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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 […]
Use of Exposure-Response (ER) Modeling of QTc Data – A Movement Away from a Thorough QT Study
Since 2005 the US Food and Drug Administration (FDA) has required the evaluation of a new molecular entity in a thorough QT (TQT) study, which is intended to determine a drug’s effect on the QT interval. The QT interval represents the duration of ventricular depolarization and subsequent cardiac repolarization, measured from the beginning of the […]
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 […]
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 […]
Histology Slide Quality
A quality histological slide contains tissue that was properly sampled, fixed, processed, embedded, microtomed, and stained without artifacts. The production of a quality slide requires work be conducted according to the highest standards during each phase of histologic processing. The first and most important steps are precise necropsy techniques (e.g., postmortem interval, tissue sample size […]
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 […]
EPL Histology – Tissue Accountability and Routine Recut Procedures
Since 1971, EPL has developed and refined methods to provide high quality and efficient histopathology services. The following information details some of the steps taken during histology processing and preparation at EPL, to ensure tissue accountability and define routine tissue recut procedures. Tissue Accountability on All Studies: Each study received at EPL will be assigned […]
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 […]
Histology – How to Ensure the Quickest Possible Timeline
With the processing of up to 50,000 tissues per month, and projects regularly flowing in and out of our labs, histology scheduling at EPL is a continual process. Recognizing that the project timeline, in addition to quality and expertise, is one of the most important factors to our clients, we’re providing the following tips on […]