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1.
Rev Paul Pediatr ; 38: e2018096, 2020.
Artigo em Inglês, Português | MEDLINE | ID: mdl-31778403

RESUMO

OBJECTIVE: To describe the profile of children and adolescents admitted for exogenous unintentional poisoning in the emergency room and analyze factors associated with subsequent in-hospital admissions. METHODS: This is a cross-sectional study based on hospital records of all subjects up to 19 years-old admitted in 2013 at a specialized toxicology service on a major public emergency hospital due to unintentional intoxication (as reported). Accidents with poisonous animals and insects were excluded. Percentages and frequencies were calculated for the qualitative variables, and measures of central tendency and dispersion for the continuous quantitative variables. Multivariate analysis was performed using binary logistic regression to identify variables associated with subsequent in-hospital admissions. RESULTS: In 2013, 353 cases were reported. Poisonings were more frequent in children 0-4 years-old (72.5%) and in boys (55%). The vast majority was of dwellers of the Metropolitan Region of Belo Horizonte (83%), and 90% of the accidental poisonings occurred at home. 82.7% of the poisonings occurred by oral ingestion, especially of medicinal (36.5%) and cleaning products (29.4% of all poisonings). Only 12.2% of the cases resulted in hospitalization, and only one resulted in death. Residing outside Belo Horizonte (OR=5.20 [95%CI 2.37-11.44]) and poisoning by two or more products (OR=4.29 [95%CI 1.33-13.82]) were considered risk factors for hospitalization. CONCLUSIONS: Accidental poisonings occurred most frequently by ingestion of household medications and cleaning products, especially among children under 4 years-old. Preventive strategies should be primarily directed for this prevalent profile.


Assuntos
Ingestão de Alimentos/fisiologia , Hospitalização/estatística & dados numéricos , Produtos Domésticos/toxicidade , Envenenamento/epidemiologia , Adolescente , Brasil/epidemiologia , Criança , Pré-Escolar , Estudos Transversais , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Hospitalização/tendências , Humanos , Lactente , Recém-Nascido , Masculino , Envenenamento/diagnóstico , Fatores de Risco , Toxicologia/normas , Adulto Jovem
2.
Ann Epidemiol ; 38: 65-69, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31564485

RESUMO

PURPOSE: Classification of overdose deaths is often geographically and demographically inconsistent. Incomplete surveillance records may distort estimates of drug overdose rates across time and place. We examined incomplete toxicology reporting among drug overdose decedents by demographic and geographic characteristics, measuring changes in missingness rates and their associations with decedent characteristics over time. METHODS: We estimated the percentage of overdose deaths reported in the National Vital Statistics System with missing toxicology results from 2010 to 2016, overall and by decedents' demographic and geographic characteristics. Multilevel logistic regression models evaluated prevalence of missingness by decedent characteristics, accounting for geographic clustering. RESULTS: Overall, 20.3% of death certificates did not indicate a specific drug, declining from 24.4% in 2010 to 14.6% in 2016. Deaths were less likely to have missing information if they occurred in counties with medical examiners versus coroners. Female decedents were more likely to have missing information than males, as were non-Hispanic whites compared with Hispanics and non-Hispanic blacks. CONCLUSIONS: The percentage of deaths with missing toxicology information declined over time, but demographic and geographic differences in missingness persist. This yields detection biases that skew temporal trends and understanding of groups impacted by the opioid epidemic.


Assuntos
Analgésicos Opioides/envenenamento , Analgésicos Opioides/toxicidade , Médicos Legistas , Coleta de Dados/métodos , Atestado de Óbito , Overdose de Drogas/mortalidade , Transtornos Relacionados ao Uso de Opioides/mortalidade , Medicamentos sob Prescrição/envenenamento , Toxicologia/estatística & dados numéricos , Adulto , Idoso , Analgésicos Opioides/administração & dosagem , Médicos Legistas/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Toxicologia/métodos , Toxicologia/normas , Estados Unidos , Adulto Jovem
3.
Toxicol Pathol ; 47(7): 887-890, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31522628

RESUMO

The National Toxicology Program (NTP) uses histopathological evaluation of animal tissues as a key element in its toxicity and carcinogenicity studies. The initial histopathological evaluations are subjected to a rigorous peer review process involving several steps. The NTP peer review process is conducted by multiple, highly trained, and experienced toxicological pathologists employing standardized terminology. In addition, ancillary data, such as body and organ weights and clinical pathology findings, are used to corroborate the diagnoses. The NTP does employ masked analysis to confirm subtle lesions or severity scores, as needed, and during its Pathology Working Groups. The use of masked analysis can have a negative effect on histopathological evaluation because it is important for the pathologist to compare treated groups to the concurrent controls, which would not be possible in a blinded evaluation. Therefore, the NTP supports an informed approach to histopathological evaluation in its toxicity and carcinogenicity studies.


