The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process. etrmalinak/shutterstock.com The US Pharmacopeial Convention ...

The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications. The words ‘method’ and ‘validation’ do not ...

This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle, which includes the activities of validation, verification, and transfer, to allow ...

This webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025:2005 for laboratory accreditation in food/water ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

Clinical development of new anticancer drugs can be compromised by a lack of qualified biomarkers. An indispensable component to successful biomarker qualification is assay validation, which is also a ...

The main objectives of this study were to develop a method for the measurement of cocaine derivatives in oral fluid by coupling a probe electrospray ionization (PESI) source with quadrupole ...