A Case Study on the Optimal Design of Clinical Pharmacology Trials with Restrictions on the Dosing Schedule

• Published in: Japanese Journal of Biometrics Vol. 30; no. 1; pp. 1 - 16
• Main Authors: Yoshimura, Isao, Hamada, Chikuma, Kikuchi, Kazuyo
• Format: Journal Article
• Language: English
• Published: The Biometric Society of Japan 2009
• Subjects: clinical pharmacology trial; dosing schedule; Ds-optimal design; enumeration algorithm

A clinical pharmacology trial, which examines the safety and pharmacodynamics of an investigational drug, is typically the first time that the drug is administered to humans. We are, therefore, often forced to maintain some restrictions on the trial conditions; for example, incremental doses in succ...