Validation of an analytical method provides evidence that when correctly applied, it produces results that are fit for purpose, thereby demonstrating the effectiveness of the method with an acceptable ...

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with ...

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process. The US Pharmacopeial Convention (USP) released a general ...

Article Views are the COUNTER-compliant sum of full text article downloads since November 2008 (both PDF and HTML) across all institutions and individuals. These metrics are regularly updated to ...

Adel B. Shehata *, Abdulrahman R. Al Askar, Mohammed A. Al Rasheed, Abdulrahman M. Al Zahrany, Fahd A. Al Kharraa, Sowailem A. Al Sowailem Chemistry Department/National Measurement and Calibration ...

The concept of an analytical lifecycle has been well received in the biopharmaceutical industry. In 2016, the US Pharmacopeia (USP) advocated for lifecycle management of analytical procedures (1) and ...

Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses 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 news that the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) intends to implement a new Quality Guideline, ICH Q14, “Analytical Procedure ...

The “3-faced construct validation method” is a routine for establishing the validity and reliability of an existing scale when adapted in a different cultural context from the context initially ...