Base de dados : MEDLINE
Pesquisa : J01.576.655.750 [Categoria DeCS]
Referências encontradas : 29720 [refinar]
Mostrando: 1 .. 10   no formato [Detalhado]

página 1 de 2972 ir para página                         

  1 / 29720 MEDLINE  
              next record last record
seleciona
para imprimir
Fotocópia
Texto completo
[PMID]:28465097
[Au] Autor:Cohet C; Rosillon D; Willame C; Haguinet F; Marenne MN; Fontaine S; Buyse H; Bauchau V; Baril L
[Ad] Endereço:GSK Vaccines, Wavre, Belgium. Electronic address: catherine.x.cohet@gsk.com.
[Ti] Título:Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer's view.
[So] Source:Vaccine;35(23):3041-3049, 2017 05 25.
[Is] ISSN:1873-2518
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure. The aim of this perspective paper is to describe the authors' experience in the design and conduct of twelve PASS that contributed to the evaluation of the benefit-risk of vaccines in real-world settings. We describe challenges and learnings from selected PASS of rotavirus, malaria, influenza, human papillomavirus and measles-mumps-rubella-varicella vaccines that assessed or identified potential or theoretical risks, which may lead to changes to risk management plans and/or to label updates. Study settings include the use of large healthcare databases and de novo data collection. PASS methodology is influenced by the background incidence of the outcome of interest, vaccine uptake, availability and quality of data sources, identification of the at-risk population and of suitable comparators, availability of validated case definitions, and the frequent need for case ascertainment in large databases. Challenges include the requirement for valid exposure and outcome data, identification of, and access to, adequate data sources, and mitigating limitations including bias and confounding. Assessing feasibility is becoming a key step to confirm that study objectives can be met in a timely manner. PASS provide critical information for regulators, public health agencies, vaccine manufacturers and ultimately, individuals. Collaborative approaches and synergistic efforts between vaccine manufacturers and key stakeholders, such as regulatory and public health agencies, are needed to facilitate access to data, and to drive optimal study design and implementation, with the aim of generating robust evidence.
[Mh] Termos MeSH primário: Sistemas de Notificação de Reações Adversas a Medicamentos
Indústria Farmacêutica/legislação & jurisprudência
Tecnologia Farmacêutica/legislação & jurisprudência
Vacinas/efeitos adversos
[Mh] Termos MeSH secundário: Vacina contra Varicela/efeitos adversos
Seres Humanos
Vacinas contra Influenza/efeitos adversos
Vacinas Antimaláricas/efeitos adversos
Vacina contra Sarampo-Caxumba-Rubéola/efeitos adversos
Vacinas contra Papillomavirus/efeitos adversos
Medição de Risco
Vacinas contra Rotavirus/efeitos adversos
Tecnologia Farmacêutica/métodos
Tecnologia Farmacêutica/organização & administração
Vacinação
Vacinas/administração & dosagem
Vacinas Atenuadas
Vacinas Combinadas/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Chickenpox Vaccine); 0 (Influenza Vaccines); 0 (Malaria Vaccines); 0 (Measles-Mumps-Rubella Vaccine); 0 (Papillomavirus Vaccines); 0 (Rotavirus Vaccines); 0 (Vaccines); 0 (Vaccines, Attenuated); 0 (Vaccines, Combined); 0 (measles, mumps, rubella, varicella vaccine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170504
[St] Status:MEDLINE


  2 / 29720 MEDLINE  
              first record previous record next record last record
seleciona
para imprimir
Fotocópia
Texto completo
[PMID]:29286057
[Au] Autor:D'Souza P
[Ad] Endereço:Clarivate Analytics, London, UK. pdsouza@clarivate.com.
[Ti] Título:Notable licensing deals in the biopharma industry in the third quarter of 2017.
[So] Source:Drugs Today (Barc);53(10):553-557, 2017 Oct.
[Is] ISSN:1699-3993
[Cp] País de publicação:Spain
[La] Idioma:eng
[Ab] Resumo:During the third quarter of 2017, Cortellis Competitive Intelligence registered 949 new deals (excluding mergers and acquisitions) added as part of its ongoing coverage of pharmaceutical licensing activity compared to 1,007 in Q2 this year and 1,023 in Q3 the previous year.
[Mh] Termos MeSH primário: Indústria Farmacêutica
Licenciamento
[Mh] Termos MeSH secundário: Contratos
Indústria Farmacêutica/economia
Seres Humanos
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180306
[Lr] Data última revisão:
180306
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171230
[St] Status:MEDLINE
[do] DOI:10.1358/dot.2017.53.10.2746403


