Core C - Pharmacokinetics

核心 C - 药代动力学

基本信息

批准号：
9089933
负责人：
PETER L. ANDERSON
金额：
$ 36.78万
依托单位：
MAGEE-WOMEN'S RES INST AND FOUNDATION
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/9089933
关键词：
AIDS prevention Address Anti-Retroviral Agents Antiviral Agents Binding Proteins Biological Biological Assay Blood Cervical Cervix Uteri Characteristics Clinical Research Clinical Trials Clinical Trials Design Coitus Collaborations Colorado Concentration measurement Data Data Analyses Development Devices Drug Kinetics Ensure Evaluation Film Formulation Future Gel Genital system Glycine decarboxylase Goals Human Human Volunteers In Vitro Laboratories Link Liquid substance Macaca Measurement Methods Modeling Outcome Pharmaceutical Preparations Pharmacodynamics Pharmacology Principal Investigator Procedures Process Property Role Sampling Site Techniques Time Tissues Topical application Update Vagina Viral Virus Woman Work base cost effective data modeling dosage drug development experience in vivo microbicide nonhuman primate pharmacodynamic model pharmacokinetic characteristic pharmacokinetic model phase 1 study programs reproductive tract research study sample collection scaffold simulation vaginal fluid vaginal microbicide

项目摘要

CORE C ABSTRACT The role of the Pharmacokinetics (PK) Core is to assay MK-2048 concentrations in blood, vaginal fluids, and genital tissues in collaboration with Projects 2-4 and Core B; and to develop a pharmacologic model encompassing in vitro, ex vivo, and in vivo data, all in an effort to support development of MK-2048 as an on - demand, coitally independent vaginal film. In this program, the PK Core is responsible for ensuring that the drug concentrations and data modeling approaches are valid and reproducible, so that drug development decisions are well-founded. Thus, the aims of the PK core are devoted to drug concentration quality and data modeling. The PK core will define variability arising from sampling procedures for vaginal fluid and cervical/vaginal tissue and will develop a physiogically-based PK model scaffold that could be generally applicable to topical drug application in the vagina and cervix. This model can be adapted for other topical drug administration modes such as gel, ring, or IUD, which would provide the basis for exploration of whether sufficient drug concentrations are achieved in the vaginal compartment for virtually any drug agent administered intra-vaginally. These efforts will support the goals of this application and advance the microbicide field by furthering the advancement of an on-demand product which could provide protection for seven days after a single application.

核心C摘要药代动力学（PK）核心的作用是在血液，阴道液和生殖组织与项目2-4和核心B合作；并开发药理学模型涵盖体外，体内和体内数据，所有这些都是为了支持MK -2048的开发作为ON- 需求，独立的阴道膜。在此程序中，PK核心负责确保药物浓度和数据建模方法是有效且可再现的，因此药物开发决策有充分的基础。因此，PK核的目的致力于药物浓度质量和数据造型。 PK核将定义由阴道液的抽样程序引起的可变性，宫颈/阴道组织，并将开发出基于物理的PK模型支架，通常可以是适用于阴道和子宫颈中局部药物施用。该模型可以适用于其他局部药物凝胶，环或宫内节育器等管理模式，这将为探索是否是否几乎任何药物的阴道室中都可以实现足够的药物浓度静脉内给药。这些努力将支持该应用程序的目标，并促进通过促进按需产品的进步，可以为保护提供保护一次申请后的七天。