Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 2.410
Filtrar
1.
Clin Ter ; 170(1): e66-e73, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31850487

RESUMO

BACKGROUND: Cross-contamination and mix-ups are among the problems which could have a negative impact on the quality of the finished product during the production of highly active or sensitizing drugs with campaign manufacturing. Standardised, validated procedures ensure quality standards are maintained during production. In spite of this, the operating conditions and applicability of methods adopted by the various regulatory agencies manifest significant differences which could consequently compromise the safety of the finished product. This work has analysed and compared the GMP of various Regulatory Agencies to examine issues connected to campaign manufacturing highly active or sensitizing drugs. METHODS: The GMP of the following Regulatory Agencies have been studied: EMA, CFDA, COFEPRIS, FDA, Health Canada, ANVISA, CDSCO, PIC/S and WHO. The study was carried out for the purpose of understanding which agencies consent to the use of campaign manufacturing for the following categories of medicinal products: hormones, immunosuppressants, cytotoxic agents, highly active pharmaceutical ingredients (APIs), biological preparations, steroids, sensitizing pharmaceutical materials, antibiotics, cephalosporins, penicillins, carbapenems and beta-lactam derivatives. RESULTS: The GMP of Health Canada, EMA, PIC/S and FDA show a number of similarities, starting with the fact that they allow campaign manufacturing for similar categories of pharmaceutical products after an appropriate risk evaluation has been performed. CFDA, WHO, ANVISA authorise campaign manufacturing in "exceptional circumstances", though they do not always define what they mean by this. COFEPRIS authorises campaign manufacturing for certain classes of drugs, while there is no mention of campaign manufacturing in the CDSCO regulations. CONCLUSIONS: Quite a few significant differences have been found in the various regulations concerning the use of campaign manufacturing and the classes of drugs that can be produced with this method. In the light of this, it is obvious that efforts to harmonise legislation internationally have not yet been successful: currently, states can adopt different quality standards. The pharmaceutical industry could use this situation to its advantage by delocalising production on the basis of existing standards. The need to harmonise GMPs is a priority which must be achieved as soon as possible.


Assuntos
Indústria Farmacêutica/legislação & jurisprudência , Indústria Farmacêutica/normas , Saúde Global/legislação & jurisprudência , Saúde Global/normas , Guias como Assunto , Medicamentos sob Prescrição/normas , Controle de Qualidade , Humanos
2.
Adv Exp Med Biol ; 1181: 187-204, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31677144

RESUMO

Ganoderma (Lingzhi) has been used as a medicinal mushroom to promote health in China for more than 2000 years. The modern research and development of Ganoderma industry started from the 1950s, in which the successful cultivation of Ganoderma fruiting body and submerged fermentation of Ganoderma mycelium lay the critical foundation for the industry development. Recent decades have witnessed the rapid development of Ganoderma industry, which is boosted through various efforts made by the government, the academia, and the industry. In this chapter, the development of Ganoderma industry in China is reviewed in terms of gross output, standards, scientific articles, patents, and associations. In addition, development of Ganoderma products and manufacturing technologies are also overviewed and summarized. In the last section, several innovation trends are suggested for the further development of Ganoderma industry.


Assuntos
Ganoderma , Produtos Biológicos , China , Indústria Farmacêutica/normas , Indústria Farmacêutica/tendências , Ganoderma/química
4.
Zhongguo Zhong Yao Za Zhi ; 44(14): 3123-3127, 2019 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-31602862

RESUMO

In the process of transforming and upgrading of traditional Chinese medicine( TCM) intelligent manufacturing,the TCM enterprises lack systematic and in-depth research on intelligent manufacturing of TCM,leading to insufficient understanding of relevant concepts,development direction,development content and other aspects,to some extent,causing fuzzy and chaotic phenomena. The theoretical model,as a higher expression level of scientific thinking,has the function of interpretation and prediction,and can provide theoretical basis as well as guide for scientific research. Therefore,this article aims to construct a theoretical model of TCM intelligent manufacturing based on the concept of flexible production and intelligent equipment for some unhealthy phenomena in the development process of TCM intelligent manufacturing. In the TCM intelligent manufacturing system,with theory model as the core,the new-generation information technology was integrated with the TCM manufacturing technology to realize the integration of informationization and industrilization as well as the landing of theoretical model. Then,a 3 D simulation model was established to provide a visual environment for intelligent manufacturing of TCM and simulate the virtual reality throughout the TCM intelligent manufacturing process. The new theoretical model in this paper,to a certain extent,can play a guiding role in the development of TCM intelligent manufacturing,and can also provide reference for the realization of TCM intelligent manufacturing.


