Dr Gerd Michael Maier
Boehringer Ingelheim Pharma
Referierende
Dr Corinna Bode
Bayer
Dr Jan Joseph
Bayer
Dr Johanna Milsmann
Boehringer Ingelheim Pharma
Zielgruppe
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
Zielsetzung
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.
Programm
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
Dissolution Testing – Regulatory Requirements (Guidelines, Pharmacopoeias, etc.)
- 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
- Regulatory requirements concerning dissolution profile comparison
- Different approaches to compare dissolution profiles: Model dependent and independent approaches
- Examples
Weitere Informationen
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona
Spain
+34 (93) 503 53 00
sants@barcelo.com
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.
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.
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.
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.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Manuela Luckhaupt, +49 6221 84 44-66, luckhaupt@concept-heidelberg.de
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Manuela Luckhaupt, +49 6221 84 44-66, luckhaupt@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 21 Sep 2027, 09:00-18:00 h
(Registration and coffee 08:30-09:00 h)
Wed, 22 Sep 2027, 08:30-15:30 h
(Registration and coffee 08:30-09:00 h)
Wed, 22 Sep 2027, 08:30-15:30 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
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E-Mail: info@concept-heidelberg.de
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