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[PMID]:28463163
[Au] Autor:Connor MJ; Tringale K; Moiseenko V; Marshall DC; Moore K; Cervino L; Atwood T; Brown D; Mundt AJ; Pawlicki T; Recht A; Hattangadi-Gluth JA
[Ad] Endereço:Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California; University of California Irvine School of Medicine, Irvine, California.
[Ti] Título:Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015.
[So] Source:Int J Radiat Oncol Biol Phys;98(2):438-446, 2017 06 01.
[Is] ISSN:1879-355X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non-radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. METHODS AND MATERIALS: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. RESULTS: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). CONCLUSIONS: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.
[Mh] Termos MeSH primário: Recall de Dispositivo Médico
Radioterapia (Especialidade)/instrumentação
Software/estatística & dados numéricos
United States Food and Drug Administration/estatística & dados numéricos
[Mh] Termos MeSH secundário: Braquiterapia/instrumentação
Distribuição de Qui-Quadrado
Bases de Dados Factuais/estatística & dados numéricos
Equipamentos e Provisões/classificação
Equipamentos e Provisões/provisão & distribuição
Modelos Lineares
Vigilância de Produtos Comercializados/normas
Vigilância de Produtos Comercializados/estatística & dados numéricos
Radioterapia (Especialidade)/estatística & dados numéricos
Planejamento da Radioterapia Assistida por Computador/instrumentação
Planejamento da Radioterapia Assistida por Computador/estatística & dados numéricos
Estatísticas não Paramétricas
Fatores de Tempo
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Em] Mês de entrada:1707
[Cu] Atualização por classe:180307
[Lr] Data última revisão:
180307
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170503
[St] Status:MEDLINE


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[PMID]:29486013
[Au] Autor:Wallach JD; Ross JS
[Ad] Endereço:Collaboration for Research Integrity and Transparency, Yale Law School, New Haven, Connecticut.
[Ti] Título:Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Evaluation Efforts.
[So] Source:JAMA;319(8):776-778, 2018 02 27.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Ácidos Cicloexanocarboxílicos
Uso Off-Label
[Mh] Termos MeSH secundário: Aminas
Seres Humanos
Vigilância de Produtos Comercializados
Ácido gama-Aminobutírico
[Pt] Tipo de publicação:EDITORIAL; COMMENT
[Nm] Nome de substância:
0 (Amines); 0 (Cyclohexanecarboxylic Acids); 56-12-2 (gamma-Aminobutyric Acid); 6CW7F3G59X (gabapentin)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180228
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.21897


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[PMID]:29386432
[Au] Autor:Uesawa Y
[Ad] Endereço:Department of Clinical Pharmaceutics, Meiji Pharmaceutical University.
[Ti] Título:[Adverse Effect Predictions Based on Computational Toxicology Techniques and Large-scale Databases].
[So] Source:Yakugaku Zasshi;138(2):185-190, 2018.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo: Understanding the features of chemical structures related to the adverse effects of drugs is useful for identifying potential adverse effects of new drugs. This can be based on the limited information available from post-marketing surveillance, assessment of the potential toxicities of metabolites and illegal drugs with unclear characteristics, screening of lead compounds at the drug discovery stage, and identification of leads for the discovery of new pharmacological mechanisms. This present paper describes techniques used in computational toxicology to investigate the content of large-scale spontaneous report databases of adverse effects, and it is illustrated with examples. Furthermore, volcano plotting, a new visualization method for clarifying the relationships between drugs and adverse effects via comprehensive analyses, will be introduced. These analyses may produce a great amount of data that can be applied to drug repositioning.
[Mh] Termos MeSH primário: Sistemas de Notificação de Reações Adversas a Medicamentos
Computadores
Bases de Dados como Assunto
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Toxicologia/métodos
[Mh] Termos MeSH secundário: Reposicionamento de Medicamentos
Valor Preditivo dos Testes
Vigilância de Produtos Comercializados
Relação Estrutura-Atividade
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[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.17-00174-4