Assuntos
Indústria Farmacêutica/normas , Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Modelos Teóricos , Comércio , Controle de Qualidade
5.
AAPS PharmSciTech ; 20(8): 313, 2019 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-31529232

RESUMO

An integrated approach based on QbD and PAT provides a systematic and innovative framework for product development, manufacturing, and quality risk management. In this context, the significance of the outcome of design of experiments (DOEs) to the selection of the product design, robust commercial manufacturing process, design space, and overall control strategy remains vital for the success of a drug product throughout its life cycle. This paper aims at discussing selected recent DOE case studies conducted during QbD-based and integrated QbD/PAT-based development of solid oral formulations and process improvement studies. The main focus of this paper is to highlight the rationales and importance of design selection during development and applications of mathematical models and statistical tools in analyzing DOE and PAT data for developing a design space, control strategy, and improved process monitoring. A total of 25 case studies (includes 9 PAT application studies) have been discussed in this paper which cover 11 manufacturing processes commonly utilized for solid dosage forms. Two case studies relevant to selection of packaging design for solid dosage forms are also briefly discussed to complete the scope. Overall, for a successful modern QbD approach, it is highly important that DOEs are conducted and analyzed in a logical sequence which involves designs that are phase-appropriate and quality-driven and facilitate both statistical and chemometric thinking at each development stage. This approach can result into higher regulatory flexibility along with lower economic burden during life cycle of a product, irrespective of regulatory path used (NDA or ANDA).


Assuntos
Formas de Dosagem , Desenho de Fármacos , Indústria Farmacêutica/normas , Embalagem de Medicamentos/normas , Controle de Qualidade , Composição de Medicamentos , Indústria Farmacêutica/métodos , Embalagem de Medicamentos/métodos , Humanos
6.
BMJ ; 366: l4217, 2019 07 10.
Artigo em Inglês | MEDLINE | ID: mdl-31292127

RESUMO

OBJECTIVES: To develop and pilot a tool to measure and improve pharmaceutical companies' clinical trial data sharing policies and practices. DESIGN: Cross sectional descriptive analysis. SETTING: Large pharmaceutical companies with novel drugs approved by the US Food and Drug Administration in 2015. DATA SOURCES: Data sharing measures were adapted from 10 prominent data sharing guidelines from expert bodies and refined through a multi-stakeholder deliberative process engaging patients, industry, academics, regulators, and others. Data sharing practices and policies were assessed using data from ClinicalTrials.gov, Drugs@FDA, corporate websites, data sharing platforms and registries (eg, the Yale Open Data Access (YODA) Project and Clinical Study Data Request (CSDR)), and personal communication with drug companies. MAIN OUTCOME MEASURES: Company level, multicomponent measure of accessibility of participant level clinical trial data (eg, analysis ready dataset and metadata); drug and trial level measures of registration, results reporting, and publication; company level overall transparency rankings; and feasibility of the measures and ranking tool to improve company data sharing policies and practices. RESULTS: Only 25% of large pharmaceutical companies fully met the data sharing measure. The median company data sharing score was 63% (interquartile range 58-85%). Given feedback and a chance to improve their policies to meet this measure, three companies made amendments, raising the percentage of companies in full compliance to 33% and the median company data sharing score to 80% (73-100%). The most common reasons companies did not initially satisfy the data sharing measure were failure to share data by the specified deadline (75%) and failure to report the number and outcome of their data requests. Across new drug applications, a median of 100% (interquartile range 91-100%) of trials in patients were registered, 65% (36-96%) reported results, 45% (30-84%) were published, and 95% (69-100%) were publicly available in some form by six months after FDA drug approval. When examining results on the drug level, less than half (42%) of reviewed drugs had results for all their new drug applications trials in patients publicly available in some form by six months after FDA approval. CONCLUSIONS: It was feasible to develop a tool to measure data sharing policies and practices among large companies and have an impact in improving company practices. Among large companies, 25% made participant level trial data accessible to external investigators for new drug approvals in accordance with the current study's measures; this proportion improved to 33% after applying the ranking tool. Other measures of trial transparency were higher. Some companies, however, have substantial room for improvement on transparency and data sharing of clinical trials.


