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1.
Eur Neuropsychopharmacol ; 83: 32-42, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38579661

RESUMO

Neurosciences clinical trials continue to have notoriously high failure rates. Appropriate outcomes selection in early clinical trials is key to maximizing the likelihood of identifying new treatments in psychiatry and neurology. The field lacks good standards for designing outcome strategies, therefore The Outcomes Research Group was formed to develop and promote good practices in outcome selection. This article describes the first published guidance on the standardization of the process for clinical outcomes in neuroscience. A minimal step process is defined starting as early as possible, covering key activities for evidence generation in support of content validity, patient-centricity, validity requirements and considerations for regulatory acceptance. Feedback from expert members is provided, regarding the risks of shortening the process and examples supporting the recommended process are summarized. This methodology is now available to researchers in industry, academia or clinics aiming to implement consensus-based standard practices for clinical outcome selection, contributing to maximizing the efficiency of clinical research.


Assuntos
Ensaios Clínicos como Assunto , Desenvolvimento de Medicamentos , Neurociências , Humanos , Ensaios Clínicos como Assunto/normas , Ensaios Clínicos como Assunto/métodos , Neurociências/normas , Neurociências/métodos , Desenvolvimento de Medicamentos/normas , Desenvolvimento de Medicamentos/métodos , Projetos de Pesquisa/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Avaliação de Resultados em Cuidados de Saúde/métodos , Resultado do Tratamento
2.
Biomark Med ; 18(6): 265-277, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38487948

RESUMO

Breast cancer treatments have evolved rapidly, and clinically meaningful biomarkers have been used to guide therapy. These biomarkers hold utility within the drug development process to increase the efficiency and effectiveness. To this purpose, the US FDA developed an evidentiary framework. Literature searches conducted of literature published between 2016 and 2022 identified biomarkers in breast cancer. These biomarkers were reviewed for drug development utility through the biomarker qualification evidentiary framework. In the breast cancer setting, several promising biomarkers (ctDNA, Ki-67 and PIK3CA) were identified. There is a need for increased transparency regarding the requirements for qualification of specific biomarkers and increased awareness of the processes involved in biomarker qualification.


[Box: see text].


Assuntos
Biomarcadores Tumorais , Neoplasias da Mama , Desenvolvimento de Medicamentos , Humanos , Neoplasias da Mama/metabolismo , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/diagnóstico , Biomarcadores Tumorais/metabolismo , Feminino , Desenvolvimento de Medicamentos/normas , Antineoplásicos/uso terapêutico
3.
Ther Innov Regul Sci ; 58(3): 404-414, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38324149

RESUMO

The International Council on Harmonisation E8 Guidance Revision 1 (ICH E8(R1)) calls for creating a Culture of Quality that "values and rewards critical thinking and open, proactive dialogue about what is critical to quality." Across the biopharma landscape, clinical sites, sponsors, and service providers are working to translate this far-reaching guideline into working practices. This manuscript deconstructs key elements that comprise the critical thinking and open, proactive Culture of Quality "enablers." In addition, maturity models are provided so readers can visualize what a Culture of Quality looks like in their clinical research organization. These provide examples of high performing cultures of quality and useful tools for teams or organizations to measure and evolve their respective quality cultures.


Assuntos
Pesquisa Biomédica , Humanos , Pesquisa Biomédica/normas , Cultura Organizacional , Desenvolvimento de Medicamentos/normas
4.
J Biol Chem ; 299(9): 105176, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37599003

RESUMO

Substance abuse is on the rise, and while many people may use illicit drugs mainly due to their rewarding effects, their societal impact can range from severe, as is the case for opioids, to promising, as is the case for psychedelics. Common with all these drugs' mechanisms of action are G protein-coupled receptors (GPCRs), which lie at the center of how these drugs mediate inebriation, lethality, and therapeutic effects. Opioids like fentanyl, cannabinoids like tetrahydrocannabinol, and psychedelics like lysergic acid diethylamide all directly bind to GPCRs to initiate signaling which elicits their physiological actions. We herein review recent structural studies and provide insights into the molecular mechanisms of opioids, cannabinoids, and psychedelics at their respective GPCR subtypes. We further discuss how such mechanistic insights facilitate drug discovery, either toward the development of novel therapies to combat drug abuse or toward harnessing therapeutic potential.


