- email:registration@pti-europe.co.uk
- phone:+44 (0) 20 7017 7481
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Dissolution Testing
16 - 17 July 2013 , Amsterdam
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INTERACTIVE WORKSHOP:
Examining the classification, criteria & regulatory guidances for biowaivers EXPERT TRAINER - ERIC BEYSSAC
Eric's research interests include in vitro in vivo correlations, sustained release drug dosage form development and in vitro dissolutionIDENTIFY
...the factors affecting dissolutionDEVELOP
...EMA and FDA-compliant dissolution testing
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Dissolution Testing
Course Objectives
Dissolution testing poses a major challenge to the pharmaceutical, biotech and generics industries both in terms of method development and regulatory compliance.
This two-day interactive training course will explain the history, benefits, importance and role of dissolution testing in drug development today. Using practical examples and case studies throughout, delegates will gain a thorough understanding of setting and establishing specifications for optimum dissolution testing.
- Clarify global regulatory requirements
- Assess new scientific developments and trends
- Design optimum method development strategies
- Identify the factors affecting dissolution
- Drive product performance and quality control
- Study design considerations for IVIVC Studies
What Will You Learn?
Key Topics Include...
Bioavailability
Bioequivalence
Analytical Chemistry
Pharmacokinetics
In vitro/In vivo Testing
Performance and Knowledge Objectives
- Identify the factors affecting dissolution
- Understand the relationship between dissolution testing and drug adsorption
- Design optimum method development strategies
- Product performance and Quality Control
- F2 similarity, biowaivers and IVIVC
- Develop EMA and FDA-compliant dissolution testing
- Select optimum test conditions and method development
- Ensure your test methods are properly validated
- Clarifying global regulatory requirements
- Assessing new scientific developments and trends
Who should attend?
This course is designed for professionals working in the following areas:
- Regulatory Affairs
- Pharmaceutical Development
- Analytical Development
- Project Management
- Quality Control
- Quality Assurance
Reviews
"Good concentrated course, even if you have considerable experience"
"An excellent course. Perfect presentations."
"Very Comprehensive course"
Dates and Venues
16 Jul 2013 - 17 Jul 2013
Amsterdam
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
