What are the requirements for the safety testing of drugs?

In New Mexico, pharmaceutical law requires drug manufacturers to perform safety testing before a drug is approved for use. In order to ensure the safety of patients, drug manufacturers must conduct pre-clinical, clinical, and post-marketing tests on drugs. Pre-clinical safety testing is conducted before a drug is approved for use. Pre-clinical testing can include animal testing, in vitro testing, and computerized models. Animal testing involves testing drugs on animals such as primates, cows, horses, and other animals to evaluate the safety and effectiveness of the drug. In vitro testing is laboratory testing that is done on live cells. Computerized models are methods of simulating the effect of a drug on the body. Clinical safety testing is a longer and more thorough form of testing than pre-clinical testing. Clinical trials involve testing the drug on humans to evaluate the safety and effectiveness of a drug. Clinical trials involve different stages, such as Phase I, Phase II, and Phase III. Phase I is a small study that focuses on the safety of the drug, Phase II is a larger study that focuses on the effectiveness of the drug, and Phase III is a larger study that compares the effectiveness of the drug to existing treatments. Lastly, post-marketing safety testing is used to monitor the safety of a drug after it has been approved for use. This type of testing is conducted to identify any potential side effects or other safety concerns that had not been identified during the clinical trials. Post-marketing testing also includes monitoring of patient safety, such as reporting of adverse effects and monitoring the effectiveness of the drug in certain populations.

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