Assuntos
Drogas Ilícitas , Receptores Acoplados a Proteínas G , Humanos , Analgésicos Opioides/metabolismo , Analgésicos Opioides/farmacologia , Canabinoides/metabolismo , Canabinoides/farmacologia , Alucinógenos/metabolismo , Alucinógenos/farmacologia , Receptores Acoplados a Proteínas G/metabolismo , Transdução de Sinais/efeitos dos fármacos , Drogas Ilícitas/metabolismo , Drogas Ilícitas/farmacologia , Modelos Moleculares , Receptores de Serotonina/metabolismo , Desenvolvimento de Medicamentos/normas
5.
Blood Rev ; 60: 101056, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-36805300

RESUMO

Approval of new agents to treat higher risk (HR) myelodysplastic syndrome (MDS) has stalled since the approval of DNA methyltransferase inhibitors (DNMTi). In addition, the options for patients with lower risk (LR) MDS who have high transfusion needs and do not harbor ring sideroblasts or 5q- syndrome are limited. Here, we review the current treatment landscape in MDS and identify areas of unmet need, such as treatment after failure of erythropoiesis-stimulating agents or DNMTis, TP53-mutated disease, and MDS with potentially targetable mutations. We discuss how our understanding of MDS pathogenesis can inform therapy development, including treating HR-MDS similarly to AML and pursuing therapies to address splicing factor mutations and dysregulated inflammation. We then bring a critical lens to current methodology of MDS studies and propose solutions to improve the efficiency and yield of these clinical trials, including using the most meaningful response metrics and expanding enrollment.


Assuntos
Desenvolvimento de Medicamentos , Síndromes Mielodisplásicas , Síndromes Mielodisplásicas/classificação , Síndromes Mielodisplásicas/tratamento farmacológico , Síndromes Mielodisplásicas/genética , Síndromes Mielodisplásicas/fisiopatologia , Desenvolvimento de Medicamentos/normas , Desenvolvimento de Medicamentos/tendências , Mutação , Terapia de Alvo Molecular/tendências , Ensaios Clínicos como Assunto , Humanos
6.
Int J Mol Sci ; 23(15)2022 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-35955432

RESUMO

There is an urgent need for analgesics with improved efficacy, especially in neuropathic and other chronic pain conditions. Unfortunately, in recent decades, many candidate analgesics have failed in clinical phase II or III trials despite promising preclinical results. Translational assessment tools to verify engagement of pharmacological targets and actions on compartments of the nociceptive system are missing in both rodents and humans. Through the Innovative Medicines Initiative of the European Union and EFPIA, a consortium of researchers from academia and the pharmaceutical industry was established to identify and validate a set of functional biomarkers to assess drug-induced effects on nociceptive processing at peripheral, spinal and supraspinal levels using electrophysiological and functional neuroimaging techniques. Here, we report the results of a systematic literature search for pharmacological probes that allow for validation of these biomarkers. Of 26 candidate substances, only 7 met the inclusion criteria: evidence for nociceptive system modulation, tolerability, availability in oral form for human use and absence of active metabolites. Based on pharmacokinetic characteristics, three were selected for a set of crossover studies in rodents and healthy humans. All currently available probes act on more than one compartment of the nociceptive system. Once validated, biomarkers of nociceptive signal processing, combined with a pharmacometric modelling, will enable a more rational approach to selecting dose ranges and verifying target engagement. Combined with advances in classification of chronic pain conditions, these biomarkers are expected to accelerate analgesic drug development.


Assuntos
Analgésicos , Biomarcadores Farmacológicos , Desenvolvimento de Medicamentos , Analgésicos/farmacologia , Analgésicos/uso terapêutico , Dor Crônica/tratamento farmacológico , Desenvolvimento de Medicamentos/métodos , Desenvolvimento de Medicamentos/normas , Humanos , Neuralgia/tratamento farmacológico , Reprodutibilidade dos Testes , Coluna Vertebral/efeitos dos fármacos , Coluna Vertebral/inervação
9.
Drug Discov Today ; 27(1): 354-361, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34597756

RESUMO

In antibody-drug conjugates (ADCs), monoclonal antibodies (mAbs) act as carriers for a cytotoxic payload providing the therapy with targeted action against cells expressing a target cell surface antigen. An appropriate choice of mAb is crucial to developing a successful ADC for clinical development. However, problems such as immunogenicity, poor pharmacokinetic (PK) and pharmacodynamic (PD) profiles and variable drug-antibody ratios (DARs) plague ADCs. In this review, we detail recent mAb-based innovations and factors that should be considered to overcome these problems to achieve a new generation of more effective ADC therapeutics.


Assuntos
Anticorpos Monoclonais/farmacologia , Desenvolvimento de Medicamentos , Imunoconjugados/farmacologia , Neoplasias/tratamento farmacológico , Antineoplásicos Imunológicos/farmacologia , Desenvolvimento de Medicamentos/métodos , Desenvolvimento de Medicamentos/normas , Desenvolvimento de Medicamentos/tendências , Humanos , Inibidores de Checkpoint Imunológico/farmacologia , Melhoria de Qualidade
11.
Int J Toxicol ; 40(6): 551-556, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34517751

RESUMO

The main considerations for the development of a formulation for preclinical safety assessment testing are explored. Intravenous, inhalation, oral and dermal dosing are given focus and although different dose routes do present their own individual challenges there are common themes that emerge. In each case it is necessary to maximise exposure to achieve high doses to satisfy regulatory requirements for safety assessment testing. This often involves producing formulations that are at the limits of solubility and maximum volumes possible for administration to different test species by the chosen route. It is concluded that for all routes it is important to thoroughly explore the stability of the test item in the proposed formulation matrix well ahead of dosing any animals, giving careful consideration to which excipients are used and what their underlying toxicity profile may be for the relevant preclinical species. In addition, determining the maximum achievable concentrations and weighing that against the maximum volumes that can be given by the chosen route in all the test species at an early stage will also give a read on whether it would be theoretically possible to achieve suitably high enough doses to support clinical work. Not doing so can cause delays in the development programme and may have ethical repercussions.


Assuntos
Composição de Medicamentos/normas , Desenvolvimento de Medicamentos/normas , Avaliação Pré-Clínica de Medicamentos/estatística & dados numéricos , Avaliação Pré-Clínica de Medicamentos/normas , Guias como Assunto , Preparações Farmacêuticas/normas , Testes de Toxicidade/normas , Composição de Medicamentos/estatística & dados numéricos , Desenvolvimento de Medicamentos/estatística & dados numéricos , Humanos , Testes de Toxicidade/estatística & dados numéricos
12.
Pharmaceut Med ; 35(4): 197-202, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34224113

RESUMO

The medical affairs function represents one of the scientific interfaces in a pharmaceutical organization. Over the last two decades, medical affairs has evolved from being a support function to a strategic pillar within organizational business units. The COVID-19 pandemic has given rise to unforeseen circumstances resulting in a dramatic change in external stakeholder engagements, catapulting the medical affairs function into leading the way on scientific engagements and patient-centric endeavors. The changes in stakeholder interactions and behavior as a result of the pandemic last year are likely to persist in the foreseeable future for which medical affairs professionals need to enhance existing skill sets and acquire expertise in newer domains. In this paper, the transformation of the medical affairs team to a key strategic partner and the skills required to strengthen this transition, in the next normal of a post-COVID world, is explored.


Assuntos
COVID-19/prevenção & controle , Desenvolvimento de Medicamentos/tendências , Indústria Farmacêutica/tendências , Participação dos Interessados , COVID-19/epidemiologia , Controle de Doenças Transmissíveis/normas , Desenvolvimento de Medicamentos/organização & administração , Desenvolvimento de Medicamentos/normas , Indústria Farmacêutica/organização & administração , Indústria Farmacêutica/normas , Acessibilidade aos Serviços de Saúde/normas , Humanos , Índia , Pandemias/prevenção & controle
13.
Int J Mol Sci ; 22(12)2021 Jun 20.
Artigo em Inglês | MEDLINE | ID: mdl-34202954

