Uncategorized

Reading Time: 3 minutesSince 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 […]

Reading Time: 2 minutesThe 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

Reading Time: 3 minutesThe 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

Reading Time: 3 minutesA 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

Reading Time: 3 minutesIt 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

Reading Time: 3 minutesKerry 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

Reading Time: 2 minutesSince 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

Reading Time: 2 minutesIn 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

Reading Time: 2 minutesWith 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

Reading Time: 2 minutesWhen 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.