Veterinary pharmaceutical companies seeking to bring a new animal drug to market must file a New Animal Drug Application (NADA). Prior to filing the application, they must submit the protocol for regulatory studies using an Investigational Veterinary Pharmaceutical Product (IVPP) as part of an INAD (Investigational New Animal Drug file).
A major component is an assessment of safety of the IVPP. According to Guideline 185, Target Animal Safety for Veterinary Pharmaceutical Products VICH GL43, CVM FDA (April 2009), for drug approval safety testing must be conducted in the species in which the drug will be used.
The major species covered by GL 185 include the following: bovine, ovine, caprine, feline, canine, porcine, equine, and poultry (chickens and turkeys). Since this guidance is harmonized internationally via the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), the data produced following a GL 185 is suitable for regulatory submission not only to the US CVM, but to regulatory authorities in EU countries and Japan.
An established leader in Target Animal Safety, Sinclair is able to work with all the major species covered by GL 185 guidance. The bulk of Sinclair studies are in dogs, and pigs, but Sinclair has on-site housing for sheep, goats, cattle, horses, and poultry (chickens and turkeys), and has conducted studies in all these species.
Sinclair is located in the heart of the Animal Health Corridor in the US Midwest, and has a deep and broad experience base in conducting preclinical studies for the discovery and development of animal therapeutics and companion animal paraciticides.
Sinclair has conducted TAS studies across a broad range of veterinary drug therapeutic indications, such as parasitology, cardiovascular, musculoskeletal/osteoarthritis, dermatology, and analgesia. All standard routes of administration are available at Sinclair – and Sinclair technicians are experts at dosing companion animals. Additionally, Sinclair is the industry leading CRO conducting safety studies in pediatric dogs.
We have worked with over 20 animal health companies and continually provide safety studies to animal health clients developing veterinary medicines for dogs. Studies have included many pediatric studies in dogs supporting labeling for dosing or treatment as young as 6 weeks. In the past 15 years, we have conducted hundreds of these studies, including well over 100 GLP studies for animal health clients, including pharmacology, tissue residue depletion target animal safety (TAS).
Why partner with Sinclair Research?
As one of the largest nonclinical CROs in North America, Sinclair Research’s scientific and technical expertise can provide you with the Target Animal Safety services you need, the data you expect, and the customer experience you deserve! Contact our team to discuss your upcoming research and meet with our scientific experts to discuss how to reach your next development milestone.
Our Target Animal Safety studies typically includes the following:
- GLP study conduct
- The IVPP evaluated should be the product intended to be marketed, using the intended route of administration.
- Study conduct in healthy animals in the species for which the drug will be used.
- Study conduct in the age range of animals that is the intended for the product. Thus, if the drug label will include juvenile animals, then the TAS study needs to occur in animals of the same age.
- The study should be randomized, controlled (placebo or negative control), and masked (blinded to treatment), as appropriate.
- The study will typically include 4 treatment groups (control, 1X, 3X, and 5X the intended treatment dose level), with 4 male and 4 female animals per group.
- Study durations are recommended to be three times the treatment duration or interval, up to 90 days. Longer term treatment duration may require study duration up to 6 months.
- Major study variables will include physical examinations and clinical observations, clinical pathology tests, necropsy, and histopathology examinations.
- Additional variables, such as toxicokinetic (TK) collection for exposure level evaluation during the study and subsequent TK modeling, may be included in the study design.