临床试验
药物开发
耐受性
药物发现
重症监护医学
转化研究
疾病
临床前试验
病理
医学物理学
医学
药品
生物信息学
生物
药理学
替代医学
作者
Olivia Mekhael,Safaa Naiel,Megan Vierhout,Aaron Hayat,Spencer Revill,Soumeya Abed,Mark D. Inman,Martin Kolb,Kjetil Ask
出处
期刊:Methods in molecular biology
日期:2021-01-01
卷期号:: 291-321
被引量:8
标识
DOI:10.1007/978-1-0716-1382-5_21
摘要
The drug discovery pipeline, from discovery of therapeutic targets through preclinical and clinical development phases, to an approved product by health authorities, is a time-consuming and costly process, where a lead candidates’ success at reaching the final stage is rare. Although the time from discovery to final approval has been reduced over the last decade, there is still potential to further optimize and streamline the evaluation process of each candidate as it moves through the different development phases. In this book chapter, we describe our preclinical strategies and overall decision-making process designed to evaluate the tolerability and efficacy of therapeutic candidates suitable for patients diagnosed with fibrotic lung disease. We also describe the benefits of conducting preliminary discovery trials, to aid in the selection of suitable primary and secondary outcomes to be further evaluated and assessed in subsequent internal and external validation studies. We outline all relevant research methodologies and protocols routinely performed by our research group and hope that these strategies and protocols will be a useful guide for biomedical and translational researchers aiming to develop safe and beneficial therapies for patients with fibrotic lung disease.
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