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2.
Pharmazie ; 73(12): 683-687, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-30522549

RESUMO

Ulinastatin vaginal suppositories, used to prevent threatened premature delivery, are frequently used in hospitals. However, there is no established method for quantifying ulinastatin contained in suppositories. Therefore, we investigated a simple and efficient method for quantifying ulinastatin contained in suppositories. Our analytical method involved removal of the base; optimising the enzyme inhibition reaction time and enzyme reaction time; and measuring the absorbance. The modified method was reproducible, operation time was significantly shortened, and cost was reduced to approximately 1/17 of that of the previously reported method. This simple and rapid quantitative method could contribute to the improvement of quality control of ulinastatin vaginal suppositories as an extemporaneous hospital preparation.


Assuntos
Química Farmacêutica/métodos , Composição de Medicamentos/métodos , Glicoproteínas/análise , Controle de Qualidade , Química Farmacêutica/economia , Composição de Medicamentos/economia , Glicoproteínas/química , Glicoproteínas/normas , Serviço de Farmácia Hospitalar/economia , Serviço de Farmácia Hospitalar/métodos , Reprodutibilidade dos Testes , Supositórios , Fatores de Tempo , Inibidores da Tripsina/análise , Inibidores da Tripsina/química , Inibidores da Tripsina/normas
3.
J Ind Microbiol Biotechnol ; 45(6): 405-415, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29749580

RESUMO

Deficiency in petroleum resources and increasing environmental concerns have pushed a bio-based economy to be built, employing a highly reproducible, metal contaminant free, sustainable and green biomanufacturing method. Here, a chiral drug intermediate L-pipecolic acid has been synthesized from biomass-derived lysine. This artificial bioconversion system involves the coexpression of four functional genes, which encode L-lysine α-oxidase from Scomber japonicus, glucose dehydrogenase from Bacillus subtilis, Δ1-piperideine-2-carboxylase reductase from Pseudomonas putida, and lysine permease from Escherichia coli. Besides, a lysine degradation enzyme has been knocked out to strengthen the process in this microbe. The overexpression of LysP improved the L-pipecolic acid titer about 1.6-folds compared to the control. This engineered microbial factory showed the highest L-pipecolic acid production of 46.7 g/L reported to date and a higher productivity of 2.41 g/L h and a yield of 0.89 g/g. This biotechnological L-pipecolic acid production is a simple, economic, and green technology to replace the presently used chemical synthesis.


Assuntos
Biomassa , Química Farmacêutica/métodos , Escherichia coli/metabolismo , Microbiologia Industrial/métodos , Lisina/química , Engenharia Metabólica/métodos , Ácidos Pipecólicos/química , Aminoácido Oxirredutases/química , Bacillus subtilis/genética , Química Farmacêutica/economia , Escherichia coli/genética , Fermentação , Glucose 1-Desidrogenase/genética , Química Verde/economia , Química Verde/métodos , Microbiologia Industrial/economia , Engenharia Metabólica/economia , Plasmídeos/genética , Pseudomonas putida/genética , Estereoisomerismo
4.
Future Med Chem ; 10(8): 837-838, 2018 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-29580099

RESUMO

Stevan Djuric speaks to Benjamin Walden, Commissioning Editor. Stevan Djuric is head of the global Medicinal Chemistry Leadership Team at AbbVie and is also Vice President of the Discovery Chemistry and Technology organization within their Discovery organization and chemistry outsourcing activities. He spoke at the Global-Medicinal-Chemistry and GPCR summit on the imperative to develop chemistry related technology that can reduce cycle time, cost of goods and improve probability of success. To this end, he discussed his efforts in the chemistry technology area with a focus on integrated synthesis-purification bioassay, and flow photochemistry and high temperature chemistry platforms.


Assuntos
Técnicas de Química Sintética , Descoberta de Drogas , Ensaios de Triagem em Larga Escala , Técnicas de Química Sintética/economia , Técnicas de Química Sintética/métodos , Química Farmacêutica/economia , Química Farmacêutica/métodos , Descoberta de Drogas/economia , Descoberta de Drogas/métodos , Ensaios de Triagem em Larga Escala/economia , Ensaios de Triagem em Larga Escala/métodos , Humanos , Preparações Farmacêuticas/síntese química , Preparações Farmacêuticas/economia , Bibliotecas de Moléculas Pequenas/síntese química , Bibliotecas de Moléculas Pequenas/economia
5.
J Pharm Biomed Anal ; 154: 166-173, 2018 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-29549855

RESUMO

In recent years, the whole field of ion-selective electrodes(ISEs) in pharmaceutical sciences has expanded far beyond its original roots. The diverse range of opportunities offered by ISEs was broadly used in a number of pharmaceutical applications, with topics presented ranging from bioanalysis of drugs and metabolites, to protein binding studies, green analytical chemistry, impurity profiling, and drug dissolution in biorelevant media. Inspired from these advances and with the aim of extending the functional capabilities of ISEs, the primary focus of the present paper is the utilization of ISE as a tool in personalized medicine. Given the opportunity to explore biological events in real-time (such as drug metabolism) could be central to personalized medicine. (ATR) is a chemo-degradable and bio-degradable pharmaceutically active drug. Laudanosine (LDS) is the major degradation product and metabolite of ATR and is potentially toxic and reported to possess epileptogenic activity which increases the risk of convulsive effects. In this work, ATR have been subjected to both chemical and biological hydrolysis, and the course of the reactions is monitored by means of a ISE. In this study, we have designed an efficient real-time tracking strategy which substantially resolve the challenges of the ATR chemical and biological degradation kinetics. By utilizing a potentiometric sensor, tracking of ATR chemical and biological degradation kinetics can be performed in a very short time with excellent accuracy. The LOD was calculated to be 0.23 µmol L-1, the potential drift was investigated over a period of 60 min and the value was 0.25 mV h-1. Real serum samples for measurement the rate of in vitro metabolism of ATR was performed. Furthermore, a full description of the fabricated screen-printed sensor was presented.


Assuntos
Atracúrio/farmacocinética , Técnicas Biossensoriais/instrumentação , Química Farmacêutica/instrumentação , Eletrodos Íon-Seletivos , Atracúrio/química , Técnicas Biossensoriais/economia , Técnicas Biossensoriais/métodos , Química Farmacêutica/economia , Química Farmacêutica/métodos , Hidrólise , Isoquinolinas/química , Isoquinolinas/farmacocinética , Potenciometria/instrumentação , Potenciometria/métodos
6.
J Pharm Biomed Anal ; 147: 323-340, 2018 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-28942107

RESUMO

This review article is aimed at providing an overview of the current market of chiral drugs by exploring which is the nowadays tendency, for the pharmaceutical industry, either to exploit the chiral switching practice from already marketed racemates or to develop de novo enantiomerically pure compounds. A concise illustration of the main techniques developed to assess the absolute configuration (AC) and enantiomeric purity of chiral drugs has been given, where greater emphasis was placed on the contribution of enantioselective chromatography (HPLC, SFC and UHPC). Afterwards, we focused our study on the cohort of 45 new drugs that have been approved by the US Food and Drug Administration (FDA) in 2015. We extracted the chemical structure of the new drugs from the FDA approval chemistry reviews available on the database of the agency's Center for Drug Evaluation and Research (CDER), and we selected a subgroup (i.e., 44% of the cohort) of small-molecule active pharmaceutical ingredients (APIs) containing one or more chirality centers. On the basis of the FDA dossiers examined, it emerged that all the chiral drugs approved by the FDA in 2015 are enantiomerically pure compounds with a well-defined AC, with the exception of one, namely lesinurad, which has been licensed as the racemate of two enantiomeric atropoisomers, arising because of the hindered rotation around the single C-N bond in the naphthalene ring. Finally, none of the previously developed racemates has been switched to the single-enantiomer version in 2015.


