Biotherapeutic medicines generated by living cells or organisms are
larger and more complex than chemically synthesized, small molecule
medicines and feature varied mechanisms of action (MOA). They also
are more prone to heterogeneity, and subtle differences may occur
across product lots, ...
International Council for Harmonisation Integrated Addendum to ICH E6
R1 - otherwise known as ICH E6 R21
- suggests centralized monitoring
be incorporated as an important monitoring methodology in clinical
trials. Different companies are taking different approaches to deploy
centralized ...
PPD’s QC bioassay laboratories in Middleton, Wisconsin, U.S., and Athlone, Ireland, previously reported observations regarding contamination control (CC) and environmental monitoring (EM) made over time and across program changes (Pharmaceutical Outsourcing, March/April 2016).
Leachables are compounds or elements that migrate from the container/closure system components, manufacturing process components or drug product delivery system components into the drug product formulations or directly to the patients under normal conditions of storage or use.
The current pharmaceutical and clinical research environment is in a constant state of change. Business decisions resulting in mergers, acquisitions and resource depletion, coupled with increasing regulatory and pharmacovigilance (PV) safety requirements, have required business leaders to make ...
Rhonda Henry has more than 27 years of clinical research experience, all of which have been with PPD. As vice president of site networks and patient centricity for the global contract research organization, Henry develops PPD’s site network strategies and patient-centric trial models to improve the ...