Covance Blog
Immunohistochemistry (IHC) is a useful tool for immunophenotyping because it enables the visualization of immune system cells in context of their tissue environment. This post examines IHC in relation to other immunophenotyping tools and highlights the challenges of interspecies interpretation of IHC from toxicological pathology during early drug or preclinical …
The following blog is an adaptation of a conference presentation by Covance in September 2020 that was also re-recorded and available here Background: Medical monitoring supports the correct determination of patient eligibility for CAR T-cell therapy and plays a key role in monitoring quality patient care throughout CAR T clinical …
The EOGRTS or OECD 443 is a scientifically and logistically complex study. Five critical success factors can help you overcome the complexities to achieve DART success.
Welcome to the October 2020 edition of the Covance DCT Blog. When sponsors consider implementing a decentralized clinical trial (DCT), one of the key challenges that has been largely aspirational until now is that the trial experience should be as seamless as possible. There are many stakeholders in any clinical …
Although most physiochemical endpoints are standard for crop and chemical active substances, selection of the right test method to assess them is critical. This blog reviews some standard endpoints and looks at the tests used, in the light of changing regulatory expectations and revised test methodologies for difficult substances.
As well as interacting with the target antigen, antibody derived therapeutics have the potential to be able to interact with components of the immune system. Interactions with the innate immune system trigger effector functions such as antibody dependent cellular cytotoxicity (ADCC), complement dependent cytotoxicity (CDC) and antibody dependent cellular phagocytosis …
The COVID-19 pandemic forced a sudden shift in the conduct of clinical trials to ensure patients stay safe and retain access to their treatments. But how has this shift affected trials that focus on pediatric populations? To better understand the voice of pediatric patients, our team at Covance recently held …
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 …
