Preclinical Development Primer 201
Preclinical Development Primer 201 builds upon the established knowledge in Preclinical Development Primer 101, utilizing real-world examples and case studies to delve deep into the specific tests and data required to file a successful Investigational New Drug (IND) application. The class focuses first on efficacy, centered around pharmacology studies, including binding and potency assays, and second on safety, including ADME, hERG, DART, PK/PD, mutagenicity, and carcinogenicity testing. This primer examines each preclinical test’s goals and outcomes, evaluating data results to determine therapeutic margin, side effects, and optimal drug concentration. Finally, the class describes the workflow, timeline, and standards for validating and qualifying these tests. Don’t miss this opportunity to understand preclinical development―secure your spot today!Â
Section 1: Overview
Discover key drug development metrics, including success rates, timelines, and costs. Get an overview of preclinical development, understand investigational new drug (IND) and clinical trial application (CTA) processes, and delve into pre-IND topics like pharmacology, pharmacokinetics, and toxicology.
Section 2: Pharmacology
Explore pharmacology essentials, including binding assays, dose-response curves, and drug mechanisms of action. Understand the design factors for drug products, and learn about challenges associated with animal models in this comprehensive course.
Section 3: Pharmacokinetics
Discover  the world of pharmacokinetics, covering ADME, regulatory compliance, bioanalytical assays, validation, and the measurement of pharmacokinetics and pharmacodynamics in this informative course.Â
Section 4: Toxicology
Explore the intricacies of animal model and species selection in preclinical testing, understanding the concordance of animal and human toxicities, differences between species, and the significance of therapeutic margin and adverse effects.
Section 5: Nonclinical IND/CTA
Learn the essentials of the Common Technical Document (CTD) and its role in IND and CTA filings, including the various types of INDs and the FDA’s Animal Rule, with a focus on effective interpretation.
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Five Takeaways
- State the FDA criteria necessary to support first-in-human clinical trials.
- List the required pharmacology assays, explain their purposes, and outline the criteria to move the candidate drug onto clinical trials.
- Analyze dose-response curves to estimate clinical starting dose levels.
- Name the required toxicology assays, list their purposes, and state the criteria to move the candidate drug onto clinical trials.
- Evaluate tissue culture and animal testing data to assess the drug candidate’s impact on safety.
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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