Population Pharmacokinetic Method to Predict Within-Subject Variability Using Single-Period Clinical Data

• Main Authors: Won-ho Kang (Author), Jae-yeon Lee (Author), Jung-woo Chae (Author), Kyeong-Ryoon Lee (Author), In-hwan Baek (Author), Min-Soo Kim (Author), Hyun-moon Back (Author), Sangkeun Jung (Author), Craig Shaffer (Author), Rada Savic (Author), Hwi-yeol Yun (Author)
• Format: Book
• Published: MDPI AG, 2021-02-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Sample sizes for single-period clinical trials, including pharmacokinetic studies, are statistically determined by within-subject variability (WSV). However, it is difficult to determine WSV without replicate-designed clinical trial data, and statisticians typically estimate optimal sample sizes usi...