In the News
Parallelism experiments: pros and cons
Jing Tu and Patrick Bennett discuss available approaches that can be used to assess key assay parameters for pharmacokinetic and biomarker ligand-binding assays.
An overview of major reforms in China’s regulatory environment
Alistair Davidson and Bill Wang analyze the potential impact of a series of regulatory changes and improvements on clinical development in China.
Standard data, extraordinary innovations in clinical trials
Tammy Jackson discusses the innovative application of CDISC SDTM standards in clinical trials.
The Changing Role of the CRO and its Effect on Project Management
Volker Hack and Denise Sackner write about the impact of increased clinical trial complexity on project management.
Troubleshooting Lab Operations: Be Proactive, Not Reactive
Chris Forsdyke reviews systems and processes that enable a laboratory to approach troubleshooting in an effective way.
Contamination Control and Environmental Monitoring Program Results
Peter Wunderli, Jon Denissen, Maggie Bach, Moira Elmore and Erica Golueke discuss the results of a monitoring program at a GMP QC cell-based (bioassay) lab, along with a risk analysis and their recommendations.
Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions
In this article, Monika Jain discusses the issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products.
CROs and Next-Gen Drug Development
PPD's David Johnston comments on the new operational, organizational and partnership-based approaches to drug development.
Solid-Phase Extraction for the Preparation of Aqueous Sample Matrices for Gas Chromatographic Analysis in Extractable/Leachable Studies
Steve Zdravkovic outlines the attributes of solid phase extraction and the advantages it offers compared to liquid/liquid extraction.
