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1.
BMC Health Serv Res ; 19(1): 952, 2019 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-31823758

RESUMO

BACKGROUND: Prevalence rates for herbal medicine (HM) have been increasing worldwide. However, little is known about prevalence, user characteristics, usage pattern and factors influencing HM usage for the general German population. METHODS: A nationwide online survey on HM usage was conducted in Germany. The 2906 participants were categorised into three groups: the ones who used HM in the last 12 months, the ones who did not use HM in the last 12 months but in their lifetime, and the ones who did not use HM until now. Data were analysed by descriptive statistics, Chi Square tests and binary hierarchical logistic regression analyses. RESULTS: Prevalence rates of HM were found to be very high for the general German population. Self-medication appeared as a common praxis, when at the same time HM users responded that they do not inform their physician about it, rate their knowledge about HM as somewhat poor, and use the internet as the most frequent source of information. The HM user in the last 12 months was found to include people that were more likely female, highly educated, privately insured, employed, and engaged in a more health-oriented lifestyle. While certain sociodemographic- and health-related variables influence HM usage vs. non-usage, they explain variance only to a limited extent. For distinguishing the user in the last 12 months vs. the less recent user who did not use HM in the last 12 months, ratings on different reasons for HM usage were found to perform better as predictors than sociodemographic- and health-related variables. CONCLUSIONS: This study demonstrated that HM usage plays an essential role in the German health-care system. Furthermore, the HM usage pattern may be potentially harmful for patients, as it included self-medication, little knowledge on interaction- and side-effects of HM, and a lack of communication with physicians about the usage. Moreover, prediction of HM usage in the previous year is impacted by variables beyond conventional sociodemographic- and health-related ones. In view of the high prevalence rates of HM in Germany, medical as well as health service providers should be aware of these issues.

3.
Artif Intell Med ; 100: 101706, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31607340

RESUMO

Artificial intelligence (AI) will pave the way to a new era in medicine. However, currently available AI systems do not interact with a patient, e.g., for anamnesis, and thus are only used by the physicians for predictions in diagnosis or prognosis. However, these systems are widely used, e.g., in diabetes or cancer prediction. In the current study, we developed an AI that is able to interact with a patient (virtual doctor) by using a speech recognition and speech synthesis system and thus can autonomously interact with the patient, which is particularly important for, e.g., rural areas, where the availability of primary medical care is strongly limited by low population densities. As a proof-of-concept, the system is able to predict type 2 diabetes mellitus (T2DM) based on non-invasive sensors and deep neural networks. Moreover, the system provides an easy-to-interpret probability estimation for T2DM for a given patient. Besides the development of the AI, we further analyzed the acceptance of young people for AI in healthcare to estimate the impact of such a system in the future.

4.
Arch Dis Child ; 104(12): 1167-1173, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31537552

RESUMO

BACKGROUND: Assessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety information more reliable and comparable across trials. Although standardised AE severity scales have been developed in other research fields, they are not suitable for use in neonates. The development of an AE severity scale to facilitate the conduct and interpretation of neonatal clinical trials is therefore urgently needed. METHODS: A stepwise consensus process was undertaken within the International Neonatal Consortium (INC) with input from all relevant stakeholders. The consensus process included several rounds of surveys (based on a Delphi approach), face-to-face meetings and a pilot validation. RESULTS: Neonatal AE severity was classified by five grades (mild, moderate, severe, life threatening or death). AE severity in neonates was defined by the effect of the AE on age appropriate behaviour, basal physiological functions and care changes in response to the AE. Pilot validation of the generic criteria revealed κ=0.23 and guided further refinement. This generic scale was applied to 35 typical and common neonatal AEs resulting in the INC neonatal AE severity scale (NAESS) V.1.0, which is now publicly available. DISCUSSION: The INC NAESS is an ongoing effort that will be continuously updated. Future perspectives include further validation and the development of a training module for users.

