Accès gratuit
Volume 64, Numéro 3, Mai-Juin 2009
Page(s) 155 - 159
Section Pharmacologie Clinique/Clinical Pharmacology
Publié en ligne 13 août 2009
  1. Marchetti S, Schellens JHM. The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials. Br J Cancer 2007; 97: 577-81 [CrossRef] [PubMed] [Google Scholar]
  2. Concept paper on the development of a CHMP guideline on the non-clinical requirements to support early phase I clinical trials with pharmaceutical compounds. EMEA/CHMP/SWP/91850/2006. [Google Scholar]
  3. Doroshow JH, Parchment RE. Oncologic phase 0 trials incorporating clinical pharmacodynamics: from concept to patient. Clin Cancer Res 2008; 14(12): 3658-63 [Google Scholar]
  4. Guidance for industry, investigators and reviewers on exploratory IND studies. FDA, January 2006. [Google Scholar]
  5. Guidance to the conduct of exploratory trials in Belgium. Working Document Federal Agency for Medicines and Health Products. [Google Scholar]
  6. Report of the international expert meeting on Exploratory clinical trial application and microdosing. 15 Sept 2007. BfArM (Germany) [Google Scholar]
  7. ICH Topic M3 (R2) Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals compounds. CHMP/ICH//286/95 July 2008 (draft in consultation). [Google Scholar]
  8. Guidance on strategies to identify and mitigate risks for First-in-Human clinical trials with investigational medicinal products. EMEA/CHMP/SWP/28367/07 (19 July 2007). [Google Scholar]
  9. Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials. EMEA, 2006. [Google Scholar]
  10. Bonnes pratiques de fabrication, Afssaps, décembre 2007. [Google Scholar]
  11. Verbruggen A, Coenen H, Deverre JR, et al. Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU. Eur J Nucl Med Mol Imaging 2008; 35: 2144-51 [CrossRef] [PubMed] [Google Scholar]
  12. Essais de première administration à l'Homme, Afssaps, juillet 2006. [Google Scholar]
  13. Guttierez M, Collyar D. Patient perspective on phase 0 clinical trials. Clin Cancer Res 2008; 14(12): 3689-91 [Google Scholar]
  14. Calvert AH, Plummer R. The development of phase I cancer trial methodologies: the use of pharmacokinetic and pharmacodynamic end points sets the scene for phase 0 cancer clinical trials. Clin Cancer Res 2008; 14(12): 3664-9 [Google Scholar]
  15. Murgo AJ, Kummar S, Rubinstein L, et al. Designing phase 0 cancer clinical trials. Clin Cancer Res 2008; 14(12): 3675-82 [Google Scholar]