Base de dados : MEDLINE
Pesquisa : H01.158.703.003 [Categoria DeCS]
Referências encontradas : 2447 [refinar]
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[PMID]:29386431
[Au] Autor:Ohashi Y
[Ad] Endereço:Quality & Regulatory Compliance Unit, Chugai Pharmaceutical Co., Ltd.
[Ti] Título:[Safe Use of Recent New Drugs-Current Status and Challenges].
[So] Source:Yakugaku Zasshi;138(2):177-183, 2018.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo: In Japan and overseas, Chugai Pharmaceutical Company handles numerous biopharmaceuticals, molecular targeted therapies and other pharmaceuticals with innovative modes of action. Expert safety evaluation is essential for promoting the appropriate use of these pharmaceuticals around the world and in gaining acceptance from patients and healthcare professionals (HCPs), while speedy decision-making is crucial for the timely collection and provision of safety information and thus ensuring safety. In 2015, we collected safety information on more than 180000 cases and evaluated it from a medical standpoint. We have established a system for recording the collected information in a global database, and are conducting signal detection of adverse drug reactions using this database. With this system, we promptly disclose information to regulatory authorities in Japan, the US, Europe and Asia. We have in-house medical doctors with abundant clinical experience who conduct expert safety evaluations. Many innovative drugs, such as anticancer drugs or biopharmaceuticals, require wider-ranging, more rigorous management, including the provision of appropriate safety information to HCPs, management of distribution through wholesalers and dispensing pharmacies, and confirmation of conditions of use, in addition to all-case registration surveillance. With progress in the development of individualized medicine and drugs with new modes of action, in order for HCPs to understand the characteristics of these new drugs and use them appropriately, pharmacists and pharmaceutical companies should cooperate in promoting their appropriate use in the spirit of 'All Pharmacists for Patients'.
[Mh] Termos MeSH primário: Bases de Dados de Produtos Farmacêuticos
Serviços de Informação sobre Medicamentos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Preparações Farmacêuticas
Farmacovigilância
Gestão de Riscos
[Mh] Termos MeSH secundário: Biofarmácia
Tomada de Decisões Gerenciais
Indústria Farmacêutica
Seres Humanos
Farmacêuticos
Medicina de Precisão/tendências
Segurança
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Pharmaceutical Preparations)
[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.17-00174-3


  2 / 2447 MEDLINE  
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[PMID]:28710854
[Au] Autor:Jiang M; Severson KA; Love JC; Madden H; Swann P; Zang L; Braatz RD
[Ad] Endereço:Massachusetts Institute of Technology, Department of Chemical Engineering, Cambridge, Massachusetts.
[Ti] Título:Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing.
[So] Source:Biotechnol Bioeng;114(11):2445-2456, 2017 Nov.
[Is] ISSN:1097-0290
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Real-time release testing (RTRT) is defined as "the ability to evaluate and ensure the quality of in-process and/or final drug product based on process data, which typically includes a valid combination of measured material attributes and process controls" (ICH Q8[R2]). This article discusses sensors (process analytical technology, PAT) and control strategies that enable RTRT for the spectrum of critical quality attributes (CQAs) in biopharmaceutical manufacturing. Case studies from the small-molecule and biologic pharmaceutical industry are described to demonstrate how RTRT can be facilitated by integrated manufacturing and multivariable control strategies to ensure the quality of products. RTRT can enable increased assurance of product safety, efficacy, and quality-with improved productivity including faster release and potentially decreased costs-all of which improve the value to patients. To implement a complete RTRT solution, biologic drug manufacturers need to consider the special attributes of their industry, particularly sterility and the measurement of viral and microbial contamination. Continued advances in on-line and in-line sensor technologies are key for the biopharmaceutical manufacturing industry to achieve the potential of RTRT. Related article: http://onlinelibrary.wiley.com/doi/10.1002/bit.26378/full.
[Mh] Termos MeSH primário: Biofarmácia/normas
Contaminação de Medicamentos/prevenção & controle
Avaliação de Medicamentos/normas
Indústria Farmacêutica/normas
Preparações Farmacêuticas/normas
Controle de Qualidade
Tecnologia Farmacêutica/normas
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Pharmaceutical Preparations)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171109
[Lr] Data última revisão:
171109
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170716
[St] Status:MEDLINE
[do] DOI:10.1002/bit.26383


