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Course Features:

CLARIFY

the theory and regulatory aspects involved in developing IVIVC models                          

EXPERT TRAINER - ERIC BEYSSAC

Eric's research interests include in vitro in vivo correlations, sustained release drug dosage form development and in vitro dissolution

IDENTIFY

...the factors affecting dissolution

DEVELOP

...EMA and FDA-compliant dissolution testing
Course Reviews
"Good concentrated course, even if you have considerable experience"
Specialist
H Lundbeck
"An excellent course. Perfect presentations."
Chemist
Leo Pharma
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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 

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

"An excellent course. Perfect presentations."
Chemist
Leo Pharma
"Good concentrated course, even if you have considerable experience"
Specialist
H Lundbeck
"Very Comprehensive course"
Technical Development Scientist
Norgine Ltd

Dates and Venues

18 Nov 2014 - 19 Nov 2014

Radisson Blu Edwardian Grafton

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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 

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