Unique Hurdles in Assessing risks for Animal Health Products


One of the most basic differences in veterinary risk assessment is that safety must be assessed in more than one species. Unlike human pharmaceuticals, which are typically developed to operate within the confines of a single species, Veterinary drug developers must establish safety profiles across a wide range of species. 

 

Designing a drug to be safe for dogs, cats, horses, and cattle all at once is like developing a drug that works safely for species as physiologically distinct as cats, cattle, and poultry. Pharmacokinetic profiles may vary significantly between species, necessitating species-specific dosing and safety evaluations. Likewise, dosage calculations become exponentially more challenging when treating an animal that can vary in weight from a small cat to a horse. These include notably different rates of metabolism, organ functions, and natural detoxification processes between species, making toxicity assessments difficult. 

The Environmental Impact Factor

Unlike human pharmaceuticals, veterinary drugs tend to enter the environment in large amounts via animal waste. For example, excretion of certain pharmaceutical compounds from medicated livestock and other farm animals can lead to their release into soil and water, with potential ecological consequences. 

 

Environmental risk assessment is now essential to the veterinary drug approval process in most regulatory frameworks. This includes evaluating: 

 

  • Effects on soil microorganisms 
  • Impact on non-target organisms 
  • Bioaccumulation potential in ecological systems 
  • Development of antimicrobial resistance in the environment 
Read more about connection to the human chain and environmental risks of veterinary pharmaceuticals here: https://resource.ddregpharma.com/blogs/navigating-the-complexities-of-risk-assessment-in-veterinary-pharmaceuticals/

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