Walker Downey & Associates, Inc.

Pathology Services

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Within the product development cycle, comprehensive assessment of pathologic changes is critical to the evaluation of nonclinical toxicology and research studies. Walker Downey & Associates pathology services functions as a fully-integrated component of our evidence-based toxicology consulting and product safety and development evaluations, or as a stand-alone service. Our pathologists provide consulting and support for Discovery research, exploratory safety assessments, proof-of-concept and investigative studies, and regulated safety studies. In addition to traditional gross and microscopic pathology services, Walker Downey & Associates offerings include special tissue stains, immunocytochemistry, ultrastructural evaluation, and other techniques to accommodate the often molecule-specific needs of the rapidly evolving molecular and cellular pathology segment of the biomedical community. Pathologic or histologic examination of tissues can also be used for animal model development to confirm that the predicted changes occur in genetically engineered and/or drug-treated animals.

	Walker Downey & Associates will serve as a product safety and development pathology consultancy for your project team from discovery and proof-of-concept through preclinical testing. We will participate in evidence-based risk assessments, expert opinions, and formal peer reviews. Our staff has extensive hands-on experience in the histopathological assessment of product safety studies and we work closely with clients to ensure protocol consistency and compliance with Good Laboratory Practice (GLP). Learn more
	Pathologists at Walker Downey & Associates will subjectively rank the degree of severity of microscopic lesions as mild, moderate. or severe. While categorical in nature, these data do not have to be restricted to nominal form. By attributing a semi-quantitative measure of degree (1+, 2+, 3+, etc) to a process, ordinal data may be generated allowing more powerful non-parametric statistical analytical techniques than those used for nominal data. In fact, if the number of datum is large, transformation and evaluation for normality may allow classical parametric analysis. Learn more
	Morphometry in pathology is the process of measuring the shape, area, and volumes of tissue structures, an important tool for the quantitative analysis of histologic data. Information derived from morphometric studies provides a more precise assessment of the physiologic or pathologic state than that which can be derived from purely descriptive means. Learn more
	The staff at Walker Downey & Associates is widely recognized as experts in their respective fields owing to their many years of professional work experience, extensive academic training, board certifications, and professional affiliations. Our authoritative, evidence-based Expert Opinions, or White Papers, have been viewed by numerous international regulatory agencies in support of his client’s submissions. Expert Opinions can be useful at any stage of the product development cycle. 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 pathology from preclinical study reports, or other written documents by our internal scientists who are experts in the field. Learn more
	The science of pathology. Learn more