Preclinical Development For Non-Scientists

  • Course Price: $150 USD
  • BIO Member Price: $120 USD
  • Course Run Time: 55 minutes
  • Course Level: Level 1 - Foundational
  • Completion Period: 2 week

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 are needed to support first-in-human clinical trials.

 

Takeaways
  1. In-depth knowledge of the preclinical development process.
  2. State the key data generated during pharmacology studies and why those data are collected.
  3. Ability to estimate clinical starting dose levels by interpreting preclinical pharmacology and toxicology results.
  4. Explain how to integrate preclinical data into the Common Technical Document.
  5. Fluency of criteria necessary to support first-in-human clinical trials.
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
Trailer
Section 1: Preclinical Overview
1
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 additio...More
Section 3: PK and PD
Demonstrates how pharmacokinetics is used to characterize the exposure-response relationship for a drug candidate, discusses the typical endpoints cal...More
Section 4: Toxicology
Describes the importance of toxicity studies and how the information obtained helps select compounds, establishes safety parameters of those compounds...More
Section 5: Preclinical Regulatory Filings
Explains what to include and how to complete the Common Technical Document.
Final Quiz
LinkedIn Certificate Demo
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent