Dissolution testing poses a major challenge to the pharmaceutical, biotech 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. 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
- A whole module devoted to case study examples
What Will You Learn
- Gain a practical introduction to the intricacies of dissolution testing with an emphasis on problems and problem solving
- Select optimum test conditions and method development
- Ensure your test methods are properly validated
- Enhance the dissolution rate and bioavailability of your compound
- Clarify the theory and regulatory aspects involved in developing IVIVC models
Who Should Attend
This course is designed for professionals working in the following areas:
- Pharmaceutical Development
- Analytical Development
- Project Management
- Quality Control
- Quality Assurance
- Regulatory Affairs
What is an Online Academy course
Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.
The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.
About PTI - Pharmaceutical Training International
PTI is a global interactive training partner committed to the personal progression of aspiring life science professionals. We have a network of expert trainers who have a minimum of 10 years’ industry experience to meet your training requirements and all our courses are CPD certified.
Our vision is to enhance key skills and competencies to drive continuous innovation and accelerate drug development. When you invest in a PTI course we want you to feel secure, inspired and ready to take on new challenges.
After completing a PTI course, you will be awarded with the CPD Certification certificate. This is a recognised independent CPD accreditation compatible with global CPD principles.
The Certificate of Achievement provides proof that you have taken the course and can be used on your CV or work portfolio.
Specifications for Small Molecule Drug Products Webinar
Led by Dr Mark Powell, a Fellow of the Royal Society of Chemistry (RSC) with over 25 years’ experience as a senior analytical chemist. In 2013, Mark set up Mark Powell Scientific, a company that offers training and consultancy services in analytical chemistry.
The webinar will cover:
- Regulatory guidance (ICH, FDA, EMA)
- Tests appropriate to different dosage forms
- Dissolution specifications for immediate-release, modified-release and extended-release drug products
- Dissolution specifications in the context of the biopharmaceutical classification system
- Control of polymorphism, enantiomeric purity, drug-related impurities and microbiological contamination
- Specifications for combination drug products
- The role of specifications in maximizing drug product stability
IVIVC – A Way to Speed up Development Using Dissolution as a Surrogate Tool.
Led by Jean-Michel Cardot, course leader for Practical Solutions for Establishing IVIVC and Bioavailability and Bioequivalence.
In 30 minutes, this webinar explores hot to optimise IVIVC using your dissolution data.
- Basis of IVIVC
- Why IVIVC and dissolution are important
- Use in development: interest and limitations
- Optimisation of formulation based on IVIVC
- Conclusions and Q&A session
Benefits of an Online Academy Course
- Learn and apply – implement what you learn during the course
- Become part of a professional learning community – discuss any problems with students and/or the trainer
- Time effective – bitesize chunks so it does not impact on your normal working day
- Cost effective – no travel expenses
- Grow as a team – with multiple licenses your team can access the course and learn together, no matter where they are in the world
Online Academy Video
Do sessions go out live?
No, all content is recorded and a set number of modules are released per week. You have unlimited access to module content once it has been released for the duration of the course and an additional two months.
Can I join after the course start date?
Yes, because modules are not live and all content is recorded you can catch up. Please contact us at firstname.lastname@example.org to enquire about joining a course after the start date.
Can I still take part if I’m away for part of the course run?
Yes. Online Academies provide a flexible learning format. As modules are not released live and are available for review, you will be able to catch up.
How long is my enrolment on the course?
You are enrolled on the course for the period that modules are being released and the trainer is active on the discussion forum (this varies from course to course – between 3 – 8 weeks) and for an additional 2 months after this to review course content.
Who do I contact if I have any problems while the course is running?
You should contact PTI.MDTI.ATIemail@example.com
When will I receive my log-on details for the course?
Once you have paid, a member of the team will be in touch with your log-in details. We must receive payment for you to access the course.
How can I access the content?
Content is hosted on our Learning Management System, which you access using your device. A link will be provided to you with your log-in details.
What if I need extra time on the course?
Please contact us at firstname.lastname@example.org if you would like extra time on your course beyond the enrolment period. Extra time is subject to approvals and fees may apply.
Week 1, module 1:
Understand the basics of dissolution
- Why use an in vitro dissolution study
- Examining quality by design (QbD) and dissolution
Week 1, 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
Week 2, module 3:
Appreciate new in vitro methods
- Evaluate in vitro method for specific dosage forms
- In vitro testing for gastrointestinal simulation
Week 2, module 4:
Development of a dissolution method
- Choice of dissolution medium
- Use and selection of a surfactant
Week 3, module 5:
Case study examples
- Examining immediate and sustained release formulations
- Assess specific dosage forms
Week 3, module 6:
Apparent and intrinsic dissolution
- Dissolution of powders
- Comparing intrinsic and apparent dissolution testing
- Case studies exploring various applications
Week 4, module 7:
Analysis of dissolution curve
- Examining F1/F2 metrics
- Exploring other approaches
Week 4, module 8:
Qualification of dissolution apparatus
- Mechanical calibration
- Performance verification test
Week 5, module 9:
Validation of a dissolution method
- Practical advice for validating a dissolution method
when & where
16 Sep - 14 Oct 2019
On-site & in-house training
Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?
Talk to us about an on-site/in-house & customised solution.