Publication on bioequivalence testing in approval applications for the development of generic drugs and additional dosage forms.
This document introduces "Bioequivalence Testing (Comparison of Pharmacokinetics)." Our company provides comprehensive support for bioequivalence (BE) testing conducted by healthy adults in the development of generic pharmaceuticals, from clinical trials to pharmacokinetic measurements and the preparation of summary reports. We conduct bioequivalence (BE) testing not only for oral formulations but also for topical formulations. For topical products, we can also perform pharmacological tests such as skin pharmacokinetic studies, blanching tests, residual amount tests, and patch tests. [Contents] ■ Main Items ■ For Customers Like This ■ 1) Bioequivalence Testing (Comparison of Pharmacokinetics) *For more details, please refer to the PDF document or feel free to contact us.
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【Testing Method <Example>】 ■Target Subjects: Healthy adult males ■Number of Cases ・Preliminary Test: 20 cases (10 cases in 1 group) ・Main Test: 40 cases (20 cases in 1 group) ■Design: Open-label, 2-drug 2-period crossover ■Investigational Drugs: Test drug and control drug ■Evaluation Items: AUC and Cmax calculated from drug concentration *For more details, please refer to the PDF document or feel free to contact us.
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For more details, please refer to the PDF document or feel free to contact us.
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Our company is engaged in the production of gene knockout mice, providing genetic information to research institutions such as universities and pharmaceutical companies, selling reagents, and conducting non-clinical and clinical trial contracts, as well as pathological diagnosis. Through the development of biological resources from individual organisms to genomes, we provide genetic information for foundational research and in the fields of medicine and healthcare. Please leave the production and sale of knockout mice, gene knockout mice, and antibodies to us.