Determination of Dosing Concentrations of Formulated APIs using the MTSA

使用 MTSA 确定配方 API 的剂量浓度

基本信息

  • 批准号:
    8404125
  • 负责人:
  • 金额:
    $ 33.75万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2012
  • 资助国家:
    美国
  • 起止时间:
    2012-06-22 至 2017-05-31
  • 项目状态:
    已结题

项目摘要

PROJECT SUMMARY (See instructions): In vitro assays used to evaluate the ability of a microbicide to prevent HIV transmission typically utilize models more relevant to the development of anti-HIV therapeutic agents and quantify virus production at short time intervals following infection (3-6 days) using insensitive methodology. To mitigate the shortcomings of these critical biological assays, we have developed a microbicide transmission and sterilization assay (MTSA) to more sensitively and quantitatively evaluate virus transmission in cell culture in the presence of microbicidal compounds. The MTSA defines the concentration of the microbicide required to totally suppress the transmission, replication, and spread of virus in cell culture and may thus help define the effective concentration of the microbicide required to be present in target cells upon delivery in a formulated microbicide product. In light of the difficulty of quantifying the dose of a microbicide product that is required for the delivery of an effective product, it is important to understand how in vitro methodology, complemented with appropriate ex vivo and in vivo pharmacokinetic and pharmacodynamics evaluations, might inform the development process and serve to better define appropriate dosing strategies. Among microbicide developers, the dosing problem is now addressed through the philosophy of
项目概述(见说明):

项目成果

期刊论文数量(0)
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Robert Walter Buckheit其他文献

Robert Walter Buckheit的其他文献

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{{ truncateString('Robert Walter Buckheit', 18)}}的其他基金

Critical Path IND-enabling Studies, Regulatory, and Product Development
关键路径 IND 支持研究、监管和产品开发
  • 批准号:
    8405106
  • 财政年份:
    2012
  • 资助金额:
    $ 33.75万
  • 项目类别:
Development and Evaluation of Dual Compartment Combination Microbicides
双室组合杀菌剂的开发与评价
  • 批准号:
    8699496
  • 财政年份:
    2012
  • 资助金额:
    $ 33.75万
  • 项目类别:
Development and Evaluation of Dual Compartment Combination Microbicides
双室组合杀菌剂的开发与评价
  • 批准号:
    8862358
  • 财政年份:
    2012
  • 资助金额:
    $ 33.75万
  • 项目类别:
Administrative
行政的
  • 批准号:
    8405107
  • 财政年份:
    2012
  • 资助金额:
    $ 33.75万
  • 项目类别:
Development and Evaluation of Dual Compartment Combination Microbicides
双室组合杀菌剂的开发与评价
  • 批准号:
    8374028
  • 财政年份:
    2012
  • 资助金额:
    $ 33.75万
  • 项目类别:
Development and Evaluation of Dual Compartment Combination Microbicides
双室组合杀菌剂的开发与评价
  • 批准号:
    8494567
  • 财政年份:
    2012
  • 资助金额:
    $ 33.75万
  • 项目类别:
Development and Evaluation of Dual Compartment Combination Microbicides
双室组合杀菌剂的开发与评价
  • 批准号:
    9060880
  • 财政年份:
    2012
  • 资助金额:
    $ 33.75万
  • 项目类别:
Advanced Preclinical and Clinical Development and Regulatory Evaluations
先进的临床前和临床开发以及监管评估
  • 批准号:
    8132428
  • 财政年份:
    2010
  • 资助金额:
    $ 33.75万
  • 项目类别:
Discovery of drugs for use in the treatment and prevention of HIV infection using
发现用于治疗和预防 HIV 感染的药物
  • 批准号:
    7932473
  • 财政年份:
    2010
  • 资助金额:
    $ 33.75万
  • 项目类别:
Development of Antimicrobial Peptides as Topical Microbicides
抗菌肽作为局部杀菌剂的开发
  • 批准号:
    8092553
  • 财政年份:
    2010
  • 资助金额:
    $ 33.75万
  • 项目类别:

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