Base de dados : MEDLINE
Pesquisa : E05.916 [Categoria DeCS]
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[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


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[PMID]:29311542
[Au] Autor:Cao J; Perez-Pinera P; Lowenhaupt K; Wu MR; Purcell O; de la Fuente-Nunez C; Lu TK
[Ad] Endereço:Synthetic Biology Group, Department of Biological Engineering and Electrical Engineering & Computer Science, Massachusetts Institute of Technology, Cambridge, MA, 02139, USA.
[Ti] Título:Versatile and on-demand biologics co-production in yeast.
[So] Source:Nat Commun;9(1):77, 2018 01 08.
[Is] ISSN:2041-1723
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Current limitations to on-demand drug manufacturing can be addressed by technologies that streamline manufacturing processes. Combining the production of two or more drugs into a single batch could not only be useful for research, clinical studies, and urgent therapies but also effective when combination therapies are needed or where resources are scarce. Here we propose strategies to concurrently produce multiple biologics from yeast in single batches by multiplexing strain development, cell culture, separation, and purification. We demonstrate proof-of-concept for three biologics co-production strategies: (i) inducible expression of multiple biologics and control over the ratio between biologic drugs produced together; (ii) consolidated bioprocessing; and (iii) co-expression and co-purification of a mixture of two monoclonal antibodies. We then use these basic strategies to produce drug mixtures as well as to separate drugs. These strategies offer a diverse array of options for on-demand, flexible, low-cost, and decentralized biomanufacturing applications without the need for specialized equipment.
[Mh] Termos MeSH primário: Produtos Biológicos/metabolismo
Preparações Farmacêuticas/metabolismo
Saccharomyces cerevisiae/metabolismo
Tecnologia Farmacêutica/métodos
[Mh] Termos MeSH secundário: Anticorpos Monoclonais/biossíntese
Anticorpos Monoclonais/isolamento & purificação
Produtos Biológicos/isolamento & purificação
Análise Custo-Benefício
Seres Humanos
Preparações Farmacêuticas/isolamento & purificação
Saccharomyces cerevisiae/crescimento & desenvolvimento
Tecnologia Farmacêutica/economia
Tecnologia Farmacêutica/instrumentação
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, U.S. GOV'T, NON-P.H.S.
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Biological Products); 0 (Pharmaceutical Preparations)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180110
[St] Status:MEDLINE
[do] DOI:10.1038/s41467-017-02587-w


  3 / 14316 MEDLINE  
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[PMID]:29220340
[Au] Autor:Savchenko LP; Mishchenko VA; Georgiyants VA
[Ad] Endereço:Department of Quality, Standardization and Certification of Drugs, Institute of Pharmacy Professionals Qualification Improvement, National University of Pharmacy, Kharkiv, Ukraine. savchenkolesia@gmail.com.
[Ti] Título:Validation of the Technological Process of the Preparation "Milk by Vidal".
[So] Source:Int J Pharm Compd;21(6):513-517, 2017 Nov-Dec.
[Is] ISSN:1092-4221
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Validation was performed on the technological process of the compounded preparation "Milk by Vidal" in accordance with the requirements of the regulatory framework of Ukraine. Critical stages of formulation which can affect the quality of the finished preparation were considered during the research. The obtained results indicated that the quality of the finished preparation met the requirements of the State Pharmacopoeia of Ukraine.
[Mh] Termos MeSH primário: Composição de Medicamentos/normas
Tecnologia Farmacêutica/normas
[Mh] Termos MeSH secundário: Anti-Infecciosos Locais/química
Antiparasitários/química
Química Farmacêutica
Controle de Qualidade
Ucrânia
[Pt] Tipo de publicação:JOURNAL ARTICLE; VALIDATION STUDIES
[Nm] Nome de substância:
0 (Anti-Infective Agents, Local); 0 (Antiparasitic Agents)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180220
[Lr] Data última revisão:
180220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171209
[St] Status:MEDLINE


  4 / 14316 MEDLINE  
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[PMID]:29220337
[Au] Autor:DePasquale S
[Ad] Endereço:BET Pharm, Lexington, Kentucky. seth.depasquale@mac.com.
[Ti] Título:Basics of Compounding: Hot Melt Extrusion.
[So] Source:Int J Pharm Compd;21(6):471-479, 2017 Nov-Dec.
[Is] ISSN:1092-4221
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Hot Melt Extrusion, a production process that has been around for quite some time, has the ability to produce innovative compounds not previously achievable with conventional methods. However, many variables need to be considered prior to production. The use of small-scale extruders and 3D printers provides compounders a pathway for developing new dosage forms at a minimal cost while initial research is being completed. This article discusses the uses of Hot Melt Extrusion, the equipment used, the current and future applications, and the challenges with the technology.
[Mh] Termos MeSH primário: Composição de Medicamentos/métodos
Tecnologia Farmacêutica/métodos
[Mh] Termos MeSH secundário: Química Farmacêutica
Preparações de Ação Retardada
Solubilidade
Paladar
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Delayed-Action Preparations)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180220
[Lr] Data última revisão:
180220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171209
[St] Status:MEDLINE


