // PLoS One. 2011. Vol. 6. № 6, e20456.
Truswell A. S. Problems with red meat in the WCRF2 // American Journal of Clinical Nutrition. 2009. Vol. 89. № 4. P. 1274–1275.
Wei E. K., Giovannucci E., Wu K., Rosner B., Fuchs C. S., Willett W. C., Colditz G. A. Comparison of risk factors for colon and rectal cancer // International Journal of Cance. 2004. January 20. Vol. 108. № 3. P. 433–442.
Tai V., Grey A., Bolland M. J. Results of observational studies: analysis of findings from the Nurses’ Health Study // PLoS One. 2014. Vol. 9. № 10, e110403.
Часть пятая
Overington J. P., Al-Lazikani B., Hopkins A. L. How many drug targets are there? // Nature reviews. Drug discovery. 2006. December. Vol. 5. № 12. P. 993–996.
Kaplan R. M., Irvin V. L. Likelihood of null effects of large NHLBI clinical trials has increased over time // Plos Оne. 2015. August 5. Vol. 10. № 8, e0132382.
Chalmers I., Glasziou P. Avoidable waste in the production and reporting of research evidence // Lancet. 2009. Vol. 374. № 9683. P. 86–89.
Prinz F., Schlange T., Asadullah K. Believe it or not: how much can we rely on published data on potential drug targets? // Nature Reviews Drug Discovery. 2011. Vol. 10. № 9. P. 712–713.
Begley C. G. Six red flags for suspect work // Nature. 2013. May 23. Vol. 497. № 7450. P. 433–434.
Begley C. G., Ellis L. M. Raise standards for preclinical cancer research // Nature. 2012. March 29. Vol. 483. P. 531–533.
Plourde G. Validation of surrogate endpoints for clinical trials // Journal of Pharmacology & Clinical Research. 2018. Vol. 5. № 2, 555657.
Васильев А. Н., Ниязов Р. Р., Гавришина Е. В., Драницына М. А., Куличев Д. А. Проблемы планирования и проведения доклинических исследований в Российской Федерации // Ремедиум. 2017. № 9. C. 6–18.
Ganellin R., Roberts S. M., Jefferies R. (eds.) Introduction to biological and small molecule drug research and development, theory and case studies. New York: Academic Press, 2013.
Patnaik A., Kang S. P., Rasco D., Papadopoulos K. P., Elassaiss-Schaap J. et al. Phase I Study of Pembrolizumab (MK-3475; Anti-PD-1 Monoclonal Antibody) in Patients With Advanced Solid Tumors // Clinical Cancer Research. 2015. Vol. 21. № 19. P. 4286–4293.
Wong C. H., Siah K. W., Lo A. W. Estimation of clinical trial success rates and related parameters // Biostatistics. 2018. January.
Lounnas V., Ritschel T., Kelder J., McGuire R., Bywater R. P., Foloppe N. Current progress in Structure-Based Rational Drug Design marks a new mindset in drug discovery // Computational and structural biotechnology journal. 2013. Vol. 5. № 6, e201302011.
Thomas D. W., Burns J., Audette J., Carroll A., Dow-Hygelund C., Hay M. Clinical development success rates 2006–2015. Biotechnology Innovation Organization. 2016. June. P. 8.
Paul S. M., Mytelka D. S., Dunwiddie C. T., Persinger C. C., Munos B. H. et al. How to improve R&D productivity: the pharmaceutical industry’s grand challenge // Nature Reviews Drug Discovery. 2010. March. Vol. 9. № 3. P. 203–214.
Schuhmacher A., Gassmann O., Hinder M. Changing R&D models in research-based pharmaceutical companies // Journal of translational medicine. 2016. Vol. 14. № 1. P. 105.
Arrowsmith J., Miller P. Trial watch: phase II and phase III attrition rates 2011–2012 // Nature reviews Drug discovery. 2013. August. Vol. 12. № 8. P. 569.
Chrisafis A. French drug trial leaves one brain dead and five critically ill // The Guardian. 2016. January 15.
Symons X. Catastrophic result in clinical trial in France // BioEdge. 2016. January17.
Allen F. ‘Like a horror film’. What was the ‘Elephant Man’ drug testing trial, what is TGN1412 and what happened to the men involved? // The Sun. 2017. February.
Attarwala H. TGN1412: From discovery to disaster // Journal of young pharmacists. 2010. July-September. Vol. 2. № 3. P. 332–336.
Tyrsin D., Chuvpilo S., Matskevich A., Nemenov D., Römer P. S., Tabares P., Hünig T. From TGN1412 to TAB08: the return of CD28 superagonist therapy to clinical development for the treatment of rheumatoid arthritis // Clinical and experimental rheumatology. 2016. July/August. Vol. 34. № 4 (Suppl 98). P. 45–48.
Hünig T. The rise and fall of the CD28 superagonis t TGN1412 and its return as TAB08: a personal account // The FEBS Journal. 2016. Vol. 283. P. 3325–3334.
Frankos V. H. FDA perspectives on the use of teratology data for human risk assessment // Fundamental and Applied Toxicology. 1985. August. Vol. 5. № 4. P. 615–625.
Schardein J. L. Chemically induced birth defects. New York: Marcel Dekker Inc, 1993.
Lumley C., Walker S. (eds.). Animal toxicity studies: their relevance for man. London: Quay, 1990. P. 49–56.
Matthews R. A. J. Medical progress depends on animal models – doesn’t it? // Journal of the Royal Society of Medicine. 2008. February. Vol. 101. № 2. P. 95–98.
Jones C. A., Watson D. J. G., Fone K. C. F. Animal models of schizophrenia // British journal of pharmacology. 2011. October. Vol. 164. № 4. P. 1162–1194.
Stebbings R., Findlay L., Edwards C., Eastwood D., Bird C., North D., Mistry Y.et al. “Cytokine storm” in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics // The Journal of Immunology. 2007. Vol. 179. № 5. P. 3325–3331.
Suntharalingam G., Perry M. R., Ward S., Brett S. J., Castello-Cortes A. et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412 // The New England Journal of Medicine. 2006. Vol. 355. № 10. P. 1018–1028.
Greek R., Shanks N., Rice M. J. The history and implications of testing thalidomide on animals // The Journal of Philosophy, Science & Law. 2011. October. Vol. 11. № 3. P. 1–32.
Brent R. L. Drug testing in animals for teratogenic effects: Thalidomide in the pregnant rat // The Journal of Pediatrics. 1964. May. Vol. 64. № 5. P. 762–770.
BaileyJ., Knight A., Balcombe J. The future of teratology research is in vitro // Biogenic Amines. 2005. Vol. 19. № 2. P. 97–145.
Nelson-Rees W. A., Daniels D. W., Flandermeyer R. R. Cross-contamination of cells in culture // Science. 1981. April 24. Vol. 212. № 4493. P. 446–452.