5.
BMC Complement Altern Med ; 19(1): 170, 2019 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-31291938

RESUMO

BACKGROUND: The use of herbal medicine (HM) has become an essential form of treatment and it is more and more common around the world. Little is known about the reasons that drive people to initially use HM or to maintain their behaviour, and whether the so-called "push and pull factors" known in the context of decision making for complementary and alternative medicine, also play a role for HM use. Here, our goal was to provide answers to these open questions and to analyse the reasons that motivate new, established and long-term HM consumers in detail. METHODS: Thirteen reasons for HM usage, which were previously identified within a qualitative approach, were analysed quantitatively in a nationwide online survey in Germany. Data of 2,192 German HM users from the general population were grouped into new, established and long-term users. We performed a factor analysis in order to identify factors underlying the set of reasons. RESULTS: We discovered a reliable factor associated with longstanding family traditions and cultural importance of HM in Germany. This finding shows that the reasons for HM use require a three-factor structure going beyond the well-known push and pull factors that explain the use of complementary and alternative medicine. In using the identified factors for further calculations, we were able to reveal important group differences and test how the factor scores perform as predictors for the new, established and long-term choice of HM. Our results showed that a high score on the push factor is associated more with initial HM usage, while long-term HM usage is impacted more by high scores on the pull and traditional factors. CONCLUSIONS: Our exploratory survey and analysis of the reasons that underlie HM usage aimed at providing a better understanding of the decision for this treatment form. The findings of our work deliver insights for medical practitioners and health-care providers, including the role of family traditions for HM usage and the finding that new HM users are driven to use this treatment form in part because of negative aspects they associate with conventional medicine.


Assuntos
Uso de Medicamentos , Medicina Herbária/estatística & dados numéricos , Adolescente , Adulto , Tomada de Decisões , Feminino , Alemanha , Medicina Herbária/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Motivação , Inquéritos e Questionários , Adulto Jovem
7.
BMC Complement Altern Med ; 18(1): 92, 2018 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-29544493

RESUMO

BACKGROUND: The use of herbal medicine, as one element of complementary and alternative medicine, is increasing worldwide. Little is known about the reasons for and factors associated with its use. This study derives insights for the use of herbal medicine in Germany regarding the usage aims, role played by the type of illness, reasons for preferred usage and sources of information. METHODS: Using a qualitative methodological approach, six focus groups (n = 46) were conducted. Two groups with young, middle-aged and elderly participants, respectively. After audiotaping and verbatim transcription, the data were analysed with a qualitative content analysis. RESULTS: We found that treating illnesses was the most frequently discussed aim for using herbal medicine over all age groups. Preventing illnesses and promoting health were less frequently mentioned overall, but were important for elderly people. Discussions on herbal medicine were associated with either mild/moderate diseases or using herbal medicine as a starting treatment before applying conventional medicine. In this context, participants emphasized the limits of herbal medicine for severe illnesses. Dissatisfaction with conventional treatment, past good experiences, positive aspects associated with herbal medicine, as well as family traditions were the most commonly-mentioned reasons why herbal medicine was preferred as treatment. Concerning information sources, independent reading and family traditions were found to be equally or even more important than consulting medicinal experts. CONCLUSIONS: Although herbal medicine is used mostly for treating mild to moderate illnesses and participants were aware of its limits, the combination of self-medication, non-expert consultation and missing risk awareness of herbal medicine is potentially harmful. This is particularly relevant for elderly users as, even though they appeared to be more aware of health-related issues, they generally use more medicine compared to younger ones. In light of our finding that dissatisfaction with conventional medicine was the most important reason for a preferred use of herbal medicine, government bodies, doctors, and pharmaceutical companies need to be aware of this problem and should aim to establish a certain level of awareness among users concerning this issue.