RESUMO

Backgroud: The prediction of drug-target interactions (DTIs) is of great significance in drug development. It is time-consuming and expensive in traditional experimental methods. Machine learning can reduce the cost of prediction and is limited by the characteristics of imbalanced datasets and problems of essential feature selection. METHODS: The prediction method based on the Ensemble model of Multiple Feature Pairs (Ensemble-MFP) is introduced. Firstly, three negative sets are generated according to the Euclidean distance of three feature pairs. Then, the negative samples of the validation set/test set are randomly selected from the union set of the three negative sets in the validation set/test set. At the same time, the ensemble model with weight is optimized and applied to the test set. RESULTS: The area under the receiver operating characteristic curve (area under ROC, AUC) in three out of four sub-datasets in gold standard datasets was more than 94.0% in the prediction of new drugs. The effectiveness of the proposed method is also shown with the comparison of state-of-the-art methods and demonstration of predicted drug-target pairs. CONCLUSION: The Ensemble-MFP can weigh the existing feature pairs and has a good prediction effect for general prediction on new drugs.


Assuntos
Algoritmos , Desenvolvimento de Medicamentos/métodos , Modelos Teóricos , Área Sob a Curva , Desenvolvimento de Medicamentos/normas , Aprendizado de Máquina , Reprodutibilidade dos Testes , Máquina de Vetores de Suporte
14.
Lancet Psychiatry ; 8(11): 1013-1016, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34087114

RESUMO

Deciding on the smallest change in an outcome that constitutes a clinically meaningful treatment effect (ie, the minimum clinically important difference [MCID]) is fundamental to interpreting clinical trial outcomes, making clinical decisions, and designing studies with sufficient statistical power to detect any such effect. There is no consensus on MCIDs for outcomes in Alzheimer's disease trials, but the US Food and Drug Administration's consideration of aducanumab clinical trials data has exposed the uncertainty of the clinical meaning of statistically significant but small improvements. Although MCIDs for outcomes, including Clinical Dementia Rating-Sum of Boxes and Mini-Mental State Examination in Alzheimer's disease have been reported, the Food and Drug Administration's guidelines, drafted in 1989 to facilitate regulatory approval of substantially effective antidementia drugs, do not specify quantified minimum differences. Although it is important that regulatory requirements encourage drug development and approval, without MCIDs, sponsors are motivated to power trials to detect statistical significance for only small and potentially inconsequential effects on clinical outcomes. MCIDs benefit patients, family members, caregivers, and health-care systems and should be incorporated into clinical trials and drug development guidance for Alzheimer's disease.


Assuntos
Doença de Alzheimer/tratamento farmacológico , Cuidadores/estatística & dados numéricos , Tomada de Decisão Clínica/ética , Atenção à Saúde/estatística & dados numéricos , Desenvolvimento de Medicamentos/normas , Doença de Alzheimer/diagnóstico , Anticorpos Monoclonais Humanizados/uso terapêutico , Ensaios Clínicos como Assunto , Desenvolvimento de Medicamentos/estatística & dados numéricos , Família/psicologia , Guias como Assunto , Humanos , Testes de Estado Mental e Demência/estatística & dados numéricos , Diferença Mínima Clinicamente Importante , Avaliação de Resultados em Cuidados de Saúde , Estados Unidos , United States Food and Drug Administration/organização & administração
15.
J Prev Alzheimers Dis ; 8(3): 306-312, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34101788

RESUMO

A diverse range of platforms has been established to increase the efficiency and speed of clinical trials for Alzheimer's disease (AD). These platforms enable parallel assessment of multiple therapeutics, treatment regimens, or participant groups; use uniform protocols and outcome measures; and may allow treatment arms to be added or dropped based on interim analyses of outcomes. The EU/US CTAD Task Force discussed the lessons learned from the Dominantly Inherited Alzheimer's Network Trials Unit (DIAN-TU) platform trial and the challenges addressed by other platform trials that have launched or are in the planning stages. The landscape of clinical trial platforms in the AD space includes those testing experimental therapies such as DIAN-TU, platforms designed to test multidomain interventions, and those designed to streamline trial recruitment by building trial-ready cohorts. The heterogeneity of the AD patient population, AD drugs, treatment regimens, and analytical methods complicates the design and execution of platform trials, yet Task Force members concluded that platform trials are essential to advance the search for effective AD treatments, including combination therapies.