Assuntos
Patologia , Toxicologia , Animais , Testes de Carcinogenicidade , Patologistas , Patologia/normas , Revisão por Pares , Controle de Qualidade , Testes de Toxicidade , Toxicologia/normas
4.
Reprod Toxicol ; 88: 91-128, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31386883

RESUMO

There is a growing demand for wild type mice and mouse models of disease that may be more representative of human conditions but there is little information on neonatal and juvenile mouse anatomy. This project produces sound and comprehensive histology background data on the developing neonatal mouse at different time points from Day 0 until Day 28. The work describes optimal methods for tissue harvesting, fixation and processing from the neonatal and juvenile mice which can be used in routine toxicology studies. A review of the available literature revealed inconsistencies in the developmental milestones reported in the mouse. Although it is true that the sequence of events during the development is virtually the same in mice and rats, important developmental milestones in the mouse often happen earlier than in the rat, and these species should not be used interchangeably.


Assuntos
Animais Recém-Nascidos/crescimento & desenvolvimento , Camundongos Endogâmicos C57BL/crescimento & desenvolvimento , Fatores Etários , Animais , Animais Recém-Nascidos/anatomia & histologia , Encéfalo/anatomia & histologia , Encéfalo/crescimento & desenvolvimento , Feminino , Vesícula Biliar/anatomia & histologia , Vesícula Biliar/crescimento & desenvolvimento , Trato Gastrointestinal/anatomia & histologia , Trato Gastrointestinal/crescimento & desenvolvimento , Intestino Grosso/anatomia & histologia , Intestino Grosso/crescimento & desenvolvimento , Intestino Delgado/anatomia & histologia , Intestino Delgado/crescimento & desenvolvimento , Rim/anatomia & histologia , Rim/crescimento & desenvolvimento , Fígado/anatomia & histologia , Fígado/crescimento & desenvolvimento , Pulmão/anatomia & histologia , Pulmão/crescimento & desenvolvimento , Masculino , Camundongos , Camundongos Endogâmicos C57BL/anatomia & histologia , Ovário/anatomia & histologia , Ovário/crescimento & desenvolvimento , Ratos , Estômago/anatomia & histologia , Estômago/crescimento & desenvolvimento , Testículo/anatomia & histologia , Testículo/crescimento & desenvolvimento , Toxicologia/normas , Útero/anatomia & histologia , Útero/crescimento & desenvolvimento
5.
Reprod Toxicol ; 88: 56-66, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31348994

RESUMO

Recently several OECD test guidelines were updated to include thyroid hormone measurements for assessing endocrine disruptor potency, which led to an imperative need to align interpretation of these results by the different stakeholders. We therefore evaluated 124 repro screening studies, which showed in 38% of the studies a statistical significant finding for T4 in at least one treatment group, probably due to disturbances of normal homeostasis causing high variation. Consequently, for a thorough evaluation it is extremely important to take the historical control range into account. In conclusion, the current testing approach is not providing specific information needed to assess endocrine disruption, as too often a statistical significant finding is noted and as down-stream adverse effects are not evaluated. Therefore, major modifications are urgently needed. Instead of extending the in vivo experiments, it should be investigated if in vitro assessments will provide more relevant information on human endocrine disruptor potential.