Assuntos
Ensaios Clínicos como Assunto , Indústria Farmacêutica/organização & administração , Disseminação de Informação , Estudos Transversais , Aprovação de Drogas , Indústria Farmacêutica/normas , Humanos , Projetos Piloto , Participação dos Interessados , Fatores de Tempo
9.
Bioprocess Biosyst Eng ; 42(9): 1399-1408, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31119388

RESUMO

There is a growing interest in mining and handling of big data, which has been rapidly accumulating in the repositories of bioprocess industries. Biopharmaceutical industries are no exception; the implementation of advanced process control strategies based on multivariate monitoring techniques in biopharmaceutical production gave rise to the generation of large amounts of data. Real-time measurements of critical quality and performance attributes collected during production can be highly useful to understand and model biopharmaceutical processes. Data mining can facilitate the extraction of meaningful relationships pertaining to these bioprocesses, and predict the performance of future cultures. This review evaluates the suitability of various metaheuristic methods available for data pre-processing, which would involve the handling of missing data, the visualisation of the data, and dimension reduction; and for data processing, which would focus on modelling of the data and the optimisation of these models in the context of biopharmaceutical process development. The advantages and the associated challenges of employing different methodologies in pre-processing and processing of the data are discussed. In light of these evaluations, a summary guideline is proposed for handling and analysis of the data generated in biopharmaceutical process development.


Assuntos
Produtos Biológicos , Indústria Farmacêutica , Heurística , Modelos Teóricos , Desenvolvimento de Medicamentos , Indústria Farmacêutica/métodos , Indústria Farmacêutica/organização & administração , Indústria Farmacêutica/normas , Humanos
12.
Int J Technol Assess Health Care ; 35(2): 160-167, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31017564

RESUMO

OBJECTIVES: Before an intervention is publicly funded within the United Kingdom, the cost-effectiveness is assessed by the National Institute of Health and Care Excellence (NICE). The efficacy of an intervention across the patients' lifetime is often influential of the cost-effectiveness analyses, but is associated with large uncertainties. We reviewed committee documents containing company submissions and evidence review group (ERG) reports to establish the methods used when extrapolating survival data, whether these adhered to NICE Technical Support Document (TSD) 14, and how uncertainty was addressed. METHODS: A systematic search was completed on the NHS Evidence Search webpage limited to single technology appraisals of cancer interventions published in 2017, with information obtained from the NICE Web site. RESULTS: Twenty-eight appraisals were identified, covering twenty-two interventions across eighteen diseases. Every economic model used parametric curves to model survival. All submissions used goodness-of-fit statistics and plausibility of extrapolations when selecting a parametric curve. Twenty-five submissions considered alternate parametric curves in scenario analyses. Six submissions reported including the parameters of the survival curves in the probabilistic sensitivity analysis. ERGs agreed with the company's choice of parametric curve in nine appraisals, and agreed with all major survival-related assumptions in two appraisals. CONCLUSIONS: TSD 14 on survival extrapolation was followed in all appraisals. Despite this, the choice of parametric curve remains subjective. Recent developments in Bayesian approaches to extrapolation are not implemented. More precise guidance on the selection of curves and modelling of uncertainty may reduce subjectivity, accelerating the appraisal process.


Assuntos
Indústria Farmacêutica/organização & administração , Neoplasias/mortalidade , Avaliação da Tecnologia Biomédica/organização & administração , Teorema de Bayes , Análise Custo-Benefício , Indústria Farmacêutica/normas , Humanos , Modelos Econômicos , Modelos Estatísticos , Anos de Vida Ajustados por Qualidade de Vida , Medicina Estatal , Análise de Sobrevida , Avaliação da Tecnologia Biomédica/normas , Reino Unido
14.
Int J Technol Assess Health Care ; 35(1): 10-16, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30789111

