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College of Veterinary Medicine

Clinical Pharmacology Laboratory

Overview

The Laboratory’s provides high quality drug analysis service for the College of Veterinary Medicine and other research collaborators. We provide expertise and have available equipment to measure drugs, drug metabolites, toxicants, and some endogenous compounds in a wide range of biological matrices. Our staff has the expertise and commitment to perform validation tests for all assays and perform quality assurance determination for all studies.

The laboratory also performs pharmacokinetic analysis for studies and provide consultation for designing pharmacokinetic experiments. We are also a teaching laboratory for pharmacology graduate students in the College.

Drug Analysis Currently Available

  • Amiloride
  • butorphanol
  • Cephalosporins (ceftazidime, cefuroxime, cefazolin, cefamandole, cephalothin, cephalexin, cefepime)
  • Chloroquine
  • Chloramphenicol
  • Cisapride
  • Florfenicol
  • Fluconazole
  • Fluoroquinolones (enrofloxacin, ciprofloxacin, premafloxacin, norfloxacin, orbifloxacin, marbofloxacin, moxifloxacin)
  • Morphine (and metabolites)
  • NSAIDs (ibuprofen, piroxicam, naproxen, flunixin, carprofen, etodolac)
  • omeprazole
  • Penciclovir, famciclovir, acyclovir, and other antiviral drugs.
  • Penicillins (ampicillin/amoxicillin, penicillin, ticarcillin)
  • Sulfonamides
  • Tepoxalin (and metabolite)
  • Tetracyclines (doxycycline, chlortetracycline, oxytetracycline, tetracycline).
  • Tramadol (and metabolites)

For drugs not listed, the laboratory has the capabilities of developing new analytical techniques.

Costs

In order to recover consumable supplies, reagents, solvents, equipment purchase and maintenance, and overhead there is a general cost of analysis. Cost varies depending on the complexity of the assay. Please check with laboratory supervisor before submitting sample. Depending on specific needs for certain assays, some costs may be higher than others. For drug assay development, costs will be determined on an individual basis depending on the length of time to develop an assay, purchase of column, difficulty of assay, and validation studies performed.

Facilities

The proposed research will be conducted in the Clinical Pharmacology of Dr. Mark G. Papich. This laboratory is well equipped and has the following equipment for HPLC drug analysis: The system includes several solvent delivery systems and gradient controller. The laboratory also has Agilent Technologies Series 1100 HPLC equipment consisting of a solvent delivery system, automated sampler, ultraviolet light, electrochemical, and fluorescence detector, and the Series 1100 integrated software for chromatogram analysis and integration. This laboratory has already validated many of the assays that will be used for drug studies in animals. Our laboratory uses USP reference standards, whenever possible and follows guidelines established by USP for chromatography analysis (USP-NF, General Chapter 621).

Data analysis

The laboratory has complete capabilities for data analysis. The assays are performed with ChemStation software for integration of chromatography. Pharmacokinetic analysis is available using state-of-the-art analytical software (WinNonlin, Version 4.01, WinNonMix, Version 2.1, SAAM-II, etc.). Statistical analysis will be performed using SAS, (SAS, Cary, NC).

  • All samples should be collected using heparin as an anticoagulant (green top tubes).
  • Centrifuge samples and collect plasma.
  • Store plasma in a sturdy, screw-top tube that can withstand -80 freezing temperatures, and shipping. (Red-top type test tubes usually crack when frozen at -80.)
  • We require a minimum of 0.5 mL (500 mL) for analysis, however 1.0 mL allows for extra in case repeat analysis is required.
  • Whenever possible, include blank plasma (untreated plasma) from untreated animals that can be used for assay calibration and quality control. Without blank samples to check, quality control cannot be assured.
  • All samples need to be clearly labeled with ink that will not wash off tube or be rubbed off. If tape is used for labeling, be sure the tape will not come off the tube under freezing conditions and when shipped.
  • Include a separate sheet, or computer file on Excel, a list of samples, dose administered, sample identification, and drug to be measured.
  • Indicate to whom an invoice can be sent to pay for drug analysis, or include with samples a purchase order number (PO number).
  • Ship samples on ice, using overnight delivery.
  • Do not ship samples on a Thursday afternoon, Friday, or prior to a holiday.
  • Samples will be analyzed by HPLC using UV or FL detection.
  • Time to analyze samples will depend on the number of samples and previous arrangements made with the laboratory manager.
  • Limit of detection (LOD) for the assay varies with each assay. Contact the lab to ensure that the limit of detection will be high enough for your drug of interest.
  • Send a note or phone to let us know to expect samples that are shipped.
  • Try to make arrangements for payment with the lab before you ship the samples. Sample cost of analysis can be variable depending on the method, sample clean-up required and other costs. Some assays may require an assay development cost also. Check with laboratory prior to sending samples to determine the cost of the study.
  • Ship samples to Dr. Mark Papich , Professor (mark_papich@ncsu.edu), or Ms. Delta Dise, Lab Supervisor, (delta_plummer@ncsu.edu) Laboratory Room B-230 College of Veterinary Medicine North Carolina State University 4700 Hillsborough Street Raleigh, North Carolina 27606 Phone: 919-513-6385.