Target Animal Safety

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 VICH* the data produced following GL 185 is suitable for regulatory submission not only to the US CVM, but to regulatory authorities in EU countries and Japan.  

The scope of a TAS study 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.

Perhaps the single most important concept contained in the TAS summary above is the concept of the target animal – i.e., testing for safety in the species intended to receive the drug when marketed. The results then are equivalent in significance to human clinical trial results. Thus, the laboratory conducting the study must have significant experience with TAS study conduct, and evaluating TAS study variables in animals. Adverse events documented in a TAS study are different than those in a standard toxicology study and may have a very large impact on the fate of the drug approval.

* International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

Sinclair is located in the heart of the Animal Health Corridor in the US Mid-West, and has a deep and broad experience base in conducting preclinical studies for the discovery and development of animal therapeutics and companion animal paraciticides. We have worked with over 20 animal health companies and continually provide safety studies to animal health clients covering companion animals, dogs and cats. Studies have included many pediatric studies in cats and 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)

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 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.

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