Case Studies
See our capabilities
These case studies represent the wide array of studies AXIS is capable of conducting for our sponsors.
Comparative BE for Biologics
Drug IV Biosimilar Study Design Comparative BE with Reference product PD and Immunogenicity assessments Multiple sites in EU and US In-house for few days followed
Multiple DDI studies with Post-menopausal Women
Drug Oral small-molecule prenylation inhibitor treatment of HepD Multiple studies Healthy volunteers equally split by gender Post menopausal women Subject Recruitment Timely recruitment/enrollment for all
TQT Study : Clinic and Bioanalysis completed within 2 months
Drug Continuous IV Infusion for 24 hr Study Requirements NDA submitted; FDA requested additional TQT study Corporate business target to submit asap Partnered with Clario
FIH – 24hr IV Infusion; Renal Impaired Subjects
Drug Continuous IV Infusion for 24 hr Multiple cohorts Healthy volunteers split by Gender and Age Mild and moderate Renal impairment patients Strict Study timeline
