Quantitative estimation of intra-subject variability in bioequivalence studies of generic solid oral dosage forms by multiple regression analysis

• Published in: Journal of drug delivery science and technology Vol. 64; p. 102656
• Main Authors: Wada, Shigenori, Kagatani, Seiya, Nakagami, Hiroaki
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 01.08.2021
• Subjects: Bioequivalence study; Generic drugs; Intra-subject variability; Multiple regression analysis; Predicted equation; Generic drugs; Bioequivalence study; Intra-subject variability; Multiple regression analysis; Predicted equation
• ISSN: 1773-2247
• DOI: 10.1016/j.jddst.2021.102656

Intra-subject variability (CVintra), which determines the 90% confidence intervals and the number of subjects needed for assessment in bioequivalence studies, is generally investigated by using pilot study Results. However, conducting pilot studies greatly affects the speed and cost of drug developm...