Empowering professionals for over 24 years

Empowering professionals for over 24 years

Preclinical Development Primer 101  | CPE – CPE LATEST

Preclinical Development Primer 101  | CPE – CPE LATEST
  • Level: Beginner
  • CPE: 1.50 Credits
  • Time: 55 Minutes

Gain business insights by understanding early drug development with Preclinical Development Primer 101. Explore the role of pharmacology, pharmacokinetics, pharmacodynamics, and toxicology in shaping strong drug candidates that meet FDA standards for IND submission and progression into clinical trials.

  1. Understand the purpose of preclinical development
  2. Learn the types of safety and efficacy studies required before IND submission
  3. Gain insight into key milestones and decision points in preclinical development
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  • 1-month access to all course material
  • CPE credits included
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  • Self-paced and on-demand
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  • Overview
  • Agenda
  • Features
  • Justify This Training
  • FAQ

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Agenda

  1. The Big Picture

    Lists the steps of the drug discovery, preclinical, and clinical development process, including activities, costs, and timing generally associated with each stage.

  2. Pharmacology

    Discusses the key data generated during pharmacology studies and how that information is used to move from animal studies to human studies.

  3. Pharmacokinetics and Pharmacodynamics

    Demonstrates the use of pharmacokinetics and pharmacodynamics to characterize the drug candidate.

  4. Toxicology

    Describes the importance of toxicity studies in guiding compound selection, defining safety parameters to inform dose and administration route.

  5. Preclinical IND/CTA

    Describes the regulatory process for advancing a candidate drug into human studies through the submission of a New Drug Application (NDA) or Clinical Trial Application (CTA).

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

Justify This Training

View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.

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