Covance Blog
Gene therapies continue to hold promise as treatments for many diseases but there are numerous and unique challenges to developing them for submission as an Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) application for use in clinical trials. These applications require an optimized scientific program designed to address …
As outlined in ICH Q6B “Test Procedures and Acceptance Criteria for Biotechnological/Biological Products” (CPMP/ICH/365/96), the regulatory expectation for any developmental biopharmaceutical is that a wide range of analytical methodologies are used to characterize the therapeutic. Generally, this means the application of orthogonal physicochemical and biophysical techniques to provide a comprehensive …
We know it is really October, but we held the posting of this edition until we could point you to the full scientific article on DCT Data Management located on Covance.com. We hope you will find it to be worth the wait! Welcome to the September edition of the Covance …
Optimization of human absorption, metabolism, and excretion (hAME) studies, and their timing, increases the chance of drug development success, saving time and resources. This digital whitepaper provides advice and insight on how to make the right choices when planning and conducting hAME studies and how to leverage preclinical and clinical …
As the pharmaceutical industry continues to seek ways to increase efficiency in bringing life-saving treatments to the patients who need them, a focus on both the ethical and financial benefits of patient-centric sampling has intensified. In this blog, Covance Director of Bioanalytical Science, Stephanie Cape, PhD, discusses the benefits, evolution …
The COVID-19 outbreak that began in Wuhan, China, in December 2019 was declared a pandemic on March 11, 2020 by the World Health Organization, and has since affected almost every country around the world. Cancer patients have been significantly impacted, through both clinical practice as well as engagement and participation …
Understanding the expectations and challenges The pharmaceutical and medical device industries are seeing a substantial increase in combination products, and the related regulatory environment has been very dynamic. Recently, I was privileged to moderate a PharmaVOICE webinar on the latest U.S. FDA post-marketing safety reporting (PMSR) ruling and guidance. Expert …
Weathering natural disasters and the COVID-19 pandemic To drive speed to therapy, reduce financial burdens and empower patient engagement, a Patient Support Services Call Center provides myriad support services that stakeholders depend upon. For pharmaceutical manufacturers, these services have gone from “nice to have” to “must-have,” driven by the growth …
Turn to Covance FSPx® to jump-start or re-start your clinical trial The COVID-19 pandemic has had a profound effect on clinical development, with hundreds of clinical trials paused or delayed. Travel restrictions and the fear of potential exposure to the virus prevented many patients from making site visits, and the …
To deliver on the mission of improving health and improving lives, patients need access to safe and effective treatments. As part of safety testing, abnormal toxicity tests, also known as general safety tests, are often performed when a drug manufacturer creates a batch of its licensed pharmaceutical or biotechnology-derived product.