Assuntos
Fitoterapia/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapias Complementares/psicologia , Terapias Complementares/estatística & dados numéricos , Feminino , Grupos Focais , Alemanha , Medicina Herbária , Humanos , Masculino , Pessoa de Meia-Idade , Fitoterapia/psicologia , Adulto Jovem
8.
Sci Rep ; 8(1): 3584, 2018 02 26.
Artigo em Inglês | MEDLINE | ID: mdl-29483707

RESUMO

In this work we addressed the problem how to fabricate self-assembling tubular nanostructures displaying target recognition functionalities. Bacterial flagellar filaments, composed of thousands of flagellin subunits, were used as scaffolds to display single-domain antibodies (nanobodies) on their surface. As a representative example, an anti-GFP nanobody was successfully inserted into the middle part of flagellin replacing the hypervariable surface-exposed D3 domain. A novel procedure was developed to select appropriate linkers required for functional internal insertion. Linkers of various lengths and conformational properties were chosen from a linker database and they were randomly attached to both ends of an anti-GFP nanobody to facilitate insertion. Functional fusion constructs capable of forming filaments on the surface of flagellin-deficient host cells were selected by magnetic microparticles covered by target GFP molecules and appropriate linkers were identified. TEM studies revealed that short filaments of 2-900 nm were formed on the cell surface. ITC and fluorescent measurements demonstrated that the fusion protein exhibited high binding affinity towards GFP. Our approach allows the development of functionalized flagellar nanotubes against a variety of important target molecules offering potential applications in biosensorics and bio-nanotechnology.


Assuntos
Flagelina/química , Nanotecnologia/métodos , Nanotubos , Anticorpos de Domínio Único/química , Sequência de Aminoácidos , Afinidade de Anticorpos , Sítios de Ligação , Proteínas de Transporte , Endo-1,4-beta-Xilanases/química , Proteínas de Fluorescência Verde/química , Proteínas de Fusão de Membrana/química , Microscopia Eletrônica de Transmissão , Nanoestruturas/química , Oligopeptídeos/química , Plasmídeos/genética , Polimerização , Salmonella/química
9.
J Pharm Pharm Sci ; 20(1): 332-348, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29145936

RESUMO

On May 12, 2017, various issues and challenges associated with biologics were discussed during a session of the annual joint conference of Canadian Society for Pharmaceutical Sciences and Canadian Chapter of Controlled Release Society at Hyatt Regency Hotel, Montréal, QC, Canada.  An update on the Canadian regulatory guidelines for biosimilars was given, followed by viewpoints expressed by regulatory, academic and industry scientists.  Topics of discussion included: reference biologic drug, clinical considerations, immunogenicity, extrapolation and clarification of terminology, product monograph, international collaboration, switching and interchangeability, naming conventions, clinical and non-clinical evaluation, authorization of indications, statistical equivalence, the nor-switch study and biologics marketplace.


Assuntos
Medicamentos Biossimilares/farmacocinética , Medicamentos Biossimilares/normas , Canadá , Substituição de Medicamentos/normas , Humanos , Legislação de Medicamentos/normas , Guias de Prática Clínica como Assunto , Equivalência Terapêutica
10.
Clin Ther ; 39(10): 1959-1969, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28987269

RESUMO

Because the highest rates of morbidity and mortality in neonates are seen in those born at <32 weeks' gestation, this group has the most urgent need for novel therapies to improve survival and outcome. Legislative efforts in the United States and Europe have attempted to address this issue by requiring the study of drugs, biological and nutritional products, devices, and other therapies in this population through a combination of high-quality regulatory and clinical trials, quality improvement initiatives, and observational studies. Because there are relatively small numbers of very preterm neonates born each year in any 1 country or continent, and because a significant number of clinical trials are recruiting at any 1 time, a neonate may meet enrollment criteria for >1 clinical trial. Neonatal units that have the infrastructure and resources to engage in research frequently face the question of whether it is permissible to enroll a neonate in >1 trial. This article examines the pertinent scientific, ethical, regulatory, and industry issues that should be taken into account when considering enrolling neonates in multiple clinical studies.