Assuntos
Guias como Assunto/normas , Organização para a Cooperação e Desenvolvimento Econômico/normas , Hormônios Tireóideos/sangue , Animais , Disruptores Endócrinos/toxicidade , União Europeia , Feminino , Humanos , Masculino , Ratos , Glândula Tireoide/efeitos dos fármacos , Tireotropina/sangue , Tiroxina/sangue , Toxicologia/métodos , Toxicologia/normas , Tri-Iodotironina/sangue , Estados Unidos
6.
Toxicol Pathol ; 47(5): 564-573, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31291835

RESUMO

In this opinion piece, we discuss some proposed principles for designating adversity and nonadversity of histopathological changes. The suggested approach categorizes the classes of findings noted in toxicity studies with illustrations and examples and suggests adversity or nonadversity for each class, in the authors' opinions, with rationales. Although the suggestions and examples offered in this opinion piece are generally in agreement with Society of Toxicologic Pathology best practices guideline on adversity, the authors suggest and highlight occasional divergences and differences of opinion. This is because making an adversity call is a complex and challenging topic that is difficult to simplify. Some of the challenges in deciding on adversity are discussed, especially those related to making an adversity call on a histopathological finding in isolation, based on the nature and extent of severity. The authors demonstrate some of these situations with examples. Finally, the authors suggest, in contrast to the guidelines, occasional use of a separate category for findings that are less easily classified. *This is an opinion article submitted to the Toxicologic Pathology Forum. It represents the views of the author(s). It does not constitute an official position of the Society of Toxicologic Pathology, British Society of Toxicological Pathology, or European Society of Toxicologic Pathology, and the views expressed might not reflect the best practices recommended by these Societies. This article should not be construed to represent the policies, positions, or opinions of their respective organizations, employers, or regulatory agencies.


Assuntos
Patologia/normas , Toxicologia/normas , Congressos como Assunto , Patologia/métodos , Guias de Prática Clínica como Assunto , Toxicologia/métodos
7.
Toxicol Pathol ; 47(5): 574-576, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31303126

RESUMO

In the article "Opinion on Designation of Adverse and Nonadverse Histopathological Findings in Toxicity Studies: The Pathologist's Dilemma," the authors Gopinath and Mowat provide a framework for designation of adversity supplemented with photomicrographic examples. Given that adversity designation can significantly impact the no observed adverse effect level and clinical trial design, it is important to carefully consider all of the criteria by which such assignments are made. We highlight some of the specific assertions within the article that could benefit from a more detailed discussion. Our primary criticism surrounds the authors' primary reliance on histopathology in isolation for adversity designation, which in our opinion provides an overly simplified depiction of the process. We provide additional perspective on how context beyond histopathology often plays a critical role in adversity designation and highlight areas where inclusion of some of these scenarios would have provided the reader a more realistic view of the complex process of assigning adversity. * This is an opinion article submitted to the Toxicologic Pathology Forum. It represents the views of the authors. It does not constitute an official position of the Society of Toxicologic Pathology, British Society of Toxicological Pathology, or European Society of Toxicologic Pathology, and the views expressed might not reflect the best practices recommended by these Societies. This article should not be construed to represent the policies, positions, or opinions of their respective organizations, employers, or regulatory agencies.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Patologia/métodos , Toxicologia/métodos , Animais , Humanos , Nível de Efeito Adverso não Observado , Patologia/normas , Toxicologia/normas
8.
Chem Biol Interact ; 310: 108736, 2019 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-31278902

RESUMO

The linear non-threshold (LNT) dose response model for cancer risk assessment has been a controversial concept since its initial proposal during the 1930s. It was long advocated by the radiation genetics community in the 1950s, some two decades prior to being generally adopted within the chemical toxicology community. This paper explores possible reasons for such major differences in the acceptance of LNT for cancer risk assessment by these two key groups of scientists.


Assuntos
Modelos Lineares , Neoplasias/etiologia , Radiação Ionizante , Medição de Risco/normas , United States Environmental Protection Agency/normas , Relação Dose-Resposta à Radiação , Humanos , Radiogenética/normas , Toxicologia/normas , Estados Unidos
9.
Nat Commun ; 10(1): 3041, 2019 07 10.
Artigo em Inglês | MEDLINE | ID: mdl-31292445

RESUMO

Metabolomics is a widely used technology in academic research, yet its application to regulatory science has been limited. The most commonly cited barrier to its translation is lack of performance and reporting standards. The MEtabolomics standaRds Initiative in Toxicology (MERIT) project brings together international experts from multiple sectors to address this need. Here, we identify the most relevant applications for metabolomics in regulatory toxicology and develop best practice guidelines, performance and reporting standards for acquiring and analysing untargeted metabolomics and targeted metabolite data. We recommend that these guidelines are evaluated and implemented for several regulatory use cases.


