Covance Blog
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 …
尽管大多数ph值ysiochemical 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 …
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 …
