In the News
Navigating the changing regulatory landscape for laboratory-developed tests: a CRO lab perspective
Poluru Reddy and Anup Madan discuss the vital role laboratory-developed tests often play in drug development and clinical trials.
Flow cytometry: a bioanalytical platform for cell and gene therapy
The authors discuss the powerful technology that flow cytometry offers the emerging cell and gene therapies field.
A reliable method for quantitating extractables and leachables in medical and pharmaceutical-grade plastics
This article presents the use of charged aerosol detection combined with LC/UV-MS to obtain a more complete E&L profile.
IVD manufacturers are being put to the test
PPD clinical research business experts comment on how the COVID-19 pandemic has accelerated the trend toward home diagnostics and raised the bar for faster, more detailed test results.
Harnessing the Power of Scientific Surveillance
The authors discuss how inclusion of scientific surveillance techniques as part of centralized monitoring enhances the ability to monitor critical and non-critical data.
Advancement of Cell Therapy in China – Challenges and Opportunities in 2023
The authors explore the advancement of CAR-T therapies in China. While initial strides were primarily being made in the U.S. markets, can both foreign and domestic players win in China’s CGT market?
Incorporating Real-world Evidence into the Life Cycle of Drug Development
Susan Oliveria discusses how and why RWD and RWE are making an important impact on the development of medicines.
Extractables & Leachables: Detecting the Unknown with E&L Analysis
The authors examine how a new generation of extraction, identification and quantification tools – now recognized as approved methods by regulatory bodies – is changing the E&L testing landscape.
Making Clinical Trials More Sustainable by Digitization and Decentralization
Michael Cohen comments on how digitizing, decentralizing and near-patient can reduce the environmental impact of clinical research.