Preclinical Development

  • Course Price: $150
  • BIO Member Price: $120
  • 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 is needed to support first-in-human clinical trials.

  1. In-depth knowledge of the preclinical development process.
  2. Understanding of the Animal Rule and how animal models enable clinical trials.
  3. Ability to estimate clinical starting dose levels by interpreting preclinical results.
  4. Knowledge of 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
  • Complete the course evaluation
Section 1: Overview
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: Pharmacokinetics
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: Nonclinical IND/CTA
Explains what to include and how to complete the Common Technical Document.
Final Quiz
Course Evaluation
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation
You have two weeks from time of purchase to complete any of the online courses. For example, if you purchase the course at 9 am on Saturday, the course will close at 9 am 14 days later.

You can pay an additional fee for an extension.

Our online courses are between 40 minutes and 85 minutes in length. We suggest allowing 20 minutes to take the end of the course quiz and 10 minutes for the course evaluation. 

Yes, each course has an accompanying pdf that contains all of the presented course information. You will be able to download the pdf once you have registered for the course. 

There are no refunds if you decide to not take the course once you have registered. 

The online courses are fully animated with a professional voice-over. Each course begin with an overview of what you will learn, the course itself, and then ends with a course quiz to assess your understanding.

You can repeat the course as often as you like within your two week run time.

You have two chances to pass the quiz. A passing score is 70% or higher. 

Each course is to be taken by one individual. If you would like to take our online courses as a group, please contact Stacey Hawkins at This email address is being protected from spambots. You need JavaScript enabled to view it. for pricing.

There are three requirements to receive your course certificate. 1. You must view the entire course. 2. You must pass the course quiz with a 70%. 3. You must complete the course evaluation. You can download and print your certificate from your dashboard.

Before moving on to the next section of our on-demand, online courses, all slides within a section must be viewed.

There is an easy way for you to see which slides you have completed and not completed in the course. Look at the menu on the left side of the course- the slides that have been seen are darkened and the slides that have not been seen are light. 


Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation