Course description
Developing Dissolution Testing Strategies
Dissolution testing is crucial in the development and manufacture of innovator and generic pharmaceuticals. Data obtained during development helps support formulation and equivalence decisions as well as quality control and release decisions. Due to its importance dissolution testing poses a major challenge to the pharmaceutical and generics industries both in terms of method development and regulatory compliance.
This 5-week online course will explain the history, benefits, importance, and role of dissolution testing in drug development today. Through case studies and examples, you will examine various techniques available and method development processes. You will explore how to analyse a dissolution curve and review qualification and validation methods.
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Suitability - Who should attend?
This course is applicable to those working in pre-clinical drug development, particular departments may include:
- Regulatory Affairs
- Pharmaceutical Development
- Analytical Development
- Project Management
- Quality Control
- Quality Assurance
Outcome / Qualification etc.
- Gain a practical introduction to the intricacies of dissolution testing with an emphasis on problems and problem solving
- Enhance the dissolution rate and bioavailability of your compound
- Select optimum test conditions and method development
- Clarify the theory and regulatory aspects involved in developing IVIVC models
- Ensure your test methods are properly validgoodated
Training Course Content
Module 1: Understand the basics of dissolution
- Why use anin-vitrodissolution study
- Examining quality by design (QbD) and dissolution
Module 2: Classical in-vitro methods for dissolution
- Explore dissolution theory
- Understanding apparatus 1 2 3 and 4
- Discussing specific methods for creams, ointments and transdermal systems
Module 3: Appreciate new in-vitro methods
- Evaluate in vitro method for specific dosage forms
- In-vitrotesting for gastrointestinal simulation
Module 4: Development of a dissolution method
- Choice of dissolution medium
- Use and selection of a surfactant
Module 6: Apparent and intrinsic dissolution
- Dissolution of powders
- Comparing intrinsic and apparent dissolution testing
- Case studies exploring various applications
Module 7: Analysis of dissolution curve
- Examining F1/F2 metrics
- Exploring other approaches
Module 8: Qualification of dissolution apparatus
- Mechanical calibration
- Performance verification test
Module 9: Validation of a dissolution method
- Practical advice for validating a dissolution method
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
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85% had applied content during the course to their role
Delivery rating:
4/5