Accès gratuit
Numéro
Thérapie
Volume 62, Numéro 3, Mai-Juin 2007
XXIIes Rencontres Nationales de Pharmacologie Clinique, Giens 7-10 octobre 2006
Page(s) 229 - 234
Section Thérapeutique/Therapeutics
DOI https://doi.org/10.2515/therapie:2007040
Publié en ligne 6 septembre 2007
  1. Clergeot A, Arnoux PY, Lassale C. Biomédicaments en France : état des lieux en 2004. La Lettre du Pharmacologue 2005; 19: 74-81
  2. Suntharalingam G, Perry MR, Ward S, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006; 355: 1018-28 [CrossRef] [PubMed]
  3. Final report on TGN1412 clinical trial. Medicines and Healthcare products Regulatory Agency, United Kingdom, 25/05/2006. http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&usSecondary=true&ssDocName=CON2023822&ssTargetNodeId=389
  4. Ohresser M, Olive D, Vanhove B, et al. Risk in drug trials. Lancet 2006; 368: 2205-6 [CrossRef]
  5. Loisel S, Ohresser M, Pallardy M, et al. Relevance, advantages and limitations of animal models used in the development of monoclonal antibodies for cancer treatment. Crit Rev Oncol Hematol 2007; 62: 34-42 [CrossRef] [PubMed]
  6. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Guidance for Industry: Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Juillet 2005. http://www.fda.gov/CDER/GUIDANCE/5541fnl.htm
  7. Direction de l'évaluation des médicaments et des produits biologiques. Département de l'évaluation des médicaments à statut particulier et des essais cliniques. Essais cliniques de première administration à l'Homme, en dose unique d'un médicament expérimental (nouvelle substance active) : Choix de la première dose, de la progression de dose et protocole d'administration aux volontaires. Afssaps, 05/09/2006. http://agmed.sante.gouv.fr/pdf/3/essais-clinique-phase1.pdf
  8. Expert Scientific Group (ESG) on phase one clinical trials. Final report. Department of Health, United Kingdom, december 2006. http://www.dh.gov.uk/assetRoot/04/14/10/43/04141043.pdf
  9. Chung KY, Shia J, Kemeny NE, et al. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol 2005; 23: 1803-10 [CrossRef] [PubMed]
  10. Cartron G, Dacheux L, Salles G, et al. Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in IgG Fc receptor FcgammaRIIIa gene. Blood 2002; 99: 754-8 [CrossRef] [PubMed]
  11. Louis E, El Ghoul Z, Vermeire S, et al. Association between polymorphism in IgG Fc receptor IIIa coding gene and biological response to infliximab in Crohn's disease. Aliment Pharmacol Ther 2004; 19: 511-9 [CrossRef] [PubMed]
  12. Miescher S, Spycher MO, Amstutz H, et al. A single recombinant anti-RhD IgG prevents RhD immunization: association of RhD-positive red blood cell clearance rate with polymorphisms in the FcgammaRIIA and FcgammaIIIA genes. Blood 2004; 103: 4028-35 [CrossRef] [PubMed]
  13. Ternant D, Paintaud G. Pharmacokinetics and concentration-effect relationships of therapeutic monoclonal antibodies and fusion proteins. Expert Opin Biol Ther 2005; 5: S37-S47 [CrossRef] [PubMed]
  14. Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med 2003; 348: 601-8 [CrossRef] [PubMed]
  15. Maini RN, Breedveld FC, Kalden JR, et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 1998; 41: 1552-63 [CrossRef] [PubMed]
  16. St Clair EW, Wagner CL, Fasanmade AA, et al. The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis: results from ATTRACT, a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002; 46: 1451-9 [CrossRef] [PubMed]
  17. Yim DS, Zhou H, Buckwalter M, et al. Population pharmacokinetic analysis and simulation of the time-concentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis. J Clin Pharmacol 2005; 45: 246-56 [CrossRef] [PubMed]
  18. Lee H, Kimko HC, Rogge M, et al. Population pharmacokinetic and pharmacodynamic modeling of etanercept using logistic regression analysis. Clin Pharmacol Ther 2003; 73: 348-65 [CrossRef] [PubMed]
  19. Berinstein NL, Grillo-Lopez AJ, White CA, et al. Association of serum rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol 1998; 9: 995-1001 [CrossRef] [PubMed]
  20. Igarashi T, Kobayashi Y, Ogura M, et al. Factors affecting toxicity, response and progression-free survival in relapsed patients with indolent B-cell lymphoma and mantle cell lymphoma treated with rituximab: a Japanese phase II study. Ann Oncol 2002; 13: 928-43 [CrossRef] [PubMed]
  21. Hale G, Rebello P, Brettman LR, et al. Blood concentrations of alemtuzumab and antiglobulin responses in patients with chronic lymphocytic leukemia following intravenous or subcutaneous routes of administration. Blood 2004; 104: 948-55 [CrossRef] [PubMed]