Core D: Drug Development
核心 D:药物开发
基本信息
- 批准号:10475155
- 负责人:
- 金额:$ 10.47万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:Basic ScienceBiologicalBiological AssayChemopreventive AgentClinicClinicalClinical DistributionClinical TrialsContractsDataDecision MakingDermalDevelopmentDocumentationDrug FormulationsEnsureEpidermisFormulationFundingGenerationsHumanIn VitroIndividualInvestigational New Drug ApplicationLaboratoriesMethodsModelingMonitorNew AgentsPharmaceutical PreparationsPharmacologic SubstancePharmacology and ToxicologyPharmacy (field)PreventionProductionPropertyQuality ControlRegulatory AffairsResearch PersonnelSafetySamplingSelection CriteriaServicesSkinSkin CancerSkin CarcinomaSolubilitySupervisionTimeTopical agentTopical applicationToxic effectToxicologyTranslatingTranslationsabsorptionchemical stabilityclinical developmentclinical translationdrug developmentefficacy evaluationin vivoin vivo Bioassaylipophilicitynovel therapeuticspre-clinicalprogramsquality assuranceresearch clinical testingresidence
项目摘要
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(桃金娘)药物开发
药物开发核心将为个别项目和整个计划项目提供服务
必要的服务和独特的药理学/毒理学、药剂学、
制造和监管事务,使局部药物的临床翻译成为可能。这一目标将是
通过以下具体目标实现:1)制备有希望的新制剂的稳定配方,
可在局部使用后通过预配方安全有效地输送到表皮
活性,b)制剂开发和c)经皮吸收和皮肤毒性的测定;以及
2)通过a)进行符合以下条件的临床前毒理学研究,促进药物进入临床
GLP实践和监测这些研究中使用的配方批次的稳定性,以及b)协调和
准备新药(IND)申请供FDA批准,并监督临床药物的生产和销售
项目3中人体试验的等级供应。这些目标的实现将使项目负责人有能力
避免表皮给药的问题,这可能会阻碍其他有希望的局部药物的开发
药物,并优化关键的选择标准,以推动新药物进入临床试验。这将是
大大提高将基础科学发现转化为新的皮肤癌化学预防药物的能力。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Heidi M. Mansour其他文献
Survival in Patients with Advanced Non-cystic Fibrosis Bronchiectasis Versus Cystic Fibrosis on the Waitlist for Lung Transplantation
肺移植候补名单上的晚期非囊性纤维化支气管扩张患者与囊性纤维化患者的生存率
- DOI:
10.1007/s00408-015-9811-x - 发表时间:
2015 - 期刊:
- 影响因子:5
- 作者:
D. Hayes;B. Kopp;J. Tobias;F. Woodley;Heidi M. Mansour;D. Tumin;S. Kirkby - 通讯作者:
S. Kirkby
Biocompatible biodegradable polymeric nanocarriers in dry powder inhalers (DPIs) for pulmonary inhalation delivery
- DOI:
10.1007/s40005-024-00671-0 - 发表时间:
2024-02-08 - 期刊:
- 影响因子:5.100
- 作者:
David Encinas-Basurto;Basanth Babu Eedara;Heidi M. Mansour - 通讯作者:
Heidi M. Mansour
Induction immunosuppression for combined heart–lung transplantation
诱导免疫抑制联合心肺移植
- DOI:
- 发表时间:
2016 - 期刊:
- 影响因子:2.1
- 作者:
D. Hayes;P. McConnell;A. Yates;J. Tobias;M. Galantowicz;Heidi M. Mansour;D. Tumin - 通讯作者:
D. Tumin
Raman characterization and chemical imaging of biocolloidal self-assemblies, drug delivery systems, and pulmonary inhalation aerosols: A review
- DOI:
10.1208/pt0804099 - 发表时间:
2007-10-01 - 期刊:
- 影响因子:4.000
- 作者:
Heidi M. Mansour;Anthony J. Hickey - 通讯作者:
Anthony J. Hickey
Reduction of lipid‐laden macrophage index after laparoscopic Nissen fundoplication in cystic fibrosis patients after lung transplantation
肺移植后囊性纤维化患者腹腔镜尼森胃底折叠术后载脂巨噬细胞指数降低
- DOI:
10.1111/ctr.12020 - 发表时间:
2013 - 期刊:
- 影响因子:2.1
- 作者:
D. Hayes;S. Kirkby;Karen S McCoy;Heidi M. Mansour;M. Khosravi;H. Strawbridge;J. Tobias - 通讯作者:
J. Tobias
Heidi M. Mansour的其他文献
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