The identification of pharmacodynamic biomarkers involves several steps: 1. Preclinical Studies: Initially, biomarkers are identified in preclinical models, such as cell cultures and animal studies. 2. Clinical Trials: These biomarkers are then validated in clinical trials involving human subjects. This step ensures that the biomarkers are relevant and reliable in predicting clinical outcomes. 3. Biostatistical Analysis: Advanced statistical methods are employed to analyze the data and confirm the association between the biomarker and the therapeutic effect or adverse outcome.
