The role of baseline covariates in assessing intrasubject parallelism in ex vivo bioassays
Author:
Affiliation:
1. Tsumura Advanced Technology Research Laboratories, Kampo Research & Development Division, Tsumura & Co.
2. International Pharmaceutical Development Department, International Pharmaceutical Research & Development Division, Tsumura & Co.
Publisher
The Biometric Society of Japan
Subject
General Medicine
Link
https://www.jstage.jst.go.jp/article/jjb/42/2/42_83/_pdf
Reference30 articles.
1. (1)Anderson, S.(1993), "Individual Bioequivalence：A Problem of Switchability(with discussion)." Biopharmaceutical Reports, 2, 1-11.
2. (2)Baljé-Volkers, C., Mzolo, T., Talens, E., IJzerman-Boon, P., and Van den Heuvel, E.(2018), "Equivalence testing for similarity in bioassays using bioequivalence criteria on the relative bioactivity" Pharmaceutical Statistics, 17, 12-24.
3. (3)Brown, E. B., Iyer, H. K. and Wang, C. M.(1997), "Tolerance Intervals for Assessing Individual Bioequivalence, " Statistics in Medicine, 16, 803-820.
4. (4)Chow, S.-C. and Liu, J.-P.(2000), Design and analysis of bioavailability and bioequivalence studies, 2nd ed., Marcel Dekker, New York.
5. (5)Council of Europe(2008), The European Pharmacopoeia 6.0., EDQM, Strasbourg, France.
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