Position paper on requirements for toxicological studies in the specific case of radiopharmaceuticals

EJNMMI Radiopharmacy and Chemistry

Volumn 1, Issue 1, 2016, Pages

  Koziorowski, J ^a   Behe, M ^b   Decristoforo, C ^c   Ballinger, J ^d   Elsinga, P ^e   Ferrari, V ^f   Kolenc Peitl, P ^g   Todde, S ^h   Mindt, T L ⁱ  

^a LINKÖPING UNIVERSITY   (Sweden)

^b ETH Zurich   (Switzerland)

^c INNSBRUCK MEDICAL UNIVERSITY   (Austria)

^d GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^e UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^f GE HEALTHCARE   (United Kingdom)

^g UNIVERSITY MEDICAL CENTRE LJUBLJANA   (Slovenia)

^h UNIVERSITY OF MILANO BICOCCA   (Italy)

ⁱ UNIVERSITY HOSPITAL BASEL   (Switzerland)

Author keywords

Position paper; Pre clinical toxicology studies; Radiopharmaceuticals

Indexed keywords

FLUORINE 18; RADIOPHARMACEUTICAL AGENT;

ARTICLE; CARCINOGENICITY; CLINICAL RESEARCH; DRUG MARKETING; GENOTOXICITY; HUMAN; ISOTOPE LABELING; MOLECULAR IMAGING; MUTAGENICITY; NONHUMAN; NUCLEAR MEDICINE; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RADIOIMMUNOTHERAPY; RISK ASSESSMENT; TERATOGENICITY; TOXICITY TESTING; TOXICOLOGY;

EID: 85049675495     PISSN: None     EISSN: 2365421X     Source Type: Journal    
DOI: 10.1186/s41181-016-0004-6     Document Type: Article

References (12)

1. Guidance for industry, Developing medical imaging drugs and biological products, Part 1: conducting safety assessments, US Food and Drug Administration, http://www.fda.gov/downloads/Drugs/…/Guidances/ucm071600.pdf.
2. Guidance for Industry, Investigators and Reviewers, Exploratory IND studies, US Food and Drug Administration, http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm078933.pdf.
3. Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins, EMEA/CHMP/BMWP/14327/2006 Rev. 1, European Medicines Agency, http://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500194507&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc.
4. Guideline on the limits for genotoxic impurities, CPMP/SWP/5199/02, European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002903.pdf.
5. ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk, EMA/CHMP/ICH/83812/2013, European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/09/WC500173445.pdf.
6. ICH guideline S6 (R1) – preclinical safety evaluation of biotechnology-derived pharmaceuticals, EMA/CHMP/ICH/731268/1998, European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002828.pdf.
7. ICH guideline S9 on nonclinical evaluation for anticancer pharmaceuticals, CHMP/ICH/646107/08, European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500043471.pdf.
8. Multidisciplinary ICH guidelines including M 7 can be found under http://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.html.
9. Note for guidance on impurities in new drug products, CPMP/ICH/2738/99, European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002676.pdf.
10. Note for guidance on impurity testing in new drug substances, CPMP/ICH/2737/99, European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002675.pdf.
11. Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals, CPMP/ICH/286/95, European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002941.pdf.
12. Opinion on use of the threshold of toxicological concern (TTC) approach for human safety assessment of chemical substances with focus on cosmetics and consumer products, SCCP/1171/08, European Commission, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_092.pdf.