Final answer:
Compounded medications must adhere to USP standards, and active pharmaceutical ingredients undergo rigorous testing to ensure safety and efficacy, including pharmacokinetic evaluation in animal studies before clinical trials.
Step-by-step explanation:
When compounded medications are used, those active pharmaceutical ingredients (APIs) must comply with the standards in a USP monograph and the applicable USP compounding standards. The USP (United States Pharmacopeia) provides guidelines for the purity, quality, strength, and consistency of APIs, ensuring that medications meet the required standards for safety and efficacy. In the drug development process, after promising compounds are discovered, they undergo pharmacokinetic evaluation in animal studies to assess various parameters including how the body affects the drug (“pharmacokinetics”) and how the drug affects the body (“pharmacodynamics”). These studies are critical before advancing a drug to clinical trials and ultimately to market.