Carcinogenicity Tests: Tests to experimentally measure the tumor-producing/cancer cell-producing potency of an agent by administering the agent (e.g., benzanthracenes) and observing the quantity of tumors or the cell transformation developed over a given period of time. The carcinogenicity value is usually measured as milligrams of agent administered per tumor developed. Though this test differs from the DNA-repair and bacterial microsome MUTAGENICITY TESTS, researchers often attempt to correlate the finding of carcinogenicity values and mutagenicity values.Carcinogens: Substances that increase the risk of NEOPLASMS in humans or animals. Both genotoxic chemicals, which affect DNA directly, and nongenotoxic chemicals, which induce neoplasms by other mechanism, are included.Neoplasms, Experimental: Experimentally induced new abnormal growth of TISSUES in animals to provide models for studying human neoplasms.Carcinogens, Environmental: Carcinogenic substances that are found in the environment.Mutagenicity Tests: Tests of chemical substances and physical agents for mutagenic potential. They include microbial, insect, mammalian cell, and whole animal tests.Rats, Inbred F344Mutagens: Chemical agents that increase the rate of genetic mutation by interfering with the function of nucleic acids. A clastogen is a specific mutagen that causes breaks in chromosomes.Toxicity Tests, Chronic: Experiments designed to determine the potential toxic effects of a long-term exposure to a chemical or chemicals.Toxicology: The science concerned with the detection, chemical composition, and biological action of toxic substances or poisons and the treatment and prevention of toxic manifestations.Salmonella typhimurium: A serotype of Salmonella enterica that is a frequent agent of Salmonella gastroenteritis in humans. It also causes PARATYPHOID FEVER.International Cooperation: The interaction of persons or groups of persons representing various nations in the pursuit of a common goal or interest.Program Evaluation: Studies designed to assess the efficacy of programs. They may include the evaluation of cost-effectiveness, the extent to which objectives are met, or impact.Vaginal Creams, Foams, and Jellies: Medicated dosage forms for topical application in the vagina. A cream is a semisolid emulsion containing suspended or dissolved medication; a foam is a dispersion of a gas in a medicated liquid resulting in a light, frothy mass; a jelly is a colloidal semisolid mass of a water soluble medicated material, usually translucent.Metronidazole: A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS. It has also been proposed as a radiation sensitizer for hypoxic cells. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985, p133), this substance may reasonably be anticipated to be a carcinogen (Merck, 11th ed).Administration, Intravaginal: The insertion of drugs into the vagina to treat local infections, neoplasms, or to induce labor. The dosage forms may include medicated pessaries, irrigation fluids, and suppositories.Gels: Colloids with a solid continuous phase and liquid as the dispersed phase; gels may be unstable when, due to temperature or other cause, the solid phase liquefies; the resulting colloid is called a sol.Spermatocidal Agents: Chemical substances that are destructive to spermatozoa used as topically administered vaginal contraceptives.Nonoxynol: Nonionic surfactant mixtures varying in the number of repeating ethoxy (oxy-1,2-ethanediyl) groups. They are used as detergents, emulsifiers, wetting agents, defoaming agents, etc. Nonoxynol-9, the compound with 9 repeating ethoxy groups, is a spermatocide, formulated primarily as a component of vaginal foams and creams.Vagina: The genital canal in the female, extending from the UTERUS to the VULVA. (Stedman, 25th ed)Mesocricetus: A genus of the family Muridae having three species. The present domesticated strains were developed from individuals brought from Syria. They are widely used in biomedical research.Cell Transformation, Neoplastic: Cell changes manifested by escape from control mechanisms, increased growth potential, alterations in the cell surface, karyotypic abnormalities, morphological and biochemical deviations from the norm, and other attributes conferring the ability to invade, metastasize, and kill.Cricetinae: A subfamily in the family MURIDAE, comprising the hamsters. Four of the more common genera are Cricetus, CRICETULUS; MESOCRICETUS; and PHODOPUS.BALB 3T3 Cells: Cell lines developed from disaggregated BALB/c mouse embryos. They are extremely sensitive to CONTACT INHIBITION, and highly susceptible to transformation by SV40 VIRUS and murine sarcoma virus (SARCOMA VIRUSES, MURINE).Embryo, Mammalian: The entity of a developing mammal (MAMMALS), generally from the cleavage of a ZYGOTE to the end of embryonic differentiation of basic structures. For the human embryo, this represents the first two months of intrauterine development preceding the stages of the FETUS.Tablets: Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)Cheek: The part of the face that is below the eye and to the side of the nose and mouth.Mifepristone: A progestational and glucocorticoid hormone antagonist. Its inhibition of progesterone induces bleeding during the luteal phase and in early pregnancy by releasing endogenous prostaglandins from the endometrium or decidua. As a glucocorticoid receptor antagonist, the drug has been used to treat hypercortisolism in patients with nonpituitary CUSHING SYNDROME.Administration, Oral: The giving of drugs, chemicals, or other substances by mouth.Tablets, Enteric-Coated: Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)Water: A clear, odorless, tasteless liquid that is essential for most animal and plant life and is an excellent solvent for many substances. The chemical formula is hydrogen oxide (H2O). (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)Pregnancy: The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.Monte Carlo Method: In statistics, a technique for numerically approximating the solution of a mathematical problem by studying the distribution of some random variable, often generated by a computer. The name alludes to the randomness characteristic of the games of chance played at the gambling casinos in Monte Carlo. (From Random House Unabridged Dictionary, 2d ed, 1993)Clinical Laboratory Information Systems: Information systems, usually computer-assisted, designed to store, manipulate, and retrieve information for planning, organizing, directing, and controlling administrative and clinical activities associated with the provision and utilization of clinical laboratory services.Algorithms: A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task.Workflow: Description of pattern of recurrent functions or procedures frequently found in organizational processes, such as notification, decision, and action.Computer Simulation: Computer-based representation of physical systems and phenomena such as chemical processes.Marketing: Activity involved in transfer of goods from producer to consumer or in the exchange of services.Animal Testing Alternatives: Procedures, such as TISSUE CULTURE TECHNIQUES; mathematical models; etc., when used or advocated for use in place of the use of animals in research or diagnostic laboratories.Toxicity Tests: An array of tests used to determine the toxicity of a substance to living systems. These include tests on clinical drugs, foods, and environmental pollutants.Economic Competition: The effort of two or more parties to secure the business of a third party by offering, usually under fair or equitable rules of business practice, the most favorable terms.Research: Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. (Webster, 3d ed)Manufactured Materials: Substances and materials manufactured for use in various technologies and industries and for domestic use.Facility Regulation and Control: Formal voluntary or governmental procedures and standards required of hospitals and health or other facilities to improve operating efficiency, and for the protection of the consumer.United States Food and Drug Administration: An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.Cosmetics: Substances intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product. (U.S. Food & Drug Administration Center for Food Safety & Applied Nutrition Office of Cosmetics Fact Sheet (web page) Feb 1995)Investigational New Drug Application: An application that must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans. This application includes results of previous experiments; how, where, and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in animal studies; and how the compound is manufactured. (From the "New Medicines in Development" Series produced by the Pharmaceutical Manufacturers Association and published irregularly.)Drug Industry: That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.Quality Control: A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)Biosensing Techniques: Any of a variety of procedures which use biomolecular probes to measure the presence or concentration of biological molecules, biological structures, microorganisms, etc., by translating a biochemical interaction at the probe surface into a quantifiable physical signal.Disposable Equipment: Apparatus, devices, or supplies intended for one-time or temporary use.Mitomycin: An antineoplastic antibiotic produced by Streptomyces caespitosus. It is one of the bi- or tri-functional ALKYLATING AGENTS causing cross-linking of DNA and inhibition of DNA synthesis.Conductometry: Determination of the quantity of a material present in a mixture by measurement of its effect on the electrical conductivity of the mixture. (Webster, 3d ed)Maackia: A plant genus of the family FABACEAE. It contains a hemagglutinin.

Evaluation of the chronic toxicity and oncogenicity of N,N-diethyl-m-toluamide (DEET). (1/865)

Chronic toxicity and/or oncogenicity studies were conducted in rats, mice, and dogs with the insect repellent DEET. DEET was mixed in the diet and administered to CD rats for two years at concentrations that corresponded to dosage levels of 10, 30 or 100 mg/kg/day for males and 30, 100, or 400 mg/kg/day for females; to CD-1 mice for 18 months at dosage levels of 250, 500, or 1000 mg/kg/day; and to dogs for one year, via gelatin capsules, at dosage levels of 30, 100, or 400 mg/kg/day. In the rodent studies, each group consisted of 60 animals of each sex, and two concurrent independent control groups, each containing 60 animals/sex were included in each study. Each group in the dog study consisted of four male and four female dogs and one control group was included in the study. Treatment-related effects were observed at the highest dose level in all three studies. For rats, the effects included decreases in body weight and food consumption and an increase in serum cholesterol in females only. In mice, the effects observed were decreases in body weight and food consumption in both sexes. The effects observed in dogs included increased incidences of emesis and ptyalism, and levels of transient reduction in hemoglobin and hematocrit, increased alkaline phosphatase (males only), decreased cholesterol, and increased potassium. One male dog in the high-dose group also exhibited ataxia, tremors, abnormal head movements, and/or convulsions on several occasions during the study. The highest no-observed-effect levels (NO-ELs) for rats, mice and dogs were determined to be 100, 500, and 100 mg/kg/day, respectively. No specific target organ toxicity or oncogenicity was observed in any of the studies.  (+info)

Administration of an unconjugated bile acid increases duodenal tumors in a murine model of familial adenomatous polyposis. (2/865)

Intestinal carcinogenesis involves the successive accumulation of multiple genetic defects until cellular transformation to an invasive phenotype occurs. This process is modulated by many epigenetic factors. Unconjugated bile acids are tumor promoters whose presence in intestinal tissues is regulated by dietary factors. We studied the role of the unconjugated bile acid, chenodeoxycholate, in an animal model of familial adenomatous polyposis. Mice susceptible to intestinal tumors as a result of a germline mutation in Apc (Min/+ mice) were given a 10 week dietary treatment with 0.5% chenodeoxycholate. Following this, the mice were examined to determine tumor number, enterocyte proliferation, apoptosis and beta-catenin expression. Intestinal tissue prostaglandin E2 (PGE2) levels were also assessed. Administration of chenodeoxycholate in the diet increased duodenal tumor number in Min/+ mice. Promotion of duodenal tumor formation was accompanied by increased beta-catenin expression in duodenal cells, as well as increased PGE2 in duodenal tissue. These data suggest that unconjugated bile acids contribute to periampullary tumor formation in the setting of an Apc mutation.  (+info)

Malignant transformation of p53-deficient astrocytes is modulated by environmental cues in vitro. (3/865)

The early incidence of p53 mutation in astrocytomas suggests that it plays an important role in astrocyte transformation. Astrocytes isolated from homozygous p53 knockout mice grow rapidly, lack contact inhibition, and are immortal. Here we tested whether the loss of p53 is sufficient for progression to tumorigenicity of astrocytes. We grew primary astrocytes under three conditions for over 120 population doublings and assessed their antigenic phenotype, chromosome number, and expression of glioma-associated genes as well as their ability to form colonies in soft agarose and tumors s.c. and intracranially in nude mice. Under two conditions (10% FCS and 0.5% FCS plus 20 ng/ml EGF), cells acquired the ability to form colonies in soft agarose and tumors in nude mice, and this was accompanied by the expression of genes, including epidermal growth factor receptor, platelet-derived growth factor receptor alpha and beta, protein kinase Cdelta, and vascular endothelial growth factor, which are known to be aberrantly regulated in human astrocytomas. Under the third condition (0.5% FCS plus 10 ng/ml basic fibroblast growth factor), astrocytes gained the ability to form colonies in soft agarose and had abnormal chromosome numbers similar to cells in the first two conditions but did not form tumors in nude mice or overexpress glioma-associated genes. These data provide experimental evidence for the idea that the malignant progression initiated by the loss of p53 may be subject to modulation by extracellular environmental influences.  (+info)

Expression of AML1-d, a short human AML1 isoform, in embryonic stem cells suppresses in vivo tumor growth and differentiation. (4/865)

The human AML1 gene encodes a heterodimeric transcription factor which plays an important role in mammalian hematopoiesis. Several alternatively spliced AML1 mRNA species were identified, some of which encode short protein products that lack the transactivation domain. When transfected into cells these short isoforms dominantly suppress transactivation mediated by the full length AML1 protein. However, their biological function remains obscure. To investigate the role of these short species in cell proliferation and differentiation we generated embryonic stem (ES) cells overexpressing one of the short isoforms, AML1-d, as well as cells expressing the full length isoforms AML1-b and AML2. The in vitro growth rate and differentiation of the transfected ES cells were unchanged. However, overexpression of AML1-d significantly affected the ES cells' ability to form teratocarcinomas in vivo in syngeneic mice, while a similar overexpression of AML1-b and AML2 had no effect on tumor formation. Histological analysis revealed that the AML1-d derived tumors were poorly differentiated and contained numerous apoptotic cells. These data highlight the pleiotropic effects of AML1 gene products and demonstrate for the first time an in vivo growth regulation function for the short isoform AML1-d.  (+info)

Marriage of a medium-term liver model to surrogate markers--a practical approach for risk and benefit assessment. (5/865)

The need for a reliable medium-term alternative to traditional long-term rodent test protocols for carcinogen risk assessment is pressing given the immense variety of compounds being developed for introduction into the human environment. The established lack of a complete correlation between mutagenicity and carcinogenicity means that recourse must be made to an in vivo model. Optimally, this model should be able to detect not only complete carcinogenic or promoting potential but also any ability to inhibit neoplasia. In order to be effective, it must take into account the available detailed knowledge on mechanisms of action of carcinogens and modulating agents. The Ito model, for which a uniquely comprehensive set of background data has already been accumulated, has a solid scientific basis; this model utilizes quantitative data for glutathione S transferase-positive foci as the preneoplasia-based surrogate end point (PSE). A very practical candidate for routine application, its predictive power, its flexibility, and its capacity to incorporate a range of mechanism-based surrogate end points (MSEs) provide a powerful tool for attainment of the twin goals of detecting carcinogenic agents and identifying promising chemopreventors.  (+info)

Comparison of the effectiveness of adenovirus vectors expressing cyclin kinase inhibitors p16INK4A, p18INK4C, p19INK4D, p21(WAF1/CIP1) and p27KIP1 in inducing cell cycle arrest, apoptosis and inhibition of tumorigenicity. (6/865)

Cell cycle regulatory proteins are important candidates for therapeutic tumour suppressors. Adenovirus vectors were constructed to overexpress cyclin kinase inhibitors p16INK4A, p18INK4C, p19INK4D, p21(WAF1/CIP1) and p27KIP1 under the control of the murine cytomegalovirus immediate early gene promoter. These vectors directed the efficient expression of each of the cyclin kinase inhibitors and induced growth arrest, inhibited DNA synthesis, and prevented phosphorylation of the retinoblastoma protein (pRb) in cell lines expressing functional pRb. In pRb-deficient cells, expression of the cyclin kinase inhibitors was not effective in inhibiting DNA replication or growth arrest. Interestingly, three of the cyclin kinase inhibitors, p16, p18 and p27 were found to induce apoptotic death in transduced HeLa and A549 cells. When the vectors were tested for their ability to inhibit tumorigenicity in a polyomavirus middle T antigen model of murine breast carcinoma, expression of the cyclin kinase inhibitors resulted in a delay in tumour formation that varied from several weeks for the p19 expressing vector to greater than 25 weeks for the p27 expressing vector. When tumours were injected directly with the adenovirus vectors expressing the cyclin kinase inhibitors, only treatment with the vector expressing p16 resulted in a delay in tumour growth.  (+info)

Tumorigenic conversion resulting from inhibition of apoptosis in a nontumorigenic HeLa-derived hybrid cell line. (7/865)

Although tumorigenicity in nude mice is one of the most important transformed phenotypes, its mechanism has been little analyzed. To understand the molecular basis of tumorigenicity, we characterized nontumorigenic CGL1 and tumorigenic CGL4 cell lines, both of which were originated from a common ancestral HeLa-human diploid fibroblast hybrid cell clone and retained a malignant state except tumorigenicity. When injected into nude mice, nontumorigenic CGL1 cells underwent apoptosis, but tumorigenic CGL4 cells did not. In vitro, CGL1 was also less resistant to various apoptotic stimuli than CGL4. These results suggested that inhibition of apoptosis may lead to tumorigenicity. To examine this hypothesis, we introduced antiapoptotic genes into the CGL1 cell line and injected the resulting clones into nude mice. The results showed that the ectopic expression of Bcl-2 or E1B19k, but not of crmA, converted CGL1 cells to tumorigenicity, suggesting strongly that this phenotype may be conferred by evasion of apoptosis.  (+info)

Increased oncogenicity of subclones of SV40 large T-induced neuroectodermal tumor cell lines after loss of large T expression and concomitant mutation in p53. (8/865)

A model for medulloblastoma-like primitive neuroectodermal tumors was established in rat using retrovirally transduced SV40 large T antigen (LT) as an inducing agent (O. D. Wiestler et al., Brain Pathol., 2: 47-59, 1992). A cell line isolated from such a tumor and clonal derivatives thereof were biologically and molecularly characterized. In the parental tumor cell line, TZ870, which had been selected for G418 resistance, virtually all cells expressed LT and wild-type p53, which were complexed to each other. When plated in soft agar, these cells grew relatively slowly and formed disperse colonies. However, when grown without selection pressure, these cells reproducibly gave rise to LT-negative and G418-sensitive derivatives, LT-0 cells. Surprisingly, these latter cells exhibited a higher degree of malignancy both in vitro, growing readily to large colonies in soft agar, and in vivo, where they gave rise to a rapidly growing malignant tumor. Clonal selection from TZ870 cells revealed two types of clones: in one type, LT expression was stably maintained, even without selection pressure, whereas the other type lost the LT coding sequences. All LT-negative clones exhibited the same phenotype as the LT-0 cells. Reexpression of LT had no effect. However, LT no longer formed complexes with p53, and p53 was metabolically stable, suggesting that it had been mutated. Sequence analyses and diagnostic restriction digests of the p53 gene revealed that (a) both the parental LT-transformed cells and their derivatives contained only one complete p53 allele and (b) all LT-positive clones expressed wild-type p53, whereas all LT-negative clones expressed a mutant allele with a common mutation at Cys-174-->Tyr, indicating their clonal origin. We assume that the loss of LT coding sequences is the consequence of the p53 mutation, perhaps by inducing genomic instability, and that both the p53 mutation and additional genetic alterations that accompany the loss of LT coding sequences might contribute to enhanced malignancy.  (+info)