Assuntos
Comitês Consultivos , Doença de Alzheimer , Anticorpos Monoclonais Humanizados/uso terapêutico , Desenvolvimento de Medicamentos/normas , Projetos de Pesquisa , Doença de Alzheimer/tratamento farmacológico , Doença de Alzheimer/genética , Peptídeos beta-Amiloides , Doenças Assintomáticas , Biomarcadores , Humanos , Avaliação de Resultados em Cuidados de Saúde , Proteínas tau
16.
Med Sci (Paris) ; 37(8-9): 759-772, 2021.
Artigo em Francês | MEDLINE | ID: mdl-34080537

RESUMO

A vaccine is required to effectively control the COVID-19 pandemic in the mid and long term. The development of vaccines against SARS-CoV-2 was initiated as soon as the genetic sequence of the virus was published, and has evolved at an unprecedented speed, with a first clinical trial launched in March 2020. One year later, more than a dozen of vaccines based on different concepts, with some having been evaluated only in clinical trials so far, are authorized under emergency procedures. Here, we review these vaccines, compare their properties and discuss the challenges they face, including the emergence of viral variants of concern.


TITLE: COVID-19, des vaccins à la vitesse de l'éclair. ABSTRACT: Un vaccin est nécessaire pour endiguer efficacement, à moyen et long terme, une pandémie comme celle de la COVID-19 (coronavirus disease 2019). Le développement de vaccins contre le virus responsable de la maladie, le SARS-CoV-2 (severe acute respiratory syndrome-coronavirus 2), a été débuté dès la publication de la séquence du génome viral. Ce développement a progressé à une vitesse sans précédent, avec un premier essai clinique réalisé peu de temps après, en mars 2020. Un an plus tard, une dizaine de vaccins reposant sur des concepts différents, dont certains n'avaient été testés que dans des essais cliniques, sont autorisés dans le cadre de procédures d'urgence. Dans cet article, nous passons en revue ces différents vaccins, nous comparons leurs propriétés et nous discutons les défis auxquels ils sont confrontés, en particulier l'émergence de nouveaux variants viraux.


Assuntos
Vacinas contra COVID-19/uso terapêutico , COVID-19/prevenção & controle , Desenvolvimento de Medicamentos , SARS-CoV-2/imunologia , Aceleração , Pesquisa Biomédica/métodos , Pesquisa Biomédica/tendências , COVID-19/epidemiologia , Desenvolvimento de Medicamentos/métodos , Desenvolvimento de Medicamentos/organização & administração , Desenvolvimento de Medicamentos/normas , Emergências , História do Século XXI , Humanos , Pandemias/prevenção & controle , Saúde Pública/métodos , Saúde Pública/tendências , Vacinação/métodos , Vacinação/estatística & dados numéricos
17.
J Clin Pharmacol ; 61 Suppl 1: S22-S27, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-34185894

RESUMO

Getting the right dose regimen for children and adolescents is important but poses great scientific, practical, and ethical challenges. At the same time, the availability of data in adults is a huge advantage and needs to be used optimally when designing studies in children and analyzing pediatric data. Furthermore, the processes of maturation and growth are always key when selecting doses for children. All the above make study adaptations and model-informed approaches imperative for dose exposure-response characterization and dose selection in children. This article summarizes the experience gained in the European Medicines Agency on this topic and proposes some general guiding principles for defining objectives, study designs, and methodology tools for pediatric dose selection.


Assuntos
Ensaios Clínicos como Assunto/organização & administração , Desenvolvimento de Medicamentos/organização & administração , Pediatria/organização & administração , Medicamentos sob Prescrição/administração & dosagem , Criança , Pré-Escolar , Ensaios Clínicos como Assunto/normas , Relação Dose-Resposta a Droga , Desenvolvimento de Medicamentos/normas , Cálculos da Dosagem de Medicamento , Europa (Continente) , Humanos , Lactente , Recém-Nascido , Modelos Biológicos , Pediatria/normas
18.
J Clin Pharmacol ; 61 Suppl 1: S52-S59, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-34185897

RESUMO

One of the biggest challenges in pediatric drug development is defining a safe and effective dose in pediatric populations, which span across a wide age and development range from neonates to adolescents. Model-informed drug development approaches are particularly suited to address knowledge gaps including data leveraging to increase the success of pediatric studies. Considering the often limited number of patients available for study and logistic difficulties to collect the necessary data in pediatric populations, the application of pharmacometrics and modeling and simulation techniques can improve clinical trial efficiency, increase the probability of regulatory success, and optimize therapeutic individualization in support of dedicated trials. This review describes the state of pediatric model-informed drug development to define the right dose for children and provides suggestions for future development.


