Toxicology can trace a portion of its origin to the identification of workplace toxicants and poisons (Zapp and Doull, 1993). Occupational toxicologists have long been significant contributors to industrial hygiene, safety, and... more
Toxicology can trace a portion of its origin to the identification of workplace toxicants and poisons (Zapp and Doull, 1993). Occupational toxicologists have long been significant contributors to industrial hygiene, safety, and occupational health programs. Occupational toxicology is the subdiscipline of toxicology that is concerned with the health effects of chemicals encountered in the workplace. It differs to some extent from industrial toxicology which, for the most part, deals with the evaluation of industrial chemicals that are products. The ultimate goal of the occupational toxicologist is to define the hazards of handling chemical raw materials, process intermediates, and finished products in order to determine appropriate handling practices. To achieve this goal, the toxicologist must not only work closely with professionals in industrial hygiene, occupational medicine, and engineering, but also integrate health risk with concerns of manufacturing, packaging, classification, labeling, and transportation of goods.
Research Interests:
Dose–Response, one of the primary underlying principles of toxicology, also provides us with the basis for risk assessment. It is the process of determining the point at which the response changes from an acceptable endpoint to an... more
Dose–Response, one of the primary underlying principles of toxicology, also provides us with the basis for risk assessment. It is the process of determining the point at which the response changes from an acceptable endpoint to an unacceptable one. This chapter describes the terminology used to describe some of the parameters used in risk assessment, including the concept of a threshold. Additionally, we discuss the validity of specific studies, the relevance of their endpoints to humans and the applicability of different routes of exposure to risk assessment. The process of assembling available data for review and evaluation is also discussed, as are sources of uncertainty and the different methods used in deriving risk values. Finally, the acceptability of risk is discussed as one of the critical variables in the risk-assessment process. Keywords: threshold; nonthreshold; endpoint of concern; critical effect; point of departure; benchmark dose; margin of safety; sensitive subpopulation; genetic polymorphisms; low dose extrapolation; uncertainty factor
Research Interests:
The active ingredients used in the pharmaceutical industry's products are designed to modify biological processes; thus, if not adequately controlled, they can place employees at risk. This chapter provides an historical look at the need... more
The active ingredients used in the pharmaceutical industry's products are designed to modify biological processes; thus, if not adequately controlled, they can place employees at risk. This chapter provides an historical look at the need for occupational exposure limits, as well as an overview of the limit-setting process.
Research Interests: Business, Communication, Documentation, Occupational Health, Environmental Monitoring, and 15 moreRisk assessment, Occupational Medicine, Medicine, Humans, Pubmed, Animals, Occupational Exposure, Risk Assessment, Toxicity Tests, Species Specificity, Drug Industry, Occupational Diseases, Biological Availability, Hazardous Substances, and Clinical Trials as Topic
Much of the data which have been generated on in vitro alternatives to the Draize eye irritation test have dealt with compounds within a specific chemical class or product category. However, in the pharmaceutical industry, it is often... more
Much of the data which have been generated on in vitro alternatives to the Draize eye irritation test have dealt with compounds within a specific chemical class or product category. However, in the pharmaceutical industry, it is often necessary to evaluate materials which are not related in structure or properties. It was thus decided to evaluate a diverse series of chemicals in seven in vitro methods for estimating ocular irritation. Thirty-seven test materials were chosen to represent a broad range of pH, solubility, and in vivo irritation potential. Assays were chosen to include as many different types of end points as practical. The group of assays was composed of TOPKAT (assessing structure-activity relationships), bovine corneal opacity-permeability (BCO-P; corneal opacity/toxicity), Eytex (protein coagulation), neutral red uptake (cytotoxicity), MTT in living dermal equivalent (cytotoxicity), Microtox (cytotoxicity in bacteria), and CAMVA (inflammation/toxicity). The results of the study indicated that, in general, the cytotoxicity end points did not correlate well with the in vivo data. The BCO-P, CAMVA, and Eytex assays had the best overall concordance (88.9, 75.8, and 75.0%, respectively) with this set of compounds. Estimation of irritation potential based on structure-activity (TOPKAT) was possible for only approximately 50% of the compounds; however, the assay showed 100% sensitivity (i.e., no false negatives), but low specificity (i.e., negatives correctly identified only 54.5% of the time). These data suggest that for screening of chemicals of diverse structure and properties, the more mechanism-based assays, as opposed to general cytotoxicity assays, hold more promise and should be further evaluated.
