Our laboratory is a dynamic working unit with the capability, experience and expertise to analyze quantitatively and qualitatively a large number of drugs (Table 1) in a variety of sample matrices. It also typically refines methodology to utilize small sample volumes appropriate for pediatric studies. Sample matrices include serum and plasma, CSF, urine and recently validated assays for dried blood spots and breast milk. CPAL has a California Clinical License and is CLIA approved for High Complexity Testing. The laboratory is enrolled in two external Proficiency Testing Programs for anti-retroviral drugs and is current with Federal Good Laboratory Practice (GLP), and Federal HIPAA guidelines. All operations are guided and managed through detailed Standard Operating Procedures (SOP). We are equipped with state-of-the-art computer-run HPLC systems with UV and Mass Spectrometric detection. Immunoassay capabilities include RIA and ELISA with computer assisted data collection and data quantitation software. Our staff is experienced in assay development, method validation and quality control. Separate workstations are maintained for each assay.
A major feature of the CPAL is sample handling. We have a bar-coding system which provides each patient sample with a unique identifier, allowing sample tracking and sample handling history to be computer stored from receipt until final long-term storage. Also attached to the barcode and rapidly accessible by computer is all available patient sample information, including drug assay results. This enables our lab to handle a large specimen volume with efficient throughput, including real-time analysis with automated reporting.
CPAL has served as a reference laboratory for the industry in 12 NDA submissions in support of licensing in the past 5 years and is currently participating in several AIDS Clinical Trials Group (ACTG) and Pediatric ACTG protocols.
Our Clinical Licensed laboratory provides the following services:
- Analyses and quantitation of antiviral (and other) drugs (Table 1) in biological matrices (mainly serum, urine and CSF) using HPLC, LC-MS or Immunoassay.
- Assays done for animal and human clinical trials.
- Real-time analysis of samples providing results within five working days of specimen receipt.
- Pharmacokinetic evaluation and interpretation of results.
- Development and validation of HPLC methods for new drugs.
- ELISA kit validated.
- CPAL is a core laboratory for the San Diego PPRU.
- Recommendations for R&D and new assays are available upon request.
UCSD Clinical Pharmacology and Assay Laboratory
9500 Gilman Drive, MC 0808
La Jolla, CA 92093-0808
USA Shipping Address:
212 Dickinson St. Bldg. CTF-B Rm. 112
San Diego, CA 92103 USA
Phone: (1+) 619-543-5293
Fax: (1+) 619-543-5422
For more information contact Diane Holland: firstname.lastname@example.org