Assuntos
Ensaios Clínicos como Assunto , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/legislação & jurisprudência , Indústria Farmacêutica/ética , Indústria Farmacêutica/legislação & jurisprudência , Humanos , Recém-Nascido , Legislação de Medicamentos , Projetos de Pesquisa
11.
J Pediatr Gastroenterol Nutr ; 64(3): 368-372, 2017 03.
Artigo em Inglês | MEDLINE | ID: mdl-27253661

RESUMO

OBJECTIVE: There is a pressing need for drug development in pediatric Crohn disease (CD). Our aim was to provide strategic approaches toward harmonization of current thinking about clinical outcome assessments (COAs) and biomarkers to facilitate drug development in pediatric CD. METHODS: Scientists from the United States Food and Drug Administration, European Medicines Agency, Health Canada, and the Pharmaceuticals and Medical Devices Agency of Japan had monthly teleconferences from January 2014 through May 2015. A literature review was conducted to assess the measurement properties of all existing COA tools and to evaluate the current landscape of biomarkers used in pediatric CD. Based on the findings of literature review, we reached the consensus on the strategic approaches for evaluating outcomes in pediatric CD trials. RESULTS: The pediatric Crohn's Disease Activity Index, Crohn's Disease Activity Index, and Harvey-Bradshaw's index were used in pediatric CD clinical studies. But they lack adequate measurement properties (validity, reliability, and ability to detect change of the treatment) that are required to support approval of products intended to treat pediatric CD. Biomarkers (ie, fecal lactoferrin, osteoprotegerin, and calprotectin) have shown some promise for their potential as noninvasive surrogate endpoints in CD. CONCLUSIONS: Lack of well-defined and reliable COAs presents a hurdle for global drug development in pediatric CD. It is essential to develop well-defined and reliable COAs that can measure meaningful clinical benefit for patients in terms of how they feel, function, and survive. Development of noninvasive biomarkers as reliable surrogate endpoints needs to be further explored.


Assuntos
Biomarcadores/metabolismo , Doença de Crohn/tratamento farmacológico , Monitoramento de Medicamentos/métodos , Fármacos Gastrointestinais/uso terapêutico , Índice de Gravidade de Doença , Criança , Ensaios Clínicos como Assunto , Doença de Crohn/diagnóstico , Doença de Crohn/metabolismo , Humanos
12.
Value Health ; 19(6): 730-733, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27712698

RESUMO

Recent legislative amendments aim to enhance the transparency of the regulatory review processes about drugs, and provide public information about Health Canada's review decisions. There is also growing recognition of the value, with respect to regulatory benefit-risk assessment, of information that could be gathered from patients-the direct users of these products. Patients can provide unique insights into practical aspects of living with their disease and its treatments-as well as gaps in treatment needs. An enhanced understanding of patients' experiences and perspectives can contribute directly to better-informed decision making about these products by regulators. Health Canada is currently exploring and examining the most effective ways to collect and consider patient input in the evaluation of therapeutic products. As part of this process, Health Canada is assessing the suitability of other existing models through environmental scans, discussions with other health authorities, and pilot projects. Lessons learned from these models can inform best practices and opportunities for patient involvement when designing a model to meet Canada's needs and context. Health Canada launched a Patient Involvement Pilot Project in 2014 to simulate how input from patients, their caregivers, health care professionals, and patient groups could be collected and incorporated in the drug submission review process. This ongoing experience and continuous learning will define better how to incorporate patient input into benefit-risk assessment and regulatory decision making throughout the life cycle of therapeutic products in Canada.


Assuntos
Tomada de Decisões , Assistência à Saúde/legislação & jurisprudência , Participação do Paciente , Canadá , Formulação de Políticas , Medicamentos sob Prescrição
13.
Mol Biotechnol ; 57(9): 814-9, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25966869

RESUMO

Flagellin, the main component of flagellar filaments, is a protein possessing polymerization ability. In this work, a novel fusion construct of xylanase A from B. subtilis and Salmonella flagellin was created which is applicable to build xylan-degrading catalytic nanorods of high stability. The FliC-XynA chimera when overexpressed in a flagellin deficient Salmonella host strain was secreted into the culture medium by the flagellum-specific export machinery allowing easy purification. Filamentous assemblies displaying high surface density of catalytic sites were produced by ammonium sulfate-induced polymerization. FliC-XynA nanorods were resistant to proteolytic degradation and preserved their enzymatic activity for a long period of time. Furnishing enzymes with self-assembling ability to build catalytic nanorods offers a promising alternative approach to enzyme immobilization onto nanostructured synthetic scaffolds.


