What is the Adaptive Sample Size Sequential Design? Adaptive Sequential Designs have been widely used in human clinical trials for new drug development since the 1970s, and can provide a variety of advantages over non-adaptive designs. In 2008, Potvin et al. proposed...
Background Psychedelics have been at the center of attention, promising to be the long-awaited revolution in the treatment of several psychiatric disorders. Psychedelics are psychoactive substances that can induce visual or auditory hallucinations, perceptual changes,...
Within a Clinical Research Organization (CRO) such as BioPharma Services, the successful execution of the clinical aspect of a study is a multidimensional and multi-faceted operation. The process often, if not always, involves multiple teams that must function as a...
Background on CNS Drugs Companies regularly approach BioPharma Services to receive practical and pragmatic feedback on the FDA mandated physical dependence studies. Central nervous system or CNS drugs need to be assessed for abuse potential – determining if patients...
The recruitment and retention of study participants are essential for the success of clinical trials, including Phase 1 clinical trials and 2 studies. Unfortunately, many clinical trials are unable to recruit a sufficient number of study participants to ensure...
Benefit Bullets: Understand Dose Proportionality: Gain insight into how dose proportionality impacts drug exposure, allowing you to predict therapeutic levels and avoid toxicity. Strategic Clinical Planning: Learn the importance of precise dose-response studies in...