Research Interests: Chemistry, Cytotoxicity, Medicine, Pharmaceutical industry, Humans, and 15 moreAnimals, Eye, Cattle, In Vivo, Corneal Opacity, Sensitivity and Specificity, Structure activity Relationship, Irritation, Cell Survival, Predictive value of tests, False Negative, Neutral Red, Chick embryo, Pharmacology and pharmaceutical sciences, and In Vitro Techniques
Research Interests: Environmental Science, Occupational Health, Risk assessment, Health Policy, Medicine, and 14 morePolicy making, Humans, Animals, Occupational Exposure, Risk Assessment, Toxicity Tests, Species Specificity, Extrapolation, Drug Industry, Toxicokinetics, Area Under Curve, Pharmaceutical preparations, guidelines as topic, and Pharmacology and pharmaceutical sciences
As part of an occupational hazard evaluation, p-bromobenzyl bromide (p-BBB) was evaluated for genotoxic activity in the Ames microbial mutagenicity assay, the alkaline elution assay for DNA strand breaks in rat hepatocytes and the in... more
As part of an occupational hazard evaluation, p-bromobenzyl bromide (p-BBB) was evaluated for genotoxic activity in the Ames microbial mutagenicity assay, the alkaline elution assay for DNA strand breaks in rat hepatocytes and the in vitro chromosome aberration assay in Chinese hamster ovary cells. The compound produced equivocal results in the microbial mutagenicity assay but was negative in the alkaline elution assay for DNA strand breaks in rat hepatocytes. The compound produced weakly positive results in the in vitro chromosome aberration assay. There was substantial cytotoxicity in all three assays. It is concluded that p-BBB is weakly genotoxic.
Research Interests: Chemistry, Molecular Biology, Cytotoxicity, DNA damage, Medicine, and 15 moreDNA, Genotoxicity, Liver, Animals, Male, Ames Test, Occupational Exposure, Chromosomes, Mutagens, Chinese hamster, CHO cells, Cricetinae, Mutagenicity tests, Chromosome aberrations, and Pharmacology and pharmaceutical sciences
ABSTRACT The presence of synthetic glucocorticosteroids (GCs) in surface water and their potential endocrine disruption (ED) activity at environmental concentrations has not been fully investigated. Synthetic GCs may interfere with... more
ABSTRACT The presence of synthetic glucocorticosteroids (GCs) in surface water and their potential endocrine disruption (ED) activity at environmental concentrations has not been fully investigated. Synthetic GCs may interfere with endogenous receptors within the hypothalamic-pituitary-gonadal (HPG) axis and disruptions of this pathway can result in decreased reproduction and/or adverse developmental effects. Betamethasone, a synthetic GC, has been on the market in the United States since the 1980's. The Pharmaceutical Assessment and Transport Evaluation model estimated betamethasone concentrations to be <0.6 ng/L in 95% of all U.S. surface waters. Concentrations of 0.01, 0.1, and 1.0 µg betamethasone/L were used in a two-generation fish full life cycle study with Japanese medaka. Gross endpoints, secondary sexual characteristics, and vitellogenin expression were evaluated. The highest concentration at which ED outcomes are not anticipated was determined to be 0.1 µg/L. The ratio of the predicted environmental concentration to the no effect concentration for ED is less than one, indicating no risk to aquatic life from environmentally relevant concentrations of betamethasone.
