Final answer:
To ensure that a drug is not toxic to normal cells, ADME profiling is crucial in the drug discovery process, using high-throughput screenings and supported by advanced bioanalytic techniques like LC-MS/MS for metabolite profiling.
Step-by-step explanation:
The process of ensuring that a drug is not toxic to normal cells involves a range of preclinical studies including ADME profiling (Absorption, Distribution, Metabolism, and Excretion), which helps to address the pharmacokinetic features of drug candidates. Initially, high-throughput screening (HTS) assays are utilized to test numerous compounds, focusing on attributes such as permeability, metabolic stability, and interactions with human cytochrome P450 enzymes (CYP). These screenings are beneficial for identifying aspects that may cause drug toxicity to normal cells. In the latter stages of drug development, in vitro and in vivo models are implemented for a comprehensive assessment of the drug's disposition.
Specifically, bioanalytic support is crucial during in vitro ADME studies and typically involves advanced techniques such as LC-MS/MS for metabolite profiling. This information is vital to medicinal chemists as they look to optimize lead compounds and ensure safety. Thus, ADME profiling is a critical component in the drug discovery process to prevent toxicity to normal cells and influence the optimization of leads for better therapeutic outcomes.