Abstract:
Regulated bioanalysis plays a critical role in drug development and discovery. Bioanalysis refers to the process of identification and quantification of analytes in biological samples. This is a multistage process that starts with method development, followed by method validation, and ends with data reporting. It is critical to apply a fit-for-purpose approach to the study-specific bioanalysis and comply with FDA guidelines and regulations to generate validated bioanalytical results. As a clinical pharmacology intern at Kartos Therapeutics, I worked with great researchers to understand the key elements of regulated bioanalysis by evaluating different clinical and nonclinical studies. Having a good understanding of the physicochemical properties of analytes and being aware of technical considerations are essential to method development. It is also necessary to evaluate the sample preparation technique so that it can achieve desired sensitivity and specificity for sample analysis. In addition, this summer internship helped me develop a holistic view of the complexities of the biopharmaceutical industry. More importantly, this internship highlighted the significance of collaboration and effective communication to expedite the drug development process. Having reliable and reproducible bioanalytical results can ensure that we properly interpret clinical PK data of the drug and provide insights into dosing decisions in clinical trials. Ultimately, these study results serve as the foundations for the safety and efficacy of the approved medicines.