Research Interests:
Cross-contamination in multi-product pharmaceutical manufacturing facilities can impact both product safety and quality. This issue has been recognized by regulators and industry for some time, leading to publication of a number of... more
Cross-contamination in multi-product pharmaceutical manufacturing facilities can impact both product safety and quality. This issue has been recognized by regulators and industry for some time, leading to publication of a number of continually evolving guidelines. This manuscript provides a historical overview of the regulatory framework for managing cross-contamination in multi-product facilities to provide context for current approaches. Early guidelines focused on the types of pharmaceuticals for which dedicated facilities and control systems were needed, and stated the requirements for cleaning validation. More recent guidelines have promoted the idea of using Acceptable Daily Exposures (ADEs) to establish cleaning limits for actives and other potentially hazardous substances. The ADE approach is considered superior to previous methods for setting cleaning limits such as using a predetermined general limit (e.g., 10 ppm or a fraction of the median lethal dose (LD50) or therapeutic dose). The ADEs can be used to drive the cleaning process and as part of the overall assessment of whether dedicated production facilities are required. While great strides have been made in using the ADE approach, work remains to update good manufacturing practices (GMPs) to ensure that the approaches are clear, consistent with the state-of-the-science, and broadly applicable yet flexible enough for adaptation to unique products and situations.
Research Interests: Computer Science, Occupational Health, Forecasting, Risk assessment, Health Policy, and 14 moreHazardous Waste, Medicine, Quality Control, Policy making, Humans, Animals, Diffusion of Innovation, Occupational Exposure, Risk Assessment, Toxicity Tests, Drug Industry, Pharmaceutical preparations, guidelines as topic, and Pharmacology and pharmaceutical sciences
... Environmental Health Criteria 170. Geneva, World Health Organization. McGourty, JC, Silas, JH, Fleming, JJ, McBurney, A., Phil, M. and Ward, JW 1985. Pharmacokinetics of beta-blocking effects of timolol in poor and extensive... more
... Environmental Health Criteria 170. Geneva, World Health Organization. McGourty, JC, Silas, JH, Fleming, JJ, McBurney, A., Phil, M. and Ward, JW 1985. Pharmacokinetics of beta-blocking effects of timolol in poor and extensive metabolizers of debrisoquin. Clin. Pharmacol. ...
Research Interests: Engineering, Ecology, Drug development, Cost effectiveness, Occupational Exposure, and 10 moreClinical Data, Control Strategy, Pharmacodynamic, Ecological Applications, Active Ingredient, Toxicokinetics, Pharmacokinetic, ENVIRONMENTAL SCIENCE AND MANAGEMENT, Ecological Risk, and acceptable daily intake
Research Interests: Environmental Science, Bioaccumulation, Environmental Health, Ecology, Risk assessment, and 15 moreExposure Assessment, Pharmaceuticals, Drinking Water, Contamination, Human health, Effluent, Risk Assessment, Ecological Applications, Literature Search, Acetylsalicylic Acid, Environment, Cancer Risk, ENVIRONMENTAL SCIENCE AND MANAGEMENT, Ecological Risk, and Human Exposure
Research Interests:
Research Interests:
Research Interests: Risk assessment, Medicine, Humans, United States, Animals, and 14 moreHuman health, MANUFACTURING PROCESS, Xenobiotics, World Health Organization, Food Additive, Risk Assessment, Drug Industry, Food and Drug Administration, Threshold Limit Values, United States Food and Drug Administration, acceptable daily intake, guidelines as topic, Human Exposure, and Pharmacology and pharmaceutical sciences
Much of the data which have been generated on in vitro alternatives to the Draize eye irritation test have dealt with compounds within a specific chemical class or product category. However, in the pharmaceutical industry, it is often... more
Much of the data which have been generated on in vitro alternatives to the Draize eye irritation test have dealt with compounds within a specific chemical class or product category. However, in the pharmaceutical industry, it is often necessary to evaluate materials which are not related in structure or properties. It was thus decided to evaluate a diverse series of chemicals in seven in vitro methods for estimating ocular irritation. Thirty-seven test materials were chosen to represent a broad range of pH, solubility, and in vivo irritation potential. Assays were chosen to include as many different types of end points as practical. The group of assays was composed of TOPKAT (assessing structure-activity relationships), bovine corneal opacity-permeability (BCO-P; corneal opacity/toxicity), Eytex (protein coagulation), neutral red uptake (cytotoxicity), MTT in living dermal equivalent (cytotoxicity), Microtox (cytotoxicity in bacteria), and CAMVA (inflammation/toxicity). The results of the study indicated that, in general, the cytotoxicity end points did not correlate well with the in vivo data. The BCO-P, CAMVA, and Eytex assays had the best overall concordance (88.9, 75.8, and 75.0%, respectively) with this set of compounds. Estimation of irritation potential based on structure-activity (TOPKAT) was possible for only approximately 50% of the compounds; however, the assay showed 100% sensitivity (i.e., no false negatives), but low specificity (i.e., negatives correctly identified only 54.5% of the time). These data suggest that for screening of chemicals of diverse structure and properties, the more mechanism-based assays, as opposed to general cytotoxicity assays, hold more promise and should be further evaluated.
