Open Advanced Search

Log in
Enterprise Plans
Free Trial

Log in
Free Trial
Enterprise Plans
Browse
Features
Pricing

DeepDyve

Advanced Search

show/hide query preview

With all of the words or DOIs:

DeepDyve's default query mode: search by keyword or DOI.

With the exact phrase:

Require these words, in this exact order. Do not surround your terms in double-quotes ("") in this field.

With at least one of the words:

Find any of these words, separated by spaces

Without the words:

Exclude each of these words, separated by spaces

With words in the article title:

Search for these terms only in the title of an article

Published between the years:

With the following authors:

Most effective as: LastName, First Name or Lastname, FN

With words in the journal name:

Search for articles published in journals where these words are in the journal name

Reset filters

Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

DeepDyve requires Javascript to function. Please enable Javascript on your browser to continue.

Dose Finding in Drug Development

Part of the Statistics for Biology and Health Book Series

Editors: Ting, Naitee

DOI: 10.1007/0-387-33706-7

ISBN: 978-0-387-29074-4

Publisher: Springer New York - Springer Journals

Jan 1, 2006

1 - 10 of 14 Chapters

Available

Introduction and New Drug Development Process

Ting, Naitee

Pages: 1 –17

[The fundamental objective of drug development is to find a dose, or dose range, of a drug candidate that is both efficacious (for improving or curing the intended disease condition) and safe (with acceptable risk of adverse effects). If such a dose range cannot be identified, the candidate would...
Available

Dose Finding Based on Preclinical Studies

Salsburg, David

Pages: 18 –29

[Before it can ever become a new drug, the candidate starts as a small molecule generated through a synthetic process or as a protein or antibody purified from a cell culture or from a modified animal or egg. There is often some biological theory that supports the creation of this candidate. It...
Available

Dose-Finding Studies in Phase I and Estimation of Maximally Tolerated Dose

Modi, Marlene

Pages: 30 –48

[Historically, drugs have been marketed at excessive doses (i.e., doses well onto the plateau of the efficacy dose–response relationship) with some patients experiencing adverse events (AEs) unnecessarily (Herxheimer, 1991; ICH-E4, 1994). Over the last 5 years, a greater effort has been made to...
Available

Dose-Finding in Oncology—Nonparametric Methods

Ivanova, Anastasia

Pages: 49 –58

[Phase I trials in oncology are conducted to obtain information on dose–toxicity relationship. Preclinical studies in animals define a dose with approximately 10% mortality (the murine LD10). One-tenth or two-tenths of the murine equivalent of LD10, expressed in milligrams per meters squared, is...
Available

Dose Finding in Oncology—Parametric Methods

Tighiouart, Mourad; Rogatko, André

Pages: 59 –72

[The primary goal of a cancer Phase I clinical trial is to determine the dose of a new drug or combination of drugs for subsequent use in Phase II trials to evaluate its efficacy. The dose sought is typically referred to as the maximally tolerated dose (MTD) and its definition depends on the...
Available

Dose Response: Pharmacokinetic–Pharmacodynamic Approach

Holford, Nick

Pages: 73 –88

[Almost all clinical trials include responses measured over time. It is valuable to understand how these responses arise as a function of treatment dose and time. It is particularly important in planning and interpreting Phase IIB (“dose response”) and Phase III (“confirmation of effectiveness”)...
Available

General Considerations in Dose–Response Study Designs

Ting, Naitee

Pages: 89 –105

[As mentioned in Chapter 1, one important step in early clinical development of a new drug is to draft a clinical development plan (CDP). Various clinical studies are designed and carried out according to this plan, and the CDP is updated over time based on newly available information. Estimation...
Available

Clinical Trial Simulation—A Case Study Incorporating Efficacy and Tolerability Dose Response

Ewy, Wayne; Lockwood, Peter; Bramson, Candace

Pages: 106 –126

[This case study is based on an early clinical development project we conducted. Details that identify the candidate compound have been obscured for confidentiality reasons, but the situation described is not uncommon in early clinical development.]
Available

Analysis of Dose–Response Studies—Emax Model

Macdougall, James

Pages: 127 –145

[The Emax model is a nonlinear model frequently used in dose–response analyses. The model is shown in Eq. (9.1)]
Available

Analysis of Dose–Response Studies—Modeling Approaches

Pinheiro, José C.; Bretz, Frank; Branson, Michael

Pages: 146 –171

[Identifying the correct dose is one of the most important and difficult goals in drug development. Selecting too high a dose can result in an unacceptable toxicity pro- file, while selecting too lowa dose decreases the chance of it showing effectiveness in Phase III trials and thus getting...

results per page

Browse All eBooks

Features

Search and discover articles on DeepDyve, PubMed, and Google Scholar
Read the full-text of open access and premium content
Organize articles with folders and bookmarks
Collaborate on and share articles and folders

Info

Pricing
Enterprise Plans
Browse Journals & Topics
About DeepDyve

Help

Help
Publishers
Contact Us

Sign up for your 14-Day Free Trial Now!

Read and print from thousands of top scholarly journals.

System error. Please try again!

Continue with Facebook

By signing up, you agree to DeepDyve’s Terms of Service and Privacy Policy.

Already have an account? Log in

Save Article to Bookmarks

Bookmark this article. You can see your Bookmarks on your DeepDyve Library.

To save an article, log in first, or sign up for a DeepDyve account if you don’t already have one.

Subscribe to Journal Email Alerts

To subscribe to email alerts, please log in first, or sign up for a DeepDyve account if you don’t already have one.

Follow a Journal

To get new article updates from a journal on your personalized homepage, please log in first, or sign up for a DeepDyve account if you don’t already have one.

Our policy towards the use of cookies

All DeepDyve websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

cookie policy