developing dissolution testing strategies · module 8: qualification of dissolution apparatus...

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Developing Dissolution Testing Strategies Gain a thorough understanding of dissolution testing and learn how to establish the safety and efficacy of drug products 5-week online course I 16 September 2019 - 14 October 2019 www.informa.com.au/dissolutiontestingstrategies

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Page 1: Developing Dissolution Testing Strategies · Module 8: Qualification of dissolution apparatus •Mechanical calibration •Performance verification test Module 9: Validation of a

Developing Dissolution Testing Strategies

Gain a thorough understanding of dissolution testing and learn how to establish the safety and efficacy of drug products

5-week online course I 16 September 2019 - 14 October 2019

www.informa.com.au/dissolutiontestingstrategies

Page 2: Developing Dissolution Testing Strategies · Module 8: Qualification of dissolution apparatus •Mechanical calibration •Performance verification test Module 9: Validation of a

Agenda:PTI

Module 1: Understand the basics of dissolution• Why use an in vitro dissolution 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 transdermalsystems

Module 3: Appreciate new in vitro methods• Evaluate in vitro method for specific dosage forms

• In vitro testing for gastrointestinal simulation

Module 4: Development of a dissolution method • Choice of dissolution medium• Use and selection of a surfactant

Module 5: Case study examples• Examining immediate and sustained release formulations• Assess specific dosage forms

Module 6: Apparent and intrinsic dissolution• Dissolution of powders• Comparing intrinsic and apparent dissolution testing

Module 7: Analysis of dissolution curve• Examining F1 /F2 metrics• Exploring other approaches

Continued ..

Page 3: Developing Dissolution Testing Strategies · Module 8: Qualification of dissolution apparatus •Mechanical calibration •Performance verification test Module 9: Validation of a

Agenda: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

Developing Dissolution Testing Strategies

Call: +61(2) 9080 4022Email: [email protected]

Course Price: Before 9 August 2019 - AUD $1,195 +10% GST Course Price: After 9 August 2019 - AUD $1,395 +10% GST4+ Delegate Discount: AUD $1,116 +10% GST

www.informa.com.au/dissolutiontestingstrategies