Ensure Your Pharmacology Data is Based on the Best Science
Exploring the relationship between pharmacokinetics (PK) and pharmacodynamics (PD) early in the drug development process is critical to clearly understand how the medication works. You need this essential scientific knowledge to be able to study and report on the therapeutic’s efficacy and safety at different doses and among different patient populations.
Developing a PK/PD program is not only required by the Food and Drug Administration (FDA), but it is also one of the most complex steps in the drug development and approval processes. Lack of time, financial resources, and unfamiliarity with FDA’s expectations are common obstacles that can inhibit the ability to design a program that results in a clear understanding of how your product works.
Without the right PK/PD study data and an understanding of the relationship, new drug application (NDA) submissions may be perceived as incomplete or unsubstantiated, leading to unexpected delays, a need for additional studies, and financial implications.
ProPharma Group: Specialized PK/PD Experts
At ProPharma Group, our experts are clinical pharmacologists who fully understand the intricacies of developing a comprehensive PK/PD program and can help you do more than simply satisfy FDA’s requirements. As an extension of your team, we help you analyze, interpret, and apply the right data to prove that your product is safe and effective. Demonstrating this to the Agency gets you one step closer to obtaining approval, thus achieving your goal of improving patient health and safety.
We have supported clients across a breadth of therapeutic areas and disease states over the last 30+ years, and are sought for our extensive experience, including small molecules, biologics, cell and gene therapies, radiopharmaceuticals, and cannabis-related products. We will help you implement a solid PK/PD program to facilitate a successful development program which will streamline the NDA review process by:
- Developing protocols: We help you determine the appropriate model to optimize your data, ensuring it is scientifically sound and meets FDA expectations
- Identifying the appropriate clinical research organization (CRO) partner for clinical studies: We assess your needs and determine appropriate options to conduct clinical studies
- Analyzing data: Our experts understand the science and can help identify the optimal balance between PK and PD. If a drug has highly variable clinical endpoints, we work with you to assess other factors, such as biomarkers to validate clinical outcomes, so you can be sure you’re submitting the most compelling data summary
- Ensuring FDA’s current expectations and requirements are met: Because of emerging technologies and a growing competitive product landscape, FDA expectations change almost daily. Our specialized team is in tune with evolving requirements and helps ensure you’re positioned for a smooth and successful NDA submission