RESUMO

OBJECTIVES: Evidence requirements and assessment methods access differ between health technology assessment (HTA) agencies. The HTA Core Model® provides a standardized approach to HTA, targeting evidence sharing and collaboration between participating HTA bodies. It is fit for purpose from an industry perspective and was used by pharmaceutical company Roche to develop a framework for internal assessment of evidence required for market access and coverage/reimbursement ("access evidence"). METHODS: Tools were developed to systematically scope, assess, plan, and summarize access evidence generation. The tools were based mainly on the first four HTA Core Model® domains and rolled-out in selected development teams in 2017. Five months after full implementation, the impact of tools was assessed in an internal survey. RESULTS: Systematic access evidence generation started with the Access Evidence Questionnaire, to scope evidence requirements and identify evidence gaps. Findings were summarized in the Access Evidence Metric, which assessed the alignment of available/planned evidence against HTA bodies' requirements and developed scope mitigation strategies. The Access Evidence Plan was then used to plan and document (additional) evidence generation. Once generated, evidence was summarized in the Access Evidence Dossier. A survey of twenty-seven Roche employees involved in evidence generation showed that the tools made discussions around access strategies and evidence more efficient and transparent. CONCLUSIONS: The HTA Core Model® provided a useful framework around which to optimize internal evidence generation and assessment. The benefits of using a standardized HTA approach in industry mirror those expected from implementing the HTA Core Model® in HTA agencies.


Assuntos
Indústria Farmacêutica/organização & administração , Marketing de Serviços de Saúde/organização & administração , Preparações Farmacêuticas , Avaliação da Tecnologia Biomédica/organização & administração , Indústria Farmacêutica/normas , Europa (Continente) , Prática Clínica Baseada em Evidências , Humanos , Marketing de Serviços de Saúde/normas , Avaliação da Tecnologia Biomédica/normas , Fatores de Tempo
15.
Cad Saude Publica ; 35(2): e00041018, 2019 02 18.
Artigo em Português | MEDLINE | ID: mdl-30785486

RESUMO

This article sought to evaluate the conformity between recommendations regarding antidepressant use during breastfeeding found in drug package inserts with recommendations from science-based bibliographic sources. We evaluated the standard drug package inserts of 23 antidepressants with active registration in Brazil. The presence of contraindications of antidepressant use during breastfeeding was compared with information present in the Brazilian Ministry of Health technical manual, the book Medications and Mothers' Milk and on the databases LactMed, Micromedex and UpToDate. In most drug package inserts (62.5%), antidepressants are contraindicated during breastfeeding. Among bibliographical sources, that percentage varied between 0% and 25%. The study shows a low conformity between drug package inserts and bibliographical sources, alerting to the need for revising the content and presentation of information present in antidepressant drug package inserts in Brazil.


Assuntos
Antidepressivos/efeitos adversos , Aleitamento Materno/efeitos adversos , Indústria Farmacêutica/normas , Rotulagem de Medicamentos/normas , Medicina Baseada em Evidências , Antidepressivos/administração & dosagem , Brasil , Serviços de Informação sobre Medicamentos/normas , Monitoramento de Medicamentos , Feminino , Humanos , Lactação/metabolismo , Exposição Materna/efeitos adversos , Fatores de Risco
16.
Crit Rev Biotechnol ; 39(3): 289-305, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30724608

RESUMO

Biotherapeutics, such as those derived from monoclonal antibodies (mAbs), are industrially produced in controlled multiunit operation bioprocesses. Each unit operation contributes to the final characteristics of the bioproduct. The complexity of the bioprocesses, the cellular machinery, and the bioproduct molecules, typically leads to inherent heterogeneity and variability of the final critical quality attributes (CQAs). In order to improve process control and increase product quality assurance, online and real-time monitoring of product CQAs is most relevant. In this review, the recent advances in CQAs monitoring of biotherapeutic drugs, with emphasis on mAbs, and throughout, the different bioprocess unit operations are reviewed. Recent analytical techniques used for assessment of product-related CQAs of mAbs are considered in light of the analytical speed and ability to measure different CQAs. Furthermore, the state of art modeling approaches for CQA estimation in real-time are presented as a viable alternative for real-time bioproduct CQA monitoring under the process analytical technology and quality-by-design frameworks in the biopharmaceutical industry, which have recently been demonstrated.


