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5.
Medicine (Baltimore) ; 99(15): e19760, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32282738

RESUMO

BACKGROUND: In recent years, metastatic castration-resistant prostate cancer (MCRPC) and studies related to MCRPC have drawn global attention. The main objective of this bibliometric study was to provide an overview of MCRPC, explore clusters and trends in research and investigate the future direction of MCRPC research. METHODS: A total of 4089 publications published between 1979 and 2018 were retrieved from the Web of Science (WoS) Core Collection database. Different aspects of MCRPC research, including the countries/territories, institutions, journals, authors, research areas, funding agencies and author keywords, were analyzed. RESULTS: The number of annual MCRPC publications increased rapidly after 2010. American researchers played a vital role in this increase, as they published the most publications. The most productive institution was Memorial Sloan Kettering Cancer Center. De Bono, JS (the United Kingdom [UK]) and Scher, HI (the United States of America [USA]) were the two most productive authors. The National Institutes of Health (NIH) funded the largest number of published papers. Analyses of keywords suggested that therapies (abiraterone, enzalutamide, etc.) would attract global attention after US Food and Drug Administration (FDA) approval. CONCLUSIONS: Developed countries, especially the USA, were the leading nations for MCRPC research because of their abundant funding and frequent international collaborations. Therapy was one of the most vital aspects of MCRPC research. Therapies targeting DNA repair or the androgen receptor (AR) signing pathway and new therapies especially prostate-specific membrane antigen (PSMA)-based radioligand therapy (RLT) would be the next focus of MCRPC research.


Assuntos
Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Neoplasias de Próstata Resistentes à Castração/secundário , Publicações/normas , United States Food and Drug Administration/organização & administração , Androstenos/uso terapêutico , Bibliometria , Neoplasias Ósseas/secundário , Reparo do DNA/efeitos dos fármacos , Humanos , Masculino , Metástase Neoplásica , Feniltioidantoína/análogos & derivados , Feniltioidantoína/uso terapêutico , Antígeno Prostático Específico/sangue , Neoplasias de Próstata Resistentes à Castração/patologia , Publicações/tendências , Receptores Androgênicos/efeitos dos fármacos , Receptores Androgênicos/genética , Reino Unido/epidemiologia , Estados Unidos/epidemiologia
7.
Lancet Gastroenterol Hepatol ; 5(3): 306-315, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31806572

RESUMO

Up to 40% of patients with primary biliary cholangitis have an incomplete response to first-line treatment with ursodeoxycholic acid. Obeticholic acid was approved by the US Food and Drug Administration in 2016 as a second-line treatment for patients with primary biliary cholangitis who are unresponsive to ursodeoxycholic acid; however, approximately 50% of patients might need additional treatments to reach therapeutic goals. A considerable need exists for effective treatment options to prevent progression to liver transplantation or death in these patients. Drugs that might modulate immunological abnormalities in primary biliary cholangitis have been studied but their effectiveness varies. Budesonide, ciclosporin, and rituximab have shown potential in modifying the disease process. Bezafibrate, a pan-peroxisome proliferator-activated receptor agonist, has been shown to ameliorate deranged bile acid homoeostasis and attenuate raised concentrations of liver enzymes associated with primary biliary cholangitis. As the mechanisms underlying the pathogenesis and progression of primary biliary cholangitis are further clarified, specific targeted therapies are under development with promising early results. Various therapeutic target bile acid homeostasis, immune dysfunction, and fibrogenetic pathways are being studied. A better understanding of the biochemical and clinical effects of the therapies in development bear discussion, both to guide the discovery of new therapies and to inform clinicians so that rational treatment regimens can be tailored to patients once they become available.


Assuntos
Homeostase/efeitos dos fármacos , Cirrose Hepática Biliar/complicações , Cirrose Hepática Biliar/tratamento farmacológico , Benzotiazóis/farmacologia , Benzotiazóis/uso terapêutico , Bezafibrato/farmacologia , Bezafibrato/uso terapêutico , Ácidos e Sais Biliares/fisiologia , Budesonida/farmacologia , Budesonida/uso terapêutico , Estudos de Casos e Controles , Ácido Quenodesoxicólico/análogos & derivados , Ácido Quenodesoxicólico/química , Ácido Quenodesoxicólico/farmacologia , Ácido Quenodesoxicólico/uso terapêutico , Colagogos e Coleréticos/química , Colagogos e Coleréticos/farmacologia , Colagogos e Coleréticos/uso terapêutico , Ensaios Clínicos como Assunto , Ciclosporina/farmacologia , Ciclosporina/uso terapêutico , Progressão da Doença , Glucocorticoides/farmacologia , Glucocorticoides/uso terapêutico , Humanos , Fatores Imunológicos/farmacologia , Fatores Imunológicos/uso terapêutico , Imunossupressores/farmacologia , Imunossupressores/uso terapêutico , Isoxazóis/farmacologia , Isoxazóis/uso terapêutico , Cirrose Hepática Biliar/metabolismo , Cirrose Hepática Biliar/fisiopatologia , Transplante de Fígado/estatística & dados numéricos , Receptores Ativados por Proliferador de Peroxissomo/agonistas , Receptores Citoplasmáticos e Nucleares/agonistas , Rituximab/farmacologia , Rituximab/uso terapêutico , Resultado do Tratamento , Estados Unidos/epidemiologia , United States Food and Drug Administration/organização & administração , Ácido Ursodesoxicólico/química , Ácido Ursodesoxicólico/farmacologia , Ácido Ursodesoxicólico/uso terapêutico
12.
Cytotherapy ; 21(7): 699-724, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31196820