  3 / 2447 MEDLINE  
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[PMID]:28655394
[Au] Autor:Kittelmann J; Lang KMH; Ottens M; Hubbuch J
[Ad] Endereço:Section IV: Biomolecular Separation Engineering, Institute of Engineering in Life Sciences, Karlsruhe Institute of Technology (KIT), Engler-Bunte-Ring 1, 76131 Karlsruhe, Germany.
[Ti] Título:Orientation of monoclonal antibodies in ion-exchange chromatography: A predictive quantitative structure-activity relationship modeling approach.
[So] Source:J Chromatogr A;1510:33-39, 2017 Aug 11.
[Is] ISSN:1873-3778
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Chromatographic separation of biopharmaceuticals in general and monoclonal antibodies (mAbs) specifically is the bottleneck in terms of cost and throughput in preparative purification. Still, generalized platform processes are used, neglecting molecule specific characteristics, defining protein-resin interaction terms. Currently used in silico modeling approaches do not consider the orientation of the molecule towards the chromatographic resins as a result of the structural features on an atomic level. This paper describes a quantitative structure-activity relationship (QSAR) approach to model the orientation of mAbs on ion exchange chromatographic matrices as a function of property distribution and mobile phase characteristics. 6 mAbs were used to build a predictive QSAR model and to investigate the preferred binding orientations and resulting surface shielding on resins. Thereby different dominating orientations, caused by composition of F fragments of the mAbs, could be identified. The presented methodology is suitable to gain extended insight in molecule orientation on chromatographic resins and to tailor purification strategies based on molecule structure.
[Mh] Termos MeSH primário: Anticorpos Monoclonais/química
Anticorpos Monoclonais/isolamento & purificação
Biofarmácia/métodos
Técnicas de Química Analítica/métodos
Cromatografia por Troca Iônica
Modelos Químicos
Relação Quantitativa Estrutura-Atividade
[Mh] Termos MeSH secundário: Fragmentos Fab das Imunoglobulinas/química
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Immunoglobulin Fab Fragments)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171017
[Lr] Data última revisão:
171017
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170629
[St] Status:MEDLINE


  4 / 2447 MEDLINE  
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[PMID]:28505573
[Au] Autor:Zheng S; Li X; Zhang X; Wang W; Yuan S
[Ad] Endereço:School of Environment, MOE Key Laboratory of Water and Sediment Sciences/State Key Lab of Water Environment Simulation, Beijing Normal University, Beijing 100875, China. Electronic address: zsk@bnu.edu.cn.
[Ti] Título:Effect of inorganic regenerant properties on pharmaceutical adsorption and desorption performance on polymer anion exchange resin.
[So] Source:Chemosphere;182:325-331, 2017 Sep.
[Is] ISSN:1879-1298
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:This study investigated the potential effect of four frequently used inorganic regenerant properties (i.e., ionic strength, cation type, anion type, and regeneration solution volume) on the desorption and adsorption performance of 14 pharmaceuticals, belonging to 12 therapeutic classes with different predominant chemical forms and hydrophobicities, using polymeric anion exchange resin (AER)-packed fixed-bed column tests. After preconditioning with NaCl, NaOH, or saline-alkaline (SA) solutions, all resulting mobile counterion types of AERs effectively adsorbed all 14 pharmaceuticals, where the preferential magnitude of OH -type = Cl + OH -type > Cl -type. During regeneration, ionic strength (1 M versus 3 M NaCl) had no significant influence on desorption performance for any of the 14 pharmaceuticals, while no regenerant cation (HCl versus NaCl) or anion type (NaCl versus NaOH and SA) achieved higher desorption efficiencies for all pharmaceuticals. A volumetric increase in 1 M or 3 M NaCl solutions significantly improved the desorption efficiencies of most pharmaceuticals, irrespective of ionic strength. The results indicate that regeneration protocols, including regenerant cation type, anion type and volume, should be optimized to improve pharmaceutical removal by AERs.
[Mh] Termos MeSH primário: Resinas de Troca de Ânions/química
Recuperação e Remediação Ambiental/métodos
Preparações Farmacêuticas/isolamento & purificação
[Mh] Termos MeSH secundário: Adsorção
Biofarmácia
Química Farmacêutica
Interações Hidrofóbicas e Hidrofílicas
Concentração Osmolar
Soluções
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anion Exchange Resins); 0 (Pharmaceutical Preparations); 0 (Solutions)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170922
[Lr] Data última revisão:
170922
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170516
[St] Status:MEDLINE


