Base de dados : MEDLINE
Pesquisa : D26.360 [Categoria DeCS]
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[PMID]:29441911
[Ti] Título:Evaluation of the pharmacokinetic parameters of standard oral antibiotics in a bioequivalence study of generic products.
[So] Source:Pharmazie;71(7):363-377, 2016 Jul 07.
[Is] ISSN:0031-7144
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:Pharmacokinetic parameters were summarized in clinical bioequivalence studies in Japan to confirm the validity for the use of parameters obtained from the clinical studies. Pharmacokinetic parameters, including maximum plasma/serum concentrations (Cmax), area under the plasma/serum drug concentration-time curve (AUC), time to achieve Cmax (Tmax), and half life (t1/2), of the standard products (original drugs) after oral administration of antimicrobials, including respiratory quinolones, cephalosporins, macrolides, and penicillin-based antibiotics were investigated by use of interview forms and/or package inserts from the generic products and the relationship among the pharmacokinetic parameters such as Cmax, AUC, Tmax, and t1/2 were estimated. In all the studies, the standard and generic products were administrated orally to healthy fasting subjects. Although there was more than a 1.5-fold difference in the Cmax and AUC0-24 h, but not in the Tmax and t1/2 values for levofloxacin tablets and cefacrol tablets, these parameters for other antibiotics were similar in various studies. The obtained results suggested that the parameters obtained from recent bioequivalence studies would be useful in identifying pharmacokinetic behavior of the original drugs, especially early time release; however, the pharmacokinetic results obtained from the recently conducted bioequivalence studies may be superior to those obtained from studies conducted in the past.
[Mh] Termos MeSH primário: Antibacterianos/farmacocinética
Medicamentos Genéricos/farmacocinética
Equivalência Terapêutica
[Mh] Termos MeSH secundário: Animais
Antibacterianos/uso terapêutico
Medicamentos Genéricos/uso terapêutico
Meia-Vida
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Anti-Bacterial Agents); 0 (Drugs, Generic)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180215
[St] Status:MEDLINE
[do] DOI:10.1691/ph.2016.6557


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[PMID]:28453645
[Au] Autor:Song H; Adamson A; Mostaghimi A
[Ad] Endereço:Harvard Medical School, Boston, Massachusetts.
[Ti] Título:Medicare Part D Payments for Topical Steroids: Rising Costs and Potential Savings.
[So] Source:JAMA Dermatol;153(8):755-759, 2017 Aug 01.
[Is] ISSN:2168-6084
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Rising pharmaceutical costs in the United States are an increasing source of financial burden for payers and patients. Although topical steroids are among the most commonly prescribed medications in dermatology, there are limited data on steroid-related spending and utilization. Objective: To characterize Medicare and patient out-of-pocket costs for topical steroids, and to model potential savings that could result from substitution of the cheapest topical steroid from the corresponding potency class. Design, Setting, and Participants: This study was a retrospective cost analysis of the Medicare Part D Prescriber Public Use File, which details annual drug utilization and spending on both generic and branded drugs from 2011 to 2015 by Medicare Part D participants who filled prescriptions for topical steroids. Main Outcomes and Measures: Total and potential Medicare and out-of-pocket patient spending. Costs were adjusted for inflation and reported in 2015 dollars. Results: Medicare Part D expenditures on topical steroids between 2011 and 2015 were $2.3 billion. Patients' out-of-pocket spending for topical steroids over the same period was $333.7 million. The total annual spending increased from $237.6 million to $775.9 million, an increase of 226.5%. Patients' annual out-of-pocket spending increased from $41.4 million to $101.8 million, an increase of 145.9%. The total number of prescriptions were 7.7 million in 2011 and 10.6 million in 2015, an increase of 37.0%. Generic medication costs accounted for 97.8% of the total spending during this time period. The potential health care savings and out-of-pocket patient savings from substitution of the cheapest topical steroid within the corresponding potency class were $944.8 million and $66.6 million, respectively. Conclusions and Relevance: Most topical steroids prescribed were generic drugs. There has been a sharp increase in Medicare and out-of-pocket spending on topical steroids that is driven by higher costs for generics. Use of clinical decision support tools to enable substitution of the most affordable generic topical steroid from the corresponding potency class may reduce drug expenditures.
[Mh] Termos MeSH primário: Medicamentos Genéricos/administração & dosagem
Financiamento Pessoal/economia
Glucocorticoides/administração & dosagem
Medicare Part D/economia
[Mh] Termos MeSH secundário: Administração Tópica
Custo Compartilhado de Seguro/economia
Custos e Análise de Custo
Sistemas de Apoio a Decisões Clínicas
Dermatologia
Custos de Medicamentos
Medicamentos Genéricos/economia
Glucocorticoides/economia
Seres Humanos
Estudos Retrospectivos
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drugs, Generic); 0 (Glucocorticoids)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE
[do] DOI:10.1001/jamadermatol.2017.1130


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[PMID]:28742419
[Au] Autor:Gomez-de-León A; Gómez-Almaguer D; Ruiz-Delgado GJ; Ruiz-Arguelles GJ
[Ad] Endereço:a Universidad Autónoma de Nuevo León , Facultad de Medicina y Hospital Universitario "Dr.José Eleuterio González". Hematology Service, Monterrey , Nuevo León , México.
[Ti] Título:Insights into the management of chronic myeloid leukemia in resource-poor settings: a Mexican perspective.
[So] Source:Expert Rev Hematol;10(9):809-819, 2017 09.
[Is] ISSN:1747-4094
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: The arrival of targeted therapy for chronic myeloid leukemia (CML) was revolutionary. However, due to the high cost of tyrosine kinase inhibitors, access to this highly effective therapy with strict monitoring strategies is limited in low to middle-income countries. In this context, following standard recommendations proposed by experts in developed countries is difficult. Areas covered: This review aims to provide an insight into the management of patients with CML living in a resource-limited setting. It addresses several issues: diagnosis, initial treatment, disease monitoring, and additional treatment alternatives including allogeneic hematopoietic stem cell transplantation. Expert commentary: Imatinib is probably the most cost-effective TKI for initial treatment in developing and underdeveloped countries. Generic imatinib preparations should be evaluated before considering their widespread use. Adherence to treatment should be emphasized. Adequate monitoring can be performed through several methods successfully and is important for predicting outcomes, particularly early in the first year, and if treatment suspension is being considered. Access to further therapeutic alternatives should define our actions after failure or intolerance to imatinib, preferring additional TKIs if possible. Allogeneic transplantation in chronic phase is a viable option in this context.
[Mh] Termos MeSH primário: Recursos em Saúde
Leucemia Mielogênica Crônica BCR-ABL Positiva/diagnóstico
Leucemia Mielogênica Crônica BCR-ABL Positiva/terapia
[Mh] Termos MeSH secundário: Antineoplásicos/administração & dosagem
Antineoplásicos/efeitos adversos
Antineoplásicos/uso terapêutico
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico
Terapia Combinada
Gerenciamento Clínico
Resistência a Medicamentos Antineoplásicos
Medicamentos Genéricos/uso terapêutico
Transplante de Células-Tronco Hematopoéticas
Seres Humanos
Adesão à Medicação
México
Estadiamento de Neoplasias
Inibidores de Proteínas Quinases/administração & dosagem
Inibidores de Proteínas Quinases/efeitos adversos
Inibidores de Proteínas Quinases/uso terapêutico
Transplante Homólogo
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antineoplastic Agents); 0 (Drugs, Generic); 0 (Protein Kinase Inhibitors)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:180225
[Lr] Data última revisão:
180225
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170726
[St] Status:MEDLINE
[do] DOI:10.1080/17474086.2017.1360180


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[PMID]:29384848
[Au] Autor:Tierrablanca LE; Ochalek J; Ford D; Babiker A; Gibb D; Butler K; Turkova A; Griffin S; Revill P; BREATHER (PENTA 16) Trial Group
[Ad] Endereço:Tecnología e Información para la Salud, Mexico City, Mexico.
[Ti] Título:Economic evaluation of weekends-off antiretroviral therapy for young people in 11 countries.
[So] Source:Medicine (Baltimore);97(5):e9698, 2018 Feb.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: To analyze the cost effectiveness of short-cycle therapy (SCT), where patients take antiretroviral (ARV) drugs 5 consecutive days a week and have 2 days off, as an alternative to continuous ARV therapy for young people infected with human immunodeficiency virus (HIV) and taking efavirenz-based first-line ARV drugs. METHODS: We conduct a hierarchical cost-effectiveness analysis based on data on clinical outcomes and resource use from the BREATHER trial. BREATHER is a randomized trial investigating the effectiveness of SCT and continuous therapy in 199 participants aged 8 to 24 years and taking efavirenz-based first-line ARV drugs in 11 countries worldwide. Alongside nationally representative unit costs/prices, these data were used to estimate costs and quality adjusted life years (QALYs). An incremental cost-effectiveness comparison was performed using a multilevel bivariate regression approach for total costs and QALYs. Further analyses explored cost-effectiveness in low- and middle-income countries with access to low-cost generic ARV drugs and high-income countries purchasing branded ARV drugs, respectively. RESULTS: At 48 weeks, SCT offered significant total cost savings over continuous therapy of US dollar (USD) 41 per patient in countries using generic drugs and USD 4346 per patient in countries using branded ARV drugs, while accruing nonsignificant total health benefits of 0.008 and 0.009 QALYs, respectively. Cost-effectiveness estimates were similar across settings with access to generic ARV drugs but showed significant variation among high-income countries where branded ARV drugs are purchased. CONCLUSION: SCT is a cost-effective treatment alternative to continuous therapy for young people infected with HIV in countries where viral load monitoring is available.
[Mh] Termos MeSH primário: Fármacos Anti-HIV/administração & dosagem
Fármacos Anti-HIV/economia
Análise Custo-Benefício
Infecções por HIV/tratamento farmacológico
Infecções por HIV/economia
[Mh] Termos MeSH secundário: Adolescente
Benzoxazinas/administração & dosagem
Benzoxazinas/economia
Criança
Esquema de Medicação
Medicamentos Genéricos/administração & dosagem
Medicamentos Genéricos/economia
Seguimentos
Custos de Cuidados de Saúde
Seres Humanos
Internacionalidade
Anos de Vida Ajustados por Qualidade de Vida
Análise de Regressão
Resultado do Tratamento
Carga Viral
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Anti-HIV Agents); 0 (Benzoxazines); 0 (Drugs, Generic); JE6H2O27P8 (efavirenz)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180221
[Lr] Data última revisão:
180221
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180201
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000009698


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[PMID]:29361660
[Au] Autor:Steiner DJ; Thomson Reuters Accelus.
[Ti] Título:Pharmaceuticals and Medical Devices: Business Practices.
[So] Source:Issue Brief Health Policy Track Serv;2017:1-38, 2017 Dec 26.
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Indústria Farmacêutica/organização & administração
Farmacoeconomia
Legislação de Medicamentos
Medicamentos sob Prescrição/economia
[Mh] Termos MeSH secundário: Analgésicos Opioides
Leis Antitruste
Suplementos Nutricionais
Custos de Medicamentos
Controle de Medicamentos e Entorpecentes/legislação & jurisprudência
Medicamentos Genéricos
Epinefrina/economia
Epinefrina/uso terapêutico
Fraude
Seres Humanos
Prescrição Inadequada
Marketing de Serviços de Saúde
Medicaid
Medicare
Uso Off-Label
Patentes como Assunto
Desvio de Medicamentos sob Prescrição
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Analgesics, Opioid); 0 (Drugs, Generic); 0 (Prescription Drugs); YKH834O4BH (Epinephrine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180219
[Lr] Data última revisão:
180219
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:180124
[St] Status:MEDLINE


