Proposing norms for clinical application of biological radiolabelled compunds. pharmacodynamic and toxicological recommendations for preclinical studies
Main Article Content
Abstract
In October of 2005 a small group of researchers from different Countries had a meeting at the International Atomic Energy Agency headquarter in Vienna, Austria; the aim was to prepare a tentative user-friendly document for personnel involved in preparation of radiopharmaceuticals based on peptides, proteins and antibodies for human use. This document should cover all practical, methodological and ethical concerns relating to radiolabelled products mentioned above and should clarify the complicated road-map that one has to follow in this area. This document does not cover the use of radiolabelled oligonucleotides, cells and other autologous products and does not provide
technical protocols on actual methodologies. Herein, we will like to present you some pharmacodynamic and toxicological recommendations for in vivo preclinical studies. This guidance only represents my own current thinking in this topic.
technical protocols on actual methodologies. Herein, we will like to present you some pharmacodynamic and toxicological recommendations for in vivo preclinical studies. This guidance only represents my own current thinking in this topic.
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How to Cite
Casacó Parada, Ángel. (1). Proposing norms for clinical application of biological radiolabelled compunds. pharmacodynamic and toxicological recommendations for preclinical studies. Nucleus, (41). Retrieved from http://nucleus.cubaenergia.cu/index.php/nucleus/article/view/495
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Ámbito Regulatorio
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2. HILLAIRET De BM, et al. Improved tumor selectivity of radiolabeled peptides by receptor and antigen dual targeting in the neurotensin receptor model. Bioconjug Chem. 2002; 13 ( 3): 654-662.
3. Guidance for Industry. S7A Safety Pharmacology Studies for Human Pharmaceuticals. ICH. 2001.
4. Guidance for Industry. S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. ICH. 1997.
5. CAVAGNARO JA. Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceiuticals. Nature Reviews Drug Discovery. 2002; 1 ( 6): 469-475.
6. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. 1997.
7. ZENG ZC, et al. Improved long-term survival for unresectable hepatocellular carcinoma (HCC) with a combination of surgery and intrahepatic arterial infusion of 131I-anti-HCC mAb. Phase I/II clinical trials. J Cancer Res Clin Oncol. 1998;( 124): 275-280.
8. BOIARDI A, et al. Intratumoral delivery of mitoxantrone in association with 90-Y radioimmunotherapy (RIT) in recurrent glioblastoma. J Neurooncol 2005; 72 ( 2): 125-31.
9. GRANA C, et al. Radioimmunotherapy in advanced ovarian cancer: is there a role for pre-targeting with (90) Y-biotin?. Gynecol Oncol. 2004; 93 ( 3): 691-698.
10. HALL EJ. Radiobiology for the Radiologist. 5th edition. Philadelphia Pa: Lippincott Williams & Wilkins. 2000.
11. VALENTIN JP, BASS AS, ATRAKCHI A, OLEJNICZAK K, KANNOSUKE F. Challenges and lessons learned since implementation of the safety pharmacology guidance ICH S7A. J Pharmacol Toxicol Methods. 2005;( 52): 22-29.
12. GARKAVIJ M, et al. Comparison of 125I and 111 In Labeled MAb BR96 for Tumor Targeting in combination with extracorporeal immunoadsorption. Clin Cancer Res. 1999;( 5): 3059-3064.
13. BEHR TM, GOLDENBERG DM, BECKER W. Reducing the renal uptake of radiolabeled antibody fragments and peptides for diagnosis and therapy: present status, future prospects and limitations. Eur J Nucl Med. 1998;( 25): 201-12.
14. SANDSTROM P, et al. Idiotypic-anti-idiotypic antibody interactions in experimental radioimmunotargeting. Clin Cancer Res. 1999;( 5): 3073-8.
15. PAGANELLI G, et al. Antibody-guided three-step therapy for high grade glioma with yttrium-90 biotin. Eur J. Nucl Med. 1999;( 26): 348-57.
16. WU AM. Tools for pretargeted radioimmunotherapy. Cancer Biother Radiopharm 2001;( 16): 103-108.
17. Guidance for Industry. Developing Medical Imaging Drug and Biological Products. Part 1: Conducting Safety Assessments. 2004.
18. GONZÁLEZ B, et al. Radiotoxicity of h-R3 monoclonal antibody labeled with 188Re administered intracerebrally in rats. Hum Exp Toxicol. 2000; 19 ( 12): 684-692.
19. GONZÁLEZ-NAVARRO B, et al. Local and systemic toxicity of h-R3, an anti-epidermal growth factor receptor monoclonal antibody, labeled with 188osmiun after the intracerebral administration in rats. Exp. Toxicol Pathol. 2005; 56 ( 4/5): 313-319.
20. Radiopharmaceuticals based on monoclonal antibodies. Directive 89/343/EEC. 1992.