Research Interests: Chemistry, Cytotoxicity, Medicine, Pharmaceutical industry, Humans, and 15 moreAnimals, Eye, Cattle, In Vivo, Corneal Opacity, Sensitivity and Specificity, Structure activity Relationship, Irritation, Cell Survival, Predictive value of tests, False Negative, Neutral Red, Chick embryo, Pharmacology and pharmaceutical sciences, and In Vitro Techniques
Research Interests: Program Evaluation, Computer Science, Occupational Health, Risk assessment, Medicine, and 15 moreQuality Control, Biological Sciences, Humans, Biomedical Research, Animals, Occupational Hygiene, Ventilation, Laboratories, Occupational Exposure, ENGINE CONTROL, Risk Assessment, Task Performance and Analysis, Personal protective equipment, Protective Factor, and Respiratory Protective Devices
Calendula flower (Calendula officinalis) (CF) has been used in herbal medicine because of its anti-inflammatory activity. CF and C. officinalis extracts (CFE) are used as skin conditioning agents in cosmetics. Although data on dermal... more
Calendula flower (Calendula officinalis) (CF) has been used in herbal medicine because of its anti-inflammatory activity. CF and C. officinalis extracts (CFE) are used as skin conditioning agents in cosmetics. Although data on dermal irritation and sensitization of CF and CFE&amp;amp;amp;amp;amp;amp;amp;#39;s are available, the risk of subchronic systemic toxicity following dermal application has not been evaluated. The threshold of toxicological concern (TTC) is a pragmatic, risk assessment based approach that has gained regulatory acceptance for food and has been recently adapted to address cosmetic ingredient safety. The purpose of this paper is to determine if the safe use of CF and CFE can be established based upon the TTC class for each of its known constituents. For each constituent, the concentration in the plant, the molecular weight, and the estimated skin penetration potential were used to calculate a maximal daily systemic exposure which was then compared to its corresponding TTC class value. Since the composition of plant extracts are variable, back calculation was used to determine the maximum acceptable concentration of a given constituent in an extract of CF. This paper demonstrates the utility and practical application of the TTC concept when used as a tool in the safety evaluation of botanical extracts.
Research Interests:
Research Interests:
A standardized respiratory questionnaire and pulmonary function tests were used to examine thirty-four employees of a snow-ski manufacturing plant, including twenty-five workers who were exposed to an epoxy resin system containing the... more
A standardized respiratory questionnaire and pulmonary function tests were used to examine thirty-four employees of a snow-ski manufacturing plant, including twenty-five workers who were exposed to an epoxy resin system containing the amine hardener 3-dimethylamino propylamine (3-DMAPA). Maximum expiratory flow-volume curves were obtained on Monday and Thursday, before and after each shift, and FVC, FEV1.0, MEF50%, and MEF25% were caculated. Environmental measurements of the total amine levels were found to range from 0.41 to 1.38 ppm. The group with the greatest exposure (0.55-1.38 ppm) showed significant decreases in lung function over Monday and over the week. Although all employees in this group showed decreases in pulmonary function, acute changes were greater in present cigarette smokers and in subjects who reported respiratory symptoms upon exposure to the epoxy resin system. There was no evidence of permanent loss of lung function in subjects with either the highest or longest exposure.
