Clinical Partnership Announcement
AXIS Clinicals LLC and Joanneum Research Forschungsgesellschaft mbH are excited to announce the first ever partnership for the clinical applications of dermal open flow microperfusion (dOFM™) technology. Combining the scientific innovations from Joanneum Research and the comprehensive capability of AXIS Clinicals to support clinical development, we believe that this partnership is a crucial milestone to […]
AXIS Clinicals, a Clinical Research Organization, welcomes Dr. Keith Gallicano as a consultant as the Senior Advisor in Clinical & Scientific Affairs.
DILWORTH, MN, 1st March, 2021 – AXIS Clinicals added another member as part of the consultation team with the welcoming of Dr. Keith Gallicano as the Senior Advisor in Clinical and Scientific Affairs. Keith Gallicano, Ph.D. (Chemistry) is a consultant in clinical pharmacology and biopharmaceutics with expertise in the areas of bioequivalence, drug-drug interactions, and pharmacokinetic, pharmacodynamic […]
How Novel Drug Delivery Systems Are Challenging Traditional BE Study Design
Bioequivalence (BE) studies have long relied on well-established assumptions about how drugs are administered, absorbed, and measured in the body. Traditional solid oral dosage forms such as tablets and capsules produce relatively predictable pharmacokinetic (PK) profiles that align well with conventional crossover BE designs and standard plasma sampling strategies. However, drug developers are increasingly moving […]
How Genetic Variability Is Being Accounted for in Bioequivalence and PK/PD Studies
As drug development becomes increasingly global, sponsors are paying closer attention to how genetic variability influences pharmacokinetics (PK), pharmacodynamics (PD), and bioequivalence (BE) outcomes. Differences in drug metabolism, transport, and receptor sensitivity across populations can meaningfully affect exposure profiles and therapeutic response. For BE and PK/PD studies in particular, these differences introduce both scientific complexity […]
The Role of Metabolomics and Biomarker Analysis in Early Phase Clinical Trials
The rise of metabolomics and biomarker analysis in early phase clinical trials is reshaping how development teams evaluate pharmacological activity, human variability, and early indicators of safety. For regulatory professionals, these tools present both opportunity and complexity. They offer stronger evidentiary support for early mechanistic understanding, yet they also introduce new demands around data interpretation, […]