One of the important steps in the medical devices, biologics and drug development process is the demonstration that it is safe to administer the product to humans for the first time (Phase I). The process is especially difficult because this demonstration of safety is most often limited to the use of preclinical in vitro and in vivo studies, including animal toxicology studies. In order to carry out this task, consideration must be given to the FDA regulatory process, the appropriate FDA and ICH guidance’s, general principles related to proper toxicology study design, specific safety considerations related to the biological product or drug class, additional safety concerns obtained from a careful scientific review of the pharmacodynamics and mechanism of action of the product, and an analysis of the risk-benefit issues associated with the product. The product development cannot proceed until preclinical toxicology study results that support safe administration of the product to humans are submitted to the FDA in a 510(k) or an IND. It is recommended this process involve continuous communication with the FDA, including a pre-IND meeting.
The services Walker Downey & Associates, Inc. provides are diverse and vary from one individual consultant to another based on the consultant’s expertise and experience. For the majority of our clients requesting statistical support, we review your specific needs and help to design a testing protocol that will maximize the data analysis phase. We will provide a written report on the statistical analysis methods and results that you can append to your final report. We can assist you by developing a statistical strategy for a new product that complies with regional or international regulatory requirements. Walker Downey & Associates, Inc. can also work with laboratories to ensure that statistical methods they employ are being conducted properly. Finally, we can interpret your statistical studies in a peer review capacity. Our Associates have many years of experience in their fields including: