Final answer:
ICH guidelines are an integral part of drug development, providing a framework for clinical trial design, conduct, and safety.
Step-by-step explanation:
The International Conference on Harmonisation (ICH) provides guidelines that are critical for the design, conduct, safety, and reporting of clinical trials. The guidelines aim to ensure high scientific quality standards and protect the welfare of trial participants across different regions by promoting harmonization. In the context of ICH E11, the guidance pertains to the inclusion of pediatric populations in clinical trials, ensuring that medicine for children is subject to the same level of rigorous research as that provided to adults.
During drug development, bioanalytical method validation is crucial to ensure the reliability of results, which is covered under ICH Q2 (R1). This validation process includes ensuring that analytical procedures are accurate, specific, reproducible, and robust. The EMA documents elaborate on the non-clinical safety studies necessary before initiating human clinical trials to ensure the compound's safety profile.
Phase I clinical trials focus on safety, tolerability and pharmacokinetics of a drug. If the compound in question does not meet the criteria, it can be dropped before moving on to further phases. Phase II trials focus on assessing dose/exposure response, while phase III clinical trials deal with efficacy and safety on a larger scale, often involving diverse patient populations across the globe.