  • It was decided that this would be best achieved by the organization of ECVAM workshops on specific topics, at which small groups of invited experts would review the current status of various types of in vitro tests and their potential uses and make recommendations about the best ways forward (1). (
  • Bioassay of 1-phenyl-2-thiourea for possible carcinogenicity/National Cancer Institute (U.S.). Division of Cancer Cause and Prevention. (
  • Tests for cancer and other long-term effects of exposure. (
  • The Department of Health and Human Services, the International Agency for Research on Cancer, and the Environmental Protection Agency (EPA) have not classified hexamethylene diisocyanate as to its human carcinogenicity. (
  • A description of methods used in the CPDB to standardize the diverse literature of animal cancer tests is presented for: 1) Criteria for inclusion of experiments 2) Standardization of average daily dose levels and 3) TD 50 estimation for a standard lifespan . (
  • These results are the source information for the Cancer Test Summary table above. (
  • The general approach taken by the document is primarily to provide guidance on how test results might be interpreted based on the outcome of standardised assays. (
  • and Armitage, 1955, Biometrics 11, 375-386) is routinely applied to carcinogenicity data as a test for linear trend in lifetime tumor incidence rates. (
  • This technique is compared to that of Bailer and Portier (1988, Biometrics 44, 417-431), who introduced a survival-adjusted quantal response test for trend in lifetime tumor incidence rates. (
  • Although the delta method approach is slightly more computationally intensive, small-sample simulations indicate that it has superior operating characteristics over the Poly-3 trend test of Bailer and Portier when background tumor incidence rates are low (under 3%) and survival patterns differ markedly across treatments. (
  • tumor development following carcinogen exposure," which demonstrate equivalent performance with the standard two-year tests. (
  • Our standardized measure of carcinogenic potency, TD 50 , is the daily dose rate in mg/kg body weight/day to induce tumors in half of test animals that would have remained tumor-free at zero dose. (
  • mouse lymphoma assay (MLA) otherwise known as in vitro mammalian cell clastogenecity, the Bruce Ames test (Ames test) and mouse micronuclei assay. (
  • The test is a colorimetric assay which measures the expression of genes induced by genotoxic agents in Escherichia coli, by means of a fusion with the structural gene for β-galactosidase. (
  • I thought you might be interested in this item at Title: Bioassay of 1-phenyl-2-thiourea for possible carcinogenicity Publisher: Bethesda, Md. : U.S. Dept. of Health, Education, and Welfare, Public Health Service, National Institutes of Health, 1978. (
  • and (ii) to review and revise WHO guidelines on laboratory and field testing of chemical and bacterial larvicides and insect growth regulators (IGRs) against mosquito larvae. (
  • The Group also reviewed and revised the draft guidelines on laboratory and field testing of chemical and bacterial larvicides and insect growth regulators against mosquito larvae, to be published as a separate document by WHOPES. (
  • Over the past century these and other species have been used to advance our knowledge of disease, to test new drugs, and to assure their safety before moving into the clinical phase with human subjects. (
  • It has not been adequately tested in other species. (
  • If the CPDB has no experiments in the sex-species group, "no test" appears. (
  • Only tests with dosing for at least ¼ the standard lifespan of the species and experiment length at least ½ the lifespan are included in the CPDB. (
  • As bacteria or cultured mammalian cells used in the in vitro genotoxicity tests have limited capacity for metabolizing drugs, several types of the metabolic activation systems are applied to the in vitro test systems. (
  • The document is not proscriptive but provides suggestions for possible next steps in testing (if any) which might be appropriate for a regulatory authority to take, given the various data scenarios. (
  • All available (eco)toxicological data from standardized or non-standardized tests. (
  • Since the chemical tested may inhibit protein synthesis at higher concentrations, which would lead to an underestimation of B-galactosidase induction, alkaline phosphatase is assayed simultaneously with β-galactosidase in order to scale the data to survivability of the cells. (
  • A method for comparing and combining short-term genotoxicity test data: the basic system. (
  • Data on health effects in humans are confined to patch tests demonstrating skin sensitization in some subjects. (
  • His laboratory was connected with her apartments by a secret passageway, so that no formulae could be stolen en route. (
