The Experts below are selected from a list of 63 Experts worldwide ranked by ideXlab platform
Oliver D Howes - One of the best experts on this subject based on the ideXlab platform.
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the use of healthy volunteers instead of patients to inform drug Dosing Studies a 11c raclopride pet study
Psychopharmacology, 2011Co-Authors: Oliver D Howes, Kyungsang Yu, Jae Min Jeong, Injin Jang, Jung Shin Park, Sanggoo Shin, Federico E Turkheimer, Shitij Kapur, Jun Soo KwonAbstract:Rationale Receptor occupancy study has been performed to evaluate pharmacokinetic profiles in new antipsychotic drug development. While these findings highlight the value of positron emission tomography (PET) for dose-finding study, what is unclear is if it is necessary to conduct these Studies in patients with schizophrenia or whether Studies in healthy volunteers are adequate.
Lesa L Aylward - One of the best experts on this subject based on the ideXlab platform.
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Biomonitoring Equivalents for molybdenum
Regulatory Toxicology and Pharmacology, 2016Co-Authors: Sean M Hays, Andy Nong, Kristin Macey, Devika Poddalgoda, Ming Lu, Lesa L AylwardAbstract:Molybdenum is an essential trace element for mammalian, plant, and other animal systems. The Institute of Medicine (IOM) has established an Estimated Average Requirement (EAR) to assure sufficient molybdenum intakes for human populations; however excessive exposures can cause toxicity. As a result, several agencies have established exposure guidance values to protect against molybdenum toxicity, including a Reference Dose (RfD), Tolerable Daily Intake (TDI) and a Tolerable Upper Intake Level (UL). Biomonitoring for molybdenum in blood or urine in the general population is being conducted by the Canadian Health Measures Survey (CHMS) and the U.S. National Health and Nutrition Examination Survey (NHANES). Using pharmacokinetic data from controlled human Dosing Studies, Biomonitoring Equivalents (BEs) were calculated for molybdenum in plasma, whole blood, and urine associated with exposure guidance values set to protect against both nutritional deficits and toxicity. The BEEARvalues in plasma, whole blood and urine are 0.5, 0.45 and 22 μg/L, respectively. The BEs associated with toxicity range from 0.9 to 31 μg/L in plasma, 0.8-28 μg/L in whole blood and 200-7500 μg/L in urine. These values can be used to interpret molybdenum biomonitoring data from a nutritional and toxicity perspective.
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Biomonitoring Equivalents for inorganic arsenic
Regulatory Toxicology and Pharmacology, 2010Co-Authors: Sean M Hays, Andy Nong, Michelle Gagné, Lesa L Aylward, Kannan KrishnanAbstract:This paper presents Biomonitoring Equivalents (BEs) for inorganic arsenic. Biomonitoring Equivalents (BEs) are defined as the concentration or range of concentrations of a chemical or its metabolite in a biological medium (blood, urine, or other medium) that is consistent with an existing health-based exposure guideline, and are derived by integrating available data on pharmacokinetics with existing chemical risk assessments. This study reviews available health-based exposure guidance values for arsenic based on recent evaluations from the United States Environmental Protection Agency (US EPA), US Agency for Toxic Substances and Disease Registry (ATSDR) and Health Canada (HC). BE values corresponding to the Reference Dose (RfD) or risk-specific doses for cancer endpoints from these agencies were derived based on kinetic data (urinary excretion) from controlled Dosing Studies in humans. The BE values presented here provide estimates of the sum of inorganic arsenic-derived urinary biomarkers (inorganic arsenic, monomethylated arsenic, and dimethylated arsenic). The BE associated with the United States Environmental Protection Agency's Reference Dose and the Agency for Toxic Substances and Disease Registry's Minimal Risk Level is 6.4μg arsenic/L urine. The BEs associated with the various cancer risk assessments are significantly lower. These BE values may be used as screening tools for evaluation of biomonitoring data for inorganic arsenic in a public health risk context. © 2010 Elsevier Inc.
Sean M Hays - One of the best experts on this subject based on the ideXlab platform.
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Biomonitoring Equivalents for molybdenum
Regulatory Toxicology and Pharmacology, 2016Co-Authors: Sean M Hays, Andy Nong, Kristin Macey, Devika Poddalgoda, Ming Lu, Lesa L AylwardAbstract:Molybdenum is an essential trace element for mammalian, plant, and other animal systems. The Institute of Medicine (IOM) has established an Estimated Average Requirement (EAR) to assure sufficient molybdenum intakes for human populations; however excessive exposures can cause toxicity. As a result, several agencies have established exposure guidance values to protect against molybdenum toxicity, including a Reference Dose (RfD), Tolerable Daily Intake (TDI) and a Tolerable Upper Intake Level (UL). Biomonitoring for molybdenum in blood or urine in the general population is being conducted by the Canadian Health Measures Survey (CHMS) and the U.S. National Health and Nutrition Examination Survey (NHANES). Using pharmacokinetic data from controlled human Dosing Studies, Biomonitoring Equivalents (BEs) were calculated for molybdenum in plasma, whole blood, and urine associated with exposure guidance values set to protect against both nutritional deficits and toxicity. The BEEARvalues in plasma, whole blood and urine are 0.5, 0.45 and 22 μg/L, respectively. The BEs associated with toxicity range from 0.9 to 31 μg/L in plasma, 0.8-28 μg/L in whole blood and 200-7500 μg/L in urine. These values can be used to interpret molybdenum biomonitoring data from a nutritional and toxicity perspective.
