Veterinary Medicinal Products

The quality and safety of veterinary medicinal products are of paramount importance for animal and food safety. To ensure this, both physicochemical and in vivo tests are performed.

Physicochemical Tests

Physicochemical tests are an integral component of quality control for pharmaceutical products and a crucial factor for ensuring efficacy and safety. These tests are performed to confirm the product's constituents, the level of impurities, and formulation-specific parameters.

• Identification Tests: Identification tests are performed to confirm the identity of active pharmaceutical ingredients and excipients in pharmaceutical products. They ensure that the product is manufactured correctly and for its intended purpose.
• Purity Tests: The undesirable content, such as residues and degradation products that might be present in the product, is determined and compared against the established limits.
• Formulation-Specific Tests: Depending on the product's form, some or all of the following tests must be conducted:
  • Dissolution and Dispersion Tests: These tests are designed to obtain data on the bioavailability of the active substance in solid oral dosage forms (tablets, capsules, etc.) by measuring its release rate.
    
  • Suspension Tests: Various methods are available to assess the physical stability of suspensions, including particle size, sedimentation, and redispersibility.
    
  • Emulsion Tests: Tests for phase separation and emulsion stability are conducted to assess whether the product's homogeneity is maintained.
  • Injectable Products: pH, osmolality, particulate impurities, sterility, and pyrogenicity are among the parameters to be examined.
  • Topical Products: Physical properties (viscosity, spreadability, particle size).
  • Oral Liquids: Simple physicochemical parameters, including pH, specific gravity, and viscosity, are evaluated.
• Assay of Active Ingredient: To demonstrate that the active substance is present in the correct quantity within the product, its quantitative determination is performed using analytical techniques.
• Stability Studies: The product is tested to determine if it remains stable throughout its shelf life under varying temperatures and humidity levels.

In-vivo Tests – Safety Studies in Target Animals

In the development of veterinary medicinal products, it is essential to assess the safety for the target animal species. These tests are conducted to ensure that the treatment is effective without compromising the health and/or life of the animals.

• Tolerance Study: This test investigates whether local or systemic reactions occur in the target animals at the recommended dose.
• Overdose Study: The safety margin of the drug is calculated by administering a quantity higher than the recommended dosage. This finding provides a means to assess the risk of overdose.
• Reproductive Toxicity Study: The reproductive organ system of the target species, the course of pregnancy, and potential effects on subsequent generations of offspring are carefully examined.
• Effects on Physiological Systems: Further effects on the cardiovascular system, respiratory system, and other vital systems are investigated as appropriate.