  • Laboratory tests performed on whole blood specimens and includes the following: White blood cell count (WBC), hematocrit (Hct), red blood cell count (RBC), hemoglobin (Hgb), differential count of white blood cells, red blood cell morphology, red blood cell indices, and platelet count. (
  • MC has been tested for carcinogenicity in several laboratory rodents. (
  • The National Library of Medicine does not test products nor does it evaluate information from the product label or the (M)SDS. (
  • The multiplicity of comparisons has given rise to concern that individual Fisher-Irwin tests could seriously overstate the experimental evidence in some situations. (
  • Target sites are listed if any author of published experimental results concluded that tumors were induced in that organ by the test agent. (
  • This paper demonstrates the use of the delta method for estimating the variance of ratio statistics derived from animal carcinogenicity experiments. (
  • Their test modifies the usual Cochran-Armitage computing formula by weighting the denominators of the response rates to reflect less-than-whole-animal contributions to risk. (
  • The Tg rasH2/CB6F1 mouse seems to be a promising candidate as an animal model for the development of a rapid carcinogenicity testing system. (
  • The literature on carcinogenicity, including the epidemiologic literature and animal bioassays, is then reviewed. (
  • The Foundation for Biomedical Research website has a table listing the animals behind top drugs and a comprehensive summary of how animal testing and research has advanced human health. (
  • Early identification of drugs that will fail testing in higher level animal models or clinical trials, lowers the over-all cost of drug development. (
  • GEN Exclusives has published an article by Amar Thyagarajan, PhD, Senior Product Manager at Taconic Biosciences, titled New Guidelines Involve the Testing Done on Animal Models . (
  • One of the first priorities set by ECVAM was the implementation of procedures which would enable it to become well-informed about the state-of-the-art of non-animal test development and validation and the potential for the possible incorporation of alternative tests into regulatory procedures. (
  • Animal testing is on the way out, as new testing technology starts to take over. (
  • some of them support the development of OECD Test Guidelines (e.g. validation reports, guidance documents, detailed review papers). (
  • ACD/Labs Package for Toxicity Screening of Impurities provides a battery of in silico tests to accurately assess the genotoxic and carcinogenic potential of impurities and degradants, found to be below the threshold of toxicological concern in drug products, helping companies remain compliant with regulatory submission requirements. (
  • Genotoxicity test is carried out so as to determine whether the anti-arthritis drug can cause genetic damage. (
  • These tests detects whether the anti-arthritis can cause alterations in chromosome and damage to DNA leading to genetic mutation and ultimately results in malignant tumour (cancerous cell). (
  • Human papillomavirus testing is now included for management of atypical glandular cytology, for follow-up after treatment for cervical intraepithelial neoplasia, and in combination with cytologic screening in women 30 years and older. (
  • The preferred management of atypical squamous cells of undetermined significance in adult women is reflex human papillomavirus DNA testing. (
  • Updated guidelines published in October 2007 place greater emphasis on testing for high-risk human papillomavirus (HPV). (
  • On August 18, 2015, FDA issued the final guidance Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems which updates and augments (but not replaces) this guidance. (
  • This document supersedes the guidance "Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems" dated January 13, 2005. (
  • This guidance provides FDA's current thinking on non-clinical engineering tests that are submitted in investigational device exemption applications (IDEs) and premarket approval applications (PMAs) to support the safety and effectiveness of intravascular stents and their associated delivery systems. (
  • The document is intended to provide guidance for evaluating chemical using standardised test guidelines. (
  • Further information regarding the use and interpretation of these tests is available in Guidance Document No. 150. (
  • Meanwhile, several short-termin vitroandin vivostudies that may be useful to assess the relative potential of fibrous substances to cause lung toxicity/carcinogenicity have been identified. (
  • Only a very few lung adenomas but no other tumors were seen as spontaneous tumors during the months of carcnogenicity tests. (
  • These modelling approaches will reduce the dependence on the use of animals as well as the costs associated with toxicity tests, and will have wide-ranging applications. (