Our laboratory is a dynamic unit with the capability, experience and expertise to quantitatively and qualitatively analyze a variety of drug analytes with an emphasis on antiviral agents in differing sample matrices. We develop methodologies to utilize small sample volumes appropriate for pediatric or other limited volume studies. Sample matrices include serum and plasma (total and unbound), CSF, urine, dried blood spots and breast milk. PPL has a California Clinical License and is CLIA approved for High Complexity Testing. The laboratory participates in an external Proficiency Testing Program 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 (SOPs). We are equipped with state-of-the-art computer-run HPLC systems with Mass Spectrometric (and UV if needed) detection. Immunoassay capabilities include ELISA with computer assisted data collection and data quantitation software. Our staff is experienced in assay development, method validation and quality control.
The laboratory utilizes a QR-code based 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. Associated with the QR-coding, and rapidly accessible by computer, is patient sample information, including drug assay results. This enables our lab to handle a large number of specimens with efficient throughput, including near real-time analysis with automated reporting.
PPPL has served as a reference laboratory for industry in several NDA submissions in support of licensing, and is currently participating in several NIH-DAIDS International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) protocols.
Our Clinical Licensed laboratory can provide the following services:
- Analyses and quantitation of antiviral (and other) drugs (Tables 1A and 1B) in biological matrices (mainly plasma, serum, urine and CSF) using HPLC, LC-MS or Immunoassay.
- Real-time analysis of samples providing results within five working days of specimen receipt.
- Pharmacokinetic evaluation, interpretation, PK/PD modeling of results.
- Development and validation of LC/MS/MS methods for new drugs.
- ELISA kit validation.
- Recommendations for R&D and new assays are available upon request.
The Pediatric Pharmacology Laboratory adjoins and shares expertise with the Skaggs School of Pharmacy and Pharmaceutical Science’s Drug Development Laboratory within the UC San Diego School of Medicine’s Medical Teaching Facility building. The UC San Diego PPL lab works closely with the UC San Diego Drug Development Laboratory
which focuses on in vitro and in vivo pre-clinical pharmacology studies. The UCSD PPL also supports pharmacometrics resources that provide PK/PD modeling and simulation services for local and NIH programs including IMPAACT Network, CHARTER, MPRINT and VRC.
UC San Diego Pediactric Pharmacology Laboratory
9500 Gilman Drive, MC 0657
La Jolla, CA 92093-0808
USA Shipping Address:
9500 Gilman Drive, MTF Room 233
San Diego, CA 92093 USA
Phone: (1+) 858-246-2900
For more information contact Dr. Jeremiah Momper: firstname.lastname@example.org