forChange is the only constant, and clinical research organizations (CROs) have evolving needs and technology, which brings change regularly. As a Phase 1 clinical trial CRO, and a heavily regulated industry, strict protocols, and compliance requirements govern every...
The issue of QT prolongation has garnered significant attention from regulatory bodies such as Health Canada, the Food and Drug Administration (FDA), and the European Medical Agency (EMA). Back to the 1950s, doctors observed an alarming phenomenon among some heart...
The clinical drug development process is challenging and time-consuming and requires the collaborative efforts of a multidisciplinary team of experts over a prolonged period of time. Accordingly, one of the challenges associated with clinical studies, including Phase...
The use of LC-MS/MS in regulated bioanalysis is common-place due to its high sensitivity, selectivity, quantitative accuracy, and reliability. Internal standards play a key role in quantitative bioanalysis, compensating for variability in the analyte response. In...
Comparative bioavailability (BA) or bioequivalence (BE) studies might be one of the most common clinical trials for both new drug innovators and the generic manufactures. Like other studies with PK endpoints, selecting an adequate and robust sampling time is essential...
Missing Data – A Common But Critical Issue in Clinical Studies In part one, of this two part blog series, we will discuss the missing data issue in clinical studies. In bioavailability (BA) and bioequivalence (BE) studies with pharmacokinetic endpoints, the occurrence...