RESUMO

Cellular & Gene Therapies (CGTs) are complex products, which have been key foci of the International Society for Cell & Gene Therapy (ISCT). For this ISCT North American Legal & Regulatory Affairs Committee review publication, CGTs include but are not limited to somatic cell-based therapies, pluripotent cell-derived cell-based therapies, gene- or non-gene-modified or gene edited versions of these cell-based therapies, in vivo gene therapies, organ/tissue engineered products, and relevant combination products. These products are regulated by the Food and Drug Administration (FDA) in the United States. This publication reviews selected laws, regulations, guidance, definitions, processes, types of meetings and submissions, and other key factors that the FDA follows and implements to regulate and support development of these types of products. These factors may be considered in order to help current and potential product developers/sponsors/applicants navigate through FDA regulatory pathways. We also review expedited programs including types of Designations available at the FDA, and their specific eligibility criteria. We include FDA and other stakeholder resources to consider regarding CGT regulation, to help prepare for CGT development and subsequent FDA approval.


Assuntos
Terapia Baseada em Transplante de Células e Tecidos , Terapia Genética/legislação & jurisprudência , Engenharia Tecidual , United States Food and Drug Administration/legislação & jurisprudência , Terapia Baseada em Transplante de Células e Tecidos/métodos , Terapia Baseada em Transplante de Células e Tecidos/normas , Humanos , Engenharia Tecidual/métodos , Engenharia Tecidual/normas , Estados Unidos , United States Food and Drug Administration/organização & administração
14.
Curr Pharm Teach Learn ; 11(7): 655-657, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31227086

RESUMO

INTRODUCTION: University professors who teach self-care and nonprescription products must decide which products and ingredients to recommend to students. The Food and Drug Administration (FDA) has approved many nonprescription ingredients as both safe and effective through the evidence-based FDA Over-the-Counter (OTC) Product Review or New Drug Application (NDA) processes. However, thousands of nonprescription products sold in community pharmacies are of unproven safety and/or efficacy. These include herbs, dietary supplements, homeopathic products, and essential oils. Selling products of unproven safety and/or efficacy can have serious consequences, exposing pharmacists to legal liability due to violations of the principles of implied and/or express warranties, as found in the Uniform Commercial Code. Further, the FDA defines products lacking proven safety and efficacy as health fraud, a crime aggressively pursued by both the FDA and the Federal Trade Commission. COMMENTARY: Faculty members who limit their nonprescription ingredient recommendations to those with FDA approval can justify those recommendations by weight of evidence. If the faculty member recommends ingredients that the FDA has not approved (e.g., kava), students should be taught that those ingredients pose unknown risks and lack proven benefit, and also that their labels virtually always lack doses proven to be safe, precautions, contraindications, and drug interactions. IMPLICATIONS: Selling unproven products can lower trust in pharmacy, cause patient harm, and expose the pharmacist to legal action. These issues should be explained to students whenever unproven products are discussed or recommended.


Assuntos
Responsabilidade Legal , Medicamentos sem Prescrição/uso terapêutico , Medição de Risco/métodos , Humanos , Medição de Risco/normas , Estados Unidos , United States Food and Drug Administration/organização & administração , United States Food and Drug Administration/tendências
15.
CPT Pharmacometrics Syst Pharmacol ; 8(6): 359-370, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31044532

RESUMO

The development of generic, single-entity, drug-device combination products for orally inhaled drug products is challenging in part because of the complex nature of device design characteristics and the difficulties associated with establishing bioequivalence for a locally acting drug product delivered to the site of action in the lung. This review examines in silico models that may be used to support the development of generic orally inhaled drug products and how model credibility may be assessed.


Assuntos
Aprovação de Equipamentos/normas , Aprovação de Drogas/organização & administração , Medicamentos Genéricos/administração & dosagem , Administração por Inalação , Administração Oral , Simulação por Computador , Aprovação de Equipamentos/legislação & jurisprudência , Medicamentos Genéricos/farmacocinética , Humanos , Nebulizadores e Vaporizadores , Equivalência Terapêutica , Estados Unidos , United States Food and Drug Administration/organização & administração
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