Base de dados : MEDLINE
Pesquisa : L01.178.682.192.836.749 [Categoria DeCS]
Referências encontradas : 2388 [refinar]
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[PMID]:28719368
[Au] Autor:Laniewicz C
[Ad] Endereço:Phoenix Controls. claniewicz@phoenixcontrols.com.
[Ti] Título:Change Is In the Air: What You Need to Know About Pharmacy Ventilation Under United States Pharmacopeia <800>.
[So] Source:Int J Pharm Compd;21(4):271-274, 2017 Jul-Aug.
[Is] ISSN:1092-4221
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:On July 1, 2018, United States Pharmacopeia <800> takes effect in those states that adopt it, and the discussion within this article may be applicable to those states that develop their own standards. United States Pharmacopeia <800> changes requirements for storage and compounding of hazardous drugs. The new requirements have important implications for air management and ventilation in some pharmacies. This article discusses how United States Pharmacopeia <800> compares to United States Pharmacopeia <797>, how the changes impact room ventilation and pressurization requirements, and how high-performance airflow control systems that ensure compliance and safety are impacted.
[Mh] Termos MeSH primário: Farmácias
Farmacopeias como Assunto
Ventilação
[Mh] Termos MeSH secundário: Seres Humanos
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170912
[Lr] Data última revisão:
170912
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170719
[St] Status:MEDLINE


  2 / 2388 MEDLINE  
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[PMID]:28557778
[Au] Autor:Allen LV
[Ad] Endereço:International Journal of Pharmaceutical Compounding. lallen@ijpc.com.
[Ti] Título:PreScription: United States Pharmacopeia Chapter <800> Comments and Alternatives.
[So] Source:Int J Pharm Compd;21(3):180, 2017 May-Jun.
[Is] ISSN:1092-4221
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Substâncias Perigosas/normas
Preparações Farmacêuticas/normas
Farmacopeias como Assunto/normas
Farmácia/normas
[Mh] Termos MeSH secundário: Composição de Medicamentos/tendências
Seres Humanos
Estados Unidos
[Pt] Tipo de publicação:EDITORIAL
[Nm] Nome de substância:
0 (Hazardous Substances); 0 (Pharmaceutical Preparations)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170713
[Lr] Data última revisão:
170713
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170531
[St] Status:MEDLINE


  3 / 2388 MEDLINE  
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[PMID]:28279253
[Au] Autor:Baylis SA; Terao E; Blümel J; Hanschmann KO
[Ad] Endereço:Paul-Ehrlich-Institut (PEI), Langen, Germany.
[Ti] Título:Collaborative study for the establishment of the Ph. Eur. Hepatitis E virus RNA for NAT testing biological reference preparation batch 1.
[So] Source:Pharmeur Bio Sci Notes;2017:12-28, 2017.
[Is] ISSN:2075-2504
[Cp] País de publicação:France
[La] Idioma:eng
[Ab] Resumo:A new European Pharmacopoeia (Ph. Eur.) biological reference preparation (BRP) had to be established further to the decision to include nucleic acid testing (NAT) for the detection of hepatitis E virus (HEV) RNA in the monograph Human plasma (pooled and treated for virus inactivation) (1646). To this purpose, an international collaborative study was launched in the framework of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Commission of the European Union (EU). The study was run in conjunction with the establishment of the 1 World Health Organization (WHO) international reference panel (IRP) for hepatitis E virus RNA genotypes (8578/13). Twenty-three laboratories used in-house developed and commercially available assays to calibrate a lyophilised candidate BRP prepared from a HEV 3f strain positive human plasma against the 1 WHO International Standard (IS) for HEV RNA (6329/10). Results from quantitative and qualitative assays were in good agreement and were combined to calculate an assigned potency. Real-time stability studies indicated that the candidate BRP is very stable at lower temperatures and is thus suitable for long-term use. Based on these results, in February 2016, the Ph. Eur. Commission adopted the candidate material as the hepatitis E virus RNA for NAT testing BRP batch 1, with an assigned unitage of 2.1 × 10 IU/vial (4.32 log IU/vial).
[Mh] Termos MeSH primário: Vírus da Hepatite E/genética
Cooperação Internacional
Técnicas de Amplificação de Ácido Nucleico/normas
Farmacopeias como Assunto/normas
Vírus de RNA/genética
[Mh] Termos MeSH secundário: Seres Humanos
Técnicas de Amplificação de Ácido Nucleico/métodos
Padrões de Referência
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170327
[Lr] Data última revisão:
170327
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170311
[St] Status:MEDLINE


