Summary
This three-day online course covers both the theory and practical aspects of pharmaceutical dissolution testing for solid oral dosage forms. The course will be valuable for those wanting a greater understanding of the science behind drug dissolution, and those developing, validating or troubleshooting dissolution tests. The characteristics of dissolution methods, especially their discriminating ability and proposed acceptance criteria, are a common cause of problems during the regulatory review of submissions for solid oral dosage forms, and this course offers advice on avoiding such problems. The course ends by describing the use of the dissolution test to support bioequivalence (biowaivers).
Learning Objectives
By attending this course, you will:
- Understand the science of dissolution testing
- Appreciate the uses and potential problems associated with compendial dissolution apparatus
- Be able to adopt a logical approach to the development of an appropriate dissolution method for both highly soluble and poorly soluble drugs
- Gain the ability to troubleshoot dissolution results logically
- Be able to design an appropriate dissolution validation study
- Understand the uses of in vitro dissolution data to support a waiver of in vivo clinical studies (biowaiver)
Key Topics
- The importance of dissolution testing – drug safety and efficacy
- Factors affecting solubility and dissolution rate (the Noyes–Whitney model)
- Dissolution testing apparatus for solid oral dosage forms – characteristics and uses
- Non-compendial apparatus (e.g. apex vessels and small-volume apparatus) – uses and justification
- Dissolution method development
- Setting appropriate dissolution specifications
- Case Study: Developing a method for a BCS Class 2 drug
- Troubleshooting dissolution methods and investigating anomalous results
- Method validation, including recent ICH guidance on life cycle management of analytical procedures
- BCS-based biowaivers and biowaivers for additional strengths
- Case Study: Biowaiver for a BCS Class 1 drug
- Participant Polls
Who should attend?
- Analytical development scientists
- Analytical development managers
- Quality control scientists
- Quality control managers
- Quality assurance professionals
- Formulation development scientists who perform dissolution testing
- Regulatory affairs professionals
- Project managers
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainer
Dissolution Testing and Biowaivers
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
