Empowering professionals for over 24 years

Empowering professionals for over 24 years

Preclinical Development Primer 201 | CPE

Preclinical Development Primer 201 | CPE
  • Level: Intermediate
  • CPE: 1.0 Credits
  • Time: 55 Minutes

Learn what it takes to meet regulatory standards and successfully file an IND application with Preclinical Development Primer 201. Analyze a real-world one-month rat study to gain first-hand experience of pharmacology and safety testing, like ADME, hERG, and carcinogenicity, to support a strong IND.

  1. Understand how animal models are used to support preclinical drug development
  2. Explore the role of pharmacokinetics and pharmacodynamics in evaluating drug candidates
  3. Recognize how dose levels and routes of administration in animals relate to human applications
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  • 1-month access to all course material
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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. Overview

    Introduces key preclinical development metrics, including pharmacology and toxicology, to inform trial design and regulatory approval.

  2. Pharmacology

    Explores core pharmacology concepts, including binding assays based on the Law of Mass Action, dose-response curves for potency and efficacy, and mechanisms of action for agonists and antagonists.

  3. Pharmacokinetics

    Focuses on PD and PK measurements, including the ADME of drugs and bioanalytical assays to determine API concentration, informing dose, frequency, and route of administration.

  4. Toxicology

    Describes the complexities of in vivo models, focusing on concordance between animal and human toxicities, and the importance of therapeutic margins and adverse effects.

  5. Nonclinical IND/CTA

    Reviews the various types of INDs and the role of the Common Technical Document (CTD) in IND and CTA filings.

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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