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...
Choosing the right pharmacokinetic (PK) model is like finding the perfect recipe for a gourmet meal; it requires precision, expertise, and a deep understanding of the ingredients involved. In the world of drug development, PK models are the secret sauce that can make...
At the 2024 DIA Annual Meeting in San Diego, the pharmaceutical and healthcare industries converged on several pivotal reflecting ongoing transformations within the sector. Here are some key themes that dominated discussions: AI in Drug Development: Discussions...
