Preclinical Safety Testing and Assessment of Veterinary Pharmaceuticals and Pharmacovigilance

The Role of the Toxicologic Pathologist in the Biopharmaceutical Industry

“…In some areas of the world, veterinary products may be partially regulated by agricultural, environmental, and/or health agencies. 52–59…”

“…In addition, for veterinary products, there are regulatory requirements to ensure that any residues persisting in tissues after slaughter of food animals, secreted into milk, or that may find their way into foods like honey, are not toxic to consumers and do not pose unacceptable risks to users. 56…”

“…For example, the results of toxicity tests may have relevance for TAS, while adverse effects in target animal studies may impact the overall safety profile and hence both consumer and user safety assessments. 53,56…”

“…Carcinogenicity studies are not required for veterinary drugs; however, sponsors of veterinary drugs intended for use in food animals must demonstrate a lack of genotoxic and carcinogenic potential prior to product approval. 56…”

“…In some areas of the world, veterinary products may be partially regulated by agricultural, environmental, and/or health agencies. [52][53][54][55][56][57][58][59] In addition, for veterinary products, there are regulatory requirements to ensure that any residues persisting in tissues after slaughter of food animals, secreted into milk, or that may find their way into foods like honey, are not toxic to consumers and do not pose unacceptable risks to users. 56 Studies to predict safety and efficacy of veterinary products are similar to those for human products and include evaluation of toxicity, pharmacology, microbiology, consumer safety, user safety, and target animal safety (TAS).…”