Blog

  • Use of Exposure-Response (ER) Modeling of QTc Data – A Movement Away from a Thorough QT Study

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    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 …

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  • Navigating the FDA Guidance for Nonclinical Abuse Liability Testing

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    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 …

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  • Stereology: Probing for Precision

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    Stereology is a tool for obtaining unbiased estimates of object numbers and/or sizes within three-dimensional regions of interest.  For biological samples, quantitative measurements are potentially more objective and accurate when compared to traditional semi-quantitative grading of findings by pathologists (i.e., scoring of morphologic changes as …

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  • Blind Slide Reading

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    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 …

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  • Using Transmission Electron Microscopy in Preclinical Safety Studies

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    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 …

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  • EPL – Independent and Employee-Owned

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    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, …

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  • Histology Slide Quality

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    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 …

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  • On-Time Pathology Reporting

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    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 …

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  • EXPEDITED SCHEDULING OF HISTOLOGY AND HISTOPATHOLOGY

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    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 …

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  • Immunohistochemical Assay Optimization – Tackling Intrinsic Study Variables

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    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 …

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