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[PMID]:29361657
[Au] Autor:Steiner DJ; Thomson Reuters Accelus.
[Ti] Título:Pharmaceuticals and Medical Devices: Cost Savings.
[So] Source:Issue Brief Health Policy Track Serv;2017:1-31, 2017 Dec 26.
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Custos de Medicamentos
Indústria Farmacêutica/economia
Farmacoeconomia/organização & administração
Medicamentos sob Prescrição/economia
[Mh] Termos MeSH secundário: Canadá
Comércio/economia
Redução de Custos
Dedutíveis e Cosseguros
Revelação
Aprovação de Drogas
Custos de Medicamentos/legislação & jurisprudência
Medicamentos Genéricos/economia
Competição Econômica
Farmacoeconomia/legislação & jurisprudência
Epinefrina/economia
Seres Humanos
Adesão à Medicação
Conduta do Tratamento Medicamentoso/economia
Medicamentos sem Prescrição/economia
Farmácias/economia
Equivalência Terapêutica
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drugs, Generic); 0 (Nonprescription Drugs); 0 (Prescription Drugs); YKH834O4BH (Epinephrine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180219
[Lr] Data última revisão:
180219
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:180124
[St] Status:MEDLINE


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[PMID]:29298119
[Au] Autor:Kiran S; Kulkarni M
[Ad] Endereço:a Council of Scientific and Industrial Research-Unit for Research and Development of Information Products (CSIR-URDIP) , India.
[Ti] Título:Secondary patents in the pharmaceutical industry: missing the wood for the trees?
[So] Source:Expert Opin Ther Pat;28(3):241-250, 2018 Mar.
[Is] ISSN:1744-7674
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: The critics of the Innovator pharmaceutical industry allege that secondary patents are trivial modifications over the primary patent, which extend its term and delay the entry of the generics in the market place. The protagonists regard secondary patents a result of continuous research and development (R&D), which help them introduce and protect new, differentiated products. Areas covered: The areas covered are Product life cycle management (PLCM), Drug approval process, Orange book (OB) listed patents, US patent data. Expert opinion: Our analysis of the patents and products of four innovators viz., AstraZeneca, Takeda, Eisai and Wyeth in the field of proton pump inhibitors (PPI's) and Merck and Pfizer in the field of Statins shows that secondary patents help innovators sustain competition against other innovators in the specific product segment. The number of secondary patents listed in OB per NCE depends on the innovators interest in exploiting the NCE, the success of R & D effort and product lifecycle management strategy in the wake of market competition. Market entry decisions of innovators are strategic rather than a mere fallout of the secondary patents granted. Entry of another innovator is more unpredictable and hurts the first entrant more vis a vis the entry of generics who can enter the market when the patents protecting a product are no more enforceable, and hence more predictable. Generic entry in the field of PPI's shows that the term of the primary patent is not extended by the secondary patents.
[Mh] Termos MeSH primário: Aprovação de Drogas/legislação & jurisprudência
Desenho de Drogas
Indústria Farmacêutica/legislação & jurisprudência
[Mh] Termos MeSH secundário: Aprovação de Drogas/economia
Indústria Farmacêutica/economia
Medicamentos Genéricos/economia
Competição Econômica/legislação & jurisprudência
Seres Humanos
Patentes como Assunto
Pesquisa/economia
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Drugs, Generic)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180215
[Lr] Data última revisão:
180215
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180104
[St] Status:MEDLINE
[do] DOI:10.1080/13543776.2018.1424134


