The Drug Development course from the University of California San Diego delves into the complex process of bringing drugs to market. With lectures from industry experts and faculty, you will gain comprehensive knowledge of clinical development stages, regulatory requirements, and study design methods.
Through an in-depth exploration of clinical trial phases, including Phase 1, 2, and 3, you will understand the critical aspects of safety, tolerability, and efficacy assessment in multiple therapeutic areas. Additionally, the course covers regulatory considerations for Investigational New Drug Applications (IND), New Drug Applications (NDA), and product labeling, providing a holistic view of the drug development process.
Certificate Available ✔Get Started / More Info
This series of modules covers various aspects of drug development, including regulatory considerations, clinical trial phases, and industry insights. Gain comprehensive knowledge about the drug development process from this course.
The welcome module introduces the course and its key objectives, providing an overview of the comprehensive content covered throughout the program.
Explore regulatory considerations for Investigational New Drug Applications, including insights into user fees, the FDA's impact on drug development, and interesting findings from ClinicalTrials.gov.
Gain insights into clinical study and start-up activities, including ethical concerns, through a series of informative modules led by industry experts.
Delve into the critical Phase 1 clinical trials, understanding major safety situations and their impact on drug development in this comprehensive module series.
Understand the significance of Phase 2 clinical trials and their impact on drug development, including insights into changing medical technology and its influence on clinical studies.
Gain industry insights into Phase 3 clinical trials, exploring considerations, globally influenced drug discoveries, collaboration stories, and the value of running studies in different countries.
Learn about the New Drug Application filing process and product labeling considerations, including discussions on data sources, drug promotion, and its impact.
Learn about cutting-edge experimental methods in systems biology, including RNA sequencing, mass spectrometry-based proteomics, flow/mass cytometry, and live-cell...
MRI Fundamentals is a comprehensive course covering the basic principles of magnetic resonance imaging (MRI). Learners will gain expertise in MRI physics, data acquisition...
This course on Systematic Review and Meta-Analysis provides a comprehensive understanding of the systematic review process and its distinct stages, enabling participants...
Whole genome sequencing of bacterial genomes - tools and applications. Learn to apply WGS technology and bioinformatic tools for surveillance and characterization...