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A perspective for biowaivers of human bioequivalence studies on the basis of the combination of the ratio of AUC to the dose and the biopharmaceutics classification system.
Sakuma S, Tachiki H, Uchiyama H, Fukui Y, Takeuchi N, Kumamoto K, Satoh T, Yamamoto Y, Ishii E, Sakai Y, Takeuchi S, Sugita M, Yamashita S. Sakuma S, et al. Among authors: tachiki h. Mol Pharm. 2011 Aug 1;8(4):1113-9. doi: 10.1021/mp100421j. Epub 2011 Jun 17. Mol Pharm. 2011. PMID: 21630662
Measurement of drug concentration in the stomach after intragastric administration of drug solution to healthy volunteers: analysis of intragastric fluid dynamics and drug absorption.
Yamashita S, Kataoka M, Higashino H, Sakuma S, Sakamoto T, Uchimaru H, Tsukikawa H, Shiramoto M, Uchiyama H, Tachiki H, Irie S. Yamashita S, et al. Among authors: tachiki h. Pharm Res. 2013 Apr;30(4):951-8. doi: 10.1007/s11095-012-0931-1. Epub 2012 Nov 21. Pharm Res. 2013. PMID: 23179782 Clinical Trial.
Multi-laboratory evaluation of immunoaffinity LC-MS-based glucagon-like peptide-1 assay.
Ishikawa R, Saito K, Tachiki H, Goda R, Arai K, Shimizu H, Andou T, Takahara K, Uchiyama H, Nitta SI, Kakehi M, Hayashi K, Katagiri N, Kojima K, Fujita H, Tsuchinaga K, Saito Y. Ishikawa R, et al. Among authors: tachiki h. Bioanalysis. 2023 Feb;15(4):207-218. doi: 10.4155/bio-2022-0240. Epub 2023 Mar 24. Bioanalysis. 2023. PMID: 36961372
51 results