  5 / 2447 MEDLINE  
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[PMID]:28346198
[Au] Autor:Akers MJ
[Ad] Endereço:Baxter BioPharma Solutions, Bloomington, Indiana. mjakers356@gmail.com.
[Ti] Título:Basics of Sterile Compounding: Biopharmaceutics of Injectable Dosage Forms.
[So] Source:Int J Pharm Compd;21(1):47-56, 2017 Jan-Feb.
[Is] ISSN:1092-4221
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Biopharmaceutics studies the relationship between the drug product and what happens after the product is administered. Since the majority of injectables are administered by the intravenous route, thus avoiding the need for drug absorption, not many articles are published compared to other routes of drug administration. However, other routes of administration for drug injection are becoming more frequent because of greater commercial availability of sustained- and controlled-release drug delivery systems. This article reviews basic principles of drug absorption, distribution, metabolism, and elimination of injectable drugs and certain physicochemical and physiological factors affecting injectable drug biopharmaceutics.
[Mh] Termos MeSH primário: Assepsia/métodos
Biofarmácia/métodos
Composição de Medicamentos/métodos
Contaminação de Medicamentos/prevenção & controle
Preparações Farmacêuticas/administração & dosagem
Farmacocinética
[Mh] Termos MeSH secundário: Formas de Dosagem
Seres Humanos
Injeções
Modelos Biológicos
Modelos Químicos
Preparações Farmacêuticas/química
Preparações Farmacêuticas/metabolismo
Solubilidade
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Dosage Forms); 0 (Pharmaceutical Preparations)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170605
[Lr] Data última revisão:
170605
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170328
[St] Status:MEDLINE


  6 / 2447 MEDLINE  
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[PMID]:28295562
[Au] Autor:Guérard M; Andreas Z; Erich K; Christine M; Martina MB; Christian W; Franz S; Thomas S; Yann T
[Ad] Endereço:Pharmaceutical Sciences, Roche Innovation Center Basel, Pharmaceutical Research and Early Development, F. Hoffmann-La Roche, Ltd, Basel, 4070, Switzerland.
[Ti] Título:Locked nucleic acid (LNA): Based single-stranded oligonucleotides are not genotoxic.
[So] Source:Environ Mol Mutagen;58(3):112-121, 2017 Apr.
[Is] ISSN:1098-2280
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Over the last decade, single stranded oligonucleotides (ON) have gained increased attention as a new drug modality. Because the assessment of genotoxicity risk during early development of pharmaceuticals is essential, we evaluated the potential of locked nucleic acids (LNA)-ONs to induce DNA damage in L5178Y tk cells both with the mouse lymphoma assay (MLA) and the micronucleus test (MNT). Further, the MLA was performed to assess gene and chromosome mutation over 3 and 24h (± metabolic activation). In addition, the MNT was performed to assess, in addition, a potential aneugenic liability. None of the experiments demonstrated a genotoxic effect for the five tested LNA-ONs. We further show data from four proprietary LNA-ONs tested in standard genotoxicity assays in vitro and partially in vivo, which were all negative. In addition, cellular and nuclear uptake of LNA-ONs in L5178Y tk cells was demonstrated. Based on the results presented here as well as in the literature about other representatives of this class, we consider LNA-ONs as generally not DNA reactive and question whether genotoxicity testing of this class of ONs should be required. This is in line with recent recommendation made by the OSWG that extensively assessed the genotoxicity of oligonucleotides. Environ. Mol. Mutagen. 58:112-121, 2017. © 2017 Wiley Periodicals, Inc.
[Mh] Termos MeSH primário: Oligonucleotídeos/toxicidade
[Mh] Termos MeSH secundário: Animais
Apoptose/efeitos dos fármacos
Apoptose/genética
Biofarmácia/métodos
Técnicas de Cultura de Células
Linhagem Celular Tumoral
Sobrevivência Celular/efeitos dos fármacos
Sobrevivência Celular/genética
Relação Dose-Resposta a Droga
Avaliação Pré-Clínica de Medicamentos
Camundongos
Testes de Mutagenicidade
Oligonucleotídeos/genética
RNA Longo não Codificante/genética
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Malat1 long non-coding RNA, mouse); 0 (Oligonucleotides); 0 (RNA, Long Noncoding); 0 (locked nucleic acid)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170726
[Lr] Data última revisão:
170726
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170316
[St] Status:MEDLINE
[do] DOI:10.1002/em.22076


  7 / 2447 MEDLINE  
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[PMID]:28275201
[Au] Autor:Jing J; Nelson C; Paik J; Shirasaka Y; Amory JK; Isoherranen N
[Ad] Endereço:Department of Pharmaceutics (J.J., C.N., Y.S., N.I.), Department of Medicine (J.A.), and Department of Comparative Medicine (J.P.), University of Washington, Seattle, Washington.
[Ti] Título:Physiologically Based Pharmacokinetic Model of All- -Retinoic Acid with Application to Cancer Populations and Drug Interactions.
[So] Source:J Pharmacol Exp Ther;361(2):246-258, 2017 May.
[Is] ISSN:1521-0103
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:All- retinoic acid ( RA) is a front-line treatment of acute promyelocytic leukemia (APL). Due to its activity in regulating the cell cycle, it has also been evaluated for the treatment of other cancers. However, the efficacy of RA has been limited by RA inducing its own metabolism during therapy, resulting in a decrease of RA exposure during continuous dosing. Frequent relapse occurs in patients receiving RA monotherapy. In an attempt to combat therapy resistance, inhibitors of RA metabolism have been developed. Of these, ketoconazole and liarozole have shown some benefits, but their usage is limited by side effects and low potency toward the cytochrome P450 26A1 isoform (CYP26A1), the main RA hydroxylase. We determined the pharmacokinetic basis of therapy resistance to RA and tested whether the complex disposition kinetics of RA could be predicted in healthy subjects and in cancer patients in the presence and absence of inhibitors of RA metabolism using physiologically based pharmacokinetic (PBPK) modeling. A PBPK model of RA disposition was developed and verified in healthy individuals and in cancer patients. The population-based PBPK model of RA disposition incorporated saturable metabolic clearance of RA, induction of CYP26A1 by RA, and the absorption and distribution kinetics of RA. It accurately predicted the changes in RA exposure after continuous dosing and when coadministered with ketoconazole and liarozole. The developed model will be useful in interpretation of RA disposition and efficacy, design of novel dosing strategies, and development of next-generation RA metabolism inhibitors.
[Mh] Termos MeSH primário: Neoplasias
Ácido Retinoico 4 Hidroxilase/metabolismo
Tretinoína
[Mh] Termos MeSH secundário: Animais
Antineoplásicos/metabolismo
Antineoplásicos/farmacocinética
Biofarmácia/métodos
Desenho de Drogas
Interações Medicamentosas
Seres Humanos
Camundongos
Neoplasias/tratamento farmacológico
Neoplasias/metabolismo
Distribuição Tecidual
Tretinoína/metabolismo
Tretinoína/farmacocinética
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents); 5688UTC01R (Tretinoin); EC 1.14.14.1 (Retinoic Acid 4-Hydroxylase)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:171031
[Lr] Data última revisão:
171031
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170310
[St] Status:MEDLINE
[do] DOI:10.1124/jpet.117.240523


  8 / 2447 MEDLINE  
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[PMID]:28267874
[Au] Autor:Manimaran M; Kannabiran K
[Ad] Endereço:Department of Bio-Medical Sciences, School of Biosciences and Technology, VIT University, Vellore, India.
[Ti] Título:Actinomycetes-mediated biogenic synthesis of metal and metal oxide nanoparticles: progress and challenges.
[So] Source:Lett Appl Microbiol;64(6):401-408, 2017 Jun.
[Is] ISSN:1472-765X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Actinomycetes-mediated biogenic synthesis of metal nanoparticles and their antimicrobial activities are well documented. Actinomycetes facilitate both intracellular and extracellular metal nanoparticles synthesis and are efficient candidates for the production of polydispersed, stable and ultra-small size metal nanoparticles. Secondary metabolites and new chemical entities derived from Actinomycetes have not been extensively studied for the synthesis of metal/metal oxide nanoparticles. The present review focuses on biogenic synthesis of metal nanoparticles from Actinomycetes and the scope for exploring Actinomycetes-derived compounds (enzymes, organics acids and bioactive compounds) as metal and metal oxide reducing agents for the synthesis of desired nanoparticles. This review also focuses on challenges faced in the applications of nanoparticles and the methods to synthesize biogenic metal nanoparticles with desired physiochemical properties such as ultra-small size, large surface to mass ratio, high reactivity etc. Methods to evade their toxicity and unique interactions with biological systems to improve their chance as an alternative therapeutic agent in medical and pharmaceutical industry are also discussed.
[Mh] Termos MeSH primário: Actinobacteria/metabolismo
Anti-Infecciosos/metabolismo
Microbiologia Industrial
Nanopartículas Metálicas/microbiologia
[Mh] Termos MeSH secundário: Actinobacteria/química
Biofarmácia
Metais/metabolismo
Nanomedicina
Óxidos/metabolismo
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Anti-Infective Agents); 0 (Metals); 0 (Oxides)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171003
[Lr] Data última revisão:
171003
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170308
[St] Status:MEDLINE
[do] DOI:10.1111/lam.12730


