在特定人群中预测药物代谢酶和载体活性变化的创新,机遇和挑战
Paresh P Chothe1, Vikram Arya2, Bhagwat Prasad2
1Drug Metabolism and Pharmacokinetics, Oncology Research and Development, AstraZeneca, Waltham, Massachusetts (P.P.C., D.R.); Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (V.A.); Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (B.P.); and Drug Metabolism and Pharmacokinetics, GlaxoSmithKline, R&D, Stevenage, United Kingdom (K.T.) paresh.chothe@astrazeneca.com.
药物代谢酶和载体 (DMETs) 研究的进展有助于药物开发. 然而,特定人群的有限数据阻碍了充分的潜力,需要进一步的研究和合作.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物新陈代谢 药物新陈代谢
- 药理动力学 药理动力学
背景情况:
- 药物代谢酶和载体 (DMET) 对药物的药理动力学,疗效和毒性至关重要.
- 在体外,体内和体内方法的显著进展改善了DMET作用的定量预测.
- 在特定人群 (如孕妇,儿科,老年人,患病者) 中对DMET变化的有限数据限制了临床应用.
研究的目的:
- 突出在特定人群中特征DMET活动变化的进展.
- 确定了解DMET临床影响的知识差距和挑战.
- 促进多方利益相关者的合作,以推进在不同人群中进行的DMET研究.
主要方法:
- 对DMET表征的in silico,in vitro和in vivo方法的审查.
- 对特定人群中DMET活性现有数据的分析.
- 确定研究缺口和未来方向.
主要成果:
- 在DMET函数的预测建模方面取得了进展.
- 对于特种人群和疾病状态中的DMET活性存在显著的数据缺口.
- 了解DMET的改变对于安全有效的药物治疗至关重要.
结论:
- 需要进一步的研究,以解决特定人群的DMET数据缺口.
- 药物处置的定量预测需要全面的DMET分析.
- 合作对于促进不同患者群体对DMET的理解至关重要.
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