Research Interests:
Toxicology can trace a portion of its origin to the identification of workplace toxicants and poisons (Zapp and Doull, 1993). Occupational toxicologists have long been significant contributors to industrial hygiene, safety, and... more
Toxicology can trace a portion of its origin to the identification of workplace toxicants and poisons (Zapp and Doull, 1993). Occupational toxicologists have long been significant contributors to industrial hygiene, safety, and occupational health programs. Occupational toxicology is the subdiscipline of toxicology that is concerned with the health effects of chemicals encountered in the workplace. It differs to some extent from industrial toxicology which, for the most part, deals with the evaluation of industrial chemicals that are products. The ultimate goal of the occupational toxicologist is to define the hazards of handling chemical raw materials, process intermediates, and finished products in order to determine appropriate handling practices. To achieve this goal, the toxicologist must not only work closely with professionals in industrial hygiene, occupational medicine, and engineering, but also integrate health risk with concerns of manufacturing, packaging, classification...
Research Interests:
ABSTRACT The presence of synthetic glucocorticosteroids (GCs) in surface water and their potential endocrine disruption (ED) activity at environmental concentrations has not been fully investigated. Synthetic GCs may interfere with... more
ABSTRACT The presence of synthetic glucocorticosteroids (GCs) in surface water and their potential endocrine disruption (ED) activity at environmental concentrations has not been fully investigated. Synthetic GCs may interfere with endogenous receptors within the hypothalamic-pituitary-gonadal (HPG) axis and disruptions of this pathway can result in decreased reproduction and/or adverse developmental effects. Betamethasone, a synthetic GC, has been on the market in the United States since the 1980's. The Pharmaceutical Assessment and Transport Evaluation model estimated betamethasone concentrations to be <0.6 ng/L in 95% of all U.S. surface waters. Concentrations of 0.01, 0.1, and 1.0 µg betamethasone/L were used in a two-generation fish full life cycle study with Japanese medaka. Gross endpoints, secondary sexual characteristics, and vitellogenin expression were evaluated. The highest concentration at which ED outcomes are not anticipated was determined to be 0.1 µg/L. The ratio of the predicted environmental concentration to the no effect concentration for ED is less than one, indicating no risk to aquatic life from environmentally relevant concentrations of betamethasone.
Research Interests:
Research Interests: Chemistry and Toxicology
The active ingredients used in the pharmaceutical industry's products are designed to modify biological processes; thus, if not adequately controlled, they can place employees at risk. This chapter provides an historical look at the... more
The active ingredients used in the pharmaceutical industry's products are designed to modify biological processes; thus, if not adequately controlled, they can place employees at risk. This chapter provides an historical look at the need for occupational exposure limits, as well as an overview of the limit-setting process.
Research Interests: Business, Communication, Documentation, Occupational Health, Environmental Monitoring, and 15 moreRisk assessment, Occupational Medicine, Medicine, Humans, United States, Animals, Occupational Exposure, Risk Assessment, Toxicity Tests, Species Specificity, Drug Industry, Occupational Diseases, Biological Availability, Hazardous Substances, and Clinical Trials as Topic
Health-based limits for active pharmaceutical ingredients (API) referred to as acceptable daily exposures (ADEs) are necessary to the pharmaceutical industry and used to derive acceptance limits for cleaning validation purposes and... more
Health-based limits for active pharmaceutical ingredients (API) referred to as acceptable daily exposures (ADEs) are necessary to the pharmaceutical industry and used to derive acceptance limits for cleaning validation purposes and evaluating cross-carryover. ADEs represent a dose of an API unlikely to cause adverse effects if an individual is exposed, by any route, at or below this dose every day over a lifetime. Derivations of ADEs need to be consistent with ICH Q9 as well as other scientific approaches for the derivation of health-based limits that help to manage risks to both product quality and operator safety during the manufacture of pharmaceutical products. Previous methods for the establishment of acceptance limits in cleaning validation programs are considered arbitrary and have largely ignored the available clinical and toxicological data available for a drug substance. Since the ADE utilizes all available pharmaceutical data and applies scientifically acceptable risk assessment methodology it is more holistic and consistent with other quantitative risk assessments purposes such derivation of occupational exposure limits. Processes for hazard identification, dose response assessment, uncertainty factor analysis and documentation are reviewed.
