Practical Solutions For Establishing In-Vitro In-Vivo Correlation - Online Academy (Four 2-Hour Sessions Over 4 Weeks)

  • ID: 4267677
  • Training
  • Region: Global
  • Pharmaceutical Training International
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A comprehensive understanding of IVIVC, its limitations, data requirements and more

In-vitro in-vivo correlation is a critical tool described in many guidelines and its usage in development is recommended to reduce the risk of in-vivo testing. Led by Jean-Michel Cardot, of Auvergne University, this 8-module course will allow you to consider the many implementation issues of IVIVC. Packed with examples and explanations, the course will build towards a comprehensive understanding of IVIVC, its limitations, data requirements and more.

What will you learn?

  • Clarify the usage of IVIVC
  • Formulate faster and better NCE and generics
  • Manage the practical hurdles of IVIVC with the right supporting data
  • Understand the impact Critical Quality Attribute on formulation
  • Decrease the risk of in In-Vivo studies
  • Save time and money in the strategic developments
  • Perform practical calculations to establish IVIVC and determine the optimal target dissolution curve for a formulation

This online academy course can be accessed from Monday 2nd October. Two modules will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

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Module 1: Introduction to IVIVC in development

  • Gain an overview of IVIVC
  • Basis of in vivo behaviour of drugs
  • Identification of limiting factors
  • Interaction between BCS (Biopharmaceutical Classification System) and IVIVC

Module 2: Introduction to IVIVC

  • Definition of IVIVC
  • Discover when IVIVC can be established
  • Learn when IVIVC should not be established
  • Gain an awareness of the limitations of IVIVC

Module 3: Data needed for IVIVC

  • Exploring in vitro dissolution methods
  • Examining in vivo methods used for IVIVC
    • Absorption
    • Determination
  • Selection of the most appropriate data to establish IVIVC

Module 4: How to establish IVIVC

  • Discover how to establish IVIVC
  • Level A
  • Level C
  • Examining predictability

Module 5: Time scaling

  • What is time scaling?
  • Determination of scaling factor
  • Learn how to use time scaling

Module 6: Overcoming the pitfalls of IVIVC

  • Overview of common pitfalls when establishing IVIVC
  • Examples of ineffective IVIVC strategies
  • Best practices to avoid these pitfalls

Module 7: Dissolution limits

  • Determination of dissolution limits
  • Various examples

Module 8: Understanding the legal framework of IVIVC

  • Gain an insight into the requirements of IVIVC in:
    • Development
    • Quality Control
    • Biowaivers
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Jean-Michel Cardot is professor and Head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Universite d’Auvergne, France. The research fields of his laboratory are dissolution, bioequivalence and IVIVC. His personal research fields are biopharmaceutical development of drugs, in vivo bioequivalence and in-vitro in-vivo correlation

Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown
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