  4 / 2388 MEDLINE  
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[PMID]:28279252
[Au] Autor:Raut S; Costanzo A; Daas A; Buchheit KH
[Ad] Endereço:National Institute for Biological Standards and Control (NIBSC), Potters Bar, EN6 3QG, Herts, UK.
[Ti] Título:Calibration of the Ph. Eur. human coagulation Factor VIII concentrate BRP batch 5.
[So] Source:Pharmeur Bio Sci Notes;2017:1-11, 2017.
[Is] ISSN:2075-2504
[Cp] País de publicação:France
[La] Idioma:eng
[Ab] Resumo:The European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for Factor VIII Concentrate batch 5 was established through a collaborative study involving 14 laboratories organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) to be used as working standard for potency determination of human coagulation Factor VIII (FVIII) preparations. The potency of the BRP batch 5 was assigned with reference to the WHO 8 International Standard (IS) for FVIII Concentrate and the BRP batch 4. Participants were instructed to perform 3 independent Factor VIII potency assays following their own routine validated methods by the chromogenic assay as it is the assay prescribed by the European Pharmacopoeia. This publication reports the results obtained during the study. The consensus potency, 9.9 IU/ampoule (n = 14) when assessed against both standards, with inter-laboratory geometric coefficients of variation (GCV) of 3.2 % and 1.9 % against the WHO 8 IS and the BRP batch 4 respectively, was consistent with the expected value. The Ph. Eur. BRP batch 5 is a freeze-dried, plasma-derived concentrate. Based on accelerated degradation studies, the stability of the material is suitable as a reference preparation. The Ph. Eur. BRP batch 5 was adopted at the 151 session of the European Pharmacopoeia Commission in March 2015 and is available from the EDQM.
[Mh] Termos MeSH primário: Química Farmacêutica/normas
Fator VIII/análise
Fator VIII/normas
Farmacopeias como Assunto/normas
[Mh] Termos MeSH secundário: Calibragem/normas
Química Farmacêutica/métodos
Europa (Continente)
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (F8 protein, human); 9001-27-8 (Factor VIII)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170327
[Lr] Data última revisão:
170327
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170311
[St] Status:MEDLINE


  5 / 2388 MEDLINE  
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[PMID]:28179113
[Au] Autor:Leonti M; Verpoorte R
[Ad] Endereço:Department of Biomedical Sciences, University of Cagliari, 09124 Cagliari, Italy. Electronic address: marcoleonti@netscape.net.
[Ti] Título:Traditional Mediterranean and European herbal medicines.
[So] Source:J Ethnopharmacol;199:161-167, 2017 Mar 06.
[Is] ISSN:1872-7573
[Cp] País de publicação:Ireland
[La] Idioma:eng
[Ab] Resumo:ETHNOPHARMACOLOGICAL RELEVANCE: Written history allows tracing back Mediterranean and European medical traditions to Greek antiquity. The epidemiological shift triggered by the rise of modern medicine and industrialization is reflected in contemporary reliance and preferences for certain herbal medicines. MATERIALS AND METHODS: We sketch the development and transmission of written herbal medicine through Mediterranean and European history and point out the opportunity to connect with modern traditions. RESULTS: An ethnopharmacological database linking past and modern medical traditions could serve as a tool for crosschecking contemporary ethnopharmacological field-data as well as a repository for data mining. Considering that the diachronic picture emerging from such a database has an epidemiological base this could lead to new hypotheses related to evolutionary medicine. CONCLUSION: The advent of systems pharmacology and network pharmacology opens new perspectives for studying past and current herbal medicine. Since a large part of modern drugs has its roots in ancient traditions one may expect new leads for drug development from novel systemic studies, as well as evidence for the activity of certain herbal preparations.
[Mh] Termos MeSH primário: Etnofarmacologia/história
Medicina Herbária/história
Medicina Tradicional/história
Farmacopeias como Assunto/história
[Mh] Termos MeSH secundário: Europa (Continente)
História do Século XV
História do Século XVI
História do Século XVII
História do Século XVIII
História Antiga
História Medieval
Seres Humanos
Região do Mediterrâneo
Fitoterapia/história
Plantas Medicinais
[Pt] Tipo de publicação:HISTORICAL ARTICLE; JOURNAL ARTICLE
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170714
[Lr] Data última revisão:
170714
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170210
[St] Status:MEDLINE