Assuntos
Química Farmacêutica/métodos , Desenho de Drogas , Indústria Farmacêutica/métodos , Marketing/métodos , Preparações Farmacêuticas/química , Animais , Química Farmacêutica/economia , Química Farmacêutica/tendências , Indústria Farmacêutica/economia , Indústria Farmacêutica/tendências , Humanos , Marketing/economia , Marketing/tendências , Preparações Farmacêuticas/economia , Estereoisomerismo
7.
Expert Opin Drug Discov ; 13(1): 39-49, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29137490

RESUMO

INTRODUCTION: The versatile multicomponent Mannich reaction occupies a salient position in organic chemistry and drug design. Sound knowledge of its scope and variations and of the biological activities of Mannich bases is crucial for the development and improvement of drugs for various diseases. Areas covered: The following article provides an overview of the latest developments in the field of drugs based on the Mannich reaction. Web-based literature searching tools such as PubMed and SciFinder were applied to obtain useful articles. In addition, pertinent literature that was recently published by the authors is discussed in this manuscript. The chemical structures of bioactive Mannich bases are also given. Expert opinion: The Mannich reaction represents a feasible and cost-effective procedure with great potential for drug development. Several newly discovered Mannich bases exhibit sound activities against various human diseases as well as favorable pharmacokinetics. Thus, scientific research about Mannich bases is prospering and appears very attractive both for chemists and for clinicians.


Assuntos
Química Farmacêutica/métodos , Desenho de Drogas , Bases de Mannich/química , Animais , Química Farmacêutica/economia , Análise Custo-Benefício , Humanos , Preparações Farmacêuticas/química
8.
J Pharm Biomed Anal ; 149: 179-184, 2018 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-29121572

RESUMO

A green, simple, accurate and highly sensitive sequential injection lab-at-valve procedure has been developed for the simultaneous determination of ascorbic acid (Asc) and rutin using 18-molybdo-2-phosphate Wells-Dawson heteropoly anion (18-MPA). The method is based on the dependence of the reaction rate between 18-MPA and reducing agents on the solution pH. Only Asc is capable of interacting with 18-MPA at pH 4.7, while at pH 7.4 the reaction with both Asc and rutin proceeds simultaneously. In order to improve the precision and sensitivity of the analysis, to minimize reagent consumption and to remove the Schlieren effect, the manifold for the sequential injection analysis was supplemented with external reaction chamber, and the reaction mixture was segmented. By the reduction of 18-MPA with reducing agents one- and two-electron heteropoly blues are formed. The fraction of one-electron heteropoly blue increases at low concentrations of the reducer. Measurement of the absorbance at a wavelength corresponding to the isobestic point allows strictly linear calibration graphs to be obtained. The calibration curves were linear in the concentration ranges of 0.3-24mgL-1 and 0.2-14mgL-1 with detection limits of 0.13mgL-1 and 0.09mgL-1 for rutin and Asc, respectively. The determination of rutin was possible in the presence of up to a 20-fold molar excess of Asc. The method was applied to the determination of Asc and rutin in ascorutin tablets with acceptable accuracy and precision (1-2%).


Assuntos
Ácido Ascórbico/análise , Análise de Injeção de Fluxo/métodos , Indicadores e Reagentes/química , Rutina/análise , Ânions/química , Ácido Ascórbico/química , Calibragem , Química Farmacêutica/economia , Química Farmacêutica/instrumentação , Química Farmacêutica/métodos , Combinação de Medicamentos , Análise de Injeção de Fluxo/economia , Análise de Injeção de Fluxo/instrumentação , Concentração de Íons de Hidrogênio , Limite de Detecção , Molibdênio/química , Ácidos Fosfóricos/química , Rutina/química , Sensibilidade e Especificidade , Comprimidos/análise , Comprimidos/química
9.
J Pharm Biomed Anal ; 149: 133-142, 2018 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-29112902

RESUMO

Vonoprazan fumarate is a novel potassium-competitive acid blocker for the treatment of acid-related diseases. In the present study, a simple, fast, and economic reversed-phase liquid chromatography (LC) method was developed for the analysis of ten related substances (raw materials, by-products and degradants) in vonoprazan fumarate. The optimized separation was performed on a Phenomenex Kinetex EVO C18 (250mm×4.6mm, 5.0µm) column. The mobile phase consisted of (A) 0.03M sodium phosphate buffer (pH adjusted to 6.5) - methanol - acetonitrile (72:25:3, v/v/v) and (B) 0.03M sodium phosphate buffer (pH adjusted to 6.5) - acetonitrile (30:70, v/v). Detection of the analytes was conducted at 230nm using a UV detector. The stability-indicating ability of this method was demonstrated by carrying out forced degradation studies. Vonoprazan underwent significant degradation when subjected to alkaline and oxidative stress conditions, while the drug proved to be stable to acidic, thermal and photolytic degradation. The degradants did not interfere with the detection of vonoprazan fumarate and its impurities. The performance of this method was validated in accordance to the regulatory guidelines recommended by the International Conference on Harmonisation (ICH) and this validation included specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and robustness. The method proposed in this paper could be applied for process development as well as quality assurance of vonoprazan in bulk drug, since no monograph is available in official compendia.


Assuntos
Contaminação de Medicamentos/prevenção & controle , Fumaratos/análise , Inibidores da Bomba de Prótons/análise , Pirróis/análise , Sulfonamidas/análise , Tecnologia Farmacêutica/métodos , Química Farmacêutica/economia , Química Farmacêutica/instrumentação , Química Farmacêutica/métodos , Cromatografia Líquida de Alta Pressão/economia , Cromatografia Líquida de Alta Pressão/instrumentação , Cromatografia Líquida de Alta Pressão/métodos , Cromatografia de Fase Reversa/economia , Cromatografia de Fase Reversa/instrumentação , Cromatografia de Fase Reversa/métodos , Análise Custo-Benefício , Estabilidade de Medicamentos , Fumaratos/química , Fumaratos/normas , Limite de Detecção , Oxirredução , Inibidores da Bomba de Prótons/química , Inibidores da Bomba de Prótons/normas , Pirróis/química , Pirróis/normas , Controle de Qualidade , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Sulfonamidas/química , Sulfonamidas/normas , Tecnologia Farmacêutica/economia , Tecnologia Farmacêutica/instrumentação , Tecnologia Farmacêutica/normas , Fatores de Tempo
10.
AAPS PharmSciTech ; 18(8): 3227-3235, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28560505

RESUMO

Liposomes, the biocompatible lipid bilayer vesicles, have attracted immense attention due to their distinctive features such as efficient vehicle for the delivery of a wide range of therapeutic agents, adjustable formulation properties, and high drug entrapment efficiency. In this contribution, we present a simple method for the preparation of liposomes using glass beads and compared the potential of this method with conventional methods of liposome preparation. The prepared liposomes were characterized by different analytical techniques (HPLC, DLS, TEM, differential scanning calorimetry, and in vitro drug release). Our findings revealed that the particle size of liposomes is mainly dependent on the size of the glass beads and the glass bead shearing time. An average liposome size of 67.7 ± 25.5 nm was obtained using 2-mm glass beads after 24-h incubation at 200 rpm. The liposomes prepared under the optimized conditions exhibited a high encapsulation efficiency of 92.1 ± 1.7% with 31.08% drug release after 360 min at 37°C. In conclusion, the developed method is a simple and convenient process of liposome preparation of different sizes with desirable entrapment efficiency capacity.


