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 Primer 101
Preclinical Development Primer 101 guides you through the essential steps of early-stage drug development and the efficacy and safety standards that must be met prior to beginning clinical trials. This class integrates the key disciplines of pharmacology, pharmacokinetics/ pharmacodynamics, and toxicology to showcase the attributes that make a compelling drug candidate. This primer finishes by revealing the regulatory steps to file an Investigational New Drug (IND) application required to initiate clinical trials. This 101 class equips you with the foundational knowledge needed to understand the basics of preclinical development. Join now and gain a command of the preclinical process!
Takeaways
- List in order the crucial steps involved in preclinical development and state the purpose of each.
- Compare the objectives of pharmacology and toxicology in preclinical development.
- Contrast the data received in pharmacodynamics and pharmacokinetic studies.
- Explain how to estimate starting does in animals using data from in silico and in vitro testing.
- State the importance of integrating data collected during pharmacology and toxicology studies into the Common Technical Document for an IND submittal.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher
Explore drug approval process for small molecules & biologics: regulatory bodies, application process, preclinical to clinical studies, final approval.
A digital strategy can no longer lie within a siloed digital or innovation team. It’s critical to integrate digital across the enterprise to maintain a competitive edge.
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.
Explore biologics discovery: target screening, validation, optimization & transition to preclinical development.