Description: This book emphasizes dose selection issues from a statistical point of view. It presents statistical applications in the design and analysis of dose–response studies. The importance of this subject can be found from the International Conference on Harmonization (ICH) E4 Guidance document. Establishing the dose–response relationship is one of the most important activities in developing a new drug. A clinical development program for a new drug can be broadly divided into four phases – namely Phases I, II, III, and IV. Phase I clinical trials are designed to study the clinical pharmacology. Information obtained from these studies will help in designing Phase II studies. Dose–response relationships are usually studied in Phase II. Phase III clinical trials are large-scale, long-term studies. These studies serve to confirm findings from Phases I and II. Results obtained from Phases I, II, and III clinical trials would then be documented and submitted to regulatory agencies for drug approval. In the United States, - viewers from Food and Drug Administration (FDA) review these documents and make a decision to approve or to reject this New Drug Application (NDA). If the new drug is approved, then Phase IV studies can be started. Phase IV clinical trials are also known as post marketing studies.
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Item Specifics
All returns accepted: ReturnsNotAccepted
Educational Level: University
Level: Advanced
Country/Region of Manufacture: United States
Number of Pages: Xiv, 248 Pages
Publication Name: Dose Finding in Drug Development
Language: English
Publisher: Springer New York
Item Height: 0.3 in
Subject: Biostatistics, Medical Law & Legislation, Pharmacology
Publication Year: 2006
Item Weight: 42.7 Oz
Type: Textbook
Author: Naitee Ting
Subject Area: Law, Medical
Item Length: 9.3 in
Item Width: 6.1 in
Series: Statistics for Biology and Health Ser.
Format: Hardcover