  3 / 29720 MEDLINE  
              first record previous record next record last record
seleciona
para imprimir
Fotocópia
[PMID]:29443467
[Au] Autor:Brown G
[Ti] Título:Aspects of Global Health Issues: Diseases, Natural Disasters, and Pharmaceutical Corporations and Medical Research.
[So] Source:ABNF J;27(3):53-57, 2016 Summer.
[Is] ISSN:1046-7041
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Global health issues are concerns of all public health officials throughout the world. This entails reviewing aspects such as the impact of poverty and the lack of access to quality health care, ignored global killers such as Diseases (Infectious diseases-Malaria, HIV/AIDS), Natural Disasters (Earthquakes, Tsunamis, Floods, and Armed Conflict), Health in the Media, and the Involvement of Pharmaceutical Corporations and Medical Research. These issues are challenges to many needless deaths. Global initiatives are not advancing as they should, such as access to drugs and medications, which some are political.
[Mh] Termos MeSH primário: Doenças Transmissíveis/terapia
Assistência à Saúde/organização & administração
Desastres
Saúde Global
Saúde Pública
Qualidade da Assistência à Saúde/organização & administração
[Mh] Termos MeSH secundário: Pesquisa Biomédica/organização & administração
Indústria Farmacêutica/organização & administração
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:180215
[St] Status:MEDLINE


  4 / 29720 MEDLINE  
              first record previous record next record last record
seleciona
para imprimir
Fotocópia
[PMID]:29430906
[Au] Autor:Martynova NA; Gorokhova LG
[Ti] Título:[Toxicological characteristics of the cinnamic].
[So] Source:Gig Sanit;95(8):779-81, 2016.
[Is] ISSN:0016-9900
[Cp] País de publicação:Russia (Federation)
[La] Idioma:rus
[Ab] Resumo:The toxic properties of the cinnamic alcohol with an aim of its hygienic rating are studied. DL for male rats, male and female mice are respectively 3300, 3000 and 2700 mg/kg. It refers to the substances of hazard class 3. The clinical picture of acute poisoning was characterized by the general depression, muscle relaxation, disorder of the movement coordination, decrease in body temperature and death in the first and the second days after the poisoning. The differences in sex and species sensitivity of the animals to the substance are not observed: the rates of species differences and sex sensitivity are ~1. Single and repeated (10 days) inhalation of the vapors of the cinnamic alcohol at the greatest possible saturation neither cause the death of mice no signs of toxicity. It has a weak ability to cumulation: the cumulation coefficient is 5.4. It has no local irritating action to the skin. Skin-resorptive and sensitizing effects are not revealed. It has a weak irritating effect on the mucous membranes of the eyes. In the subacute experiment after the introduction of the substance into the stomach in a total dose equal to 5.2 DL we noted the lag of the experimental animals in body weight gain from the control ones, the increase in the activity of y-glutamyl transpeptidase and transaminases in serum. In the peripheral blood the decrease in hemoglobin, erythrocytes and eosinophils count is revealed. The threshold of the acute inhalation effect is 140 mg/m (by the reduction in the number of erythrocytes and hemoglobin in peripheral blood). Tentative safe level of the exposure to the cinnamic alcohol in the air of the working zone is 5 mg/m (vapors).
[Mh] Termos MeSH primário: Indústria Farmacêutica/normas
Exposição Ocupacional
Saúde do Trabalhador/normas
Propanóis
[Mh] Termos MeSH secundário: Animais
Modelos Animais de Doenças
Substâncias Perigosas/química
Substâncias Perigosas/toxicidade
Concentração Máxima Permitida
Exposição Ocupacional/efeitos adversos
Exposição Ocupacional/normas
Propanóis/química
Propanóis/toxicidade
Ratos
Testes de Toxicidade/métodos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Hazardous Substances); 0 (Propanols); SS8YOP444F (cinnamyl alcohol)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180301
[Lr] Data última revisão:
180301
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180213
[St] Status:MEDLINE


  5 / 29720 MEDLINE  
              first record previous record next record last record
seleciona
para imprimir
Fotocópia
[PMID]:29424993
[Au] Autor:Martynova NA; Zakharenkov VV; Oleshchenko AM; Gorokhova LG
[Ti] Título:[Hygienic standardization of 2-formylphenoxyethane acid in the air of the working zone Hygiene of Children and Adolescents].
[So] Source:Gig Sanit;95(7):633-6, 2016.
[Is] ISSN:0016-9900
[Cp] País de publicação:Russia (Federation)
[La] Idioma:rus
[Ab] Resumo:The toxic properties of 2-formylphenoxyethane acid for hygienic standardization in the air of the working zone were studied. DL of the substance under the introduction into the stomach for male rats, male and female mice was 5354, 3698 and 4322 mg/kg. This compound refers to moderately hazardous substances. No significant differences in species and gender sensitivity of animals to the substance were found. This compound possesses a strong ability to the accumulation: C accounts of 2.9. It has a marked irritating effect to the mucous membranes of eyes and the moderate impact to the skin. It has a toxic effect on the liver, kidneys, central nervous system. The threshold of acute inhalation effect (Lim) equals to 120.3 mg/m. It has no irritating effect to the respiratory tract at Lim level. The tentative safe exposure level of 2-formylphenoxyethane acid in the air of working zone equals to 1 mg/m.
[Mh] Termos MeSH primário: Amiodarona/química
Indústria Farmacêutica/normas
[Mh] Termos MeSH secundário: Poluentes Ocupacionais do Ar/análise
Poluentes Ocupacionais do Ar/química
Animais
Antiarrítmicos/química
Modelos Animais de Doenças
Seres Humanos
Concentração Máxima Permitida
Doenças Profissionais/induzido quimicamente
Doenças Profissionais/prevenção & controle
Ratos
Testes de Toxicidade/métodos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Air Pollutants, Occupational); 0 (Anti-Arrhythmia Agents); N3RQ532IUT (Amiodarone)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180301
[Lr] Data última revisão:
180301
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180210
[St] Status:MEDLINE


  6 / 29720 MEDLINE  
              first record previous record next record last record
seleciona
para imprimir
Fotocópia
[PMID]:29292914
[Au] Autor:Eberhard J
[Ti] Título:Grova anklagelser mot skånsk onkologi kan inte stå oemotsagda..
[So] Source:Lakartidningen;114, 2017 11 02.
[Is] ISSN:1652-7518
[Cp] País de publicação:Sweden
[La] Idioma:swe
[Mh] Termos MeSH primário: Neoplasias Colorretais/tratamento farmacológico
Fidelidade a Diretrizes
[Mh] Termos MeSH secundário: Conflito de Interesses
Indústria Farmacêutica
Hospitais Universitários/normas
Seres Humanos
Suécia
[Pt] Tipo de publicação:LETTER
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180301
[Lr] Data última revisão:
180301
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180103
[St] Status:MEDLINE


  7 / 29720 MEDLINE  
              first record previous record next record last record
seleciona
para imprimir
Fotocópia
Texto completo
[PMID]:29386431
[Au] Autor:Ohashi Y
[Ad] Endereço:Quality & Regulatory Compliance Unit, Chugai Pharmaceutical Co., Ltd.
[Ti] Título:[Safe Use of Recent New Drugs-Current Status and Challenges].
[So] Source:Yakugaku Zasshi;138(2):177-183, 2018.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo: In Japan and overseas, Chugai Pharmaceutical Company handles numerous biopharmaceuticals, molecular targeted therapies and other pharmaceuticals with innovative modes of action. Expert safety evaluation is essential for promoting the appropriate use of these pharmaceuticals around the world and in gaining acceptance from patients and healthcare professionals (HCPs), while speedy decision-making is crucial for the timely collection and provision of safety information and thus ensuring safety. In 2015, we collected safety information on more than 180000 cases and evaluated it from a medical standpoint. We have established a system for recording the collected information in a global database, and are conducting signal detection of adverse drug reactions using this database. With this system, we promptly disclose information to regulatory authorities in Japan, the US, Europe and Asia. We have in-house medical doctors with abundant clinical experience who conduct expert safety evaluations. Many innovative drugs, such as anticancer drugs or biopharmaceuticals, require wider-ranging, more rigorous management, including the provision of appropriate safety information to HCPs, management of distribution through wholesalers and dispensing pharmacies, and confirmation of conditions of use, in addition to all-case registration surveillance. With progress in the development of individualized medicine and drugs with new modes of action, in order for HCPs to understand the characteristics of these new drugs and use them appropriately, pharmacists and pharmaceutical companies should cooperate in promoting their appropriate use in the spirit of 'All Pharmacists for Patients'.
[Mh] Termos MeSH primário: Bases de Dados de Produtos Farmacêuticos
Serviços de Informação sobre Medicamentos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Preparações Farmacêuticas
Farmacovigilância
Gestão de Riscos
[Mh] Termos MeSH secundário: Biofarmácia
Tomada de Decisões Gerenciais
Indústria Farmacêutica
Seres Humanos
Farmacêuticos
Medicina de Precisão/tendências
Segurança
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Pharmaceutical Preparations)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180202
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.17-00174-3


  8 / 29720 MEDLINE  
              first record previous record next record last record
seleciona
para imprimir
Fotocópia
Texto completo
[PMID]:28742898
[Au] Autor:Jain N; Hwang T; Franklin JM; Kesselheim AS
[Ad] Endereço:Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts.
[Ti] Título:Association of the Priority Review Voucher With Neglected Tropical Disease Drug and Vaccine Development.
[So] Source:JAMA;318(4):388-389, 2017 07 25.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Produção de Droga sem Interesse Comercial/estatística & dados numéricos
Medicina Tropical
[Mh] Termos MeSH secundário: Ensaios Clínicos Fase I como Assunto/estatística & dados numéricos
Indústria Farmacêutica
Financiamento Governamental
Seres Humanos
Produção de Droga sem Interesse Comercial/legislação & jurisprudência
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Em] Mês de entrada:1709
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170726
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.7467


  9 / 29720 MEDLINE  
              first record previous record next record last record
seleciona
para imprimir
Fotocópia
Texto completo
[PMID]:29320302
[Au] Autor:Joffe S; Lynch HF
[Ad] Endereço:From the Department of Medical Ethics and Health Policy, Perelman School of Medicine, and the Leonard Davis Institute of Health Economics, University of Pennsylvania (S.J., H.F.L.), and the Children's Hospital of Philadelphia (S.J.) - all in Philadelphia.
[Ti] Título:Federal Right-to-Try Legislation - Threatening the FDA's Public Health Mission.
[So] Source:N Engl J Med;378(8):695-697, 2018 Feb 22.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Aprovação de Drogas/legislação & jurisprudência
Drogas em Investigação
Regulamentação Governamental
Acesso aos Serviços de Saúde/legislação & jurisprudência
Legislação de Medicamentos
Segurança do Paciente/legislação & jurisprudência
United States Food and Drug Administration/legislação & jurisprudência
[Mh] Termos MeSH secundário: Ensaios Clínicos Fase I como Assunto
Estado Terminal
Avaliação de Medicamentos/legislação & jurisprudência
Indústria Farmacêutica/legislação & jurisprudência
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Seres Humanos
Responsabilidade Legal
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drugs, Investigational)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMp1714054


  10 / 29720 MEDLINE  
              first record previous record
seleciona
para imprimir
Fotocópia
Texto completo
[PMID]:28464141
[Au] Autor:Larkin I; Ang D; Steinhart J; Chao M; Patterson M; Sah S; Wu T; Schoenbaum M; Hutchins D; Brennan T; Loewenstein G
[Ad] Endereço:University of California, Los Angeles.
[Ti] Título:Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing.
[So] Source:JAMA;317(17):1785-1795, 2017 May 02.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: In an effort to regulate physician conflicts of interest, some US academic medical centers (AMCs) enacted policies restricting pharmaceutical representative sales visits to physicians (known as detailing) between 2006 and 2012. Little is known about the effect of these policies on physician prescribing. Objective: To analyze the association between detailing policies enacted at AMCs and physician prescribing of actively detailed and not detailed drugs. Design, Setting, and Participants: The study used a difference-in-differences multivariable regression analysis to compare changes in prescribing by physicians before and after implementation of detailing policies at AMCs in 5 states (California, Illinois, Massachusetts, Pennsylvania, and New York) that made up the intervention group with changes in prescribing by a matched control group of similar physicians not subject to a detailing policy. Exposures: Academic medical center implementation of policies regulating pharmaceutical salesperson visits to attending physicians. Main Outcomes and Measures: The monthly within-drug class market share of prescriptions written by an individual physician for detailed and nondetailed drugs in 8 drug classes (lipid-lowering drugs, gastroesophageal reflux disease drugs, diabetes drugs, antihypertensive drugs, hypnotic drugs approved for the treatment of insomnia [sleep aids], attention-deficit/hyperactivity disorder drugs, antidepressant drugs, and antipsychotic drugs) comparing the 10- to 36-month period before implementation of the detailing policies with the 12- to 36-month period after implementation, depending on data availability. Results: The analysis included 16 121 483 prescriptions written between January 2006 and June 2012 by 2126 attending physicians at the 19 intervention group AMCs and by 24 593 matched control group physicians. The sample mean market share at the physician-drug-month level for detailed and nondetailed drugs prior to enactment of policies was 19.3% and 14.2%, respectively. Exposure to an AMC detailing policy was associated with a decrease in the market share of detailed drugs of 1.67 percentage points (95% CI, -2.18 to -1.18 percentage points; P < .001) and an increase in the market share of nondetailed drugs of 0.84 percentage points (95% CI, 0.54 to 1.14 percentage points; P < .001). Associations were statistically significant for 6 of 8 study drug classes for detailed drugs (lipid-lowering drugs, gastroesophageal reflux disease drugs, antihypertensive drugs, sleep aids, attention-deficit/hyperactivity disorder drugs, and antidepressant drugs) and for 9 of the 19 AMCs that implemented policies. Eleven of the 19 AMCs regulated salesperson gifts to physicians, restricted salesperson access to facilities, and incorporated explicit enforcement mechanisms. For 8 of these 11 AMCs, there was a significant change in prescribing. In contrast, there was a significant change at only 1 of 8 AMCs that did not enact policies in all 3 areas. Conclusions and Relevance: Implementation of policies at AMCs that restricted pharmaceutical detailing between 2006 and 2012 was associated with modest but significant reductions in prescribing of detailed drugs across 6 of 8 major drug classes; however, changes were not seen in all of the AMCs that enacted policies.
[Mh] Termos MeSH primário: Centros Médicos Acadêmicos/estatística & dados numéricos
Conflito de Interesses
Indústria Farmacêutica
Prescrições de Medicamentos/estatística & dados numéricos
Política Organizacional
Médicos/estatística & dados numéricos
Medicamentos sob Prescrição/uso terapêutico
[Mh] Termos MeSH secundário: Anticolesterolemiantes/uso terapêutico
Antidepressivos/uso terapêutico
Anti-Hipertensivos/uso terapêutico
Antipsicóticos/uso terapêutico
California
Fármacos Cardiovasculares/uso terapêutico
Seres Humanos
Hipnóticos e Sedativos/uso terapêutico
Hipoglicemiantes/uso terapêutico
Illinois
Relações Interprofissionais
Massachusetts
New York
Pennsylvania
Análise de Regressão
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anticholesteremic Agents); 0 (Antidepressive Agents); 0 (Antihypertensive Agents); 0 (Antipsychotic Agents); 0 (Cardiovascular Agents); 0 (Hypnotics and Sedatives); 0 (Hypoglycemic Agents); 0 (Prescription Drugs)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:180227
[Lr] Data última revisão:
180227
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170503
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.4039



página 1 de 2972 ir para página                         
   


Refinar a pesquisa
  Base de dados : MEDLINE Formulário avançado   

    Pesquisar no campo  
1  
2
3
 
           



Search engine: iAH v2.6 powered by WWWISIS

BIREME/OPAS/OMS - Centro Latino-Americano e do Caribe de Informação em Ciências da Saúde