Assuntos
Desenvolvimento de Medicamentos/organização & administração , Modelos Biológicos , Pediatria/organização & administração , Medicamentos sob Prescrição/administração & dosagem , Criança , Simulação por Computador , Desenvolvimento de Medicamentos/normas , Europa (Continente) , Humanos , Pediatria/normas
19.
J Clin Pharmacol ; 61 Suppl 1: S28-S35, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-34185898

RESUMO

Dosing is a critical aspect of drug development in pediatrics that has led to trial failures and the inability to label the drug for pediatric use by the US Food and Drug Administration. Developing a structured approach for pediatric dose selection requires knowledge of the current approaches and their success or failure. This study describes the current experience with pediatric dosing methods from 2012 to 2020 and had 2 primary objectives: (1) to identify how the initial pediatric dose was selected and (2) to identify the pivotal dosing strategy used to identify the initially selected dose for safety and efficacy for pediatric clinical trials. Through September 2020, a total of 275 pediatric drug development programs were characterized for initial and pivotal dosing strategies. The success rate for labeling for pediatric use was 76.4%. The most common initial dosing strategy was previous experience with the product, followed by allometric scaling and exposure matching with adults. The most common pivotal dosing strategy was titration to target response in 33% of programs, with the second and third most common being pharmacokinetic/pharmacodynamic studies (30%) and exposure matching (20%), respectively. Additionally, about one-half of pediatric programs incorporated model-informed drug development. The emergence of titration to target response may signal a shift toward precision medicine in pediatric patients. Future work in pediatric drug dose selection should move toward the development of a structured pediatric dose selection approach.


Assuntos
Desenvolvimento de Medicamentos/organização & administração , Modelos Biológicos , Pediatria/organização & administração , Medicamentos sob Prescrição/administração & dosagem , United States Food and Drug Administration/estatística & dados numéricos , Animais , Criança , Simulação por Computador , Modelos Animais de Doenças , Relação Dose-Resposta a Droga , Desenvolvimento de Medicamentos/normas , Cálculos da Dosagem de Medicamento , Rotulagem de Medicamentos , Humanos , Pediatria/normas , Medicamentos sob Prescrição/farmacocinética , Estados Unidos
20.
J Clin Pharmacol ; 61 Suppl 1: S36-S51, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-34185896

RESUMO

Precision dosing is progressing beyond the conceptual and proof-of-concept stages toward implementation. As the availability of dosing algorithms, tools, and platforms increases, so do the investment in technology services and actual implementation of clinical services offering these solutions to patients. Nowhere is this needed more than in pediatric populations, which are still reliant on adult drug development and bridging strategies to support dosing, often in the absence of actual dose-finding studies in the target pediatric population. Still, there is more work to be done to ensure that proper governance of these services is maintained, and that sustainability of these early implementations is guided by new science as it evolves and meaningful outcome data to confirm that such services deliver on both clinical and economic return on investment. In addition, the field should ensure that all approaches beyond a therapeutic drug monitoring-driven, pharmacokinetic-centric approach should be considered as the tools and services evolve, especially when pediatric-specific pharmacokinetic/pharmacodyamic and pharmacogenetic data are available and shown to be useful to guide dosing. This review evaluates current pediatric precision dosing efforts, highlighting their utility, longevity, and sustainability and assesses the current process for implementing such approaches examining current barriers that stand in the way of broader implementation and the stakeholders that must engage to ensure its ultimate success.


Assuntos
Desenvolvimento de Medicamentos/organização & administração , Modelos Biológicos , Pediatria/organização & administração , Medicina de Precisão/métodos , Medicamentos sob Prescrição/administração & dosagem , Criança , Relação Dose-Resposta a Droga , Desenvolvimento de Medicamentos/normas , Monitoramento de Medicamentos/métodos , Humanos , Pediatria/normas , Testes Farmacogenômicos/métodos , Medicina de Precisão/normas , Medicamentos sob Prescrição/farmacocinética
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