Development, Quality Control, and In Vivo Relevance
21/22 September 2027, Barcelona, Spain
Course No. 23134
Speakers
Dr Gerd Michael Maier
Boehringer Ingelheim Pharma
Dr Corinna Bode
Bayer
Dr Jan Joseph
Bayer
Dr Johanna Milsmann
Boehringer Ingelheim Pharma
Target Group
This Education Course will be of significant value to
Laboratory managers
Quality control managers
Analytical scientists
R&D / formulation scientists
Senior laboratory personnel
Regulatory affairs professionals
QA professionals
Objectives
The dissolution test is a key test parameter for assessing the performance of solid and semi-solid dosage forms during both drug development and quality control. In these areas, it is used to ensure batch-to-batch consistency and to provide process control information as part of the overall approach to process validation.
This GMP Education Course on Dissolution Testing aims to provide delegates with a sound understanding of the principles and best practices of dissolution testing. As dissolution testing is a highly interdisciplinary topic, a broad range of areas related to both the development and commercial phases will be discussed.
You will learn:
how to characterize formulations
how to support formulation and process development
how to evaluate the impact of formulation and process parameters changes
how to control the quality of clinical trial supplies and commercial products using dissolution testing as a QC tool
how to support drug product stability testing
how to justify formulation and manufacturing changes, e.g. in accordance with SUPAC and biowaiver requirements
how to predict in vivo Performance
Due to the wide range of applications and the sensitivity of dissolution testing, sound method development and validation are essential. In addition, dissolution apparatus qualification, dissolution specification setting, dissolution profile comparison, and the handling of OOS/OOE results will be covered.
Workshops are also part of the course in order to encourage the exchange of experience and to allow interactive and in depth discussions of the subject.
Programme
Fundamentals of Dissolution Testing: From Physicochemistry to Bioavailability
Mechanism and theories of solid dissolution (e.g. diffusion layer model)
Intrinsic dissolution rate
Sink conditions
Kinetics of drug release
Relationship between dissolution and bioavailability
Quality Control dissolution testing and in vivo predictive dissolution testing
Biopharmaceutics Classification System
Fraction of a dose absorbed classification system
Hurdles and limitations of dissolution testing
Development of Dissolution Methods – The Balancing Act between Quality Control and Clinical Relevance
Method development for Immediate Release, Extended Release and Delayed Release formulations
Regulatory recommendations
Dissolution apparatus and medium selection
Use of surfactants
Adequate discriminatory capability
Standard Dissolution Test Conditions
Evaluation of bio-relevance
Dissolution methods for developing an IVIVE/C to gain regulatory flexibility
Prerequisites of international and mostly harmonized pharmacopeias (USP, EP, Pharm Jap)
Miniaturization of dissolution tests
General guidelines for dissolution testing
Contents and differences in Chinese pharmacopeia
Validation of dissolution test methods
Bioequivalence considerations
Special in vitro bioequivalence applications in Japan
Waiving dissolution tests by disintegration tests
Setting Specifications for Dissolution Methods
How to set adequate dissolution specifications for various types of formulations
Requirements of different Pharmacopoeias and Guidelines
Specifics and exceptions
Workshop I: Setting Specifications
Presentation of case studies and discussion of potential results
Q&A session
Mechanical Calibration & Performance Verification Test (PVT)
Regulatory basis
Fundamentals of instrument qualification
Qualification and calibration of dissolution apparatuses
Mechanical calibration
USP Performance Verification Test (PVT)
Deviations and OOC
Case Study: Application of Dissolution Testing in Industrial Drug Product Development
Discussion of various case studies occurring during product development
Automation in Dissolution Testing
Why and when is automation valuable?
Various types of dissolution systems
New products on the market
Dissolution Testing throughout the Drug Product Development Lifecycle: In vivo Relevance and Biowaivers
Use of dissolution testing during drug product development
What is Biorelevance? Meaning and misconceptions
How to establish a link between dissolution and bioavailability
The role of IVIVC
Setting biorelevant dissolution specifications
BCS based biowaivers
Waivers based on proportional similarity
Country specific regulatory differences
Case studies
OOS Results in Dissolution Testing
Regulatory aspects
Dissolution methods having appropriate discriminatory power
General OOS procedure for dissolution testing
Defining and handling of OOS results including CAPA
OOS evaluation for immediate release products
OOS evaluation for capsules
OOS evaluation for modified-release products
OOT/OOE results: Evaluating stability effects by applying dissolution testing
Analytical Validation of Dissolution Testing Methods
Pharmacopoeial and regulatory recommendations
Validation characteristicsc - Specificity, Linearity, Precision, Accuracy and Robustness - Validation of automated procedures
Some practical recommendations for performing the validation and recommended acceptance criteria
Dissolution method transfer
Workshop II: Analytical Validation of Dissolution Methods
Putting theory to work (case studies): - Develop validation protocol for validation of dissolution methods for solid oral dosage forms - Pitfalls in performing the experiments
Dissolution Profile Comparison – Approaches and Issues
Importance of dissolution profile comparisons during drug product development and for a commercial product
Different approaches to compare dissolution profiles: Model dependent and independent approaches
Examples
Further Information
Venue Barceló Sants Hotel Plaça dels Països Catalans, s/n 08014 Barcelona Spain +34 (93) 503 53 00 sants@barcelo.com
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT) Non-ECA Members EUR 2,090 ECA Members EUR 1,890 APIC Members EUR 1,990 EU GMP Inspectorates EUR 1,045 The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments.
VAT is reclaimable.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
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