Preclinical Development Primer 101
*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 Credits: 1.5
Overview:
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.
- 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.
- Session 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.
- Session 5: Nonclinical IND/CTA: Explains what to include and how to complete the Common Technical Document.
By the end of the course, participants will be able to:
- 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.
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