Category: Toxicology
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 […]
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. […]
Get to Know Aclairo
Aclairo® Pharmaceutical Development Group, Inc. is committed to delivering independent and objective nonclinical and regulatory advice to the pharmaceutical industry. Every member of Aclairo’s staff strives to provide our clients with superior advice, analysis, work product and program assistance. Aclairo’s unique experience and capabilities help our clients’ development programs succeed. Our senior consultants are experienced ex-FDA […]
EPL’s SEND Capabilities
The Standard for Exchange of Nonclinical Data (SEND) provides preclinical study data standards that will allow for a more consistent and streamlined review process by the US FDA. In general, SEND formats apply to studies started after Dec. 17, 2016 for NDAs, BLAs, and ANDAs, and studies that start after Dec. 17, 2017 for INDs. […]
EPL to Participate in Webinar: Using Electron Microscopy in Nonclinical Studies
Dr. Tom Steinbach from EPL will be the featured speaker for the Webinar titled, “Using Electron Microscopy in Nonclinical Studies,” which is jointly sponsored by the Society of Toxicologic Pathology-India (STP-I), International Federation of Societies of Toxicologic Pathologists (IFSTP), and International Academy of Toxicologic Pathology (IATP). This webinar will be held on Thursday, May 25, […]
Experimental Pathology Laboratories and WestChina-Frontier PharmaTech Form Strategic Alliance for Preclinical Services
Experimental Pathology Laboratories, Inc. (EPL), and West China-Frontier PharmaTech Co., Ltd. (WCFP) announce a Strategic Alliance to enhance Preclinical Services. This alliance is targeted to bolster the rapid growth of WCFP by specifically providing EPL’s Pathology Peer Review Services for WCFP projects that are being submitted to international regulatory agencies. WCFP is experiencing rapid growth […]
Experimental Pathology Laboratories, Aclairo Pharmaceutical Development Group, and Expedient Solutions International Form Strategic Alliance to Enhance Pathology and Regulatory Consulting Services to the Greater China Region
Experimental Pathology Laboratories, Inc. (EPL), Aclairo Pharmaceutical Development Group, Inc. (Alcairo), and Dr. Ada H.C. Kung with Expedient Solutions International (ESI) announce a new strategic alliance to enhance Preclinical Pathology and Regulatory Consulting Services to the Greater China pharmaceutical and biotechnology industry. This alliance is targeted to expand and enhance EPL, Aclairo, and ESI’s capabilities […]