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!
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.
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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
FAQ
- How long do I have to complete an on-demand course? You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
- What happens if I don’t complete the course in one year? There are no time extensions. If you want to complete the course, you must purchase it again.
- How long are the on-demand classes? Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes. The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
- Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
- What is the format of the on-demand classes? The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
- Can I repeat the course? You can repeat the course as often as you like within your one-year access.
- How many times can I take the course quiz? You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
- May I share a course I purchased with others? Each course is to be taken by one individual. If you want to learn as a group, please contact us at training@biotechprimer.com for group pricing.
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