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[PMID]:29298008
[Au] Autor:Novik GA; Khaleva EG; Bychkova NV; Zdanova MV
[Ti] Título:Evaluation of Efficacy and Safety of Longterm Feeding with Amino Acid-Based Formula in Infants with Cow's Milk Protein Allergy: Results of the Open-Label Prospective Controlled Post-Registration Trial.
[So] Source:Vestn Ross Akad Med Nauk;71(6):446-57, 2016.
[Is] ISSN:0869-6047
[Cp] País de publicação:Russia (Federation)
[La] Idioma:eng
[Ab] Resumo:Background: The cow's milk allergy (CMA) prevalence is 2−3% in children under one year. Approximately in 5% of cases transferring to extensively hydrolysed formula (eHF) doesn't lead to disappearance of CMA symptoms. Aims: Evaluation of efficacy and safety of amino-acid formula (AAF) longterm feeding in children under one year and development of predictors of successful transfer from AAF to eHF. Materials and Methods: In open-label prospective post-registration trial duration of 365 days were included 43 children aged from 3 to 12 months with CMA. CMA was based on Russian and international guidelines. When a patient was included in the trial, child received eHF for 4 weeks with the evaluation of the effect of elimination diet (ED): in case of absence of effect, for diagnostic purposes child feed with AAF for 2 weeks and upon receiving the effect, child continued to receive it for at least 6 months. Diet was considered effective if there were observed disappearance of clinical manifestations of CMA during of formula using. Results: Children fed with AAF gain weight and increased height statistically higher during the first 6 months, compared with children receiving eHF, but without subsequent difference in a year. After 4 weeks' of AAF feeding, there was a significant decrease in SCORAD index from 46.84 (SD 4.164) to 2.52 (SD 2.204) (p=0.005); disappearance of gastrointestinal manifestations of CMA from 3 to 14 day. After 4 weeks, the 100% normalization of previously elevated faecal calprotectin (p<0.05) was observed; and after 6months. ED, in 60% of children normalization of the index of activation of basophils with milk was observed. 38.7% of children were transferred to eHF in 6 months, 12.9% and 25.8% in 9 and 12 months respectively. Conclusions: Use of AAF for children with CMA is an effective and safe treatment without lengthening the period of elimination, which is necessary for the formation of tolerance to cow's milk protein and has a positive impact on weight and height. Normalization of specific activation of basophils with milk could be considered as a predictor of successful transfer from AAF to eHF in children with CMA.
[Mh] Termos MeSH primário: Aminoácidos/farmacologia
Fórmulas Infantis
Hipersensibilidade a Leite
Hidrolisados de Proteína/farmacologia
[Mh] Termos MeSH secundário: Antropometria/métodos
Desenvolvimento Infantil/fisiologia
Feminino
Seres Humanos
Imunoglobulina E/análise
Lactente
Fórmulas Infantis/análise
Fórmulas Infantis/química
Fórmulas Infantis/classificação
Masculino
Hipersensibilidade a Leite/diagnóstico
Hipersensibilidade a Leite/dietoterapia
Hipersensibilidade a Leite/etiologia
Hipersensibilidade a Leite/fisiopatologia
Monitorização Fisiológica/métodos
Vigilância de Produtos Comercializados/métodos
Estudos Prospectivos
Federação Russa
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Amino Acids); 0 (Protein Hydrolysates); 37341-29-0 (Immunoglobulin E)
[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:180104
[St] Status:MEDLINE
[do] DOI:10.15690/vramn757


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[PMID]:29215916
[Au] Autor:Solotke MT; Dhruva SS; Downing NS; Shah ND; Ross JS
[Ad] Endereço:a School of Medicine , Yale University , New Haven , CT , USA.
[Ti] Título:New and incremental FDA black box warnings from 2008 to 2015.
[So] Source:Expert Opin Drug Saf;17(2):117-123, 2018 Feb.
[Is] ISSN:1744-764X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The boxed warning (also known as 'black box warning [BBW]') is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drugs after FDA approval. METHODS: We identified all post-marketing BBWs from January 2008 through June 2015 listed on FDA's MedWatch and Drug Safety Communications websites. We used each drug's prescribing information to classify its BBW as new, major update to a preexisting BBW, or minor update. We then characterized these BBWs with respect to pre-specified BBW-specific and drug-specific features. RESULTS: There were 111 BBWs issued to drugs on the US market, of which 29% (n = 32) were new BBWs, 32% (n = 35) were major updates, and 40% (n = 44) were minor updates. New BBWs and major updates were most commonly issued for death (51%) and cardiovascular risk (27%). The new BBWs and major updates impacted 200 drug formulations over the study period, of which 64% were expected to be used chronically and 58% had available alternatives without a BBW. CONCLUSIONS: New BBWs and incremental updates to existing BBWs are frequently added to drug labels after regulatory approval.
[Mh] Termos MeSH primário: Rotulagem de Medicamentos/legislação & jurisprudência
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Vigilância de Produtos Comercializados
[Mh] Termos MeSH secundário: Seres Humanos
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180216
[Lr] Data última revisão:
180216
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171208
[St] Status:MEDLINE
[do] DOI:10.1080/14740338.2018.1415323


