Skip to main content Accessibility help

We use cookies to distinguish you from other users and to provide you with a better experience on our websites. Close this message to accept cookies or find out how to manage your cookie settings.

Close cookie message
×
Hostname: page-component-cd9895bd7-dk4vv Total loading time: 0 Render date: 2024-12-28T00:04:02.875Z Has data issue: false hasContentIssue false

Chapter 5 - Phase II development and the path to personalized medicine in CNS disease

Published online by Cambridge University Press:  05 July 2012

By
Douglas E. Feltner  and
Kenneth R. Evans
Edited by
Amir Kalali ,
Sheldon Preskorn ,
Joseph Kwentus  and
Stephen M. Stahl
Amir Kalali
Affiliation:
University of California, San Diego
Sheldon Preskorn
Affiliation:
University of Kansas School of Medicine
Joseph Kwentus
Affiliation:
University of Mississippi
Stephen M. Stahl
Affiliation:
University of California, San Diego
Get access

Summary

This chapter addresses general Phase II clinical development issues and pitfalls and the relationship of Phase II to the preceding and subsequent phases of development, and then focuses on the new issues introduced into Phase II development by the emergence of personalized medicine. The dosing frequency to test should be derived from preclinical data and from human biomarker evidence of the development of and recovery from tolerance to intended effect. Indication selection, matching targets to patients, can be facilitated by collecting appropriate genetic or other biological information about the proposed subject population, and assuring that the biology of the subjects is matched to the drug candidate's proposed mechanism. Biomarker technologies have proven their mettle in a number of applications, and practical methods are now available that enable the drug development process. CNS drug developers and their development plans need to adapt to incorporate the changes brought by personalized medicines.
Type
Chapter
Information
Essential CNS Drug Development , pp. 70 - 91
Publisher: Cambridge University Press
Print publication year: 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Save book to Kindle

To save this book to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×