Assuntos
Anticorpos Monoclonais/análise , Produtos Biológicos/normas , Indústria Farmacêutica/normas , Controle de Qualidade , Anticorpos Monoclonais/uso terapêutico , Produtos Biológicos/análise , Produtos Biológicos/uso terapêutico , Humanos
18.
AAPS J ; 21(2): 19, 2019 01 23.
Artigo em Inglês | MEDLINE | ID: mdl-30673891

RESUMO

The establishment of an in vitro-in vivo correlation (IVIVC) is considered the gold standard to establish in vivo relevance of a dissolution method and to utilize dissolution data in the context of regulatory bioequivalence questions, including the development of dissolution specifications. However, several recent publications, including industry surveys and reviews from regulatory agencies, have indicated a low success rate for IVIVCs, especially for immediate-release formulations. In recent years, the use of physiologically based pharmacokinetics (PBPK) and absorption modeling, as a tool to facilitate formulation development, has been attracting increased attention. This manuscript provides an industry perspective on the current challenges with establishing IVIVCs and the potential PBPK and absorption modeling offer to increase their impact. Case studies across both immediate-release and extended-release formulations from five pharmaceutical companies are utilized to demonstrate how physiologically based IVIVC (PB-IVIVC) may facilitate drug product understanding and to inform bioequivalence assessment and clinically relevant specifications. Finally, PB-IVIVC best practices and a strategy for model development and application are proposed.


Assuntos
Absorção Fisiológica , Produtos Biológicos/farmacocinética , Desenvolvimento de Medicamentos/normas , Indústria Farmacêutica/normas , Modelos Biológicos , Administração Oral , Produtos Biológicos/administração & dosagem , Preparações de Ação Retardada/administração & dosagem , Preparações de Ação Retardada/farmacocinética , Desenvolvimento de Medicamentos/métodos , Liberação Controlada de Fármacos , Guias como Assunto , Humanos , Solubilidade , Equivalência Terapêutica
19.
Jpn J Infect Dis ; 72(3): 133-141, 2019 May 23.
Artigo em Inglês | MEDLINE | ID: mdl-30504646

RESUMO

Biological products, such as vaccines, blood products, antitoxins, and antivenoms, are released into the market following a lot release conducted by National Regulatory Authorities or National Control Laboratories, even if their manufacturing and marketing have been authorized. Independent lot release by regulatory authorities is not a procedure unique to Japan, but is performed worldwide. Previously, Japan carried out lot release mainly by laboratory tests, and the manufacturers' in-house test records were used as a reference, not involved in the decision of lot release. Conversely, the international standard procedure promoted by the World Health Organization (WHO) includes a document review of the manufacturers' summary protocols, and laboratory tests are listed as an optional procedure. To harmonize with the WHO recommended international method, Japan modified the procedure and introduced a document review in addition to laboratory tests for vaccines in 2012. Since then, substantial knowledge regarding vaccine quality has been obtained during the process of summary protocol reviewing. Here, we outline the current status of the lot release procedure in Japan. We shed light on its history and show recent research based on the knowledge obtained from the protocol review to improve efficiency of laboratory testing and international harmonization.


Assuntos
Indústria Farmacêutica/normas , Controle de Qualidade , Vacinas/normas , Órgãos Governamentais , História do Século XX , História do Século XXI , Humanos , Imunização/história , Japão , Medição de Risco , Vacinas/história , Organização Mundial da Saúde
20.
J AOAC Int ; 102(2): 421-426, 2019 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-30157992

RESUMO

In an industry that has only recently and slowly moved out of the shadows of illegality, regulations and guidelines for cannabis product safety are just catching up to the standards of other industries. Often, our industry has had to introduce best practices and self-regulation to ensure the safety of our products and customers, as well as to help any regulating body in building such frameworks. This article will focus on how OutCo has implemented Hazard Analysis and Critical Control Point (HACCP) protocols to ensure the safety of every aspect of the production pipeline. The prevention of mold growth in drying flowers would be a classic example of food safety and is our prime example of how HACCP has informed our approach to this task. HACCP also contributed to the prevention of pesticide contamination, worker safety, and cannabis oil formulation.


Assuntos
Cannabis/química , Indústria Farmacêutica/normas , Inocuidade dos Alimentos/métodos , Indústria de Processamento de Alimentos/normas , Extratos Vegetais/química , Extratos Vegetais/normas , Plantas Medicinais/química , Humanos , Extratos Vegetais/isolamento & purificação , Controle de Qualidade
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA