When transferring a method from R&D to quality control, success hinges on discovering where “the best” and “the most reliable” intersect. Analytical method transfer suffers from many of the same ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

AAPS, San Antonio (Oct. 31)-Industry and regulatory agency concerns over process variability have prompted both groups to take a closer look at analytical method transfer processes. Pappa presented ...

These must report preliminary research findings that are highly original, of immediate interest and are likely to have a high impact. Communications are given priority treatment, are fast-tracked ...

To develop effective food control systems, regulatory bodies and laboratories in Member States must have the capability to apply sound sampling schemes and analytic methods. Our efforts focus on the ...

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...

Last month, we discussed the different forms of data analysis and their applicability across different organizations and different uses cases. Understanding the landscape of available data analytics ...