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The availability of multiple acceptable criteria for dose selection will provide greater flexibility in optimising the design of carcinogenicity studies for therapeutic agents.
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The sievert is the unit of radiation equivalent dose, H, that is used for radiation protection purposes, for engineering design criteria and for legal and administrative purposes.
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To this end, the new trial should have the same important design features (primary variables, the dose of the active comparator, eligibility criteria, etc.) as the previously conducted superiority trials in which the active comparator clearly demonstrated clinically relevant efficacy, taking into account advances in medical or statistical practice relevant to the new trial.
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compare the results of the safety analyses with design limits and dose acceptance criteria
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Study OMC-GHB-2 This study was designed as a prospective, randomized, double-blind, placebo- controlled, parallel-group, multi-centre trial with three doses of sodium oxybate and a placebo in narcoleptic patients meeting specific American Sleep Disorders Association (ASDA) criteria for narcolepsy.
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More specifically, the dose acceptance criteria are design criteria.
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One of the main recommendations of the ICCVAM workshop was that there should be a validation study on the use of in vitro cytotoxicity assays for predicting rodent oral lethal doses and human lethal concentrations, since the MEIC programme was not designed to represent a formal validation study conducted according to currently-accepted international criteria.
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7.1 Introduction Principal Aims and Scope of the Code Principal Aims Scope Responsibility and Personnel Responsibility Responsible User X-Ray Equipment Operators Students or Operators-in-Training Building and Installation Requirements Design Criteria General Recommendations Radiation Protection Surveys General Procedures Survey Report Equipment Specifications X-Ray Equipment Protective Clothing Darkroom and Film Processing Procedures to Reduce Dose to X-Ray Personnel General Recommendations
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To this end, RD-337 version 2 provides quantitative criteria and goals for nuclear power plant designs, in the form of dose acceptance criteria and safety goals. 4.2.1 Dose acceptance criteria
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If the product is tolerated only at lower level than ten times of the highest recommended dose, the study shall be designed in such a way that a margin of safety for the additive can be calculated and additional end-points (by necropsy, histology if relevant, and other appropriate criteria) shall be provided.
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If the product is tolerated only at lower level than ten times of the highest recommended dose, the study shall be designed in such a way that a margin of safety for the additive can be calculated and additional end-points (by necropsy, histology if relevant, and other appropriate criteria) shall be provided
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In the Canadian nuclear regulatory framework, safety goals are formulated in addition to the deterministic design requirements and the dose acceptance criteria so that risk to the public that originates from accidents outside the design basis is considered.
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These studies provide data in support of the indication for sodium oxybate in the treatment of cataplexy associated with narcolepsy. Study OMC-GHB-2 This study was designed as a prospective, randomized, double-blind, placebo- controlled, parallel-group, multi-centre trial with three doses of sodium oxybate and a placebo in narcoleptic patients meeting specific American Sleep Disorders Association (ASDA) criteria for narcolepsy.
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These analyses confirm that the design is capable of meeting the safety requirements, dose acceptance criteria and safety goals.
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These analyses confirm that the design is capable of meeting the safety requirements, dose acceptance criteria and safety goals.
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These analyses confirm that the design is capable of meeting the safety requirements, dose acceptance criteria and safety goals.
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The safety analysis confirms that the design is capable of meeting the safety requirements, dose acceptance criteria and safety goals.
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There is some evidence of increased tumour incidence in animals but the data are limited because the studies involve a single species, strain or experiment; study design (i.e., dose levels, duration of exposure and follow-up, survival, number of animals) or reporting is inadequate; the neoplasms produced often occur spontaneously and have been difficult to classify as malignant by histological criteria alone (e.g., lung and liver tumours in mice).
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There is some evidence of increased tumour incidence in animals but the data are limited because the studies involve a single species, strain or experiment; study design (i.e., dose levels, duration of exposure and follow-up, survival, number of animals) or reporting is inadequate; the neoplasms produced often occur spontaneously and have been difficult to classify as malignant by histological criteria alone (e.g., lung and liver tumours in mice).
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Deterministic safety analysis is performed to demonstrate that the dose acceptance criteria for accidents within the design basis are met with a high degree of confidence.
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Design, location and application criteria for installed area gamma radiation dose rate monitoring equipment for use in nuclear power plants during normal operation and anticipated operational occurrences PPUB PPUB
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The application should demonstrate that all levels of defence in depth are addressed, and should confirm that the facility’s design is capable of meeting the applicable dose acceptance criteria and safety goals.
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In Canada, recent practice in establishing the size of exclusion zones incorporates security and robustness design considerations, environmental factors, evacuation needs, land use and dose acceptance criteria.
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The safety analysis shall demonstrate achievement of all levels of defence in depth, and confirm that the design is capable of meeting the applicable expectations, dose acceptance criteria and safety goals.
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The safety analysis should demonstrate achievement of all levels of defence in depth and should confirm that the facility’s design is capable of meeting the applicable expectations, dose acceptance criteria and safety goals.
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43 sinne gevind in 18 ms. Hulle kom uit baie bronne en word nie nagegaan nie.