Assuntos
Flagelina/metabolismo , Nanotubos , Xilanos/metabolismo , Bacillus subtilis/metabolismo , Salmonella/metabolismo
14.
J Clin Pharmacol ; 55 Suppl 3: S123-32, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24965228

RESUMO

Monoclonal antibodies have become mainstays of treatment for many diseases. After more than a decade on the Canadian market, a number of authorized monoclonal antibody products are facing patent expiry. Given their success, most notably in the areas of oncology and autoimmune disease, pharmaceutical and biotechnology companies are eager to produce their own biosimilar versions and have begun manufacturing and testing for a variety of monoclonal antibody products. In October of 2013, the first biosimilar monoclonal antibody products were approved by the European Medicines Agency (Remsima™ and Inflectra™). These products were authorized by Health Canada shortly after; however, while the EMA allowed for extrapolation to all of the indications held by the reference product, Health Canada limited extrapolation to a subset of the indications held by the reference product, Remicade®. The purpose of this review is to discuss the Canadian regulatory framework for the authorization of biosimilar mAbs with specific discussion around the clinical requirements for establishing (bio)-similarity and to present the principles that are used in the clinical assessment of New Drug Submissions for intended biosimilar monoclonal antibodies. Health Canada's current views regarding indication extrapolation, product interchangeability, and post-market surveillance are discussed as well.


Assuntos
Anticorpos Monoclonais , Medicamentos Biossimilares , Aprovação de Drogas , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais/farmacocinética , Anticorpos Monoclonais/farmacologia , Anticorpos Monoclonais/uso terapêutico , Medicamentos Biossimilares/efeitos adversos , Medicamentos Biossimilares/farmacocinética , Medicamentos Biossimilares/farmacologia , Medicamentos Biossimilares/uso terapêutico , Canadá , Humanos , Vigilância de Produtos Comercializados , Equivalência Terapêutica
15.
Biochim Biophys Acta ; 1843(11): 2414-23, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25068520

RESUMO

Flagella, the locomotion organelles of bacteria, extend from the cytoplasm to the cell exterior. External flagellar proteins are synthesized in the cytoplasm and exported by the flagellar type III secretion system. Soluble components of the flagellar export apparatus, FliI, FliH, and FliJ, have been implicated to carry late export substrates in complex with their cognate chaperones from the cytoplasm to the export gate. The importance of the soluble components in the delivery of the three minor late substrates FlgK, FlgL (hook-filament junction) and FliD (filament-cap) has been convincingly demonstrated, but their role in the transport of the major filament component flagellin (FliC) is still unclear. We have used continuous ATPase activity measurements and quartz crystal microbalance (QCM) studies to characterize interactions between the soluble export components and flagellin or the FliC:FliS substrate-chaperone complex. As controls, interactions between soluble export component pairs were characterized providing Kd values. FliC or FliC:FliS did not influence the ATPase activity of FliI alone or in complex with FliH and/or FliJ suggesting lack of interaction in solution. Immobilized FliI, FliH, or FliJ did not interact with FliC or FliC:FliS detected by QCM. The lack of interaction in the fluid phase between FliC or FliC:FliS and the soluble export components, in particular with the ATPase FliI, suggests that cells use different mechanisms for the export of late minor substrates, and the major substrate, FliC. It seems that the abundantly produced flagellin does not require the assistance of the soluble export components to efficiently reach the export gate.

