Translational Drug Development Core
We are here to assist you in moving your compound from the lab toward clinical trials.
Promising compounds need assistance moving from the lab toward clinical trials, which generate the in vivo data needed for continued federal funding and licensing.
We provide services and expertise in bioanalytical drug metabolism and preclinical pharmacokinetics in order to help faculty bridge this gap.
With solid data, researchers can meet the short timelines from provisional to full patent to licensing, enhance federal funding, and accelerate the transformation of new therapeutic interventions for the treatment and prevention of diseases.
To help scientists succeed in this space, we provide the following:
Having a clear, precise plan is critical in moving a compound forward. Our expert team will individually evaluate your needs and provide direction for next steps.
- Plan needs for bioanalytical or animal testing
- Direct to appropriate collaborators for measurement of other endpoints where necessary, or to other services/companies for outsourcing when most appropriate
- Assistance/guidance on preparation of relevant data for licensing submission
Critical animal studies are needed to advance a compound from a lead compound based on in vitro data, to transition to full blown preclinical studies. Laboratory services are directed closely with our consultations.
- Bioavailability/pharmacokinetic studies in mice or rats following per-oral, intranasal, intravenous and intraperitoneal routes of administration
- Gender-related pharmacokinetic studies
- Tissue distribution studies
- Dose proportionality pharmacokinetic studies
- Excretion studies in urine and feces
- Brain-to-plasma ratios
- Metabolite identification
- Data analysis
Essential for defining whether a compound is “druggable” – whether it has pharmacokinetic and drug metabolism properties that make it a reasonable drug candidate to move forward.
Bioanalytical method development and validation
- UPLC-UV-MS and/or UPLC-MS/MS method development and validation in biological matrices (blood, plasma, serum, and tissue homogenates)
- Solubility determination
- Acid dissociation constant (pKa) determination
- Partition coefficient determination
Modeling and simulation
- Pharmacokinetic data analysis, pharmacokinetic simulation, covariate modelling and PK-PD modelling using WinNonlin and/or NONMEM
In vitro pharmacokinetic studies
- Metabolic stability studies using liver and/or intestinal microsomes
- Protein binding studies
- Serum and plasma stability studies
- Intestinal permeability studies
- Metabolite identification
- CYP phenotyping and inhibition studies
- Red blood cell and plasma partitioning studies
- Enzyme kinetics studies
Leadership and Contact Information
Director | Christopher R. McCurdy, PhD, FAAPS
Professor of Medicinal Chemistry
Laboratory Director | Bonnie A. Avery, PhD
Clinical Professor of Pharmaceutics