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Biomonitoring Equivalents for inorganic arsenic
Regulatory Toxicology and Pharmacology, 2010Co-Authors: Sean M Hays, Andy Nong, Michelle Gagné, Lesa L Aylward, Kannan KrishnanAbstract:This paper presents Biomonitoring Equivalents (BEs) for inorganic arsenic. Biomonitoring Equivalents (BEs) are defined as the concentration or range of concentrations of a chemical or its metabolite in a biological medium (blood, urine, or other medium) that is consistent with an existing health-based exposure guideline, and are derived by integrating available data on pharmacokinetics with existing chemical risk assessments. This study reviews available health-based exposure guidance values for arsenic based on recent evaluations from the United States Environmental Protection Agency (US EPA), US Agency for Toxic Substances and Disease Registry (ATSDR) and Health Canada (HC). BE values corresponding to the Reference Dose (RfD) or risk-specific doses for cancer endpoints from these agencies were derived based on kinetic data (urinary excretion) from controlled Dosing Studies in humans. The BE values presented here provide estimates of the sum of inorganic arsenic-derived urinary biomarkers (inorganic arsenic, monomethylated arsenic, and dimethylated arsenic). The BE associated with the United States Environmental Protection Agency's Reference Dose and the Agency for Toxic Substances and Disease Registry's Minimal Risk Level is 6.4μg arsenic/L urine. The BEs associated with the various cancer risk assessments are significantly lower. These BE values may be used as screening tools for evaluation of biomonitoring data for inorganic arsenic in a public health risk context. © 2010 Elsevier Inc.
Jun Soo Kwon - One of the best experts on this subject based on the ideXlab platform.
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the use of healthy volunteers instead of patients to inform drug Dosing Studies a 11c raclopride pet study
Psychopharmacology, 2011Co-Authors: Oliver D Howes, Kyungsang Yu, Jae Min Jeong, Injin Jang, Jung Shin Park, Sanggoo Shin, Federico E Turkheimer, Shitij Kapur, Jun Soo KwonAbstract:Rationale Receptor occupancy study has been performed to evaluate pharmacokinetic profiles in new antipsychotic drug development. While these findings highlight the value of positron emission tomography (PET) for dose-finding study, what is unclear is if it is necessary to conduct these Studies in patients with schizophrenia or whether Studies in healthy volunteers are adequate.
Andy Nong - One of the best experts on this subject based on the ideXlab platform.
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Biomonitoring Equivalents for molybdenum
Regulatory Toxicology and Pharmacology, 2016Co-Authors: Sean M Hays, Andy Nong, Kristin Macey, Devika Poddalgoda, Ming Lu, Lesa L AylwardAbstract:Molybdenum is an essential trace element for mammalian, plant, and other animal systems. The Institute of Medicine (IOM) has established an Estimated Average Requirement (EAR) to assure sufficient molybdenum intakes for human populations; however excessive exposures can cause toxicity. As a result, several agencies have established exposure guidance values to protect against molybdenum toxicity, including a Reference Dose (RfD), Tolerable Daily Intake (TDI) and a Tolerable Upper Intake Level (UL). Biomonitoring for molybdenum in blood or urine in the general population is being conducted by the Canadian Health Measures Survey (CHMS) and the U.S. National Health and Nutrition Examination Survey (NHANES). Using pharmacokinetic data from controlled human Dosing Studies, Biomonitoring Equivalents (BEs) were calculated for molybdenum in plasma, whole blood, and urine associated with exposure guidance values set to protect against both nutritional deficits and toxicity. The BEEARvalues in plasma, whole blood and urine are 0.5, 0.45 and 22 μg/L, respectively. The BEs associated with toxicity range from 0.9 to 31 μg/L in plasma, 0.8-28 μg/L in whole blood and 200-7500 μg/L in urine. These values can be used to interpret molybdenum biomonitoring data from a nutritional and toxicity perspective.
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Biomonitoring Equivalents for inorganic arsenic
Regulatory Toxicology and Pharmacology, 2010Co-Authors: Sean M Hays, Andy Nong, Michelle Gagné, Lesa L Aylward, Kannan KrishnanAbstract:This paper presents Biomonitoring Equivalents (BEs) for inorganic arsenic. Biomonitoring Equivalents (BEs) are defined as the concentration or range of concentrations of a chemical or its metabolite in a biological medium (blood, urine, or other medium) that is consistent with an existing health-based exposure guideline, and are derived by integrating available data on pharmacokinetics with existing chemical risk assessments. This study reviews available health-based exposure guidance values for arsenic based on recent evaluations from the United States Environmental Protection Agency (US EPA), US Agency for Toxic Substances and Disease Registry (ATSDR) and Health Canada (HC). BE values corresponding to the Reference Dose (RfD) or risk-specific doses for cancer endpoints from these agencies were derived based on kinetic data (urinary excretion) from controlled Dosing Studies in humans. The BE values presented here provide estimates of the sum of inorganic arsenic-derived urinary biomarkers (inorganic arsenic, monomethylated arsenic, and dimethylated arsenic). The BE associated with the United States Environmental Protection Agency's Reference Dose and the Agency for Toxic Substances and Disease Registry's Minimal Risk Level is 6.4μg arsenic/L urine. The BEs associated with the various cancer risk assessments are significantly lower. These BE values may be used as screening tools for evaluation of biomonitoring data for inorganic arsenic in a public health risk context. © 2010 Elsevier Inc.