  6 / 2388 MEDLINE  
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[PMID]:28107333
[Au] Autor:Polovich M
[Ad] Endereço:Georgia State University.
[Ti] Título:U.S. Pharmacopeial Chapter <800>: Be Ready to Comply by July 2018 
.
[So] Source:Clin J Oncol Nurs;21(1):116-119, 2017 Feb 01.
[Is] ISSN:1538-067X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The U.S. Pharmacopeial Convention's "Chapter <800> Hazardous Drugs-Handling in Healthcare Settings" is a new part of the National Formulary that describes standards-expectations for practice-for all aspects of handling and administering hazardous drugs (HDs). Some of the standards will require changes in policies, procedures, and practices for nurses. This article provides an overview of the new standards and the impact they will have on nurses who prepare and administer chemotherapy and other HDs.
.
[Mh] Termos MeSH primário: Fidelidade a Diretrizes/estatística & dados numéricos
Exposição Ocupacional/prevenção & controle
Saúde do Trabalhador
Farmacopeias como Assunto/normas
Guias de Prática Clínica como Assunto
[Mh] Termos MeSH secundário: Antineoplásicos/administração & dosagem
Antineoplásicos/efeitos adversos
Congressos como Assunto
Feminino
Seres Humanos
Masculino
National Institute for Occupational Safety and Health (U.S.)/normas
Exposição Ocupacional/efeitos adversos
Enfermagem Oncológica/métodos
Roupa de Proteção/utilização
Gestão da Segurança/normas
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antineoplastic Agents)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171013
[Lr] Data última revisão:
171013
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:170121
[St] Status:MEDLINE
[do] DOI:10.1188/17.CJON.116-119


  7 / 2388 MEDLINE  
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[PMID]:28024259
[Au] Autor:Jedynak L; Jedynak M; Kossykowska M; Zagrodzka J
[Ad] Endereço:Pharmaceutical Research Institute, R&D Analytical Chemistry Department, Rydygiera 8, 01-793 Warsaw, Poland. Electronic address: l.jedynak@ifarm.eu.
[Ti] Título:A novel method for the determination of chemical purity and assay of menaquinone-7. Comparison with the methods from the official USP monograph.
[So] Source:J Pharm Biomed Anal;135:116-125, 2017 Feb 20.
[Is] ISSN:1873-264X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:An HPLC method with UV detection and separation with the use of a C30 reversed phase analytical column for the determination of chemical purity and assay of menaquinone-7 (MK7) in one chromatographic run was developed. The method is superior to the methods published in the USP Monograph in terms of selectivity, sensitivity and accuracy, as well as time, solvent and sample consumption. The developed methodology was applied to MK7 samples of active pharmaceutical ingredient (API) purity, MK7 samples of lower quality and crude MK7 samples before purification. The comparison of the results revealed that the use of USP methodology could lead to serious overestimation (up to a few percent) of both purity and MK7 assay in menaquinone-7 samples.
[Mh] Termos MeSH primário: Química Farmacêutica/métodos
Contaminação de Medicamentos
Farmacopeias como Assunto
Vitamina K 2/análogos & derivados
[Mh] Termos MeSH secundário: Cromatografia Líquida de Alta Pressão/métodos
Farmacopeias como Assunto/normas
Fotólise
Espectrofotometria Ultravioleta/métodos
Estados Unidos
Vitamina K 2/análise
Vitamina K 2/metabolismo
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
11032-49-8 (Vitamin K 2); 8427BML8NY (vitamin MK 7)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170524
[Lr] Data última revisão:
170524
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161227
[St] Status:MEDLINE


