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!
Non-CPE Credit
CPE Credit
Section 1: The Big Picture
Describes timing and cost for the major drug development steps by reviewing industry statistics.
Section 2: Pharmacology
Discusses the key data generated during pharmacology studies and how that information is used to move from animal studies to human studies. In addition, specific challenges in assessing pharmacology in biologics and small molecule drug candidates are explored.
Section 3: Pharmacokinetics and Pharmacodynamics
Demonstrates how pharmacokinetics is used to characterize the exposure-response relationship for a drug candidate, discusses the typical endpoints calculated, and describes bioanalytical assay and validation criteria.
Section 4: Toxicology
Describes the importance of toxicity studies and how the information obtained helps select compounds, establishes safety parameters of those compounds and influences animal model choice, dose selection, and routes of administration for the candidate drug. Concepts such as therapeutic margins and subjectivity in making conclusions based on sample study data are explored.
Section 5: Nonclinical IND/CTA
Explains what to include and how to complete the Common Technical Document.
Five 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 dose 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.
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates