(1979), Validation and Characterisation of the L5178Y/TK+/- Mouse Lymphoma Mutagen Assay System, Mutat.
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and Brown M.M.M., (1979) Validation and Characterisation of the L5178Y/TK+/- Mouse Lymphoma Mutagen Assay System.
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Anwendungsgebiet a) ATC b) Indikationa) A16AA04 b) Nephropathic cystinosisa) V08CA05 b) Detection and characterisation of liver lesions

Presentation a)Form b)Dose c)Number of Presentations

Liegt die Exposition weit genug unter dem DNEL-Wert, mit anderen Worten, liegt das Risikoverhältnis (Risk Characterisation Ratio - RCR) klar unter 1, gilt das Risiko als ausreichend beherrscht.
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Should the exposure be sufficiently lower than the DNEL, in other words, should the risk characterisation ratio (RCR) be clearly below 1, risk is considered to be adequately controlled.
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CPMP/ICH/302/95 (S6) (in Zusammenarbeit mit der SWP)CPMP/BWP/877/96CPMP/BWP/477/97CPMP/BWP/269/95(revision 2)Titel der LeitlinieHarmonisation of requirements for influenza vaccines Core SPC for human immunoglobulin Quality of biotechnological products: viral safety evaluation of biotechnological products derived from cell lines of human or animal origin Quality of biotechnological/biological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products Preclinical safety evaluation of biotechnology-derived pharmaceuticals

Title of guideline Harmonisation of requirements for influenza vaccines Core SPC for human immunoglobulin Quality of biotechnological products: viral safety evaluation of biotechnological products derived from cell lines of human or animal origin Quality of biotechnological/biological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products

Titel des Dokuments Note for guidance on non-clinical testing of herbal drug preparations with long-term marketing experience -guidance to facilitate mutual recognition and use of bibliographic data Concept paper for a Note for Guidance on the investigation of biopharmaceutical characterisation and bioavailability/bioequivalence of herbal drugs/preparations Position paper on the risk associated with the use of herbal products containing estragole Position paper on the risk associated with the use of herbal products containing methyleugenol Position paper on the risk associated with the use of herbal products containing á-and -asarone Position paper on the use of Sassafras albidum as active substance or ingredient in herbal medicinal products Concept paper on the levels of scientific evidence required for the authorisation of well-established use and traditional herbal medicinal products Core-data on Urticae radix Core-data on Lini semen Core-data on Rosmarini folium cum flore Core-data on Primulae Radix

Concept paper for a Note for Guidance on the investigation of biopharmaceutical characterisation and bioavailability/bioequivalence of herbal drugs/preparations Position paper on the risk associated with the use of herbal products containing estragole Position paper on the risk associated with the use of herbal products containing methyleugenol