Sensitivity of pretargeted 68Ga PET-CT to detect colorectal carcinoma liver metastases in a mouse model: Comparison with 18FDG PET-CT. This is an ASCO Meeting Abstract from the 2015 ASCO Annual ...

Method-transfer kits help simplify analytical method transfer for global site certifications. Method transfers are required to enable critical medications to reach ...

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 ...

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 ...

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 ...

Successful introduction of new anticancer agents into the clinic is often hampered by a lack of qualified biomarkers. Studies have been conducted of 17 ELISAs ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...