新方法方法:临床药学家应该为什么做好准备
Yanguang Cao1, William Polacheck2
1Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
临床药理学家是实施药物开发新方法的关键. 他们的合作有助于减少早期药物研究中的动物试验.
科学领域:
- 药理学
- 毒理学
- 药物开发
背景情况:
- 新方法 (NAM) 对于监管提交越来越重要.
- 越来越需要减少临床前研究中的动物试验.
研究的目的:
- 突出临床药理学家在采用NAM中的关键作用.
- 强调NAM在研究新药 (IND) 应用中减少动物使用的潜力.
主要方法:
- 临床药理学家和临床前/翻译团队之间的合作.
- 开发,量化和实施国家管理机制.
- 在药物开发管道中整合NAM.
主要成果:
- 临床药理学家可以促进NAM的成功整合.
- 有效实施NAM可以显著减少动物使用.
- 通过强大的方法来改善药物开发的早期数据.
结论:
- 临床药理学家对于推进药物开发中的NAM至关重要.
- 临床药理学家的专业知识对于NAM的监管接受至关重要.
- 在临床药理学家的支持下, NAM 的采用有望实现更为道德和高效的药物开发.
更多相关视频
08:20Systematic Approach to Identify Novel Antimicrobial and Antibiofilm Molecules from Plants' Extracts and Fractions to Prevent Dental Caries
Published on: March 31, 2021
08:59An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
Published on: December 3, 2020
相关概念视频
Preclinical Development: Overview
Clinical Trials: Overview
Drug Administration and Therapy Phases: Overview
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Model Approaches for Pharmacokinetic Data: Physiological Models
Drug Discovery: Overview
Model-Independent Approaches for Pharmacokinetic Data: Noncompartmental Analysis
One important characteristic of noncompartmental analyses is that drug exposure increases proportionally with increasing doses. This...
