Dissolution Testing - Live Online Training Development / Quality Control and in vivo Relevance

Dissolution Testing - Live Online Training

Seminar Nr. 20274

This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager". Learn more.

All times mentioned are CEST.


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de


Dr Ragna Hoffmann, Boehringer Ingelheim
Dr Gerd Michael Maier, Boehringer Ingelheim
Dr. Uwe Muenster, Bayer AG
Dr Alexander Pontius, Bayer AG


This Live Online Training 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.


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  guidances 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 Live Online Training 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.


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.

Technical Requirements

We use Webex Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.


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
Dissolution Testing throughout the Drug Product Development Lifecycle
  • 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
Dissolution Testing – Regulatory Guidelines
  •  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
Development of Dissolution Methods - The balancing Act between Quality Control and Clinically 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
  •  Case studies
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
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
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
Automation in Dissolution Testing
  • Why and when is automation valuable?
  •  Various types of dissolution systems
  •  New products on the market
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
Dissolution Profile Comparison; Approaches and Issues
  • Importance of dissolution profile comparisons during drug product development and for a commercial product
  • Regulatory requirements concerning dissolution profile comparison
  • Different approaches to compare dissolution profiles: Model dependent and independent approaches
  • Examples
How to Set Specifications: Sharing Information of the Learned Theories
  •  Presentation of Case Studies and discussion of potential results
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
Case Study
Application of Dissolution Testing in Industrial Drug Product Development

Discussion of various case studies occurring during product development
Q&A sessions
Q&A sessions on both days ensure interaction and that your questions are answered


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