Artificial intelligence (AI) - based technologies are increasingly finding applications in multiple industries, including the pharmaceutical field. AI integration into drug development contributes to the enhancement of testing accuracy and efficiency, expedites the...
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Bioanalytical Lab: The Benefits of High Quality
The bioanalytical laboratory of BioPharma Services Inc. (BPSI) has a proven track record for scientific excellence, perseverance, and an unwavering commitment to provide services of the highest quality. This has allowed establishment of efficient laboratory workflows...
Change Management of Computerized Systems and Common Challenges
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...
Advancing Regulatory Framework for Predicting the Proarrhythmic Risk
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...
Why Every Phase 1 Clinical Study Needs a “Protocol Champion”
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...
Internal Standard Responses in LC-MS/MS Based Bioanalysis: Friend or Foe?
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...