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[PMID]:29199437
[Au] Autor:Vajó P; Gyurján O; Szabó ÁM; Kalabay L; Vajó Z; Torzsa P
[Ad] Endereço:Klinikai Központ, Debreceni Egyetem, Általános Orvostudományi Kar Debrecen.
[Ti] Título:[Safety data of the new, reduced-dose influenza vaccine FluArt after its first season on the market].
[Ti] Título:Az új, csökkentett dózisú, hazai gyártású influenzavakcina (FluArt) forgalomba hozatalát követo elso szezonjának biztonságossági vizsgálata..
[So] Source:Orv Hetil;158(49):1953-1959, 2017 Dec.
[Is] ISSN:0030-6002
[Cp] País de publicação:Hungary
[La] Idioma:hun
[Ab] Resumo:INTRODUCTION: The currently licensed seasonal influenza vaccines contain split, subunit or whole virions, typically in amounts of 15 µg hemagglutinin per virus strain for adult and up to 60 µg in elderly patients. AIM: The present study reports safety data of the newly licensed, reduced dose vaccine with 6 µg of hemagglutinin per strain produced by Fluart (Hungary) after its first season on the market. The main objective of enhanced safety surveillance was to detect a potential increase in reactogenicity and allergic events that is intrinsic to the product in near real-time in the earliest vaccinated cohorts. METHOD: The study methods were based on the Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU by the European Medicines Agency. STATISTICS: We used the Fisher exact test with 95% confidence intervals. RESULTS: We studied 587 patients and detected a total 24 adverse events, all of which have already been known during the licensing studies of the present vaccine. The frequencies of the adverse events were not different from what had been seen with the previously licensed 15 µg vaccine. CONCLUSIONS: Based on the results, the authors conclude that the new, reduced dose vaccine FluArt is safe and tolerable. Orv Hetil. 2017; 158(49): 1953-1959.
[Mh] Termos MeSH primário: Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Glicoproteínas de Hemaglutininação de Vírus da Influenza/administração & dosagem
Vacinas contra Influenza/administração & dosagem
[Mh] Termos MeSH secundário: Estudos de Coortes
Glicoproteínas de Hemaglutininação de Vírus da Influenza/efeitos adversos
Seres Humanos
Hungria
Vacinas contra Influenza/efeitos adversos
Vigilância de Produtos Comercializados/estatística & dados numéricos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Hemagglutinin Glycoproteins, Influenza Virus); 0 (Influenza Vaccines)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180213
[Lr] Data última revisão:
180213
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171205
[St] Status:MEDLINE
[do] DOI:10.1556/650.2017.30877


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[PMID]:28468688
[Au] Autor:Rahman MS; Yoshida N; Tsuboi H; Keila T; Sovannarith T; Kiet HB; Dararth E; Zin T; Tanimoto T; Kimura K
[Ad] Endereço:Drug Management and Policy, Kanazawa University, Kanazawa, Japan. rahmansofique@gmail.com.
[Ti] Título:Erroneous formulation of delayed-release omeprazole capsules: alert for importing countries.
[So] Source:BMC Pharmacol Toxicol;18(1):31, 2017 May 03.
[Is] ISSN:2050-6511
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Poor drug quality is a matter of serious concern, especially in countries where drug regulation and law enforcement are constrained by limited resources. This study was carried out to investigate the cause of quality failure of omeprazole in Cambodia in 2010 and Myanmar in 2014. METHODS: We conducted pharmacopoeial quantity, content uniformity and dissolution tests of 156 samples of omeprazole capsules collected in Cambodia in 2010 and Myanmar in 2014. High failure rates were found, especially in dissolution testing, and detailed investigation of several unacceptable samples was carried out by means of in-vitro dissolution profiling, scanning electron microscopy (SEM) and X-ray computed tomography (X-ray CT) to identify the cause of failure. RESULTS: Dissolution profiling with and without the acid stage showed that acid caused premature omeprazole release, indicating that the enteric coating of the omeprazole granules was ineffective. SEM examination of two failed samples revealed cracked and broken granules mixed with apparently intact omeprazole granules in the capsule. X-ray CT examination indicated that some granules of failed samples completely lacked enteric coating, and others had incomplete and non-uniform enteric coating or malformation. CONCLUSIONS: Omeprazole capsules collected in Myanmar and Cambodia showed high failure rates in pharmacopoeial tests, especially dissolution tests. Some samples were found to have ineffective or absent enteric coating of the granules, resulting in premature dissolution and degradation in acidic conditions. This is a potentially serious public health issue that needs to be addressed by regulatory authorities in Cambodia and Myanmar, possibly through a collaborative initiative with manufacturers.
[Mh] Termos MeSH primário: Preparações de Ação Retardada/normas
Composição de Medicamentos/normas
Omeprazol/normas
[Mh] Termos MeSH secundário: Camboja
Cromatografia Líquida de Alta Pressão
Indústria Farmacêutica
Microscopia Eletrônica de Varredura
Mianmar
Vigilância de Produtos Comercializados
Tomografia Computadorizada por Raios X
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Delayed-Action Preparations); KG60484QX9 (Omeprazole)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180213
[Lr] Data última revisão:
180213
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170505
[St] Status:MEDLINE
[do] DOI:10.1186/s40360-017-0138-5


