Pediatric Pharmacology Research Unit Network

儿科药理学研究单位网络

• 批准号: 7345487
• 负责人: Laura P James
• 金额: $ 36.92万
• 依托单位: ARKANSAS CHILDREN'S HOSPITAL RES INST
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-03-21 至 2010-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7345487
• 关键词: Accounting; Adverse effects; Age; Arkansas; Asthma; Attention deficit hyperactivity disorder; Biological Availability; Caring; Characteristics; Child; Childhood; Clinical; Clinical Data; Clinical Pharmacology; Clinical Research; Code; Condition; Development; Discipline of Nursing; Disease; Dose; Drug Formulations; Drug Kinetics; Drug Labeling; Drug usage; Effectiveness; Environment; Environment Design; Enzymes; Faculty; Fellowship; Genes; Genetic Polymorphism; Genotype; Goals; Growth; Health; Health Personnel; Health Professional; Individual; Innovative Therapy; Institutes; Knowledge; Label; Lead; Legal patent; Life; Manufacturer Name; Marketing; Medical; Medical Students; Methods; Mission; Neonatal; Newborn Infant; Nursing Students; Oral; Outcome; Outcome Measure; Pediatric Hospitals; Pediatric Research; Performance; Pharmaceutical Preparations; Pharmacists; Pharmacodynamics; Pharmacogenomics; Pharmacologic Substance; Pharmacology; Pharmacology and Toxicology; Pharmacotherapy; Pharmacy Students; Phase I/II Trial; Phase III Clinical Trials; Phenotype; Physicians; Population; Population Study; Procedures; Proteomics; Protocols documentation; Provider; Purpose; Receptor Down-Regulation; Research; Research Contracts; Research Design; Research Personnel; Research Project Grants; Research Proposals; Safety; Science; Standards of Weights and Measures; Students; Therapeutic; Therapeutic Human Experimentation; Training; United States; Universities; Variant; Work; base; design; drug market; drug metabolism; experience; improved; innovation; novel; novel strategies; organizational structure; pediatric department; pediatric pharmacology; programs; quality assurance; receptor; response; tool

DESCRIPTION (provided by applicant): To improve therapeutic outcomes in children, it is necessary to conduct well-designed clinical research under the guidance of experts in a safe and ethical environment. The overall objective of clinical research in children is to develop and evaluate new treatments for pediatric diseases, disseminate the knowledge gained from the research, and encourage a culture in which this new knowledge is used to promote evidence-based medical care delivered by well-informed, competent providers. To meet this challenge, the overall objective of the proposed Pediatric Pharmacology Research Unit (PPRU) at the Arkansas Children's Hospital (ACM) is to join with other experts in pediatric clinical pharmacology to form a multi-center, collaborative network whose primary purposes are to: (1) to design, implement, and complete clinical studies of new and already marketed drugs, with the ultimate goal of expanding the drug label to include dosing and safety information specific to the pediatric population; (2) to conduct translational and clinical research designed to define the developmental characteristics of drug metabolism, elimination, and action, accounting for individual Variation based on genotype and phenotype; (3) to develop novel approaches and methods designed to improve the quality and value of the knowledge gained from therapeutic research; and (4) to train health care professionals in clinical and developmental pharmacology. To accomplish these objectives, an organizational structure supporting functional units designed to meet each of these objectives is in place. The PPRU at ACH operates under a detailed set of standard operating procedures, with quality assurance and continuous quality improvement activities, to provide a safe, ethical environment designed to protect children as they participate in critical pediatric research projects. Specific research proposals offered in this application were developed to examine significant therapeutic and safety questions arising from two common pediatric diseases, asthma and attention deficit hyperactivity disorder (ADHD). A well-defined program to educate students as well as experienced health care providers is in place. Ultimately, the primary mission of the PPRU Network, to improve pediatric therapeutics.

描述（由申请人提供）： 为了改善儿童的治疗结果，在安全和道德环境中的专家的指导下，有必要进行精心设计的临床研究。儿童临床研究的总体目标是开发和评估针对小儿疾病的新治疗方法，传播从研究中获得的知识，并鼓励一种新知识来促进良好，有能力的提供者提供的新知识。为了应对这一挑战，阿肯色州儿童医院（ACM）提议的小儿药理学研究部（PPRU）的总体目标是与小儿临床药理学的其他专家一起，以形成一个多中心，协作网络，其主要目的是：（1）涵盖新的和已培养的药物的最终范围，并涵盖了新的临床范围，并涵盖了新的临床研究，并涵盖了新的临床研究，并构成了临床的临床范围，并构成了培训的临床安全，并构成了临床的安全性。小儿人口； （2）进行旨在定义药物代谢，消除和作用的发育特征的转化和临床研究，以根据基因型和表型来解释个体变异； （3）开发旨在提高治疗研究所获得的知识质量和价值的新颖方法和方法； （4）培训临床和发育药理学的医疗保健专业人员。为了实现这些目标，建立了旨在实现这些目标的功能单元的组织结构。 ACH的PPRU在一系列详细的标准操作程序下运行，并具有质量保证和持续的质量改进活动，以提供一个安全，道德的环境，旨在保护儿童参加关键的儿科研究项目。该应用程序中提供的具体研究建议是为了检查由两种常见的儿科疾病，哮喘和注意力缺陷多动障碍（ADHD）引起的重大治疗和安全问题。一项定义明确的计划，以教育学生以及经验丰富的医疗保健提供者。最终，PPRU网络的主要任务是改善小儿治疗剂。