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[PMID]:28458360
[Au] Autor:Yoshida H; Shibata H; Izutsu KI; Goda Y
[Ad] Endereço:Division of Drugs, National Institute of Health Sciences.
[Ti] Título:Comparison of Dissolution Similarity Assessment Methods for Products with Large Variations: f Statistics and Model-Independent Multivariate Confidence Region Procedure for Dissolution Profiles of Multiple Oral Products.
[So] Source:Biol Pharm Bull;40(5):722-725, 2017.
[Is] ISSN:1347-5215
[Cp] País de publicação:Japan
[La] Idioma:eng
[Ab] Resumo:The current Japanese Ministry of Health Labour and Welfare (MHLW)'s Guideline for Bioequivalence Studies of Generic Products uses averaged dissolution rates for the assessment of dissolution similarity between test and reference formulations. This study clarifies how the application of model-independent multivariate confidence region procedure (Method B), described in the European Medical Agency and U.S. Food and Drug Administration guidelines, affects similarity outcomes obtained empirically from dissolution profiles with large variations in individual dissolution rates. Sixty-one datasets of dissolution profiles for immediate release, oral generic, and corresponding innovator products that showed large variation in individual dissolution rates in generic products were assessed on their similarity by using the f statistics defined in the MHLW guidelines (MHLW f method) and two different Method B procedures, including a bootstrap method applied with f statistics (BS method) and a multivariate analysis method using the Mahalanobis distance (MV method). The MHLW f and BS methods provided similar dissolution similarities between reference and generic products. Although a small difference in the similarity assessment may be due to the decrease in the lower confidence interval for expected f values derived from the large variation in individual dissolution rates, the MV method provided results different from those obtained through MHLW f and BS methods. Analysis of actual dissolution data for products with large individual variations would provide valuable information towards an enhanced understanding of these methods and their possible incorporation in the MHLW guidelines.
[Mh] Termos MeSH primário: Química Farmacêutica/estatística & dados numéricos
Solubilidade
[Mh] Termos MeSH secundário: Administração Oral
Algoritmos
Química Farmacêutica/métodos
Interpretação Estatística de Dados
Bases de Dados Factuais
Medicamentos Genéricos/química
Japão
Modelos Estatísticos
Análise Multivariada
Equivalência Terapêutica
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drugs, Generic)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180212
[Lr] Data última revisão:
180212
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170502
[St] Status:MEDLINE
[do] DOI:10.1248/bpb.b16-00904


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[PMID]:29365306
[Au] Autor:Martin EG; Schackman BR
[Ad] Endereço:From the Rockefeller Institute of Government and the Department of Public Administration and Policy, University at Albany, State University of New York, Albany (E.G.M.); and the Department of Healthcare Policy and Administration, Weill Cornell Medical College, New York (B.R.S.).
[Ti] Título:Treating and Preventing HIV with Generic Drugs - Barriers in the United States.
[So] Source:N Engl J Med;378(4):316-319, 2018 Jan 25.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Antirretrovirais/uso terapêutico
Custos de Medicamentos
Medicamentos Genéricos/uso terapêutico
Infecções por HIV/tratamento farmacológico
[Mh] Termos MeSH secundário: Antirretrovirais/economia
Redução de Custos
Combinação de Medicamentos
Quimioterapia Combinada
Medicamentos Genéricos/economia
Infecções por HIV/prevenção & controle
Seres Humanos
Seguro de Serviços Farmacêuticos/economia
Legislação de Medicamentos
Marketing
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Retroviral Agents); 0 (Drug Combinations); 0 (Drugs, Generic)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180208
[Lr] Data última revisão:
180208
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180125
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMp1710914


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[PMID]:29281155
[Au] Autor:Nesser N; Splinter GL
[Ti] Título:Keeping Health Care Affordable: One Way OHCA Does it.
[So] Source:J Okla State Med Assoc;109(9):453-4, 2016 09.
[Is] ISSN:0030-1876
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Custos de Medicamentos
Política de Saúde
Medicaid
[Mh] Termos MeSH secundário: Orçamentos
Indústria Farmacêutica
Medicamentos Genéricos
Custos de Cuidados de Saúde
Seres Humanos
Oklahoma
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drugs, Generic)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180123
[Lr] Data última revisão:
180123
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171228
[St] Status:MEDLINE



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