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.
Xyzagen offers services in:
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.
Xyzagen can take your phase 1 or patient phase 2 data and model the concentration. Modeling and describing the data in a compartmental model allows a sponsor to begin to simulation different dosing intervals or dose levels. The sponsor can incorporate pharmacodynamic data and simulate exposure response relationships between your drug and select biomarkers. The modeling does not need to be complex incorporating a large number of covariates. It’s best to start simple and build the model in phases until it matches the actual exposure profiles generated from the clinical studies
Not all manufacturing site technology transfers are similar. In order to move certain drugs to a new manufacturing site, such as extended release formulations, there is a requirement to conduct a bioequivalence study to support the technology transfer. There are times that the manufacture may want to change the formulation in the process of the technology transfer. Xyzagen has experience and success in developing and transferring an extended release formulation from one type of XR formulation to another XR formulation. Both XR formulations proved to be bioequivalent.
A large number of midsize and large pharma companies outsource their drug manufacturing and collaborate with other companies for the marketing and distribution of their products. Minimum production batches sometimes begin to outstrip sales or the licensor decides to move out of the market or change the formulation of the XR product. These are the realities of the business. This doesn’t mean that a company can’t change their formulation during a technology transfer.
Xyzagen can support and analyze the biopharmaceutics and PK/BE analysis for complicated or simple tech transfer studies.
Xyzagen can provide CDISC SDTM PC and PP domains for regulatory submission.
