滥用责任的每次评估都是有关分子的独特，重申了早期意识的重要性，了解当前的监管景观，并能够衡量您的开发和营销售后。
In our以前的博客文章，我们专注于早期药物滥用潜在测试的价值。在这篇博客中，我们将深入研究滥用责任测试的重要监管和市场准入考虑因素，可以帮助毒品开发人员最大限度地提高其分子的潜力。
适应最新的监管变更
尽管目前的监管指导方针，行为和计划，但没有单一的成功策略。正在进行的阿片类药物流行病和处方药的滥用引发了一个更保守的监管环境，这些监管环境总体上的滥用责任评估。
In the United States, the FDA currently has three guidelines regarding drug abuse: the 2010 draft guidance on the assessment of abuse potential of drugs, the 2015 guidance on the evaluation and labeling of abuse-deterrent opioids, and the 2016 draft guidance on abuse-deterrent formulations of generic opioids.
在全球范围内，这European Medicines Agency (EMA)/Committee for Medicinal Products for Human Use (CHMP) has also adopted guidelines, as has Health Canada. The International Conference on Harmonization (ICH) also provides guidance supporting the design of both nonclinical and clinical evaluation of abuse potential.
Sponsors developing a new molecular entity that affects the central nervous system should understand the regulatory shifts, challenges and opportunities for accurately assessing the abuse liability potential of their drug.
Open a dialogue with regulatory agencies
滥用责任测试的不断发展的指导和要求可能难以导航，但有帮助。鉴于审查和潜在的人力成本增加，这尤其重要：2014年，近200万名美国人依赖或滥用处方阿片类药物1。
The FDA has shown that it is willing to work closely with sponsors with the goal of developing more reliable nonclinical models and clinical study designs that facilitate the development of novel analgesics with lower potential of abuse. In addition, contract research organizations often help sponsors prepare for and guide these critical conversations with various regulatory agencies.
Incorporate market access perspectives
除了临床疗效和安全，利益相关者和付款人需要证据表明产品提供了令人信服的价值。在运行一套综合滥用责任研究时，考虑市场准入/报销策略也是明智的。
根据滥用责任测试的结果，产品可能需要调度受控物质法案1970年,这将决定特定的标签,record keeping/dispensing limits and face distribution restrictions – all factors that may impact market access. The earlier a sponsor begins crafting its market value story and identifying the best connection between their product and the market, the better the chance for commercial success.
在Covance，我们的专家团队旨在为客户创造全面的监管战略，并为该领域的政策讨论做出贡献。景气积极参与交叉公司滥用责任委员会在这一点College on Problems of Drug Dependency (CPDD)。学到更多关于我们的药物滥用责任专业知识和解决方案如何帮助推进您的分子。
1物质滥用和心理健康服务管理局那National Survey on Drug Use and Health那2014.
