PK, PKPD, AND ER ANALYSIS

The FDA uses these analyses to approve and label drug products

I am specialized in performing population PK, PKPD, ER analysis. In short, I can develop population models ensuring you get the information you need for your internal and regulatory decision making in a timely manner. For instance, I can help you to understand the sources of variability of your drug. I can also help you to identify if dose adjustments based on patients characteristics (e.g. body weight, age, sex, and race), or vulnerable populations (e.g. liver and/or renal impairment), or concomitant medications are warranted. Moreover, I can assist you to identify the relationship between drug exposure and efficacy, safety, and/or biomarkers. Furthermore, I can optimize the design of your future studies (see more here) and help you to avoid label restrictions by making informed recommendations.