Assuntos
Vidro/química , Lipossomos/síntese química , Lipossomos/economia , Tamanho da Partícula , Anfotericina B/síntese química , Anfotericina B/economia , Varredura Diferencial de Calorimetria/economia , Varredura Diferencial de Calorimetria/métodos , Química Farmacêutica/economia , Química Farmacêutica/métodos , Colesterol/síntese química , Colesterol/economia , Análise Custo-Benefício , Fosfatidilcolinas/síntese química , Fosfatidilcolinas/economia , Resistência ao Cisalhamento
11.
Am Univ Law Rev ; 66(3): 911-70, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28233970

RESUMO

The pharmaceutical market is divided into two types of compounds: small-molecule chemical compounds and large-molecule biologics. Due to biologics' molecular sizes and the current scientific state of biologics manufacturing, manufacturing facilities and processes require frequent reassessment to ensure production of safe, pure, and potent therapeutics. Manufacturers utilize patent and drug regulatory law to protect their investments and simultaneously signal where innovation and investment are lacking. The current four- and twelve-year regimented structures of the Biologics Price, Competition, and Innovation Act do not keep pace with scientific development; biologics manufacturing processes drift with time, and if a manufacturer can obtain a higher degree of process control, then it should not feel restricted to wait until their exclusivity period lapses. Currently, the FDA rarely grants market exclusivity privileges for manufacturing process improvements alone; hence, manufacturing processes--or at least large portions thereof--are typically withheld as trade secrets or strategically claimed within companion composition claims. As a result, significant opportunity exists in regulatory framework to incentivize the research and development of biologics manufacturing processes. By creating a one- to four-year data exclusivity extension opportunity, manufacturers will feel more comfortable reinvesting their returns on investment towards manufacturing efficiency, and manufacturers can capitalize on the complex-molecule nature of their biologic.


Assuntos
Produtos Biológicos/economia , Medicamentos Biossimilares/economia , Química Farmacêutica/economia , Química Farmacêutica/legislação & jurisprudência , Aprovação de Drogas/economia , Aprovação de Drogas/legislação & jurisprudência , Legislação de Medicamentos/economia , Patentes como Assunto/legislação & jurisprudência , Preparações Farmacêuticas/economia , Descoberta de Drogas/economia , Descoberta de Drogas/legislação & jurisprudência , Setor de Assistência à Saúde/economia , Setor de Assistência à Saúde/legislação & jurisprudência , Humanos , Estados Unidos
12.
ACS Chem Neurosci ; 7(10): 1315-1316, 2016 10 19.
Artigo em Inglês | MEDLINE | ID: mdl-27623164

RESUMO

Small molecules remain the backbone for modern drug discovery. They are conceived and synthesized by medicinal chemists, many of whom were originally trained as organic chemists. Support from government and industry to provide training and personnel for continued development of this critical skill set has been declining for many years. This Viewpoint highlights the value of organic chemistry and organic medicinal chemists in the complex journey of drug discovery as a reminder that basic science support must be restored.


Assuntos
Química Orgânica , Química Farmacêutica , Descoberta de Drogas , Química Orgânica/economia , Química Orgânica/educação , Química Farmacêutica/economia , Química Farmacêutica/educação , Descoberta de Drogas/métodos , Fenômenos de Química Orgânica , Apoio à Pesquisa como Assunto
13.
Am J Health Syst Pharm ; 73(3): 121-5, 2016 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-26796904

RESUMO

PURPOSE: The results of a study to assess the financial impact of an automatic formulary substitution of ipratropium-albuterol nebulization solution for ipratropium-albuterol metered-dose inhalers (MDIs) at an academic health system are reported. METHODS: The study was conducted at a 1242-bed urban academic health system. Data were collected regarding all respiratory medication administrations during a three-month period before the MDI-to-nebulizer substitution (October-December 2012) and the same period of 2013 (after the substitution was implemented). Purchasing data were compared between the two time periods to measure the impact of the formulary substitution on pharmacy department costs, and documented administrations were assessed to evaluate associated changes in respiratory therapist (RT) workload. RESULTS: With 100% prescriber compliance with the formulary substitution, the number of MDI administrations of ipratropium-albuterol declined from 13,667 in October-December 2012 to zero in the same period of 2013. The substitution required expenditures for equipment (vibrating mesh nebulizer technology and patient-specific kits) and RT personnel (one additional RT was hired), but those added costs were substantially outweighed by cost savings resulting from a substantial reduction in overall respiratory drug spending. CONCLUSION: An automatic substitution of ipratropium-albuterol nebulization solution for MDIs resulted in a three-month savings of $99,359 in drug cost and an extrapolated full-year savings of $397,436. When additional costs associated with the substitution were taken into account, there was an overall savings of $146,806 during the implementation year and a projected savings of $257,936 for each following year.


