Developing multipurpose reproductive health technologies: an integrated strategy.
Developing multipurpose reproductive health technologies: an integrated strategy.
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DOI：
10.1155/2013/790154
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发表时间：
2013
影响因子：
1.7
通讯作者：
Young Holt B
中科院分区：
文献类型：
--
作者：
Harrison PF;Hemmerling A;Romano J;Whaley KJ;Young Holt B
世界各地的妇女经常同时面临两个生殖健康挑战：需要避孕和防止性传播感染，尤其是艾滋病毒/艾滋病。虽然受孕和感染具有相同的解剖位置和传播方式，但迄今为止还没有同时解决这一现实的生殖健康技术。现有的相关技术要么是避孕的，要么是抗感染的，数量有限，需要不同的行政管理模式。因此，这些“单一适应症”技术不能完全满足与许多妇女生活中的关键事件密切相关的实质性生殖健康需求。本文回顾了开发多用途预防技术的综合尝试--“MPTS”产品，其明确设计的目的是同时满足避孕和防止性传播感染的需要。该报告描述了一项创新和迭代的MPT产品开发战略，包括以下组成部分：确定对这类技术的不同需求和生殖健康优先事项的全球变化；确定“目标产品概况”作为研究和开发“路线图”的框架；整理综合MPT流水线并确定重大流水线的特征；探索预期的监管要求；确定解决问题和资源投资的候选人的优先次序；以及实施辅助宣传议程，以支持这一广泛的努力。
Women worldwide confront two frequently concurrent reproductive health challenges: the need for contraception and for protection from sexually transmitted infections, importantly HIV/AIDS. While conception and infection share the same anatomical site and mode of transmission, there are no reproductive health technologies to date that simultaneously address that reality. Relevant available technologies are either contraceptive or anti-infective, are limited in number, and require different modes of administration and management. These “single-indication” technologies do not therefore fully respond to what is a substantial reproductive health need intimately linked to pivotal events in many women's lives. This paper reviews an integrated attempt to develop multipurpose prevention technologies—“MPTs”—products explicitly designed to simultaneously address the need for both contraception and protection from sexually transmitted infections. It describes an innovative and iterative MPT product development strategy with the following components: identifying different needs for such technologies and global variations in reproductive health priorities, defining “Target Product Profiles” as the framework for a research and development “roadmap,” collating an integrated MPT pipeline and characterizing significant pipeline gaps, exploring anticipated regulatory requirements, prioritizing candidates for problem-solving and resource investments, and implementing an ancillary advocacy agenda to support this breadth of effort.