Core D: Drug Development

核心 D：药物开发

• 批准号: 10686383
• 负责人: Heidi M. Mansour
• 金额: $ 10.93万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-10 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10686383
• 关键词: Basic Science; Biological; Biological Assay; Chemopreventive Agent; Clinic; Clinical; Clinical Distribution; Clinical Trials; Contracts; Data; Decision Making; Dermal; Development; Documentation; Drug Formulations; Ensure; Epidermis; Formulation; Funding; Generations; Human; In Vitro; Individual; Investigational New Drug Application; Laboratories; Methods; Modeling; Monitor; New Agents; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Pharmacology and Toxicology; Pharmacy (field); Prevention; Production; Property; Quality Control; Regulatory Affairs; Research Personnel; Safety; Sampling; Selection Criteria; Services; Skin; Skin Cancer; Skin Carcinoma; Solubility; Time; Topical agent; Topical application; Toxic effect; Toxicology; Translating; Translations; absorption; chemical stability; clinical development; clinical translation; drug development; efficacy evaluation; in vivo; in vivo Bioassay; lipophilicity; manufacture; novel therapeutics; pre-clinical; programs; quality assurance; research clinical testing; residence

ABSTRACT Core D (Myrdal) Drug Development The Drug Development Core will serve the individual Projects and the Program Project as a whole by providing necessary services and a unique combination of expertise in pharmacology/toxicology, pharmaceutics, manufacturing and regulatory affairs that enable the clinical translation of topical agents. This objective will be accomplished by the following Specific Aims: 1) To prepare stable formulations of promising new agents that can be safely and effectively delivered to the epidermis following topical application through a) preformulation activities, b) formulation development and c) determination of percutaneous absorption and dermal toxicity; and 2) Facilitate the translation of agents into the clinic by a) performing preclinical toxicology studies consistent with GLP practices and monitoring the stability of the formulation lots used in these studies, and b) coordinating and preparing New Drug (IND) applications for FDA approval and supervising production and distribution of clinical grade supply for human trials in Project 3. Implementation of these aims will allow Project Leaders the ability to circumvent problems with epidermal delivery which may hinder development of otherwise promising topical agents, and optimize the crucial selection criteria for advancement of new agents to clinical testing. This will greatly enhance the ability to translate basic science discoveries into new skin cancer chemopreventive drugs.

摘要 核心D（Myrdal）药物开发 药物开发核心将为单个项目和整个计划项目提供服务， 必要的服务和药理学/毒理学，制药学， 制造和法规事务，使局部药物的临床翻译。这一目标将是 1）制备有前景的新药剂的稳定制剂， 可以在局部施用后安全有效地递送至表皮 活性，B）制剂开发和c）经皮吸收和皮肤毒性的测定;和 2)通过a）进行符合以下要求的临床前毒理学研究， GLP实践和监测这些研究中使用的制剂批次的稳定性，以及B）协调和 准备新药（IND）申请FDA批准，监督临床药物的生产和分销 为项目3中的人体试验提供等级供应。这些目标的实现将使项目负责人能够 避免了表皮递送的问题，这些问题可能阻碍开发其他有前途的局部给药方法。 代理商，并优化关键的选择标准，推进新的代理商的临床试验。这将 大大提高了将基础科学发现转化为新的皮肤癌化学预防药物的能力。