Document text
Principal Investigator: Sara K Quinney
Organization: INDIANA UNIVERSITY INDIANAPOLIS
Fiscal Year: 2024
Award: $60,958
Funding agency: National Cancer Institute
ABSTRACT, Clinical Pharmacology Analytical Core (CPAC)
The Indiana University Simon Comprehensive Cancer Center (IUSCCC) Clinical Pharmacology Analytical Core
(CPAC) provides multifaceted expertise in bioanalytical methodology and clinical pharmacology to provide
investigators with robust information including in vivo pharmacokinetics, drug-drug interactions, in vitro drug
metabolic stability, stereoselective metabolism, metabolite identification, formulation optimization, protein
binding, drug purity verification, and drug stability. CPAC's expertise in bioanalytical analysis is coupled with
state-of-the-art laboratory equipment including three UHPLC triple quadrupole QTRAP mass spectrometers (LC-
MS/MS QTRAP) for quantification of drugs and metabolites, two of which were recently purchased through a
collaboration of the IU School of Medicine and IUSCCC, one HPLC photo diode array system, LC-UV
technologies, and a Biomek 4000 liquid handling robot, all to facilitate the research and development of drugs
and new chemical entities. CPAC and IUSCCC's leadership have defined three specific aims for this Shared
Resource: Aim 1. Provide IUSCCC members with broad, high-quality small molecule bioanalytical services from
various matrices in expedited timelines; Aim 2. Facilitate cancer drug discovery and development research by
working closely with investigators and the Cancer Drug Discovery and Development Accelerator (CD3A) group
to establish effective lead generation and lead optimization strategies; and Aim 3. Provide detailed pre-clinical
and clinical data analysis, including non-compartmental and compartmental pharmacokinetic (PK) analysis and
pharmacokinetic/pharmacodynamic (PK/PD) modeling. Through these aims, CPAC has supported CD3A and
clinical investigators by providing cost-effective, validated assays to support in vitro and in vivo ADME and PK
analyses of small molecules. Over the past three years, CPAC has supported 32 IUSCC investigators on
numerous projects, with over 2200 service hours devoted to method development, formulation optimization,
solubility assessment, protein binding, and metabolic stability and analyte quantification in over 4000 tissue and
plasma samples. Over the next five years, it is anticipated that demand will continue to grow for these services
and expertise to support the growing number of preclinical drug development programs supported by CD3A and
advancement of candidate drug molecules towards clinical trials.
Terms: <Abnormal Assessment of Metabolism><Animal Model><Animal Models and Related Studies><Anti-Cancer Agents><Antineoplastic Agents><Antineoplastic Drugs><Antineoplastics><Area><Assay><Binding><Binding Proteins><Bioassay><Bioavailability><Biological><Biological Assay><Biological Availability><Blood Plasma><Body Tissues><CCSG><Cancer Center Support Grant><Cancer Drug><Clinical><Clinical Cancer Center><Clinical Data><Clinical Investigator><Clinical Pharmacology><Clinical Research><Clinical Study><Clinical Trials><Collaborations><Comprehensive Cancer Center><Coupled><Data><Data Analyses><Data Analysis><Development and Research><Disease><Disorder><Drug Interactions><Drug Kinetics><Drug Stability><Drug Therapy><Drugs><Evaluation><Formulation><Generalized Growth><Generations><Glass><Goals><Growth><Guidelines><HPLC><Half-Life><High Performance Liquid Chromatography><High Pressure Liquid Chromatography><High Speed Liquid Chromatography><Hour><Human><In Vitro><Indiana><Intermediary Metabolism><Investigators><Lead><Leadership><Ligand Binding Protein><Ligand Binding Protein Gene><Link><Liquid substance><Measures><Medication><Metabolic><Metabolic Processes><Metabolic Studies><Metabolism><Metabolism Studies><Methodology><Methods><Modeling><Modern Man><Molecular Interaction><Neoplastic Disease Chemotherapeutic Agents><PBPK><PK/PD><Pb element><Pharmaceutical Preparations><Pharmacodynamics><Pharmacokinetics><Pharmacotherapy><Phase><Physiologic Availability><Plasma><Plasma Serum><Policies><Polypropylenes><Pre-clinical Drug Testing/Development><Preclinical Drug Development><Preclinical Drug Testing/Development><Probability><Process><Program Development><Propene Polymers><Property><Propylene Polymers><Protein Binding><R & D><R&D><Research Design><Research Personnel><Research Support><Researchers><Resource Sharing><Reticuloendothelial System, Serum, Plasma><Robot><Sampling><Services><Solubility><Study Type><System><Technology><Temperature><Testing><Therapeutic><Time><Tissue Growth><Tissue Sample><Tissues><Tube><Tumor-Specific Treatment Agents><Universities><Urine><Validation><anti-cancer drug><biologic><bound protein><cost effective><data integration><data interpretation><design><designing><drug candidate><drug development><drug discovery><drug efficacy><drug metabolism><drug treatment><drug/agent><experiment><experimental research><experimental study><experiments><fluid><heavy metal Pb><heavy metal lead><in silico><in vivo><lab equipment><laboratory equipment><laboratory technology><lead optimization><liquid><mass spectrometer><medical college><medical schools><member><metabolic abnormality assessment><method development><model of animal><new anti-cancer agent><new anticancer agent><new anticancer drug><new antineoplastic><new cancer drug><new chemical entity><novel anti-cancer agent><novel anti-cancer drug><novel anticancer agent><novel anticancer drug><novel antineoplastic><novel cancer drug><ontogeny><pharmacodynamic model><pharmacokinetic model><pharmacokinetics and pharmacodynamics><pharmacologic><physiologically based pharmacokinetics><pre-clinical><pre-clinical drug development><pre-clinical study><preclinical><preclinical study><programs><research and development><response to therapy><response to treatment><school of medicine><small molecule><stability testing><study design><success><therapeutic response><therapy response><timeline><treatment response><treatment responsiveness><validations>