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...
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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...
A Simulation-based Decision Guide to Evaluate Missing Data in Clinical Studies
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...
A Simulation-based Decision Guide to Navigate Missing Data in Clinical Studies
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...
Clinical Research Coordinator (CRC) Journeys at BioPharma Services
This blog unfolds the varied journeys of three individuals at BioPharma Services, each narrating their unique experience in the clinical research landscape. From the initial steps as interns to evolving into Clinical Research Coordinators, their stories reflect the...
Crossing Clinical Frontiers: My Transition from CAMH to Phase 1 Studies Manager
In a world where our beginnings often predetermine our paths, my story is a testament to the power of perseverance, adaptability, and an unyielding commitment to excellence. Born into the confines of traditional Chinese customs, my journey has been about challenging...