Clinical Pharmacology Laboratory

The Clinical Pharmacology Lab (CPL) in the Auburn University College of Veterinary Medicine Anatomy, Physiology and Pharmacology Department, offers drug analysis services and therapeutic drug monitoring for veterinary practitioners and commercial veterinary diagnostic laboratories in the US and abroad, as well as analytical chemistry support for research projects needing drug quantification.

Studying the detection, quantification, use and effects of drugs in animals, the CPL leverages the team’s combined expertise for performance of assay validation tests and quality assurance determinations. The CPL is equipped with instrumentation such as:

• FDA human-approved automated clinical chemistry and immunoassay analyzer (Siemens Dimension Xpand Plus)
• High-Performance Liquid Chromatography with UV or fluorescence detection (HPLC-UV/FL)
• Ultra-Performance Liquid Chromatography with mass spectrophotometry detection (UPLC-MS/MS)

Services

Online Payment Portal

Our Team

Hours of Operation

Monday through Thursday
8:00 am to 5:00 pm Central

Friday
8:00 am to 3:00 pm Central

The CPL will be closed on all official Auburn University holidays as listed here. Do not ship samples the day before holidays.

Contact

Phone: (334) 844-7187
Fax: (334) 844-7188
Email: clinpharm@vetmed.auburn.edu

Sample and supply shipping address:

Clinical Pharmacology Laboratory
1500 Wire Rd.
Auburn, AL 36849

Mailing address (for invoice and accounting only):

Clinical Pharmacology Laboratory
Department of Anatomy, Physiology and Pharmacology
College of Veterinary Medicine
Auburn University
212 Greene Hall
Auburn, AL 36849-5518

Therapeutic Drug Monitoring

TDM is a clinical application for individualizing drug dosage by maintaining plasma or blood drug concentration within a target therapeutic range. To submit samples for TDM, complete and submit the Online Submission Form. Available TDM test assays are summarized in Table 1. 

Using the online submission form, you are eligible for a FedEx discount to save up to 50% on standard overnight shipping. As soon as your sample information has been submitted, you will see an option to print a FedEx label, as well as an estimated shipping cost if you choose to print and use the provided label. While FedEx is our preferred shipping method, UPS Next Day Air Saver can be used if more convenient.

Tests can be run on a STAT basis, meaning they will be run on the day of receipt if received early enough in the day or not in the normal CPL schedule for that test. Call ahead to facilitate a more rapid turnaround time if necessary. Be sure to mark the appropriate box on the submission form if requesting STAT service. The fee for most STAT testing is $60 for the first test (or peak and trough) on that patient and $30 for subsequent tests on that same sample submission for that patient. The HPLC assay test fee is $200 per assay. STAT fee is added to the cost of monitoring.

For non-human primate sample submission, we are required to follow established protocols in our Biological Use Authorization (BUA) as approved by Auburn University’s Office of Risk Management and Safety. Please review and follow instructions for submitting non-human primate sample(s) before submission of the Primate only TDM submission form (PDF) and corresponding samples.

Due to the cost of required PPE to ensure safe handling of primate samples and the time required to follow the safety protocols outlined in our BUA, a $50 per test (or peak and trough) sample handling fee will be added. If you need assistance with the submission process, please contact the CPL via email or phone listed in the contact section of this page.

NEW TDM SERVICE
Mycophenolate Mofetil / Mycophenolic Acid (Canine Only)

We will offer a new drug monitoring service for mycophenolate mofetil (MMF) or mycophenolic acid (MPA) in canines only, beginning June 1, 2023. Introductory pricing of $75 for single samples and $120 for both peak and trough samples.

MMF/MPA monitoring is both complicated and limited by the lack of studies correlating concentration and immune suppression in animals. Thus, avoiding toxicity and determining concentrations should be the primary goal. Without consensus regarding MMF therapeutic ranges in animals, establishing the individual patient’s therapeutic range is critical.

Clinical pharmacology and disposition 

MMF is an immunosuppressant increasingly used to treat immune-mediated diseases in dogs and cats. MMF is a prodrug whose efficacy is based on conversion to an active metabolite, mycophenolic acid (MPA) and other MPA derivatives. MMF shows rapid oral absorption and reaches maximum concentration rapidly within 0.5 to 2 hours. The half-life of these metabolites is generally less than 12 hours, indicating the potential need for q 12 h dosing intervals, depending on the therapeutic indications. The short half-life also suggests that monitoring peak and trough concentrations is important. Without evidence and not knowing if peak or trough concentrations are more predictive of therapeutic response, the prudent approach is to measure a peak and trough to determine the individual patient’s MPA half-life (and potentially trough concentrations from that point on). If the patient cannot stay for 2-hour and 12-hour samples, the trough can be collected just before the next dose. The patient can be dosed and the peak collected after 1 or 2 hours.

Note: if the half-life in the patient is short and the interval is 24 hours, concentrations may not be detectable at 24 hours. 

Sample requirements:
0.5 mL Plasma (no separator gel tube)
DOGS ONLY

Collection times: 
Peak sample:    1-2 hours post-dose
Trough sample: Before the next dose

Method: immunoassay detecting MPA and other active metabolites

Shipping: Since MPA is temperature-sensitive, overnight shipping of sample(s) on ice is required. Do not ship samples on Friday or Saturday.

Analytical Services

Analytical Chemistry Services consisting of analysis of multiple samples and data (e.g., pharmacokinetic studies, statistical analyses) are offered through the CPL for research projects, which varies from TDM services on clinical patients. We offer development and validation of analytical methods tailored to a particular research project. If you have a project in need of analytical support, contact the pharmacologist and lab manager for more details.

Analytical fees for a new analytical method which include development, validation and data analyses are determined based on a case-by-case basis and based on the complexity of the analysis/project. Pricing typically ranges from $100 to $300 per sample, depending on the assay (sample preparation, reagent costs, compound of interest [e.g., parent compound, metabolites, enantiomers], sensitivity) and the number of samples.

Submission Process

• Request quote by completing the Analytical Service Request form (PDF) and emailing it to the pharmacologist and lab manager who will respond with a price estimate and timeline.
• Download and complete the Research Sample Submission Spreadsheet (Excel) and ship with project samples.
• Remit fee payment through our Online Payment Portal.