Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates. Q. I head up the ...

Techniques like SPME and QueChERS enhance sustainability by minimizing solvent and consumable use in sample preparation. With ...

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 ...

Responding to a lack of sensitive analytical methods for detecting associated medications in complex wastewater matrices, ...

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

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 ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

In this article, the author modestly expresses his views on the use and understanding of linearity, a key parameter to be determined in analytical method validation in quality control laboratories (QC ...

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 ...

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 ...