We are always interested in ensuring good science, reducing animal use and generating quality data. To this end, performing pilot/exploratory studies provides a solid base with which to move forward with further testing.
We also work with a number of Sponsors on proof-of-concept laboratory efficacy and safety studies. Frequently, these are innovative, first-in-species therapies. We understand the need for rapid, high quality reporting in high throughput model systems. We strive to provide clear unequivocal answers early in the drug development process through sound study design and quality science.
Target Animal Safety Studies (TAS)
KFI has conducted GLP Target Animal Safety studies for FDA, EPA, and EMEA submission. We produce comprehensive protocols that receive regulatory concurrence with minimal comment. We conduct our studies in close communication with our Sponsors. We understand that, unlike general toxicology studies, TAS study data ends up in the public domain and on the drug label. With over ten years of experience in this area, we are proud that, all TAS studies submitted for regulatory review have been accepted with little or no substantive comment. We take pride in ensuring concise, comprehensive, quality submissions that smoothly negotiate the regulatory process.
Bioequivalence Studies (BE)
Bioequivalence studies are conducted in compliance with GLP regulations and Center for Veterinary Medicine (CVM) bioequivalence guidelines to support abbreviated new animal drug applications. Kingfisher International Inc. manages all in-life aspects of bioequivalence studies. We have several preferred audited bioanalytical laboratories we subcontract to for method development; validation, and sample analysis.
We strongly recommend that Sponsors conduct pilot non-GLP pharmacokinetic studies prior to embarking on GLP BE studies. These studies allow for bioanalytical method refinement, confirmation of sampling time points, identification of “highly variable” drugs, and estimations of pivotal study sample size. They help ensure that the GLP BE protocol is scientifically sound and poised for success!
We have assisted several sponsors in early stage drug screening studies using a variety of models. Our goal in these projects is to work towards a clearly defined “GO/NO-GO” answer with regard to preliminary tolerance and/or efficacy.
Some of the areas we have worked in include:
- Analgesic efficacy
- Chemotherapeutic safety
- Surgical modelling systems
- Dose range finding / toxicity modelling
- Nutraceutical safety
- Acceptability testing
Clinical Pathology Laboratory Services
KFI provides in-house GLP/GCP compliant Clinical Pathology Laboratory testing for:
- Hematology (including manual differentials)
- Clinical chemistry
All our clinical pathology analysers have been validated to provide precision, accuracy, and stability in dogs and cats. We also subscribe to external quarterly validation programs for these instruments. We have generated in-house normal reference ranges that include animals of all ages.
We are pleased to offer GLP-compliant clinical pathology services to external research partners. Contact us for more details.
Contract Quality Assurance
We have two quality assurance professionals on staff and are pleased to offer external QA support for academic and private research facilities needing GLP or GCP QA. We also offer half day and full day GLP/GCP training sessions that can be customized to fit the needs of your team. Contact us for more details.