16.
J Pediatr Gastroenterol Nutr ; 58(6): 679-83, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24866781

RESUMO

OBJECTIVES: There is a pressing need for drug development in pediatric ulcerative colitis (UC). Lack of scientific consensus on efficacy endpoints and disease outcome assessments presents a hurdle for global drug development in pediatric UC. Scientists from 4 regulatory agencies convened an International Inflammatory Bowel Disease Working Group (i-IBD Working Group) to harmonize present thinking about various aspects of drug development in pediatric UC globally. METHODS: The i-IBD Working Group was convened in 2012 by scientists from the US Food and Drug Administration, European Medicines Agency, Health Canada, and the Pharmaceuticals and Medical Devices Agency of Japan. The members of this group considered reasons for differences in their acceptance of efficacy endpoints and disease activity indices used in pediatric UC, reviewed the available literature, and developed consensus opinions regarding approaches for evaluating outcomes in pediatric UC trials. RESULTS: There is lack of harmonization in using efficacy endpoint and outcome assessments including disease activity indices to assess clinical benefit in pediatric UC trials. Many disease activity indices have been developed, but their biometric properties, such as responsiveness, reliability, and validity, have not been properly validated. Biomarkers, such as fecal calprotectin and lactoferrin, are being investigated for their potential as noninvasive surrogate endpoints in UC. CONCLUSIONS: Consensus on the efficacy endpoints, disease activity indices, and outcome assessments is needed for globalization of pediatric UC trials. The i-IBD Working Group offers several perspectives to facilitate harmonization across regions. The development of noninvasive biomarkers as reliable surrogate endpoints needs to be explored further.


Assuntos
Ensaios Clínicos como Assunto , Colite Ulcerativa/tratamento farmacológico , Projetos de Pesquisa , Canadá , Criança , Comportamento Cooperativo , Europa (Continente) , Humanos , Japão , Estados Unidos
17.
J Pediatr Gastroenterol Nutr ; 58(6): 684-8, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24866782

RESUMO

OBJECTIVES: To facilitate global drug development, the International Pediatric Inflammatory Bowel Disease Working Group (i-IBD Working Group) discussed data extrapolation, trial design, and pharmacokinetic (PK) considerations for drugs intended to treat pediatric ulcerative colitis (UC), and considered possible approaches toward harmonized drug development. METHODS: Representatives from the US Food and Drug Administration, European Medicines Agency, Health Canada, and the Pharmaceuticals and Medical Devices Agency of Japan convened monthly to explore existing regulatory approaches, reviewed the results of a literature search, and provided perspectives on pediatric UC drug development based on the available medical literature. RESULTS: Although pediatric UC, when compared with UC in adults, has a similar disease progression and response to intervention, the similarity of the exposure-response relation has not been adequately established. Consequently, clinical endpoints should be selected to optimally assess efficacy in children. The inclusion of a placebo control in pediatric trials to assure assay sensitivity may be appropriate under limited circumstances. In clinical studies, although the drug under investigation could provide possible direct benefit, placebo treatment should present no more than a minor increase over minimal risk to children with UC. CONCLUSIONS: Partial extrapolation of efficacy from informative adult studies may be appropriate. Placebo-controlled efficacy trials are scientifically and ethically appropriate for pediatric UC given appropriate patient selection and the use of early escape. Clinical studies in pediatric UC may include initial dose-finding studies and exposure-response modeling followed by an efficacy and safety study to further explore the exposure-response relation.


Assuntos
Ensaios Clínicos como Assunto , Colite Ulcerativa/tratamento farmacológico , Projetos de Pesquisa , Canadá , Criança , Comportamento Cooperativo , Relação Dose-Resposta a Droga , Europa (Continente) , Humanos , Japão , Farmacocinética , Efeito Placebo , Estados Unidos
20.
Biologicals ; 40(6): 517-27, 2012 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23084808

RESUMO

In May 2012, Health Canada and other participants held a National Summit on Subsequent Entry Biologics (SEBs). Health Canada released a guidance document in March 2010 describing policy positions and data requirements for approval of SEBs. While Health Canada and health agencies in other regulatory jurisdictions are aligned on many scientific principles related to biosimilar drugs, Health Canada's specific requirements may not be widely understood by many Canadian stakeholders. The Summit provided an opportunity for education and dialog among physicians who prescribe biologics, provincial payers, and industry on the following topics: preclinical and clinical comparability studies; manufacturing and other product differences; extrapolation of indications; substitution and interchangeability of SEBs with reference biologic drugs in clinical practice; payers' current perspective; pharmacovigilance and naming. It is anticipated that the consensus reached at this meeting will further educate Canadian healthcare professionals, provincial payers, and insurers about the appropriate use of SEBs, and may be of general interest to others internationally.


Assuntos
Produtos Biológicos , Aprovação de Drogas/legislação & jurisprudência , Canadá , Indústria Farmacêutica
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