  8 / 2388 MEDLINE  
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[PMID]:27987393
[Au] Autor:Kormány R; Molnár I; Fekete J
[Ad] Endereço:Egis Pharmaceuticals Plc., Budapest, Hungary. Electronic address: kormany.robert@egis.hu.
[Ti] Título:Renewal of an old European Pharmacopoeia method for Terazosin using modeling with mass spectrometric peak tracking.
[So] Source:J Pharm Biomed Anal;135:8-15, 2017 Feb 20.
[Is] ISSN:1873-264X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:An older method for terazosin was reworked in order to reduce the analysis time from 90min (2×45min) to below 5min. The method in European Pharmacopoeia (Ph.Eur.) investigates the specified impurities separately. The reason of the different methods is that the retention of two impurities is not adequate in reversed phase, not even with 100% water. Therefore ion-pair-chromatography has to be applied and since that two impurities absorb at low UV-wavelength they had to be analyzed by different method than the other specified impurities. In our new method we could improve the retention with pH elevation using a new type of stationary phases available for high pH applications. Also a detection wavelength could be selected that is appropriate for the detection and quantification of all impurities. The method development is the bottleneck of liquid chromatography even today, when more and more fast chromatographic systems are used. Expert knowledge with intelligent programs is available to reduce the time of method development and offer extra information about the robustness of the separation. Design of Experiments (DoE) for simultaneous optimization of gradient time (t ), temperature (T) and ternary eluent composition (t ) requires 12 experiments. A good alternative way to identify a certain peak in different chromatograms is the molecular mass of the compound, due to its high specificity. Liquid Chromatography-Mass Spectrometry (LC-MS) is now a routine technique and increasingly available in laboratories. In our experiment for the resolution- and retention modeling the DryLab4 method development software (Version 4.2) was used. In recent versions of the software the use of (m/z)-MS-data is possible along the UV-peak-area-tracking technology. The modelled and measured chromatograms showed excellent correlations. The average retention time deviations were ca. 0.5s and there was no difference between the predicted and measured R -values.
[Mh] Termos MeSH primário: Modelos Moleculares
Farmacopeias como Assunto
Prazosina/análogos & derivados
Espectrometria de Massas em Tandem/métodos
[Mh] Termos MeSH secundário: Cromatografia Líquida de Alta Pressão/métodos
Cromatografia Líquida de Alta Pressão/normas
Europa (Continente)
Espectrometria de Massas/métodos
Espectrometria de Massas/normas
Farmacopeias como Assunto/normas
Prazosina/análise
Prazosina/química
Espectrometria de Massas em Tandem/normas
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
8L5014XET7 (Terazosin); XM03YJ541D (Prazosin)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170524
[Lr] Data última revisão:
170524
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161218
[St] Status:MEDLINE


  9 / 2388 MEDLINE  
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[PMID]:27894973
[Au] Autor:Rivera D; Verde A; Obón C; Alcaraz F; Moreno C; Egea T; Fajardo J; Palazón JA; Valdés A; Signorini MA; Bruschi P
[Ad] Endereço:Depto. Biología Vegetal, Campus de Espinardo, Universidad de Murcia, Murcia, Spain. Electronic address: drivera@um.es.
[Ti] Título:Is there nothing new under the sun? The influence of herbals and pharmacopoeias on ethnobotanical traditions in Albacete (Spain).
[So] Source:J Ethnopharmacol;195:96-117, 2017 Jan 04.
[Is] ISSN:1872-7573
[Cp] País de publicação:Ireland
[La] Idioma:eng
[Ab] Resumo:ETHNOPHARMACOLOGICAL RELEVANCE: This paper has two overarching aims: (1) presenting the results of studying the Albacete tariff of medicines of 1526 and (2) broadly analyzing the origin and influences of medicinal traditional knowledge in the region of Albacete, Spain. We use historical and modern literature that may have influenced this knowledge. Our primary goal was to determine the ingredients used in the pharmacy in the 16th century CE in Albacete through the analysis of the tariff, and our secondary goal was to investigate until when ingredients and uses present in pharmacy and herbals persisted in later periods. METHODS: The identity of medicines and ingredients was determined by analyzing contemporary pharmacopoeias and classical pharmaceutical references. We analyzed further 21 sources (manuscripts, herbals, and books of medicines, pharmacopoeias, pharmacy inventories, and modern ethnobotanical records) for the presence/absence of ingredients and complex formulations of the tariff. Using factorial and cluster analysis and Bayesian inference applied to evolution models (reversible-jump Markov chain Monte Carlo), we compared textual sources. Finally, we analyzed the medicinal uses of the top 10 species in terms of frequency of citation to assess the dependence of modern ethnobotanical records on Renaissance pharmacy and herbals, and, ultimately, on Dioscorides. RESULTS: In Albacete 1526, we determined 101 medicines (29 simple drugs and 72 compound medicines) comprising 187 ingredients (85% botanical, 7.5% mineral, and 7.5% zoological substances). All composed medicines appear standardized in the pharmacopoeias, notably in the pharmacopoeia of Florence from 1498. However, most were no longer in use by 1750 in the pharmacy, and were completely absent in popular herbal medicine in Albacete 1995 as well as in Alta Valle del Reno (Italy) in 2014. Among the ingredients present in different formulation are the flowers of Rosa gallica, honey (Apis mellifera), the roots of Nardostachys jatamansi, and Convolvulus scammonia, pistils of Crocus sativus, grapes and raisins (Vitis vinifera), rhizomes of Zingiber officinale, bark of Cinnamomum verum, leaves and fruits of Olea europaea, mastic generally of Pistacia lentiscus, and wood of Santalum album. The statistical analysis of sources produces four well-separated clusters (Renaissance Herbals and Pharmacopoeias, Ethnobotany and Folk Medicine, Old phytotherapy, and Modern phytotherapy including Naturopathy) confirming our a priori classification. The clade of Renaissance Herbals and Pharmacopoeias appears separated from the rest in 97% of bootstrapped trees. Bayesian inference produces a tree determined by an initial set of two well-distinct core groups of ingredients: 64, locally used in Mediterranean Europe during centuries; and 45, imported, used in pharmacy during centuries. Complexity reached its maximum in Albacete 1526 and contemporary pharmacopoeias, gradually decreasing over time. The analysis of medicinal uses of the top 10 ingredients showed low coincidence between Dioscorides and different Renaissance herbals or medical treatises and of all of them with ethnobotany in Albacete. CONCLUSIONS: Regarding our question: is there something new under the sun? In some aspects, the answer is "No". The contrast between expensive drugs, highly valued medicines, and unappreciated local wild medicinal plants persists since the Salerno's school of medicine. Old medicine in Mediterranean Europe, as reflected by Albacete 1526 tariff of medicines, involved strict formulations and preferences for certain ingredients despite other ingredients locally available but underappreciated. This confirms the fact that any system of medicine does not get to use all available resources. Ethnobiological records of materia medica, in rural areas of Albacete, describe systems with a high degree of stability and resilience, where the use of local resources, largely wild but also cultivated, is predominant in contrast with the weight of imported exotic products in pharmacy.
[Mh] Termos MeSH primário: Etnobotânica
Medicina Tradicional
Farmacopeias como Assunto
Fitoterapia
Preparações de Plantas/uso terapêutico
Plantas Medicinais
[Mh] Termos MeSH secundário: Teorema de Bayes
Análise por Conglomerados
Características Culturais
Difusão de Inovações
Etnobotânica/história
Etnobotânica/tendências
Análise Fatorial
Conhecimentos, Atitudes e Prática em Saúde/etnologia
História do Século XVI
História do Século XVII
História do Século XVIII
História do Século XIX
História do Século XX
História do Século XXI
Seres Humanos
Cadeias de Markov
Medicina Tradicional/história
Medicina Tradicional/tendências
Análise Multivariada
Farmacopeias como Assunto/história
Fitoterapia/história
Fitoterapia/tendências
Plantas Medicinais/classificação
Espanha
[Pt] Tipo de publicação:HISTORICAL ARTICLE; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Plant Preparations)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170703
[Lr] Data última revisão:
170703
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161130
[St] Status:MEDLINE


  10 / 2388 MEDLINE  
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[PMID]:26987647
[Au] Autor:Garattini L; Padula A
[Ad] Endereço:IRCCS Institute for Pharmacological Research "Mario Negri", 24020, Ranica, Italy. lgarattini@marionegri.it.
[Ti] Título:'Appropriateness' in Italy: A 'Magic Word' in Pharmaceuticals?
[So] Source:Appl Health Econ Health Policy;15(1):1-3, 2017 Feb.
[Is] ISSN:1179-1896
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Mh] Termos MeSH primário: Tratamento Farmacológico/normas
[Mh] Termos MeSH secundário: Controle de Custos/economia
Controle de Custos/métodos
Custos de Medicamentos
Prescrições de Medicamentos/economia
Prescrições de Medicamentos/normas
Tratamento Farmacológico/economia
Seres Humanos
Itália
Farmacopeias como Assunto
Alocação de Recursos/economia
Alocação de Recursos/métodos
[Pt] Tipo de publicação:EDITORIAL
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170817
[Lr] Data última revisão:
170817
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160319
[St] Status:MEDLINE
[do] DOI:10.1007/s40258-016-0240-7



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