The PPS encompasses all scientific analyses related to pharmacology, once the specimen has been collected and stored. There is a multi-step process to evaluate how the drug is being handled by the body after administration. The first step is to measure the drug concentrations longitudinally. This step is performed by the CPP’s Bioanalytical Unit:
The Bioanalytical Section of the CPP is responsible for the measurement of drug concentrations in samples, either clinical or nonclinical. Our facility is staffed by a PhD Staff Scientist/Deputy Head of the CPP, a PhD lab manager, a post-doctoral fellow, and four post-baccalaureate chemists.
The Bioanalytical facility contains 5 triple-quadrupole mass spectrometers (MS/MS) with ESI/APCI sources, each with ultra-performance liquid chromatography (LC) systems that are used for organic, small molecule therapeutics. The Bioanalytical facility also has an inductively-coupled plasma mass spectrometer (ICP-MS) for quantitative inorganic/elemental analysis (e.g. cisplatin, oxaliplatin, carboplatin). Additionally, the Bioanalytical Section can develop and validate ligand-binding assays (e.g. ELISA) for the measurement of biologics and macromolecules.
All bioanalytical assays are developed and validated per FDA and ICH guidance for method validation, with FDA bioanalytical reports available upon request to support NDA submissions.
Once drug concentrations are measured in all samples from a PK study (clinical or nonclinical), step 2 is the pharmacokinetic (PK) analysis for the drug(s) of interest in a particular study. The PPS uses PK software that is validated per FDA 21 CFR Part 11 regulations. The PPS can provide PK data in CDISC (either SEND or SDTM) format and reports for IND and NDA/ANDA submissions. Additionally, support for pharmacokinetic-pharmacodynamic (PK/PD) modeling and simulation of investigational agents or combination therapies to predict exposure-response in future trials, food effect analysis, and concentration-QT effect for new anticancer agents (Pharmacometrics).
Preclinical Pharmacology Unit
The PPS is also open to collaboration for new anticancer agents that are being introduced into preclinical models and can develop bioanalytical assays to quantitate and characterize preclinical drug metabolism and pharmacokinetics in preclinical models. The PPU within the PPS can also develop formulations of new chemical entities and characterize protein binding, in vitro metabolism and transport, in vitro and in vivo (animal) drug-drug interactions, and bioequivalence (new formulations, food effect studies, etc) studies in animals.
Staff Scientist: Cody Peter
Phone: (240) 858-3204
10 Center Drive, Room 5A03
Bethesda, MD 20892
The Preclinical Pharmacokinetics Core is open to all NCI intramural investigators.