Research Interests:
Research Interests:
Research Interests:
... Case Studies of Categorical Data-Derived Adjustment Factors Bruce D. Naumann,1* Keith C. Silverman,1 Rakesh Dixit,2 Ellen C. Faria,1 and Edward V. Sargent1 1Merck & Co., Inc., Whitehouse Station, NJ 08889; 2Merck Research... more
... Case Studies of Categorical Data-Derived Adjustment Factors Bruce D. Naumann,1* Keith C. Silverman,1 Rakesh Dixit,2 Ellen C. Faria,1 and Edward V. Sargent1 1Merck & Co., Inc., Whitehouse Station, NJ 08889; 2Merck Research Laboratories, West Point, PA 19486 ...
Research Interests: Biology, Ecology, Risk assessment, Categorical data analysis, Case Study, and 14 moreMode of action, Risk Assessment, Angiotensin Converting Enzyme, Ecological Applications, Toxicokinetics, ACE Inhibitor, ENVIRONMENTAL SCIENCE AND MANAGEMENT, Safety Factor, Ecological Risk, acceptable daily intake, Adverse effect, Categorical Data, Nonsteroidal Anti-inflammatory Drug, and Reference Dose
Timolol maleate is a non-selective beta-adrenergic blocking agent currently used primarily to reduce intraocular pressure in the treatment of glaucoma. It also produces effects on the heart and bronchial smooth muscle and all of these... more
Timolol maleate is a non-selective beta-adrenergic blocking agent currently used primarily to reduce intraocular pressure in the treatment of glaucoma. It also produces effects on the heart and bronchial smooth muscle and all of these effects are of potential concern in workers handling this active pharmaceutical ingredient. The disposition of timolol maleate is influenced by a polymorphism in oxidative metabolism
Research Interests: Pharmacology, Polymorphism, Kinetics, Ecology, Pharmacokinetics, and 14 moreMedicine, Smooth muscle, Case Study, Intraocular Pressure, Heart rate, Pharmacodynamics, Ecological Applications, Active Pharmaceutical Ingredient, Area Under the Curve, ENVIRONMENTAL SCIENCE AND MANAGEMENT, Safety Factor, Oxidative Metabolism, acceptable daily intake, and timolol
Research Interests:
Research Interests:
Research Interests:
Cross-contamination in multi-product pharmaceutical manufacturing facilities can impact both product safety and quality. This issue has been recognized by regulators and industry for some time, leading to publication of a number of... more
Cross-contamination in multi-product pharmaceutical manufacturing facilities can impact both product safety and quality. This issue has been recognized by regulators and industry for some time, leading to publication of a number of continually evolving guidelines. This manuscript provides a historical overview of the regulatory framework for managing cross-contamination in multi-product facilities to provide context for current approaches. Early guidelines focused on the types of pharmaceuticals for which dedicated facilities and control systems were needed, and stated the requirements for cleaning validation. More recent guidelines have promoted the idea of using Acceptable Daily Exposures (ADEs) to establish cleaning limits for actives and other potentially hazardous substances. The ADE approach is considered superior to previous methods for setting cleaning limits such as using a predetermined general limit (e.g., 10 ppm or a fraction of the median lethal dose (LD50) or therapeutic dose). The ADEs can be used to drive the cleaning process and as part of the overall assessment of whether dedicated production facilities are required. While great strides have been made in using the ADE approach, work remains to update good manufacturing practices (GMPs) to ensure that the approaches are clear, consistent with the state-of-the-science, and broadly applicable yet flexible enough for adaptation to unique products and situations.