Assuntos
Poluição Ambiental/legislação & jurisprudência , Metabolômica/normas , Guias de Prática Clínica como Assunto , Projetos de Pesquisa/normas , Toxicologia/normas , Monitoramento Ambiental/legislação & jurisprudência , Monitoramento Ambiental/métodos , Poluição Ambiental/prevenção & controle , Substâncias Perigosas/análise , Substâncias Perigosas/toxicidade , Humanos , Metabolômica/legislação & jurisprudência , Toxicologia/legislação & jurisprudência
10.
Toxicol Lett ; 314: 10-17, 2019 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-31082523

RESUMO

Botanical safety science continues to evolve as new tools for risk assessment become available alongside continual desire by consumers for "natural" botanical ingredients in consumer products. Focusing on botanical food/dietary supplements a recent international roundtable meeting brought together scientists to discuss the needs, available tools, and ongoing data gaps in the botanical safety risk assessment process. Participants discussed the key elements of botanical safety evaluations. They provided perspective on the use of a decision tree methodology to conduct a robust risk assessment and concluded with alignment on a series of consensus statements. This discussion highlighted the strengths and vulnerabilities in common assumptions, and the participants shared additional perspective to ensure that this end-to-end safety approach is sufficient, actionable and timely. Critical areas and data gaps were identified as opportunities for future focus. These include, better context on history of use, systematic assessment of weight of evidence, use of in silico approaches, inclusion of threshold of toxicological concern considerations, individual substances/matrix interactions of plant constituents, assessing botanical-drug interactions and adaptations needed to apply to in vitro and in vivo pharmacokinetic modelling of botanical constituents.


Assuntos
Árvores de Decisões , Suplementos Nutricionais/efeitos adversos , Preparações de Plantas/efeitos adversos , Toxicologia/métodos , Animais , Consenso , Qualidade de Produtos para o Consumidor , Relação Dose-Resposta a Droga , Humanos , Modelos Biológicos , Segurança do Paciente , Preparações de Plantas/farmacocinética , Medição de Risco , Fatores de Risco , Toxicocinética , Toxicologia/normas
11.
Ann Biol Clin (Paris) ; 77(2): 219-224, 2019 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-30998200

RESUMO

Toxicological screening is a specific approach to analytical toxicology that uses analytical tools such as GC-MS, LC-UV (diode array) or LC-MS. Toxicological screening allows the detection and simultaneous identification of a large number of compounds. The results may be based on the use of one or more techniques. As part of the accreditation process for medical biology examinations according to standard NF EN ISO 15189, the group from SFTA and SFBC recommends an approach to accredit toxicological screening. Indeed, the complexity of the accreditation of this analysis comes in particular from the high number of compounds that can be detected. Validation parameters are discussed in the specific context of toxicological screening by considering two distinct approaches: the simple identification of compounds, or the identification and estimation of a range of concentration related to clinical outcomes.


Assuntos
Acreditação , Química Clínica/normas , Testes Diagnósticos de Rotina/normas , Toxicologia/normas , Química Clínica/métodos , Química Clínica/organização & administração , Cromatografia Líquida , Testes Diagnósticos de Rotina/métodos , Contaminação de Equipamentos , Cromatografia Gasosa-Espectrometria de Massas , Ensaios de Triagem em Larga Escala/métodos , Ensaios de Triagem em Larga Escala/normas , Humanos , Programas de Rastreamento/métodos , Programas de Rastreamento/normas , Controle de Qualidade , Sociedades Médicas/organização & administração , Sociedades Médicas/normas , Espectrometria de Massas em Tandem , Toxicologia/métodos , Toxicologia/organização & administração , Estudos de Validação como Assunto
12.
Toxicol Pathol ; 47(4): 461-468, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31018785

RESUMO

Anatomic pathology and clinical pathology end points are standard components of almost every nonclinical general toxicity study conducted during the risk assessment of novel pharmaceuticals and chemicals. On occasion, an ultrastructural pathology evaluation using transmission electron microscopy (TEM) may be included in nonclinical toxicity studies. Transmission electron microscopy is most commonly used when a light microscopic finding may require further characterization that could inform on the pathogenesis and/or mechanism of action. Regulatory guidance do not address the use of TEM in general study designs nor whether these assessments should be performed in laboratories conducted in compliance with Good Laboratory Practices. The Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathology (STP) formed a Working Group to assess the current practices on the use of TEM in nonclinical toxicity studies. The Working Group constructed a survey sent to members of societies of toxicologic pathology in the United States, Europe, Britain, and Japan, and responses were collected through the STP for evaluation by the Working Group. The survey results and regulatory context are discussed, as are "points to consider" from the collective experience of the Working Group. This survey indicates that TEM remains an essential diagnostic option for complementing toxicologic pathology evaluations. *This Points to Consider article is a product of a Society of Toxicologic Pathology (STP) Working Group commissioned by the Scientific and Regulatory Policy Committee (SRPC) of the STP. It has been reviewed and approved by the SRPC and Executive Committee of the STP but it does not represent a formal Best Practice recommendation of the Society; rather, it is intended to provide key "points to consider" in designing nonclinical studies or interpreting data from toxicity and safety studies intended to support regulatory submissions. The points expressed in this document are those of the authors and do not reflect views or policies of the employing institutions. Readers of Toxicologic Pathology are encouraged to send their thoughts on these articles or ideas for new topics to the Editor.


Assuntos
Microscopia Eletrônica de Transmissão , Patologia Clínica/métodos , Toxicologia/métodos , Comitês Consultivos , Animais , Avaliação Pré-Clínica de Medicamentos/métodos , Avaliação Pré-Clínica de Medicamentos/normas , Guias como Assunto , Humanos , Microscopia Eletrônica de Transmissão/métodos , Microscopia Eletrônica de Transmissão/normas , Patologia Clínica/legislação & jurisprudência , Patologia Clínica/normas , Sociedades Científicas , Testes de Toxicidade/métodos , Testes de Toxicidade/normas , Toxicologia/legislação & jurisprudência , Toxicologia/normas , Estados Unidos , United States Food and Drug Administration
13.
Toxicol Pathol ; 47(4): 436-443, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30722763

RESUMO

Digital pathology is defined as the ability to examine digitized microscopic slides and to generate qualitative and quantitative data. The field of digital pathology is rapidly evolving and has the potential to revolutionize toxicologic pathology. Techniques such as automated 2-D image analysis, whole slide imaging, and telepathology are already considered "mature" technologies and have been used for decades in exploratory studies; however, many organizations are reluctant to use digital pathology in regulatory toxicology studies. Innovative technologies using digitized slides including high-content imaging modalities and artificial intelligence are still under development but are increasingly used in toxicologic pathology. While software validation requirements are already described, clear guidance for application of these rules to the digital pathology field are few and the acceptance of these technologies by regulatory authorities remains necessary for successful adoption of digital pathology into the mainstream of toxicologic pathology. This topic was discussed during a roundtable at the 2018 Annual Congress of the French Society of Toxicologic Pathology. This opinion article summarizes the discussion regarding the current questions and challenges on the integration of innovative digital pathology tools within a good laboratory practice framework and is meant to stimulate further discussion among the toxicologic pathology community. *This is an opinion article submitted to the Toxicologic Pathology Forum and does not constitute an official position of the Society of Toxicologic Pathology or the journal Toxicologic Pathology. The views expressed in this article are those of the authors and do not necessarily represent the policies, positions, or opinions of their respective agencies and organizations. The Toxicologic Forum is designed to stimulate broad discussion of topics relevant to regulatory issues in Toxicologic pathology. Readers of Toxicologic Pathology are encouraged to send their thoughts on these articles or ideas for new topics to toxicologicpathologyforum@toxpath.org .


Assuntos
Processamento de Imagem Assistida por Computador/normas , Telepatologia/tendências , Toxicologia/tendências , Humanos , Microscopia/métodos , Microscopia/normas , Guias de Prática Clínica como Assunto , Telepatologia/normas , Toxicologia/normas
14.
Toxicol Pathol ; 47(2): 100-107, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30636543

RESUMO

Whole slide imaging (WSI) technology has advanced to a point where it has replaced the glass slide as the primary means of pathology evaluation within many areas of medical pathology. The deployment of WSI in the field of toxicologic pathology has been delayed by a lack of clarity around the degree of validation required for its use on Good Laboratory Practice (GLP) studies. The current opinion piece attempts to provide a high-level overview of WSI technology to include basic methodology, advantages and disadvantages over a conventional microscope, validation status of WSI scanners, and perceived concerns over regulatory acceptance for the use of WSI for (GLP) peer review in the field of toxicologic pathology. Observations are based on the extensive use by AstraZeneca of WSI for the peer review of non-GLP studies conducted at Charles River facilities and represent the experiences of the authors. Note: This is an opinion article submitted to the Toxicologic Pathology Forum. It represents the views of the author(s). It does not constitute an official position of the Society of Toxicologic Pathology, British Society of Toxicological Pathology, or European Society of Toxicologic Pathology, and the views expressed might not reflect the best practices recommended by these Societies. This article should not be construed to represent the policies, positions, or opinions of their respective organizations, employers, or regulatory agencies.


Assuntos
Interpretação de Imagem Assistida por Computador/métodos , Patologia/métodos , Revisão dos Cuidados de Saúde por Pares/métodos , Toxicologia/métodos , Humanos , Interpretação de Imagem Assistida por Computador/normas , Patologia/normas , Revisão dos Cuidados de Saúde por Pares/normas , Toxicologia/normas
16.
Basic Clin Pharmacol Toxicol ; 124(5): 560-567, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30561843

RESUMO

Toxicological and pharmacological information from human cells and tissues provides knowledge readily applicable to human safety assessment and to the efficacy assessment of pharmaceuticals. The 3R principle in animal studies includes the use of human material in the R of Replacement. The Reduction and Refinement Rs are related to animal use. Knowledge of the 3Rs and successful 3R methods are a prerequisite for the Reduction of animal experiments in the future. More collaboration among researchers using experimental animals and those working in vitro is necessary with mutual respect. The OECD Guidelines for the Testing of Chemicals have included the animal-free part of the 3Rs in guidances for the development and reporting of Adverse Outcome Pathways (AOPs), which is to be part of the Integrated Approaches to Testing and Assessment (IATA). The 3R centres established to help fulfil the Directive 2010/63/EU play an important role to promote the 3Rs and in the development of animal-free toxicology. Research centres in each Nordic country are founded upon solid research activities in cell and organ toxicity, including major EU programmes to promote 3Rs and implementation of good practices and methods broadly in all stakeholders of industry, regulators and academia. In the light of this, the Nordic Symposium on Toxicology and Pharmacology without Animal Experiments addressed more adopted/modified test guidelines or new test guidelines for new end-points, or hazard challenges, new in vitro 3D models, speeding up transfer of knowledge from research to regulation to understand AOP and towards IATA.


Assuntos
Farmacologia/métodos , Toxicologia/métodos , Experimentação Animal/legislação & jurisprudência , Experimentação Animal/normas , Animais , Avaliação Pré-Clínica de Medicamentos/métodos , Farmacologia/legislação & jurisprudência , Farmacologia/normas , Países Escandinavos e Nórdicos , Toxicologia/legislação & jurisprudência , Toxicologia/normas
17.
Med Hypotheses ; 121: 160-163, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30396472

RESUMO

Municipal fluoridation was a mid-twentieth century innovation based on the medical hypothesis that consuming low doses of fluoride when young provided protection against cavities with only a small risk of mild dental fluorosis, a cosmetic effect. In the 21st century, more than half of American teens are afflicted by dental fluorosis with approximately one in five having moderate to severe dental fluorosis in at least two teeth. Scientific literature since the 1990s has found that even low doses of fluoride adversely affect cognitive-behavioral development and that deficits are correlated with the severity of dental fluorosis in afflicted individuals. Evidence of neurotoxic impact from low dose systemic exposure to fluoride prompted an investigation by a branch of the governmental agency that has promoted fluoridation policy since its 1940's inception. This review identifies ten significant flaws in the design of an animal experiment conducted by the U.S. National Toxicology Program as part of that investigation into the neurotoxic impact of systemic prenatal and postnatal fluoride exposure. The authors hypothesize that organizational bias can and does compromise the integrity of fluoride research.


Assuntos
Fluoretos/análise , Saúde Pública/métodos , Toxicologia/métodos , Toxicologia/normas , Adolescente , Animais , Criança , Cárie Dentária/prevenção & controle , Água Potável , Feminino , Fluoretação , Fluorose Dentária/prevenção & controle , Humanos , Testes de Inteligência , Neurotoxinas/análise , Gravidez , Ratos , Ratos Long-Evans , Projetos de Pesquisa , Risco , Estados Unidos
18.
Am J Public Health ; 108(12): 1682-1687, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30359109

