Search results with tag "Carcinogenicity"
GUIDELINE ON THE NEED FOR CARCINOGENICITY STUDIES …
database.ich.orgCarcinogenicity studies may be recommended for some pharmaceuticals if there is concern about their carcinogenic potential. Criteria for defining these cases should be very carefully considered because this is the most important reason to conduct carcinogenicity studies for most categories of pharmaceuticals. Several factors which
ADDENDUM TO THE GUIDELINE ON TESTING FOR …
database.ich.org61 carcinogenicity potential, the approach described in S1B of conducting a 2-year rat 62 carcinogenicity study together with a carcinogenicity assessment in mice (short term or 2-year 63 study) remains the most appropriate strategy. 64 2.1 Factors to consider for a …
S 1 A The Need for Carcinogenicity Studies of …
www.ema.europa.eu© EMEA 2006 2 GUIDELINE ON THE NEED FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS 1. INTRODUCTION The objectives of carcinogenicity studies are to identify a tumorigenic potential in animals
Safety Data Sheet EQUATE - Amazon S3
s3-us-west-1.amazonaws.comCarcinogenicity Assessment of carcinogenicity: The product has not been tested. The statement has been derived from the properties of the individual components. The results of various animal studies gave no indication of a carcinogenic effect. Reproductive toxicity
GENERAL TOXICOLOGY: NON-RODENT SPECIES IN SAFETY …
www.criver.comCARCINOGENICITY TESTING 27 EVERY STEP OF THE WAY The objectives of carcinogenicity studies • Identification of carcinogenic properties of a test item • Identification of target organs • Characterisation of dose response relationship • Identification of NOEL or NOAEL
US EPA - Chemicals Evaluated for Carcinogenic Potential ...
npic.orst.edupotential carcinogenicity hazard for that chemical. This date provides a key as to which set of cancer guidelines were used in the review. Note that the classification of potential carcinogenicity generally is not reevaluated unless new data are submitted.
NIOSH List of Antineoplastic and Other Hazardous Drugs in ...
www.cdc.govCarcinogenicity Teratogenicity or other developmental toxicity† Reproductive toxicity† *ASHP [1990] definition of hazardous drugs 1. Genotoxicity (i.e., mutagenicity and clastogenicity in short-term test systems) 2. Carcinogenicity in animal models, in the patient population, or both, as reported by the Interna-
S9 Q&A Step 5 Nonclinical evaluation for anticancer ...
www.ema.europa.eurecurrence rate, then further studies (e.g., carcinogenicity, a complete program on reproductive and developmental toxicity) are likely to be needed prior to marketing. In cases in which these factors are less defined and recurrence is high or rapid then the need for additional studies and their timing can be addressed on a case-by-case basis,
ICH guideline M7 on assessment and control of DNA reactive ...
www.ema.europa.eua DNA reactive mechanism of carcinogenicity and therefore are not in scope of the ICH M7 guidance (e.g., acetamide and hydroxylamine). M7 Q&As 5 3.2 Should mutagenic, non-carcinogenic impurities be controlled according to ICH M7? No. Mutagens that are demonstrated to be non-carcinogenic in appropriate and well- ...
S 3 A Toxicokinetics: A Guidance for Assessing Systemic ...
www.ema.europa.euToxicity studies which may be usefully supported by toxicokinetic information include single and repeated-dose toxicity studies, reproductive, genotoxicity and carcinogenicity studies. Toxicokinetic information may also be of value in assessing the implications of a proposed change in the clinical route of administration. 3.
IARC Monographs Volume 112: evaluation of
www.iarc.who.int11 countries met at IARC 3–10 March 20on15 to assess the carcinogenicity of tetrachlorvinphos, parathion, malathion, diazinon and glyphosate. The in, -person meeting followed nearly a year of review and preparation by the IARC secretariat and the Working Group, including a comprehensive review of the latest available scientific evidence.
Red Meat and PRocessed Meat - World Health Organization
monographs.iarc.who.intprogramme is to elaborate and publish in the form of monographs critical reviews of data on carcinogenicity for agents to which humans are known to be exposed and on specific exposure situations; to evaluate these data in terms of human risk
HALDOL - Food and Drug Administration
www.accessdata.fda.govThe need for continued treatment should be reassessed periodically. ... Carcinogenicity studies using oral haloperidol were conducted in Wistar rats (dosed at up to 5 mg/kg daily for 24 months) and in Albino Swiss mice (dosed at up to 5 mg/kg daily for 18 months). In the rat study survival was less than optimal in all
DRAFT OECD GUIDELINE FOR THE TESTING OF CHEMICALS
www.oecd.org2 INITIAL CONSIDERATIONS 5. In the assessment and evaluation of the potential carcinogenicity and chronic toxicity of a chemical, all available information on …
DRAFT OECD GUIDELINE FOR THE TESTING OF …
www.oecd.orgDraft Consultant Proposal v. 6 OECD TG 451 November 2008 1 DRAFT OECD GUIDELINE FOR THE TESTING OF CHEMICALS Test Guideline 451: Carcinogenicity …
BATCH Q: Quality - International Council for …
www.ich.orgICH Guidelines Index BATCH S: Safety Finalised Guidelines (Step 4) S1A Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals Nov. 1995
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