Preclinical Development Primer 201
*This microcourse includes optional CPE Credits and is powered by Biotech Primer, a trusted leader in life science training that simplifies complex topics for non-scientists.
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Optional CPE Credit: 1.0
Overview:
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.
- 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.
- Session 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.
- Session 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.
By the end of the course, participants will be able to:
- 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.
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