RESUMO

OBJECTIVES: To demonstrate the severity of undercounting opioid-involved deaths in a local jurisdiction with a high proportion of unspecified accidental poisoning deaths. METHODS: We matched toxicology data to vital records for all accidental poisoning deaths (n = 1238) in Marion County, Indiana, from January 2011 to December 2016. From vital records, we coded cases as opioid involved, specified other substance, or unspecified. We extracted toxicology data on opioid substances for unspecified cases, and we have reported corrected estimates of opioid-involved deaths after accounting for toxicology findings. RESULTS: Over a 6-year period, 57.7% of accidental overdose deaths were unspecified and 34.2% involved opioids. Toxicology data showed that 86.8% of unspecified cases tested positive for an opioid. Inclusion of toxicology results more than doubled the proportion of opioid-involved deaths, from 34.2% to 86.0%. CONCLUSIONS: Local jurisdictions may be undercounting opioid-involved overdose deaths to a considerable degree. Toxicology data can improve accuracy in identifying opioid-involved overdose deaths. Public Health Implications. Mandatory toxicology testing and enhanced training for local coroners on standards for death certificate reporting are needed to improve the accuracy of local monitoring of opioid-involved accidental overdose deaths.


Assuntos
Coleta de Dados/métodos , Overdose de Drogas/mortalidade , Entorpecentes/envenenamento , Vigilância em Saúde Pública/métodos , Toxicologia/estatística & dados numéricos , Médicos Legistas/normas , Médicos Legistas/estatística & dados numéricos , Atestado de Óbito , Humanos , Indiana/epidemiologia , Toxicologia/métodos , Toxicologia/normas
19.
Toxicol Pathol ; 46(8): 1006-1012, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30295163

RESUMO

The Standard for the Exchange of Nonclinical Data (SEND) is an implementation of the Study Data Tabulation Model for nonclinical studies that enables the U.S. Food and Drug Administration (FDA) to modernize and streamline the review process. As a result, patients may benefit from speedier approval of new drugs. However, SEND implementation and compliance can be challenging and require effective cooperation between pharmaceutical companies and contract research organizations. In order to improve Society of Toxicologic Pathology (STP) members' awareness about SEND, including the steps, obstacles, and mistakes to avoid in its implementation while applying for FDA approval, the Career Development and Outreach Committee of the STP sponsored a career development lunchtime series panel discussion entitled "The Standard for the Exchange of Nonclinical Data (SEND): Challenges and Promise" in conjunction with the STP 37th Annual Symposium. The presentations and discussion at this workshop provided perspectives of experts including pathologists and information technology professionals familiar with the SEND submission process and FDA reviewers. This article is designed to provide brief summaries of their talks as well as the questions asked during this well-received panel discussion.


Assuntos
Aprovação de Drogas/métodos , Avaliação Pré-Clínica de Medicamentos/normas , Toxicologia/normas , Animais , Toxicologia/métodos , Estados Unidos , United States Food and Drug Administration
20.
Toxicol Pathol ; 46(8): 920-924, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30189790

RESUMO

This article provides a synopsis of the first two presentations from the second scientific session of the 37th Annual Symposium of the Society of Toxicologic Pathology in Indianapolis, Indiana, on June 18, 2018; the session focused on acute kidney injury. The first presentation, given by Dr. Kevin McDorman, focused on "Fundamentals of Renal Tubule and Interstitial Anatomy and Physiology." Several common background findings from toxicity studies were additionally discussed. Lastly, factors that impact the relevance and usefulness of historical control data, such as quality and consistency of histopathology, were discussed. The second presentation, given by Dr. Torrie Crabbs, provided a review of International Harmonization of Nomenclature and Diagnostic Criteria (INHAND), Standard for Exchange of Nonclinical Data (SEND), and drug-induced kidney injury (DIKI) nomenclature. INHAND is a global collaborative project that provides internationally accepted standardized nomenclature and diagnostic criteria for proliferative and nonproliferative changes in laboratory animals in toxicity and carcinogenicity studies. SEND is currently a required standard for data submission to the Food and Drug Administration (FDA). Since the FDA has indicated its preference for INHAND nomenclature, SEND will predominately use INHAND terminology; thus, familiarity with INHAND terminology is critical for toxicologic pathologists. The diagnostic features of three common DIKI findings, in addition to several complicated INHAND terminologies, were reviewed.


Assuntos
Túbulos Renais/anatomia & histologia , Túbulos Renais/fisiologia , Patologia/normas , Terminologia como Assunto , Toxicologia/normas , Animais , Humanos , Patologia/métodos , Toxicologia/métodos
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