Phase 1 studies are typically conducted in healthy volunteers at purpose designed Phase 1 units. Xyzagen, as your clinical pharmacology representative, can be an integral component of your Phase 1 team, along with data management, bioanalysis, clinical operations and statistics, clinical monitoring and medical writing.
Real Time Pharmacokinetic Analysis: Xyzagen can provide real time pharmacokinetic analysis within flexible study designs, particularly FTIH (first-time-in-human) studies that have strict PK stopping and dose escalation criteria.
Non-Compartmental PK Analysis: Whether your study is a FTIH or simple single dose or multiple dose ascending PK study, food effect or more complicated drug-drug interaction studies, Xyzagen can support the PK analysis and reporting
There are a number of therapeutic areas and development programs that do not require companies conducting pharmacokinetic assessments in healthy volunteers since it would be unethical. Some of these therapeutic areas are in acute surgical pain indications or ophthalmology, but not exclusively. Xyzagen can work with your clinical development and operations team to help design the PK component then support the analysis of your drug in the target patient population.
Real Time Pharmacokinetic Analysis: Xyzagen can provide real time pharmacokinetic analysis within a multiple dose cohort phase 2 study in patients.
Non-Compartmental PK Analysis: Whether your study is a FTIH or simple single dose or multiple dose ascending PK study, food effect or more complicated drug-drug interaction studies, Xyzagen can support the PK analysis and reporting.
