How to answer basic physical chemical questions for your chemical and agrochemical substances when test guidance changes and as regulatory standards evolve

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.


Biological characterization of mAbs: role of Fc receptors in activating and regulating immune response

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 …


Biological characterization of mAbs: assessment of Fc-mediated effector function

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 …

Optimizing ADME/hAME studies

Optimize your ADME/hAME study to overcome barriers and avoid delays for drug development success

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 …


Patient-Centric Sampling Evolution

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 …

Covid Temp Check

Adapting oncology clinical research practices and therapeutic development strategies in the covid-19 era

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 …


Combination Products: Post-marketing safety reporting

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 …