Validation

June 17, 2021

The Analytical Detective: Understanding Impurities in the Molecule Assessment Process

Colman Byrne, a senior analytical services expert at DSI, describes the molecule assessment process as detective work, in which physical chemists assess different pieces of information to solve a puzzle. Questions that must be answered in the process include: What is the product supposed to be and do?
July 15, 2021

The Analytical Detective: Benefit-Risk Balance and the Analytical Testing Process

In any pharmaceutical development program, there are risk-benefit analyses being done to assist with decision-making processes. Expedited development presents a different balance to a company’s risk-benefit in order to bring a particular molecule forward as quickly as possible because of the potential benefits.