  5 / 14316 MEDLINE  
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[PMID]:29200316
[Au] Autor:Debevec V; Srcic S; Horvat M
[Ad] Endereço:a Sandoz Development Center , Lek Pharmaceuticals, d.d. , Ljubljana , Slovenia.
[Ti] Título:Scientific, statistical, practical, and regulatory considerations in design space development.
[So] Source:Drug Dev Ind Pharm;44(3):349-364, 2018 Mar.
[Is] ISSN:1520-5762
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:The quality by design (QbD) paradigm guides the pharmaceutical industry towards improved understanding of products and processes, and at the same time facilitates a high degree of manufacturing and regulatory flexibility throughout the establishment of the design space. This review article presents scientific, statistical and regulatory considerations in design space development. All key development milestones, starting with planning, selection of factors, experimental execution, data analysis, model development and assessment, verification, and validation, and ending with design space submission, are presented and discussed. The focus is especially on frequently ignored topics, like management of factors and CQAs that will not be included in experimental design, evaluation of risk of failure on design space edges, or modeling scale-up strategy. Moreover, development of a design space that is independent of manufacturing scale is proposed as the preferred approach.
[Mh] Termos MeSH primário: Indústria Farmacêutica/métodos
Indústria Farmacêutica/estatística & dados numéricos
Projetos de Pesquisa/estatística & dados numéricos
Tecnologia Farmacêutica/métodos
Tecnologia Farmacêutica/estatística & dados numéricos
[Mh] Termos MeSH secundário: Controle de Qualidade
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180201
[Lr] Data última revisão:
180201
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171205
[St] Status:MEDLINE
[do] DOI:10.1080/03639045.2017.1409755


  6 / 14316 MEDLINE  
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[PMID]:29030070
[Au] Autor:Buffin S; Ikhelef N; Prudent J; Dubayle J; Nougarede N; Varenne MP; Moste C; Legastelois I
[Ad] Endereço:Research and Development, Sanofi Pasteur, Marcy L'Etoile, France. Electronic address: sophie.buffin@sanofi.com.
[Ti] Título:A latex agglutination assay to quantify the amount of hemagglutinin protein in adjuvanted low-dose influenza monovalent vaccines.
[So] Source:J Virol Methods;251:46-53, 2018 Jan.
[Is] ISSN:1879-0984
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:To formulate inactivated influenza vaccines, the concentration of hemagglutinin (HA) must be accurately determined. The standard test currently used to measure HA in influenza vaccines is the Single Radial Immunodiffusion (SRID) assay. We developed a very rapid, simple and sensitive alternative quantitative HA assay, namely the Latex Agglutination Assay (LAA). The LAA uses the Spherotest technology, which is based on the agglutination of HA-specific immunoglobulin-coated latex beads. The amount of HA in a sample is calculated from the level of bead agglutination by a simple absorbance measurement at 405nm against a standard curve generated using a monovalent vaccine standard. In less than 2hours, tens of samples could be quantified using the LAA as opposed to 2days for the SRID assay. Ten steps are required to complete an SRID assay as compared to 6 steps for the LAA, from sample preparation through spectrophotometric analysis. Furthermore, the limit of detection of the LAA was found to be approximately 15ng HA/mL, similar to an ELISA, with the quantification of less than 1.8µg HA/mL. The quantification limit of the SRID is usually considered to be approximately 5µg HA/mL. The development of the assay and a comparison of the titers obtained by SRID and LAA for several monovalent vaccines corresponding to various strains were performed. For A/H5N1 and A/H1N1 monovalent vaccines, the LAA was found to be linear and accurate as compared to the SRID. The precision of the LAA was close to that of the standard test, and good reproducibility from one laboratory to another was observed. Moreover, the LAA enabled HA quantification in AlOOH-adjuvanted and in emulsion-adjuvanted low-dose vaccines as well as unadjuvanted vaccines. In conclusion, LAA may be useful to rapidly and accurately measure influenza HA protein in monovalent vaccines, especially in those containing less than 5µg/mL of HA in the presence of an adjuvant.
[Mh] Termos MeSH primário: Glicoproteínas de Hemaglutininação de Vírus da Influenza/análise
Vacinas contra Influenza/imunologia
Testes de Fixação do Látex/métodos
Tecnologia Farmacêutica/métodos
[Mh] Termos MeSH secundário: Fatores de Tempo
[Pt] Tipo de publicação:EVALUATION STUDIES; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Hemagglutinin Glycoproteins, Influenza Virus); 0 (Influenza Vaccines)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180201
[Lr] Data última revisão:
180201
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171015
[St] Status:MEDLINE


