Animal health programs have consistently been supported by KCAS with increasing study complexities although they have constituted a small percentage of the overall pharmaceutical development, these programs have consistently been supported by KCAS with increasing study complexities.
ANIMAL HEALTH – LABORATORY SUPPORT
KCAS is not only centrally located in the US, but in the heart of the Animal Health Corridor. Over the years, our scientists have provided bioanalytical support for a diverse range of Animal Health products varying from dog chews to cattle ear tags. Regulatory oversight of these products is with the FDA’s Center for Veterinary Medicine (CVM), which has special requirements.
Bioanalytical method employed in CVM submissions have many of the same elements as Human FDA submissions, but require additional in-phase inspections and reporting specifications. When pharmaceutical agent is intended for administration in food-producing animals, these agents require data from marker residue depletion studies to determine an appropriate withdrawal period when the drug is deemed no longer present in the last tissue to clear (i.e., liver, kidney). Targeted tissues may also include meat, milk and eggs.
Tissue depletion study trials are highly coordinated, formal investigations involving the sponsor, multiple contract research organizations (CRO) and the CVM. The CRO labs (typically 3) and the CVM are versed in the established method(s) and blinded samples are sent to each laboratory for analysis. The results of the blinded samples from each laboratory must meet established acceptance criteria for the method to be deemed acceptable for future use by CVM/USDA in monitoring the presence of the drug in the food chain. KCAS has successfully participated in these trials over the years with another scheduled for September of this year.
A fair number of animal health programs that we have supported involve “re-purposing” of approved drugs in new ways. This can involve taking an approved drug for use in humans (such as the anti-hypertensive drug benazepril) for use in companion animals or reformulating an oral or intravenous drug (such as an analgesic) for topical use for ease of administration.
Over the last 39+ years, KCAS has supported Animal Health products, CVM trials, and 505(b)(2) studies and can assist in appropriate drug development and support for your needs.