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2.
JAMA ; 323(9): 829-830, 2020 03 03.
Artículo en Inglés | MEDLINE | ID: mdl-32125384
3.
Infect Dis Poverty ; 9(1): 27, 2020 Mar 13.
Artículo en Inglés | MEDLINE | ID: mdl-32164743

RESUMEN

BACKGROUND: China has emerged as a powerful platform for global pharmaceutical research and development (R&D) amid the 2014 Ebola outbreak. The research and development impact of developing countries on prevention and control of infectious disease outbreaks has long been underestimated, particularly for emerging economies like China. Here, we studied its research and development progress and government support in response to Ebola outbreak by timeline, input, and output at each research and development stage. This study will contribute to a deeper understanding of the research and development gaps and challenges faced by China, as well as providing evidence-based suggestions on how to accelerate the drug development process to meet urgent needs during future outbreaks. METHODS: Data were obtained from the National Nature Science Foundation of China database, PubMed database, Patent Search System of the State Intellectual Property Office of China, National Medical Products Administration, national policy reports and literature between Jan 1st, 2006 and Dec 31st, 2017. An overview of research funding, research output, pharmaceutical product patent, and product licensed was described and analyzed by Microsoft Excel. A descriptive analysis with a visualization of plotting charts and graphs was conducted by reporting the mean ± standard deviation. RESULTS: China has successfully completed the research and development of the Ebola Ad5-EBOV vaccine within 26 months, while the preparation and implementation of clinical trials took relative long time. The National Nature Science Foundation of China funded CNY 44.05 million (USD 6.27 million) for Ebola-related researches and committed strongly to the phase of basic research (87.8%). A proliferation of literature arose between 2014 and 2015, with a 1.7-fold increase in drug research and a 2.5-fold increase in diagnostic research within 1 year. Three years on from the Ebola outbreak, six Ebola-related products in China were approved by the National Medical Products Administration. CONCLUSIONS: China has started to emphasize the importance of medical product innovation as one of the solutions for tackling emerging infectious diseases. Continuing research on the development of regulatory and market incentives, as well as a multilateral collaboration mechanism that unifies cross-channel supports, would advance the process for China to enter global R&D market more effectively.


Asunto(s)
Enfermedades Transmisibles Emergentes/prevención & control , Brotes de Enfermedades/prevención & control , Vacunas contra el Ebola , Fiebre Hemorrágica Ebola/prevención & control , Investigación Farmacéutica , China , Industria Farmacéutica , Ebolavirus , Fiebre Hemorrágica Ebola/epidemiología , Humanos , Investigadores , Apoyo a la Investigación como Asunto
13.
Expert Rev Clin Pharmacol ; 13(2): 115-134, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-31958027

RESUMEN

Introduction: Pharmacometabolomics is an emerging science pursuing the application of precision medicine. Combining both genetic and environmental factors, the so-called pharmacometabolomic approach guides patient selection and stratification in clinical trials and optimizes personalized drug dosage, improving efficacy and safety.Areas covered: This review illustrates the progressive introduction of pharmacometabolomics as an innovative solution for enhancing the discovery of novel drugs and improving research and development (R&D) productivity of the pharmaceutical industry. An extended analysis on published pharmacometabolomics studies both in animal models and humans includes results obtained in several areas such as hepatology, gastroenterology, nephrology, neuropsychiatry, oncology, drug addiction, embryonic cells, neonatology, and microbiomics.Expert opinion: a tailored, individualized therapy based on the optimization of pharmacokinetics and pharmacodynamics, the improvement of drug efficacy, and the abolition of drug toxicity and adverse drug reactions is a key issue in precision medicine. Genetics alone has become insufficient for deciphring intra- and inter-individual variations in drug-response, since they originate both from genetic and environmental factors, including human microbiota composition. The association between pharmacogenomics and pharmacometabolomics may be considered the new strategy for an in-deep knowledge on changes and alterations in human and microbial metabolic pathways due to the action of a drug.


Asunto(s)
Metabolómica/métodos , Preparaciones Farmacéuticas/administración & dosificación , Farmacogenética/métodos , Animales , Descubrimiento de Drogas/métodos , Industria Farmacéutica/métodos , Humanos , Preparaciones Farmacéuticas/metabolismo , Investigación Farmacéutica/métodos , Medicina de Precisión/métodos
15.
World J Microbiol Biotechnol ; 36(1): 15, 2020 Jan 02.
Artículo en Inglés | MEDLINE | ID: mdl-31897837

RESUMEN

The transglutaminases form a large family of intracellular and extracellular enzymes that catalyze cross-links between protein molecules. Transglutaminases crosslinking properties are widely applied to various industrial processes, to improve the firmness, viscosity, elasticity, and water-holding capacity of products in the food and pharmaceutical industries. However, the extremely high costs of obtaining transglutaminases from animal sources have prompted scientists to search for new sources of these enzymes. Therefore, research has been focused on producing transglutaminases by microorganisms, which may present wider scope of use, based on enzyme-specific characteristics. In this review, we present an overview of the literature addressing the origins, types, reactions, and general characterizations of this important enzyme family. A second review will deal with transglutaminases applications in the area of food industry, medicine, pharmaceuticals and biomaterials, as well as applications in the textile and leather industries.


Asunto(s)
Bacterias/enzimología , Transglutaminasas/genética , Transglutaminasas/metabolismo , Secuencia de Aminoácidos , Proteínas Bacterianas/genética , Proteínas Bacterianas/metabolismo , Industria Farmacéutica , Industria de Alimentos , Humanos , Familia de Multigenes , Industria Textil
18.
AAPS PharmSciTech ; 21(2): 44, 2020 Jan 02.
Artículo en Inglés | MEDLINE | ID: mdl-31897807

RESUMEN

The application and impact of human dose projection (HDP) has been well recognized in the late drug development phase, with increasing appreciation earlier during discovery and early development. This commentary describes the perspective of pharmaceutical scientists on the evolving application and impact of HDP at various phases from discovery to early development, including lead generation, lead optimization, lead up to candidate nomination, and early drug development. The underlying fundamental concepts and key input parameters for HDP are briefly discussed. A broad overview of phase-specific tools and approaches commonly utilized for human dose projection in the pharmaceutical industry is provided. A discussion of phase-appropriate implementation strategies, associated limitations/assumptions and continuous refinement for HDP from discovery to early development is presented. The authors describe the phase-specific applications of human dose projection to facilitate key assessments and relative impact on decision points.


Asunto(s)
Desarrollo de Medicamentos/métodos , Descubrimiento de Drogas/métodos , Preparaciones Farmacéuticas/administración & dosificación , Animales , Química Farmacéutica , Relación Dosis-Respuesta a Droga , Diseño de Drogas , Industria Farmacéutica , Predicción , Humanos , Farmacocinética
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