Dissolution Testing
Development - Quality Control - and in vivo Relevance
(Im Auftrag der European Compliance Academy)

Dissolution Testing Development - Quality Control - and in vivo Relevance (Im Auftrag der European Compliance Academy)

Prague, Czech Republic

Seminar Nr. 16905


Kosten

Non-ECA Members: EUR 1690,--
ECA Members: EUR 1490,--
EU GMP Inspectorates: EUR 845,--
APIC Members (does not include ECA membership): EUR 1590,--

Alle Preise zzgl. MwSt.

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

Sprecher

Dr Kerstin Pauli, Bayer AG

Dr Alexander Pontius, Bayer AG

Dr Jochen Scher., Boehringer Ingelheim

Dr Ferdinand Steierhoffer, Boehringer Ingelheim

Zielsetzung

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.

Dissolution testing:
to characterize formulations
to support formulation and process development
to evaluate the impact of formulation and process parameters changes
to control the quality (QC tool) of clinical trial supplies and the commercial product
to support drug product stability testing
to justify formulation/production changes (e.g., according to SUPAC, Biowaivers)
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.

Hintergrund

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 gastrointestinal 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 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.

Programm

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 pharmacopeia (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, for capsules,
  • 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
Case Study: Application of Dissolution Testing in Industrial Drug Product Development
Discussion of various case studies occurring during product development

WORKSHOP I
How to Set Specifications: Sharing Information of the Learned Theories

Presentation of Case Studies and discussion of potential results
Q&A Session

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

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