PK/PD Services

The PK/PD Resource is available to assist investigators in the design of clinical studies which incorporate clinical pharmacology or pharmacokinetic/pharmacodynamic questions. Emphasis is placed on designing studies to optimize efficiency and scientific rigor. The Resource is also available to assist investigators with the develpment of new assay methodologies, and with PK/PD data analysis. Investigators are encouraged to consult the PK/PD Resource as early as possible during the planning phases of project or grant development.

Analytical Capabilities of the PK/PD Resource: The Resource offers Elemental analysis, Drug/metabolite and other small molecule measurements as well as real time qRT-pcr.

Examples of each are listed below.

Elemental Analysis (Atomic Absorption)

Assays available

Platinum based compounds (oxaliplatin, cisplatin, carboplatin)
Selenium based compounds (Selenomethionine; methylselenocysteine)
Gold

Drug/metabolite and other small molecule analysis (LC/MS/MS; HPLC, RIA)

Assays available

Antimetabolies: Gemcitabine and dFdU (HPLC; L/MS/MS); Capecitabine (LC/MS/MS); 5FU (LC/MS/MS)
Taxanes: Docetaxel (LC/MS/MS); Paclitaxel (LC/MS/MS); IDN5390(LC/MS/MS)
Topoisomerase targeted agents: Irinotecan, SN-38, SN-38G (HPLC); Etoposide (HPLC)
Anthracyclines: Doxorubicin and Daunorubicin (HPLC)
Vitamin-D/metabolites (RIA, HPLC, LC/MS/MS)
Retinoids: Retinoic Acid (HPLC)
Targeted Agents : Sunitinib and SU11262 (LC/MS/MS)
Polyamines and analogs: Difluoromethyl ornithine (HPLC), Putrescine, spermidine and spermine (HPLC); N1N11diethylnorspermine (HPLC)
Cytoprotective and chemopreventive agents: Mesna (HPLC), BNP7787 (HPLC) and thiols (cysteine, homocysteine and glutathione) (HPLC); N-Acetylcysteine (HPLC)
Others: Nilutamide (HPLC, UV), Thiols (HPLC, UV), Tryptophan and Kynurenine (UPLC), Novobiocin (UPLC)

Molecular Assays:

Gene expression assays from tumor biopsies, xenografts, and cell cultures using real time quantitative RT-PCR (examples include: Thymydilate synthase; Thymidine phosphorylase; Dihydropyrimidine dehydrogenase; Excision cross complementing gene-1; γglutamylcysteine synthase; γglutamyltranspeptidase; xeroderma pigmentosum-A; Cyclo-oxygenase-2; Glutathione S-transferase π; DT-diaphorase; Spermine/spermidine N1-acetyl transferase; Spermine oxidase; polyamine oxidase; cytidine deaminase; carboxylesterase, ornithine decarboxylase and S-aenosylmethionine decarboxylase)
Taqman Low Density Array (TLDA) capabilities allowing for customizable analysis of up to 384 genes on a single plate.

Data Analysis and PK/PD Modeling:

The PK/PD Resource offers pharmacokinetics/pharmacodynamics analysis that includes non-compartmental methods, mathematical PK/PD modeling, population pharmacokinetics/pharmacodynamics analysis, as well as optimal sampling approaches to improve the efficiency of a clinical trial design.