BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
Preclinical Development
Preclinical Development focuses on both small and large molecule drug safety assessments and regulatory requirements. This course also explains how clinical starting dose levels are estimated. Learn what preclinical criteria is needed to support first-in-human clinical trials.
Takeaways
- In-depth knowledge of the preclinical development process.
- Understanding of the Animal Rule and how animal models enable clinical trials.
- Ability to estimate clinical starting dose levels by interpreting preclinical results.
- Knowledge of how to integrate preclinical data into the Common Technical Document.
- Fluency of criteria necessary to support first-in-human clinical trials.
Download Course Syllabus
Certificate Requirements
- View the entire course
- Pass course exam with a 70 percent
- Complete the course evaluation
Do you need to understand the drug development process, including details about a drug's life cycle from its discovery through post-marketing studies? This is the course for you.
The Regulatory Process provides a summary of the regulatory bodies involved in approving both small molecule drugs and biologics.
Drug Discovery of Biologics explains the steps involved in discovering new biologics, with a special...
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