Pharmacokinetics (PK) modeling has been a useful tool thorough from pre-clinic to clinical (from Phase 1 to 3) in drug development, clinical research, and therapeutic optimization for centuries. The PK model used quantitative parameters to describe the complex...
BioPharma Services Inc. is a place where diversity truly thrives. It isn’t just a buzzword—it’s the heartbeat of our organization. With team members hailing from all corners of the globe, our workplace is a vibrant mosaic of cultures, languages, and traditions....
IND-enabling studies are crucial for advancing a New Chemical Entity (NCE) from preclinical evaluation to its first-in-human clinical trial. These studies comprehensively assess the NCE's safety, pharmacology, and manufacturing processes, leading to the submission of...
Clinical drug development progresses with the conduct of clinical trials, with different phases of clinical trials focusing on different aspects of the development process. Phase 1 clinical trials, including first-in-human studies, evaluate the safety and dose range...
Although strictly controlled, the introduction of therapeutic medications to normal healthy subjects can entail certain risks to the participants. For example, hypoglycemia is notably an anticipated adverse outcome in BA/BE and Phase 1 clinical trials involving...
Abstract. In this blog, we provide a comparison between simulation-based and conventional statistical methods, examining their respective principles, applications, strengths, and weaknesses. We provide a simple real-life example to illustrate similarities and...