Assuntos
Química Farmacêutica/economia , Análise Custo-Benefício , Custos de Medicamentos , Pneumopatias Obstrutivas/tratamento farmacológico , Nebulizadores e Vaporizadores/economia , Administração por Inalação , Albuterol/administração & dosagem , Broncodilatadores/administração & dosagem , Quimioterapia Combinada/economia , Hospitais Universitários , Humanos , Ipratrópio/administração & dosagem , Ohio
14.
Int J Tuberc Lung Dis ; 19 Suppl 1: 32-38, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26564538

RESUMO

BACKGROUND: Assessing the state of country readiness for the introduction of new, child-friendly anti-tuberculosis formulations can highlight potential bottlenecks, facilitate early planning, and accelerate access to appropriate treatment for children with tuberculosis (TB). METHODS: To understand pathways and potential obstacles to the introduction of new pediatric formulations, we performed a desk review of key policy documents and conducted 146 stakeholder interviews in 19 high-burden countries. RESULTS: Issuance of World Health Organization (WHO) guidance serves as the trigger for considering adoption in most countries; however, the degree of alignment with WHO recommendations and duration of introduction processes vary. Endorsement by experts and availability of local evidence are leading criteria for adoption in upper-middle- and high-income countries. Ease of administration, decreased pill burden, and reduced treatment costs are prioritized in low- and lower-middle-income settings. Countries report an average of 10 steps on the path to new treatment introduction, with core steps taking between 18 and 71 months. CONCLUSIONS: The process of new treatment introduction is complicated by diverse country processes, adoption criteria, and evidence requirements. Challenges differ between low- and middle-to-high-income countries. Responsiveness to the unique hurdles faced across settings is important in ensuring a sustainable market for improved pediatric anti-tuberculosis treatment.


Assuntos
Antituberculosos/economia , Química Farmacêutica/economia , Tuberculose/tratamento farmacológico , Tuberculose/economia , Antituberculosos/administração & dosagem , Criança , Custos de Cuidados de Saúde , Humanos , Guias de Prática Clínica como Assunto , Organização Mundial da Saúde
15.
Int J Tuberc Lung Dis ; 19 Suppl 1: 61-68, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26564545

RESUMO

There is a growing number of children worldwide accessing second-line anti-tuberculosis drugs for multidrug-resistant tuberculosis (TB); however, there are very few child-friendly formulations. For paediatric use, dispersible tablets offer distinct advantages over liquid formulations and other approaches. This is particularly relevant for TB, where stability, long shelf-life and reduced manufacturing, transport and storage costs are all critical to ensuring that drugs are accessible and affordable. In addition, fixed-dose combinations that reduce the pill burden and provide adequate taste masking may promote long-term adherence to anti-tuberculosis treatment and prevention regimens likely to last many months in children. Partial adherence may result in treatment failure and the further selection and spread of resistant mycobacteria. Unfortunately, no second-line TB paediatric drugs exist in dispersible formulations. We discuss here the main obstacles to developing such tablets and present strategies for overcoming them. We also advocate for timely anticipation of paediatric use when new TB drugs are being developed, and for the development of child-friendly anti-tuberculosis formulations in general.


Assuntos
Antituberculosos/administração & dosagem , Química Farmacêutica/economia , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico , Criança , Humanos , Falha de Tratamento
16.
Int J Tuberc Lung Dis ; 19 Suppl 1: 69-74, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26564546

RESUMO

Despite urgent need, the development, approval and availability of child-friendly anti-tuberculosis drugs lag significantly behind that of adults, with children having been ignored in anti-tuberculosis drug development research. This paper outlines possible strategies for accelerating and better integrating the development of drugs and regimens for pediatric tuberculosis (TB) into existing drug development pathways for adults: initiation of pediatric studies of new treatments as soon as promising efficacy data have been generated in adults following successful phase II studies, shifting from the current age de-escalated approach to concomitant enrollment of children from the various age groups in studies, and leveraging the concepts of both the Unified Pathway and regimen development that have helped speed the study and development of novel regimens in adults.


