Case Studies

We contribute to unique needs and resolve client product development and regulatory issues, as illustrated in these examples.

ISO 10993 & OECD Standards Example

Client A inquired about a device study micronucleus assay under ISO and OECD standards. Sinclair Research attempted hand counts on bone marrow slides but this approach was very labor intensive. Flow cytometry equipment was added to our Clinical Pathology Laboratory for supporting the Device Group micronucleus assay and other studies. This method was more efficient and provided more accurate results. Validation of assay was completed for ISO, OECD, and JMHLW-Japan standards. Studies were performed for client. Client A is extremely pleased.

Phototoxicity Example

Client B submitted an inquiry on our website for a miniature swine skin phototoxicity model. We brought in expertise, utilized resources to develop the model, and collected and summarized the data. This data became useful in protocol design. Sinclair Research performed the protocol and reported findings to the client. Client B is pleased. Overall validation of model was published as peer reviewed manuscript and manuscript and poster were presented at a major scientific meeting. All parties become excited about future possibilities. Studies are now becoming routine.

Reprotoxicology Example

Client C inquired about a large Segment I DART breeding-to-farrowing study in miniature swine. Sinclair Research Study Director and Manager of Production Facility pulled together resources to execute this study. The study was a huge undertaking and a total success. The study report was presented as a poster session at a major scientific meeting, is being used in FDA submission, and will be published as a peer-reviewed manuscript. Client and consultant are very pleased. Having a board-certified veterinary theriogenologist on staff was invaluable.

Mouse Molecular Bio ELISA Panel Example

Client D desired inflammation multiple mediator panel data on a research compound. Mouse molecular bio FCAP ELISA panel for immune mediators of inflammation was planned. ELISA beads, reagents, reader, software, and mice were purchased. Sinclair Research validated a multiplex FCAP assay for seven mediators of inflammation. This assay was used in a study testing a compound for anti-inflammatory PD properties. Client D is pleased.

 Preclinical Toxicokinetics Example

Client E asked for toxicokinetics and recovery studies along with GLP dermal toxicity studies in miniature swine. Sinclair Research wrapped these three studies together, saving time and resources. Client E approves.

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