《Atuka：2025优化帕金森疾病治疗药物的临床前研究白皮书（英文版）（15页）.pdf》由会员分享，可在线阅读，更多相关《Atuka：2025优化帕金森疾病治疗药物的临床前研究白皮书（英文版）（15页）.pdf（15页珍藏版）》请在三个皮匠报告上搜索。

1、Optimizing Preclinical Studies for Parkinsons disease therapeuticsA strategic approach to animal model selectionBy Tom Johnston,PhD Patrick A.Howson,PhD Chief Operating Officer Chief Innovation Officer Atuka Inc.Atuka Inc.WHITE PAPEROptimizing preclinical studies for Parkinsons disease therapeuticsC

2、ontentsDesigning a high-quality preclinical package 3Selecting an appropriate animal model of Parkinsons disease 6Stage of development of therapeutic 8Indication 9Mechanism of action 9Type of therapeutic 10Pharmacokinetics and biodistribution 10Endpoints 11Partnering with Atuka 12Optimizing preclini

3、cal studies for Parkinsons disease Optimizing Preclinical Studies for Parkinsons Disease Therapeutics3A reliable,high-quality preclinical package is designed to assess the potential benefit of a new therapeutic,and minimize translational risk before it proceeds to costly and time-consuming clinical

4、trials.Its precisely in this assessment of efficacy,however,where too many preclinical studies come up short.Often,its clear that a drug has some potential value in treating a disease,but not necessarily so clear how that value can be realized.While the FDA assesses approvals for a therapeutics movi

5、ng into clinical trials on the basis of safety,toxicology,and CMC parameters,its Investigational New Drug(IND)application places less emphasis on the treatments potential clinical benefit.This means that ensuring the preclinical efficacy package is providing high-quality data that supports the propo

6、sed design of a Phase II study is the responsibility of the company developing the therapeutic.This document is a guide to the processes we use at Atuka to help our collaborators design the most impactful and robust studies for a preclinical efficacy package.While it is not possible to cover all sce