For more than 20 years, PPD® Laboratories' bioanalytical lab has been conducting customized assay development and validation for both branded and generic veterinary pharmaceuticals. Our dedicated animal health project managers leverage our experience and scientific expertise to ensure the success of each and every project.
Our experience includes:
- True GLP bioequivalence studies in plasma for large and small animals
- Tissue residue studies at concentrations below that of the residue marker
- Bioavailability studies to demonstrate true cause of therapeutic effect
- Quantitative testing of immune response and immunogenicity for vaccines
All testing for veterinary pharmaceuticals, from pilot to pivotal studies are conducted to true GLP standards. Our breadth of experience and capability spans small molecules, biologics and vaccines and involves a wide variety of disciplines including chromatography, ligand-binding, cell-based assays and molecular platforms.
Our capabilities include:
- Discovery analysis and formulation development studies to hone in on final product specifications
- Development of the study protocol and sample analysis plan to streamline the preconcurrence process
- Customized proprietary assay development and validation
Our state-of-the-art laboratories and instrumentation are ever expanding and include multiple platforms for most assay types as well as high throughput liquid handling systems.
Important Regulatory Exposure
The success of veterinary pharmaceutical development hinges on successful navigation through the unique regulatory process. PPD Laboratories’ bioanalytical lab has an excellent working relationship with the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) and several international health and drug safety agencies. We were one of the first labs to submit electronic hyperlinked reports to the FDA-CVM. This new approach has streamlined the approval process for clients.
Scope of Support for Veterinary Pharmaceutical Development
The animal health industry touches virtually all of us either through the food chain or via companion animals. PPD Laboratories understands the importance of keeping the animal population healthy and therefore provides specialized and customized services specifically for our veterinary clients.
PPD Laboratories provides lab services to benefit the health of the animal population. Our development expertise and technical capabilities help our veterinary clients bend the cost and time curve of drug development in order to deliver life-changing therapies to the market as efficiently as possible.
PPD Laboratories does not maintain vivariums or perform testing on animals.
Explore our experience: