FEATURED ARTICLES
Many ’omics’ technologies have now become the primary way of discovering new biomarkers, and validation of these biomarkers is a relatively new and evolving concept. By Michael V. Milburn, John A. Ryals, and Lining Guo
-
Comment On Biopharmaceutical Classification System And Formulation Development
This is the first installment in a series of articles that will provide an overview of an area of potential interest to the readers of Pharmaceutical Online and Outsourced Pharma. By Mark Mitchnick, MD, and Robert W. Lee, PhD
-
Considerations In Using Foreign Trial Data In U.S. NDA Submissions
More and more drug companies are finding it financially advantageous to conduct clinical trials in foreign countries and to include data from these trials in NDA submissions. When offshore trials are properly conducted and the data is properly handled, this strategy can accelerate approval and lower the cost of drug development. By Ken Phelps, Camargo Pharmaceutical Services
-
Successful Bioanalysis Outsourcing In Support Of Drug Development Program: Key To Risk Mitigation Planning For Mid-Study Method Transfer We have developed processes to enable consistent method performance during method transfer. This has ensured timely method transfer validation and study sample analysis in support of new drug development and product commercialization.