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[PMID]:28448359
[Au] Autor:Aschenbrenner DS
[Ad] Endereço:Diane S. Aschenbrenner is an assistant professor at Notre Dame of Maryland University in Baltimore. She also coordinates Drug Watch: daschenbrenner@ndm.edu.
[Ti] Título:Rare Allergic Reaction to Topical Chlorhexidine Gluconate.
[So] Source:Am J Nurs;117(5):20, 2017 May.
[Is] ISSN:1538-7488
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Anafilaxia/induzido quimicamente
Anti-Infecciosos Locais/efeitos adversos
Clorexidina/análogos & derivados
[Mh] Termos MeSH secundário: Anafilaxia/enfermagem
Clorexidina/efeitos adversos
Seres Humanos
Vigilância de Produtos Comercializados
[Pt] Tipo de publicação:NEWS
[Nm] Nome de substância:
0 (Anti-Infective Agents, Local); MOR84MUD8E (chlorhexidine gluconate); R4KO0DY52L (Chlorhexidine)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180131
[Lr] Data última revisão:
180131
[Sb] Subgrupo de revista:AIM; IM; N
[Da] Data de entrada para processamento:170428
[St] Status:MEDLINE
[do] DOI:10.1097/01.NAJ.0000516268.32086.24


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[PMID]:29240330
[Au] Autor:Price WN
[Ad] Endereço:University of Michigan Law School.
[Ti] Título:Regulating Black-Box Medicine.
[So] Source:Mich Law Rev;116(3):421-74, 2017.
[Is] ISSN:0026-2234
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they lack both expertise and proprietary information. How should we ensure that medical algorithms are safe and effective? Medical algorithms need regulatory oversight, but that oversight must be appropriately tailored. Unfortunately, the Food and Drug Administration (FDA) has suggested that it will regulate algorithms under its traditional framework, a relatively rigid system that is likely to stifle innovation and to block the development of more flexible, current algorithms. This Article draws upon ideas from the new governance movement to suggest a different path. FDA should pursue a more adaptive regulatory approach with requirements that developers disclose information underlying their algorithms. Disclosure would allow FDA oversight to be supplemented with evaluation by providers, hospitals, and insurers. This collaborative approach would supplement the agency's review with ongoing real-world feedback from sophisticated market actors. Medical algorithms have tremendous potential, but ensuring that such potential is developed in high-quality ways demands a careful balancing between public and private oversight, and a role for FDA that mediates--but does not dominate--the rapidly developing industry.
[Mh] Termos MeSH primário: Algoritmos
Tomada de Decisões Assistida por Computador
Diagnóstico por Computador
Regulamentação Governamental
[Mh] Termos MeSH secundário: Técnicas de Apoio para a Decisão
Seres Humanos
Colaboração Intersetorial
Segurança do Paciente
Vigilância de Produtos Comercializados
Kit de Reagentes para Diagnóstico/normas
Software
Telemedicina
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Reagent Kits, Diagnostic)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180105
[Lr] Data última revisão:
180105
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:171215
[St] Status:MEDLINE


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[PMID]:28458414
[Au] Autor:Kumar R; Kalaiselvan V; Verma R; Kaur I; Kumar P; Singh GN
[Ad] Endereço:National Coordination Centre-Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, India.
[Ti] Título:Veterinary pharmacovigilance in India: A need of hour.
[So] Source:Indian J Pharmacol;49(1):2-3, 2017 Jan-Feb.
[Is] ISSN:1998-3751
[Cp] País de publicação:India
[La] Idioma:eng
[Ab] Resumo:Veterinary pharmacovigilance (PV) is important for the Medicine which are used for treating disease in animals. It becomes more important when these animals are further used for producing food. Adverse drug reactions (ADRs) have a direct impact on animals and indirect impact on human beings, for example, through milk products, other animal producing food products. Currently, PV program of India is playing a vital role in assessing the safety of medicines in Indian Population. The safety of medicine in animals can be assessed by veterinary PV. The research institutes involved in animal research and veterinary hospitals can be considered as ADR monitoring centers to assess the safety of medicines on animals.
[Mh] Termos MeSH primário: Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/veterinária
Farmacovigilância
Vigilância de Produtos Comercializados/métodos
Drogas Veterinárias/efeitos adversos
[Mh] Termos MeSH secundário: Sistemas de Notificação de Reações Adversas a Medicamentos
Animais
Seres Humanos
Índia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Veterinary Drugs)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:171229
[Lr] Data última revisão:
171229
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170502
[St] Status:MEDLINE
[do] DOI:10.4103/0253-7613.201035



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