Research Interests: Computer Science, Occupational Health, Forecasting, Risk assessment, Health Policy, and 14 moreHazardous Waste, Medicine, Quality Control, Policy making, Humans, Animals, Diffusion of Innovation, Occupational Exposure, Risk Assessment, Toxicity Tests, Drug Industry, Pharmaceutical preparations, guidelines as topic, and Pharmacology and pharmaceutical sciences
Dose–Response, one of the primary underlying principles of toxicology, also provides us with the basis for risk assessment. It is the process of determining the point at which the response changes from an acceptable endpoint to an... more
Dose–Response, one of the primary underlying principles of toxicology, also provides us with the basis for risk assessment. It is the process of determining the point at which the response changes from an acceptable endpoint to an unacceptable one. This chapter describes the terminology used to describe some of the parameters used in risk assessment, including the concept of a threshold. Additionally, we discuss the validity of specific studies, the relevance of their endpoints to humans and the applicability of different routes of exposure to risk assessment. The process of assembling available data for review and evaluation is also discussed, as are sources of uncertainty and the different methods used in deriving risk values. Finally, the acceptability of risk is discussed as one of the critical variables in the risk-assessment process. Keywords: threshold; nonthreshold; endpoint of concern; critical effect; point of departure; benchmark dose; margin of safety; sensitive subpopulation; genetic polymorphisms; low dose extrapolation; uncertainty factor
Research Interests:
Page 1. Copyright© 1999, CRC Press LLC — Files may be downloaded for personal use only. Reproduction of this material without the consent of the publisher is prohibited. Hum. Ecol. Risk Assess. Vol. 5, No. 5, 1999 1059 Data-Derived... more
Page 1. Copyright© 1999, CRC Press LLC — Files may be downloaded for personal use only. Reproduction of this material without the consent of the publisher is prohibited. Hum. Ecol. Risk Assess. Vol. 5, No. 5, 1999 1059 Data-Derived Adjustment Factors ...
Research Interests: Clinical Trial, Ecology, Medicine, Population, Standard Deviation, and 10 moreScientific Data, Ecological Applications, Environmental Protection Agency, Area Under the Curve, Cancer Risk, Pharmacokinetic, General Population, ENVIRONMENTAL SCIENCE AND MANAGEMENT, Ecological Risk, and acceptable daily intake
Research Interests: Water quality, Environmental Health, Ecology, Risk assessment, Exposure Assessment, and 12 moreDrinking Water, Surface Water, Human health, Water Quality, Risk Assessment, Sewage Treatment Plant, Ecological Applications, Literature Search, Acetylsalicylic Acid, Cancer Risk, ENVIRONMENTAL SCIENCE AND MANAGEMENT, and Human Exposure
... Environmental Health Criteria 170. Geneva, World Health Organization. McGourty, JC, Silas, JH, Fleming, JJ, McBurney, A., Phil, M. and Ward, JW 1985. Pharmacokinetics of beta-blocking effects of timolol in poor and extensive... more
... Environmental Health Criteria 170. Geneva, World Health Organization. McGourty, JC, Silas, JH, Fleming, JJ, McBurney, A., Phil, M. and Ward, JW 1985. Pharmacokinetics of beta-blocking effects of timolol in poor and extensive metabolizers of debrisoquin. Clin. Pharmacol. ...
Research Interests: Engineering, Ecology, Drug development, Cost effectiveness, Occupational Exposure, and 10 moreClinical Data, Control Strategy, Pharmacodynamic, Ecological Applications, Active Ingredient, Toxicokinetics, Pharmacokinetic, ENVIRONMENTAL SCIENCE AND MANAGEMENT, Ecological Risk, and acceptable daily intake
Research Interests:
This article presents currently suggested approaches to setting acceptance limits for cleaning agents, some of the difficulties with these approaches, emphasizing the need to move to a health-based approach as was suggested for APIs. Two... more
This article presents currently suggested approaches to setting acceptance limits for cleaning agents, some of the difficulties with these approaches, emphasizing the need to move to a health-based approach as was suggested for APIs. Two previous articles in this series discussed acceptance limits for Active Pharmaceutical ingredients (APIs) and moving to a health-based approach. This article will discuss the currently suggested approaches to setting acceptance limits for cleaning agents, some of the difficulties with these approaches, and emphasize the need to move to a health-based approach as was suggested for APIs.