  9 / 2447 MEDLINE  
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[PMID]:28257576
[Au] Autor:Chan R; Benet LZ
[Ad] Endereço:Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California , San Francisco, California 94143-0912, United States.
[Ti] Título:Evaluation of DILI Predictive Hypotheses in Early Drug Development.
[So] Source:Chem Res Toxicol;30(4):1017-1029, 2017 Apr 17.
[Is] ISSN:1520-5010
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Drug-induced liver injury (DILI) is a leading cause of drug failure in clinical trials and a major reason for drug withdrawals. DILI has been shown to be dependent on both daily dose and extent of hepatic metabolism. Yet, early in drug development daily dose is unknown. Here, we perform a comprehensive analysis of the published hypotheses that attempt to predict DILI, including a new analysis of the Biopharmaceutics Drug Disposition Classification System (BDDCS) in evaluating the severity of DILI warnings in drug labels approved by the FDA and the withdrawal status due to adverse drug reactions (ADRs). Our analysis confirms that higher doses ≥50 mg/day lead to increased DILI potential, but this property alone is not sufficient to predict the DILI potential. We evaluate prior attempts to categorize DILI such as Rule of 2, BSEP inhibition, and measures of key mechanisms of toxicity compared to BDDCS classification. Our results show that BDDCS Class 2 drugs exhibit the highest DILI severity and that all of the published methodologies evaluated here, except when daily dose is known, do not yield markedly better predictions than BDDCS. The assertion that extensive metabolized compounds are at higher risk of developing DILI is confirmed but can be enhanced by differentiating BDDCS Class 2 from Class 1 drugs. We do not propose that the BDDCS classification, which does not require knowledge of the clinical dose, is sufficiently predictive/accurate of DILI potential for new molecular entities but suggest that comparison of proposed DILI prediction methodologies with BDDCS classification is a useful tool to evaluate the potential reliability of newly proposed algorithms. CONCLUSION: The most successful approaches to predict DILI potential all include a measure of dose, yet there is a quantifiable uncertainty associated with the predicted dose early in drug development. Here, we compare the possibility of predicting DILI potential using the BDDCS classification versus previously published methods and note that many hypothesized predictive DILI metrics do no better than just avoiding BDDCS Class 2 drugs.
[Mh] Termos MeSH primário: Doença Hepática Induzida por Substâncias e Drogas/patologia
Modelos Teóricos
[Mh] Termos MeSH secundário: Biofarmácia/classificação
Avaliação Pré-Clínica de Medicamentos
Rotulagem de Medicamentos
Seres Humanos
Índice de Gravidade de Doença
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1704
[Cu] Atualização por classe:171108
[Lr] Data última revisão:
171108
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170304
[St] Status:MEDLINE
[do] DOI:10.1021/acs.chemrestox.7b00025


  10 / 2447 MEDLINE  
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[PMID]:28254086
[Au] Autor:Lacy-Jones K; Hayward P; Andrews S; Gledhill I; McAllister M; Abrahamsson B; Rostami-Hodjegan A; Pepin X
[Ad] Endereço:Simcyp Limited, Blades Enterprise Centre, John Street, Sheffield, UK, S2 4SU. Electronic address: kristin.lacy-jones@certara.com.
[Ti] Título:Biopharmaceutics data management system for anonymised data sharing and curation: First application with orbito IMI project.
[So] Source:Comput Methods Programs Biomed;140:29-44, 2017 Mar.
[Is] ISSN:1872-7565
[Cp] País de publicação:Ireland
[La] Idioma:eng
[Ab] Resumo:The OrBiTo IMI project was designed to improve the understanding and modelling of how drugs are absorbed. To achieve this 13 pharmaceutical companies agreed to share biopharmaceutics drug properties and performance data, as long as they were able to hide certain aspects of their dataset if required. This data was then used in simulations to test how three in silico Physiological Based Pharmacokinetic (PBPK) tools performed. A unique database system was designed and implemented to store the drug data. The database system was unique, in that it had the ability to make different sections of a dataset visible or hidden depending on the stage of the project. Users were also given the option to hide identifying API attributes, to help prevent identification of project members from previously published data. This was achieved by applying blinding strategies to data parameters and the adoption of a unique numbering system. An anonymous communication tool was proposed to exchange comments about data, which enabled its curation and evolution. This paper describes the strategy adopted for numbering and blinding of the data, the tools developed to gather and search data as well as the tools used for communicating around the data with the aim of publicising the approach for other pre-competitive research between organisations.
[Mh] Termos MeSH primário: Biofarmácia
Bases de Dados Factuais
Disseminação de Informação
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170411
[Lr] Data última revisão:
170411
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170304
[St] Status:MEDLINE



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