Carcinogenicity Studies definition

Carcinogenicity Studies means the following carcinogenicity studies in rats and mice: (1) [ * ].
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Carcinogenicity Studies means the following carcinogenicity studies in rats and mice: (1) [*].
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Carcinogenicity Studies means animal studies designed to evaluate the carcinogenic effects, if any, of long-term exposure to Compound..
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Examples of Carcinogenicity Studies in a sentence

  • Literature information: ECHA Dossier; Carcinogenicity: Method: OECD Guideline 451 (Carcinogenicity Studies); Result: negative.

  • Literature information: ECHA Dossier; Carcinogenicity: Method: OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies); Species: Mouse.; Results: Non-carcinogenic if DMSO extract as measured by IP346 is less than 3% w/w.

  • Literature information: ECHA Dossier; Carcinogenicity: Method: OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies); Species: Mouse.; Results: Non-carcinogenic if DMSO extract as measured by IP346 is less than 3% m/m.

  • Refer ICH Guideline on Need for Carcinogenicity Studies of Pharmaceuticals (S1A) for a consistent definition of the circumstances under which it is necessary to undertake carcinogenicity studies on new drugs.

  • Table 1.1: Summary of Carcinogenicity Studies in Mice and Rats Tumour Type Species Tumour Type Species Antipsychotic drugs have been shown to chronically elevate prolactin levels in rodents.

  • Literature information: ECHA Dossier; Carcinogenicity: Method: OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies); Species: Mouse.; Result: Non-carcinogenic if DMSO extract as measured by IP346 is less than 3% w/w.

  • Refer ICH Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals (S1C) for the criteria for selection of the high dose for carcinogenicity studies of therapeutics.

  • Literature information: ECHA Dossier; Carcinogenicity: Method: OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies); Species: Mouse.; Result: Non-carcinogenic if DMSO extract as measured by IP346 is less than 3% m/m.

  • Chronic inhalation toxicity: Method: OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies, 6h/d); Species: Rat; Exposure duration: approx.

  • Method: OECD Guideline 451 (Carcinogenicity Studies, 6h/d); Species: Rat,oral.; Exposure duration: 2 years; Result: NOAEC >= 2000 ppm; Literature information: ECHA Dossier; Reproductive toxicity: Method: OECD Guideline 416 (Two-Generation Reproduction Toxicity Study); Species: Rat; Result: NOAEL = 400 mg/kg; Literature information: ECHA Dossier; 1.


More Definitions of Carcinogenicity Studies

Carcinogenicity Studies means, with respect to a Licensed Product, two year carcinogenicity studies performed in rats (and mice if requested by the FDA or other Regulatory Authority) as outlined in ICH guidelines X0X, X0X and S1C.
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Related to Carcinogenicity Studies

  • Carcinogen means a chemical that causes an increased incidence of benign or malignant neoplasms, or a substantial decrease in the latency period between exposure and onset of neoplasms through oral or dermal exposure, or through inhalation exposure when the cancer occurs at nonrespiratory sites in at least one (1) mammalian species or man through epidemiological studies or clinical studies, or both.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Biological agent shall mean any pathogenic (disease producing) micro-organism(s) and/or biologically produced toxin(s) (including genetically modified organisms and chemically synthesized toxins) which cause illness and/or death in humans, animals or plants.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Subsurface tracer study means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Compounds means any or all of the following chemicals, as the context requires:

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Radionuclide means a radioactive element or a radioactive isotope.

  • Corrosion inhibitor means a substance capable of reducing the corrosivity of water toward metal plumbing materials, especially lead and copper, by forming a protective film on the interior surface of those materials.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Clinical Trial means any human clinical trial of a Product.

  • Infectious Disease means an illness that is capable of being spread from one individual to another.

  • Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.