Course description
Strategies for Developing IVIVC Studies
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.
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Suitability - Who should attend?
This course will be of interest to professionals working in the pharmaceutical & generics industry and also their service providers. In particular, professionals working in analytical science and development or quality control should attend. Relevant departments may include:
- Scientific Research
- Analytical Development
- Formulation
- Early Development
- Regulatory Affairs
- Quality Assurance
- Quality Control
Outcome / Qualification etc.
- Gain a comprehensive introduction to the IVIVC
- Determine scaling factors and how to successfully use them to develop an IVIVC
- Familiarise yourself with the full scope of the data requirements and activities of IVIVC
- Calculate an effective IVIVC strategy to avoid pitfalls
- Discover how to establish an IVIVC
- Build on your knowledge of the legal and regulatory framework of IVIVC
Training Course Content
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
Why choose PTI
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Quality of content:
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85% had applied content during the course to their role
Delivery rating:
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