Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...

As drug developers pursue increasingly complex therapies, traditional bioanalytical approaches are being put to the test. How ...

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 ...

Real world analysis of VTE incidence in lung cancer: A comprehensive assessment of the Khorana score and other clinical factors in predicting VTE incidence. This is an ASCO Meeting Abstract from the ...

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Cardiovascular diseases are the major cause of global mortality, and often require the concomitant use of a number of drugs to prevent and reduce these deaths. The challenge is to find effective and ...

Simply put, orthogonal validation uses additional methods that provide very different selectivity to the primary method to confirm or refute a finding. All methods are independent approaches that can ...

LC-MS/MS has been increasingly adopted by clinical laboratories due to the potential it has for increased sensitivity and specificity over more commonly used analytical techniques. However, ...

A team of biologists and computer scientists has mapped out a network of interactions for how plant genes coordinate their response to nitrogen, a crucial nutrient and the main component of fertilizer ...

In this study, 15 different mycotoxins were estimated in three staple cereals from selected agro-ecological regions in Nigeria using a ‘novel’ green extraction method, pressurized hot water extraction ...