  7 / 14316 MEDLINE  
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[PMID]:28967287
[Au] Autor:Wei Q; Keck CM; Müller RH
[Ad] Endereço:a Department of Pharmaceutics, Biopharmaceutics and NutriCosmetics, Institute of Pharmacy , Freie Universität Berlin , Berlin , Germany.
[Ti] Título:Solidification of hesperidin nanosuspension by spray drying optimized by design of experiment (DoE).
[So] Source:Drug Dev Ind Pharm;44(1):1-12, 2018 Jan.
[Is] ISSN:1520-5762
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To accelerate the determination of optimal spray drying parameters, a "Design of Experiment" (DoE) software was applied to produce well redispersible hesperidin nanocrystals. SIGNIFICANCE: For final solid dosage forms, aqueous liquid nanosuspensions need to be solidified, whereas spray drying is a large-scale cost-effective industrial process. METHODS: A nanosuspension with 18% (w/w) of hesperidin stabilized by 1% (w/w) of poloxamer 188 was produced by wet bead milling. The sizes of original and redispersed spray-dried nanosuspensions were determined by laser diffractometry (LD) and photon correlation spectroscopy (PCS) and used as effect parameters. In addition, light microscopy was performed to judge the redispersion quality. RESULTS: After a two-step design of MODDE 9, screening model and response surface model (RSM), the inlet temperature of spray dryer and the concentration of protectant (polyvinylpyrrolidone, PVP K25) were identified as the most important factors affecting the redispersion of nanocrystals. As predicted in the RSM modeling, when 5% (w/w) of PVP K25 was added in an 18% (w/w) of hesperidin nanosuspension, subsequently spray-dried at an inlet temperature of 100 °C, well redispersed solid nanocrystals with an average particle size of 276 nm were obtained. By the use of PVP K25, the saturation solubility of the redispersed nanocrystals in water was improved to 86.81 µg/ml, about 2.5-fold of the original nanosuspension. In addition, the dissolution velocity was accelerated. CONCLUSIONS: This was attributed to the additional effects of steric stabilization on the nanocrystals and solubilization by the PVP polymer from spray drying.
[Mh] Termos MeSH primário: Dessecação/métodos
Hesperidina/química
Nanopartículas/química
Povidona/química
Tecnologia Farmacêutica/métodos
[Mh] Termos MeSH secundário: Solubilidade
Água/química
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
059QF0KO0R (Water); E750O06Y6O (Hesperidin); FZ989GH94E (Povidone)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180111
[Lr] Data última revisão:
180111
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171003
[St] Status:MEDLINE
[do] DOI:10.1080/03639045.2017.1285309


  8 / 14316 MEDLINE  
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[PMID]:28832224
[Au] Autor:Chaudhary RS; Patel C; Sevak V; Chan M
[Ad] Endereço:a Apotex Inc., Technical Operations - Technical Support Services , Toronto , Canada.
[Ti] Título:Effect of Kollidon VA 64 particle size and morphology as directly compressible excipient on tablet compression properties.
[So] Source:Drug Dev Ind Pharm;44(1):19-29, 2018 Jan.
[Is] ISSN:1520-5762
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:The study evaluates use of Kollidon VA 64 and a combination of Kollidon VA 64 with Kollidon VA 64 Fine as excipient in direct compression process of tablets. The combination of the two grades of material is evaluated for capping, lamination and excessive friability. Inter particulate void space is higher for such excipient due to the hollow structure of the Kollidon VA 64 particles. During tablet compression air remains trapped in the blend exhibiting poor compression with compromised physical properties of the tablets. Composition of Kollidon VA 64 and Kollidon VA 64 Fine is evaluated by design of experiment (DoE). A scanning electron microscopy (SEM) of two grades of Kollidon VA 64 exhibits morphological differences between coarse and fine grade. The tablet compression process is evaluated with a mix consisting of entirely Kollidon VA 64 and two mixes containing Kollidon VA 64 and Kollidon VA 64 Fine in ratio of 77:23 and 65:35. A statistical modeling on the results from the DoE trials resulted in the optimum composition for direct tablet compression as combination of Kollidon VA 64 and Kollidon VA 64 Fine in ratio of 77:23. This combination compressed with the predicted parameters based on the statistical modeling and applying main compression force between 5 and 15 kN, pre-compression force between 2 and 3 kN, feeder speed fixed at 25 rpm and compression range of 45-49 rpm produced tablets with hardness ranging between 19 and 21 kp, with no friability, capping, or lamination issue.
[Mh] Termos MeSH primário: Excipientes/química
Povidona/química
Comprimidos/química
[Mh] Termos MeSH secundário: Dureza
Tamanho da Partícula
Povidona/análise
Pressão
Solubilidade
Tecnologia Farmacêutica
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Excipients); 0 (Tablets); FZ989GH94E (Povidone)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180111
[Lr] Data última revisão:
180111
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170824
[St] Status:MEDLINE
[do] DOI:10.1080/03639045.2017.1371735


  9 / 14316 MEDLINE  
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[PMID]:28743552
[Au] Autor:Liu R; Li L; Yin W; Xu D; Zang H
[Ad] Endereço:School of Pharmaceutical Sciences, Shandong University, Wenhuaxi Road 44, Jinan, 250012, China.
[Ti] Título:Near-infrared spectroscopy monitoring and control of the fluidized bed granulation and coating processes-A review.
[So] Source:Int J Pharm;530(1-2):308-315, 2017 Sep 15.
[Is] ISSN:1873-3476
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:The fluidized bed granulation and pellets coating technologies are widely used in pharmaceutical industry, because the particles made in a fluidized bed have good flowability, compressibility, and the coating thickness of pellets are homogeneous. With the popularization of process analytical technology (PAT), real-time analysis for critical quality attributes (CQA) was getting more attention. Near-infrared (NIR) spectroscopy, as a PAT tool, could realize the real-time monitoring and control during the granulating and coating processes, which could optimize the manufacturing processes. This article reviewed the application of NIR spectroscopy in CQA (moisture content, particle size and tablet/pellet thickness) monitoring during fluidized bed granulation and coating processes. Through this review, we would like to provide references for realizing automated control and intelligent production in fluidized bed granulation and pellets coating of pharmaceutical industry.
[Mh] Termos MeSH primário: Espectroscopia de Luz Próxima ao Infravermelho
Tecnologia Farmacêutica
[Mh] Termos MeSH secundário: Química Farmacêutica
Excipientes
Tamanho da Partícula
Comprimidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Excipients); 0 (Tablets)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180109
[Lr] Data última revisão:
180109
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170727
[St] Status:MEDLINE


  10 / 14316 MEDLINE  
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[PMID]:28461268
[Au] Autor:Dillon C; Hughes H; O'Reilly NJ; McLoughlin P
[Ad] Endereço:Pharmaceutical and Molecular Biotechnology Research Centre (PMBRC), Waterford Institute of Technology, Cork Road, Waterford, Ireland. Electronic address: cdillon@wit.ie.
[Ti] Título:Formulation and characterisation of dissolving microneedles for the transdermal delivery of therapeutic peptides.
[So] Source:Int J Pharm;526(1-2):125-136, 2017 Jun 30.
[Is] ISSN:1873-3476
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:The highly effective barrier properties of the stratum corneum (SC) limit the application of transdermal delivery to relatively small, lipophilic molecules. Microneedles (MNs) however, offer a route to effectively deliver a wide range of pharmaceuticals through the skin, bypassing the SC in a non-invasive and pain-free manner. This study presents a dissolving MN system composed of polyvinylpyrrolidone (PVP) and trehalose to encapsulate active pharmaceutical peptides within the MN matrix. Rapid systemic delivery is then achieved once the needles have penetrated the SC and dissolved in the interstitial fluid of the skin. A variety of characterisation techniques were carried out to determine the optimum formulation. A model peptide, polymyxin B, was then incorporated into the MN system and delivered through porcine skin. In addition, the activity of the model drug was monitored during all stages of the formulation process.
[Mh] Termos MeSH primário: Administração Cutânea
Sistemas de Liberação de Medicamentos
Microinjeções
Peptídeos/administração & dosagem
[Mh] Termos MeSH secundário: Animais
Química Farmacêutica
Agulhas
Pele
Suínos
Tecnologia Farmacêutica
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Peptides)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180104
[Lr] Data última revisão:
180104
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170503
[St] Status:MEDLINE



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