This GMP Education Course on Dissolution Testing aims at providing delegates with a sound understanding of the principles and best practices in dissolution testing.
As Dissolution represents a very interdisciplinary topic, a broad variety of areas within the development and commercial phase will be discussed. You will get to know
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 (QC tool) of clinical Trial supplies and the commercial product
how to support drug product stability testing
how to justify formulation/production changes (e.g., according to SUPAC, Biowaivers)
how to predict in vivo performance
Due to the wide range of applications and the sensitivity of dissolution testing, sound method development and validation is of essential importance. Furthermore, also knowledge on dissolution apparatus qualification, dissolution specification setting, dissolution profile comparison and handling of OOS/OOE results will be trained and discussed.
Background
The dissolution test is a key test parameter for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control. In these fields it is used to assure batch-to-batch quality as well as providing process control information as part of the approach to Process Validation.
Dissolution testing is usually connected to in vivo performance because the API must be released from the formulation in the gastro intestinal tract (GIT) before in vivo absorption can occur. Therefore, dissolution testing is generally employed during Drug Product development and optimization. A dissolution test should therefore have adequate discriminatory power to detect relevant Drug Product changes.
Where dissolution testing data can be shown to be correlated to in vivo performance, clinical trials may be avoided by in vitro dissolution studies under certain circumstances, thereby reducing development time and costs.
There are many dissolution guidance and associated guidelines (e.g. FDA, EMA and the Pharmacopoeias) dealing with Scale-up and Post-Approval Changes, Bioequivalence studies, Waiver of in vivo Bioavailability and Bioequivalence Studies. Additionally, there are some country-specific dissolution requirements which are very challenging for global pharmaceutical companies.
This GMP Education Course will, therefore, cover the following topics:
physicochemical and biopharmaceutical foundations
dissolution method development,
validation of the dissolution methodology
approaches for setting specifications
OOS and OOE Results in dissolution testing
statistical methods for comparing dissolution profiles
approaches for substitution of BE-studies (biowaiver) and
approaches to establish in vitro in vivo correlations (IVIVC)
country-specific dissolution requirements and challenges
In addition, the expectations of the European Medicines Agency (EMA) and of the pharmacopoeias (Ph.Eur. 2.9.3 and USP Chapters <711> and <1092>) including USP Reference Standard Tablets and Mechanical calibration for the dissolution apparatus qualification will be discussed.
The objective of this course is to cover all aspects of dissolution testing with a focus on practical examples. 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.
Target Group
This Education Course will be of significant value to
Laboratory managers
Quality control managers
Analytical scientists
Senior laboratory staff
from quality control units in the pharmaceutical industry who are responsible for GMP Compliance in the analytical laboratory.
Date & Venue
Date Tuesday, 01 July 2025, 9.00 h – 18.00 h (Registration and coffee 8.30 – 9.00 h) Wednesday, 02 July 2025, 8.30 h – 15.30 h
Venue DoubleTree by Hilton Berlin Ku´Damm Los-Angeles-Platz 1 10789 Berlin Phone: +49 (0) 30 2127 0 E-Mail: info@doubletreeberlinkudamm.com
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: How to Set Specifications: Sharing Information of the Learned Theories
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 (including OOE)
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 (e.g., ICH Q2 (R1),USP <1092>, RDC No. 166/2017)
Validation characteristics: - 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
Testimonials
Seminar Programme as PDF