Translational Drug Development Core

Left to right: Abhisheak Sharma, PhD, Research Assistant Professor & Assistant Director, Pharmaceutics, UF College of Pharmacy;  Christopher McCurdy, PhD, FAAPS, Director and Professor, Medicinal Chemistry, UF College of Pharmacy
Left to right: Abhisheak Sharma, PhD, Research Assistant Professor & Assistant Director, Pharmaceutics, UF College of Pharmacy; Christopher McCurdy, PhD, FAAPS, Director and Professor, Medicinal Chemistry, UF College of Pharmacy

We are here to assist you in moving your compound from the lab to preclinical studies

Promising compounds need assistance moving from the lab into preclinical studies, which generate in vivo data needed for continued federal funding and licensing.

The CTSI Translational Drug Development Core provides services and expertise in bioanalysis, 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:

Consultation regarding testing, collaboration, and licensing submission.

biomedical sciences

Laboratory services to assist in advancing a lead compound based on in vitro data, to transition to full blown preclinical studies

Chemistry lab

Bioanalytical services to define the full in vivo pharmacokinetic profile (Absorption, Distribution, Metabolism, & Excretion-ADME) of a compound

emerging pathogens

Consultation

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

two scientists collaborating in a lab

Direct to appropriate collaborators for measurement of other endpoints where necessary, or to other services/companies for outsourcing when most appropriate

Biomedical science collaboration between a teacher and student

Assistance/guidance on preparation of relevant data for licensing submission

emerging pathogens

Translational Drug Development Core Services

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Analytical method development and validation using UPLC-PDA/QDA, UPLC-MS/MS, UHPLC-Q-TOF

  • Analysis of formulations for Active Pharmaceutical Ingredients (API)(Formulation Analysis)
  • Analysis of complex natural products for content (Natural Product Analysis)
  • Bioanalytical method development (Bioanalysis)
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Physiochemical Analysis

  • Solubility
  • Acid dissociation constant (pKa)
  • Partition coefficient
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Absorption

  • Stability in simulated gastric and intestinal fluid
  • Permeability studies using CaCO2 cell line
  • Transporter studies using transfected MDCK/HEK cell lines
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Distribution

  • Stability in plasma/serum
  • Plasma protein binding
  • RBC to plasma partitioning study
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Metabolism studies

  • Metabolic stability using microsomes (liver, intestinal), S9, brain homogenate, and hepatocytes
  • CYP inhibition and reaction phenotyping
  • In vitro (microsomes, S9, hepatocytes) and in vivo metabolite identification (Phase I and Phase II)
  • UDP glucuronosyltransferases inhibition
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In vivo studies

  • Bioavailability/pharmacokinetic studies in mice, rats, or dogs following per-oral, subcutaneous, intravenous and intraperitoneal routes of administration
  • Gender-related pharmacokinetics
  • Tissue distribution
  • Dose proportionality pharmacokinetics
  • Drug disposition in urine, bile, and feces
  • Brain-to-plasma ratios
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Modeling and simulation

  • Determination of exposure-response relationships, population pharmacokinetics, in vitro-in vivo extrapolation, prediction of human dose, PBPK, and covariatemodelling
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Human clinical trials

  • Bioanalysis of test samples from clinical trials

Leadership and contact information

Photo of Dr. Chris McCurdy

Christopher R. McCurdy, PhD, FAAPS

Professor of Medicinal Chemistry
Phone: (352) 294-8691
Contact via email


For general information or to set up a consultation, contact: