Walker Downey & Associates, Inc.

Statistical Services

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Once a company has a viable product (one that has shown the potential for benefit through preclinical pharmacodynamics or proof-of-concept studies and can be manufactured with reasonable consistency), the next step in development is to provide evidence in an IND (Investigational New Drug) Application that it is safe to administer the product to humans for the first time (Phase I clinical trial). This evidence is gathered from a well-designed program of appropriate statistically-powered preclinical/nonclinical studies. It is at this IND stage that the preclinical toxicology studies play perhaps their most important role. More specifically, the design and planning of an appropriate toxicology program to support a Phase I clinical trial and the statistical interpretation of the resulting data in terms of safety requires careful consideration of an entire array of different factors, including the FDA regulatory process, the relevant FDA and ICH guidance/points-to-consider documents, general principles related to the statistical design of an appropriate toxicology program, safety issues specific to a product class, a scientific evaluation of any risk inherent in a specific product, risk assessment issues, and differences in regulatory philosophy between the CBER, CDER and CDRH, and the international agencies.

Walker Downey & Associates prides itself in its product-specific preclinical concept protocols, statistically-powered and prepared with justification for the type-B pre-IND meeting with the appropriate agency. Following concept protocol approval by the agency we, acting as your Authorized Representative, will solicit bids from our list of reputable Contract Research Organizations (CRO) and function as the Study Monitor to assure the satisfactory completion and reporting of all testing. After “doing the right test right” we will summarize the testing for your Investigators Brochure (IB), 510(k) or IND (Section 8).

Oftentimes, an evidence-based expert opinion will satisfy the requirements for some regulatory toxicology, thereby potentially reducing costs to the client and sparing experimental animals. Since preclinical testing is a time-consuming process that requires careful planning and evaluation early on and throughout development, Walker Downey & Associates makes every effort to promote this formal expert opinion approach. A summary of our Statistical Services is provided below. Click on any learn more for additional discussions.

	Walker Downey & Associates will serve as an evidence-based product safety and development statistical consultancy for your project team from discovery and proof-of-concept through clinical testing. We will develop data analysis strategies for all areas of product development. Our staff has extensive hands-on experience developing and auditing the statistical package applied to safety studies and we work closely with clients to ensure appropriate statistics, protocol consistency and compliance with Good Laboratory Practice (GLP). Learn more
	Data Mining is often considered to be "a blend of statistics, AI [artificial intelligence], and data base research", which until very recently was not commonly recognized as a field of interest for statisticians. Due to its applied importance, however, the field is emerging as a rapidly growing and major area in statistics where important theoretical advances are being made. Please contact us to see how Walker Downey & Associates Statistical Services can help your company through Data Mining. Learn more
	Reliability theory developed apart from the mainstream of probability and statistics, and was used primarily as a tool to help nineteenth century maritime and life insurance companies compute profitable rates to charge their customers. Even today, the terms “failure rate” and “hazard rate” are often used interchangeably. Some of the concepts, terms, and models needed to describe, estimate and predict reliability include: reparable systems, non-repairable populations, and life-time distribution models; reliability or survival function; failure (or hazard) rate. Contact us to see how we can help with your product reliability estimation. Learn more
	The process of peer review is considered critical to establishing a reliable body of research and knowledge. Regulatory agents charged with acting upon a submission can only be expert in a limited area; thus they welcome and rely to some degree on the third-party peer-review process to lend additional credibility to the research. Walker Downey & Associates will facilitate a peer review of preclinical study reports, or other written documents by our internal scientists who are experts in the field. Learn more
	A longitudinal study is a correlational research study that involves repeated observations of the same items over long periods of time. Longitudinal studies are often used in preclinical and clinical studies to study trends across the duration of testing. Walker Downey & Associates can use longitudinal study design/analysis to maximize the power of the client’s research investigations. Learn more
	Bioavailability has an indisputable importance for exposure and effect assessment. Although a variety of definitions, concepts and methods has been proposed, the adequate implementation of bioavailability into risk assessment strategies remains an important tool among chemists, toxicologists and decision makers. Walker Downey & Associates applies its expert Statistical Services to help clients evaluate data collected for product bioavailability determinations. Learn more
	Walker Downey & Associates’ in-depth knowledge of statistical modeling for pharmacokinetics facilitates the client’s prediction of the absorption, distribution, metabolism and excretion (ADME) of a compound. We will examine your own in-house data or we will help to identify a CRO suitable for your product and protocol requirements. We will also provide management of the CRO from contract details through study reporting, or provide peer-review of any study report that you may have generated. Learn more
	The science of statistics Learn more