Assuntos
Antituberculosos/administração & dosagem , Química Farmacêutica/economia , Tuberculose/tratamento farmacológico , Criança , Ensaios Clínicos Fase II como Assunto , Humanos , Pediatria
17.
Zhongguo Zhong Yao Za Zhi ; 40(9): 1639-43, 2015 May.
Artigo em Chinês | MEDLINE | ID: mdl-26323121

RESUMO

The general situation of the approved and concluded projects of National Natural Science Foundation of China in the field of processing Chinese Materia Medica in recent five years has been reviewed. The progresses and achievements of some projects have been summarized in accordance with research area such as the processing principle, the processing technology, quality evaluation, toxicity and safety evaluation, etc. The researchers and project support units of the funded projects have been analyzed, and the problems of the applications have been also summarized.


Assuntos
Pesquisa Biomédica/economia , Química Farmacêutica/economia , Organização do Financiamento/economia , Organização do Financiamento/organização & administração , Materia Medica/economia , Medicina Tradicional Chinesa/economia , Pesquisa Biomédica/organização & administração , Química Farmacêutica/organização & administração , China , Humanos
19.
J Manag Care Spec Pharm ; 21(4): 269-75, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25803760

RESUMO

BACKGROUND: Value-based insurance design attempts to align drug copayment tier with value rather than cost. Previous implementations of value-based insurance design have lowered copayments for drugs indicated for select "high value" conditions and have found modest improvements in medication adherence. However, these implementations have generally not resulted in cost savings to the health plan, suggesting a need for increased copayments for "low value" drugs. Further, previous implementations have assigned equal copayment reductions to all drugs within a therapeutic area without assessing the value of individual drugs. Aligning the individual drug's copayment to its specific value may yield greater clinical and economic benefits. In 2010, Premera Blue Cross, a large not-for-profit health plan in the Pacific Northwest, implemented a value-based drug formulary (VBF) that explicitly uses cost-effectiveness analyses after safety and efficacy reviews to estimate the value of each individual drug. Concurrently, Premera increased copayments for existing tiers. OBJECTIVE: To describe and evaluate the design, implementation, and first-year outcomes of the VBF. METHODS: We compared observed pharmacy cost per member per month in the year following the VBF implementation with 2 comparator groups: (1) observed pharmacy costs in the year prior to implementation, and (2) expected costs if no changes were made to the pharmacy benefits. Expected costs were generated by applying autoregressive integrated moving averages to pharmacy costs over the previous 36 months. We used an interrupted time series analysis to assess drug use and adherence among individuals with diabetes, hypertension, or dyslipidemia compared with a group of members in plans that did not implement a VBF.  RESULTS: Pharmacy costs decreased by 3% compared with the 12 months prior and 11% compared with expected costs. There was no significant decline in medication use or adherence to treatments for patients with diabetes, hypertension, or dyslipidemia. CONCLUSIONS: The VBF and copayment changes enabled pharmacy plan cost savings without negatively affecting utilization in key disease states.


Assuntos
Química Farmacêutica/economia , Análise Custo-Benefício , Custos de Medicamentos , Revisão de Uso de Medicamentos/economia , Seguro de Serviços Farmacêuticos/economia , Aquisição Baseada em Valor/economia , Planos de Seguro Blue Cross Blue Shield/economia , Química Farmacêutica/métodos , Análise Custo-Benefício/métodos , Custos de Medicamentos/tendências , Revisão de Uso de Medicamentos/métodos , Revisão de Uso de Medicamentos/tendências , Humanos , Seguro de Serviços Farmacêuticos/tendências , Aquisição Baseada em Valor/tendências
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