Studies about Pets and Pharmacies
Some people may think that veterinary drugs are of lesser quality than those used for humans. In fact, however, precisely the same laboratory formulations and methodology must be used to manufacture both types of drugs and vaccines (biologicals). That is to say, exactly the same approach is used for veterinary pharmaceuticals that are used for the production and testing of human drugs.
In the United States, the Food and Drug Administration (FDA) must approve a drug for use in domestic animals and pets. All of these drugs are first investigated and analyzed in the laboratory using lab animals to test the effects and potencies. And then field testing is conducted.
As an example, one important and predominant study was performed for an insulin product for cats. The thoroughness and scrutiny employed is typical of drug research. Every drug must be tested in a controlled study.
During these tests Severe Adverse Event(s) (known as SAEs) are reported daily to the pharmaceutical manufacturer and testing agency, if it is separate. In this context, severe can refer to any reaction, from rashes to death. The term means anything that requires intervention, and that could be a result of the drug being tested.
The drug referred to is for use in cats who suffer hyperglycemic signs and symptoms due to diabetes mellitus. The first phase of the study involved 187 cats, 176 of whom received the medication. This period was called Effectiveness Field Study. Sometimes it is called Effectiveness Trial Study. Thanks to www.medpets.de for these information.
Events reported included lesions and thickening at the injection site. There were also reports of hypoglycemic events such as stupor, as well as other outcomes. Observations included vomiting, dry coat and black stool. The list in this article is not an all-inclusive. All reports make account of resolution, appropriate therapy and dose adjustments.
Those cats that finished the first study (145 of them) went on to an Extended Use Field Study that lasted 136 days. Reports for these clinical observations are numerous and detailed. Some of these are event case management statements, and Suspected Unexpected Serious Adverse Reaction reports (SUSARS). There is accounting required by the United States and the European Union (EU). Any pet owner using a drug that is on the market can obtain a copy of a Material Safety Data Sheet (MSDS). A pet owner information sheet is automatically provided with all prescriptions.
