Category: Safety Assessment
EPL – Independent and Employee-Owned
Experimental Pathology Laboratories, Inc. (EPL) is an independent, private, employee-owned company that is recognized internationally for its ability to meet the needs of the scientific community and the challenges of preclinical safety testing and development with high quality histopathology services. EPL was founded in 1971, and became an employee-owned company in 1992. EPL is proud […]
Aclairo Welcomes Dr. Heath Thomas as New President
Experimental Pathology Laboratories, Inc. (EPL) and Aclairo Pharmaceutical Development Group, Inc. (Aclairo) are excited to announce that Dr. Heath Thomas has joined Aclairo as President and Senior Consultant. Dr. Thomas is a board-certified veterinary pathologist with over 20 years of experience in drug development from time spent with SmithKline Beecham, DuPont Pharmaceuticals, and GlaxoSmithKline, as […]
Navigating the FDA Guidance for Nonclinical Abuse Liability Testing
The goal of this discussion is to help one understand and address the Food and Drug Administration’s Guidance for Industry, “Assessment of Abuse Potential of Drugs” Drug abuse is the intentional, non-therapeutic use of a drug or substance to achieve a desired psychological or physiological effect. Abuse potential is a characteristic of a drug that […]
Blind Slide Reading
In toxicologic pathology, “blind slide reading” involves procedures in which the pathologist is unaware of the treatment group status of individual animals during the histologic slide evaluation phase of a toxicologic bioassay. Blind slide reading continues to be a controversial topic, despite published recommendations on this subject authored by professional societies and governmental regulatory agencies […]
Using Transmission Electron Microscopy in Preclinical Safety Studies
The use of Transmission Electron Microscopy (TEM) in preclinical studies has significantly waned in the last 20 or so years. There are multiple reasons for this. TEM is expensive and labor intensive. Compared to standard histopathology, TEM requires significantly more time and money to analyze samples. The cost of maintaining an electron microscope is practical […]
On-Time Pathology Reporting
It is every client’s desire and expectation that their study report will be completed “On-Time” or better yet, be available ahead of schedule. There are a number of factors that determine whether a pathology report will be early, on time, or in the worst case scenario, delayed. Most situations are readily managed, but in rare […]
EXPEDITED SCHEDULING OF HISTOLOGY AND HISTOPATHOLOGY
Kerry Crabb, HTL(ASCP), is the Manager of North Carolina Laboratory Operations at EPL. Kerry joined EPL in 2015, and brought with him over 25 years of experience in managing histology laboratories. Kerry’s experience at both large pharmaceutical and agrochemical companies gave him a broad knowledge on some of the best practices related to histology and […]
Immunohistochemical Assay Optimization – Tackling Intrinsic Study Variables
Immunohistochemistry (IHC) is employed routinely for investigative and diagnostic evaluations of antigen-antibody interactions within cells or tissues. While most IHC target antigens are proteins, other antigenic biological substrates can also be recognized by antibodies (e.g., carbohydrates, lipids, or nucleic acids). Accurate and reproducible results are achieved when procedures used to identify and localize tissue antigens […]
Information List for EPL’s Unique Pathology Peer Review System
In 2017, EPL has conducted 189 pathology peer reviews, including 28 peer reviews on 2-year carcinogenicity studies and transgenic rasH2 mouse 26-week carcinogenicity projects. Each project requires set up of our unique peer review system ahead of the actual peer review conduct. Our PQA software program is a computerized pathology peer review procedure developed at […]
EPL Pathology Peer Review
When selecting a Pathology Peer Review provider, experience is an important factor to consider in order to ensure high quality pathology data. Over the last two years alone, EPL has conducted more than 250 pathology peer reviews. These pathology peer reviews have been conducted internationally, with reviews being performed across North America, Asia, and Europe. […]