Dissolution Testing, Bioequivalence and Bioavailability Strategies

As technology advances and regulations tighten, the competition to get new drugs on to the market has never been fi ercer. The next few years look to be a critical time for the pharmaceutical industry. The development pipeline looks increasingly sparse, so equipping your business with cutting edge technologies and effi cient strategies for drug development and reformulation will be the best way to keep profi ts high. Visiongain’s Dissolution Testing, Bioequivalence & Bioavailability Strategies Conference is packed with the latest updates, insights and practical advice that will equip you with latest drug analysis tools. Whether your company’s strategy for development lies in the extension of product life cycle with novel reformulations, the production of generic alternatives or just increasing effi ciency of existing portfolios; improving the effi cacy of your dissolution testing methods and your bioavailability and bioequivalence studies will help achieve these goals. Dissolution testing methods must keep up with the new challenges posed by poorly soluble and lipophilic drugs. Bioequivalence and bioavailability studies must meet stricter EMEA and FDA guidelines. Successful novel dosage forms and accurate PK-PD modelling must be achieved early in the development cycle. This 2-day event will provide you with an invaluable opportunity to exchange experiences through interactive discussions and hear case studies presented by the industry’s leading professionals.

• Identify current method development problems and the associated dosage forms

• Develop useful and standardised methods to meet the challenges of new dosage forms

• Encourage innovation of new methodologies

• Gain a more in depth understanding of the IVIVC Explore new technologies/equipment for in vitro release testing of novel dosage forms

• Discuss of validation principles for new and standard methods I look forward to meeting you at the conference Best regards

Best Regards

Who should attend?

VPs Directors, Heads, Managers and Scientists in:
• Analytical Development
• Stability
• Chemistry
• Regulatory Affairs
• Quality Control/ Quality Assurance
• Pharmacokinetics/Pharmacodynamics
• Pharmaceutical Development
• Formulation
• Metrology
• Clinical Development
• Research & Development

Day 1, DISSOLUTION TESTING, BIOEQUIVALENCE & BIOAVAILABILITY STRATEGIES
THURSDAY 26TH JUNE 2008

Dr Alexander Mullen
Strathclyde Institute of Pharmacy and Biomedical Sciences
University of Strathclyde

• IVIVC Bioequivalence studies: focus on suspensions
• USP apparatus IV impact on dissolution studies
• Critical validation parameters for dissolution methods

Dr Daniel Abran
Manager, Pharmaceutical Development
Sandoz

Dr Eric Beyssac
Professor of Pharmaceutics
University of Auvergne

• Introduction to topical semisolid dosage forms - market share and importance
• Development of and challenges in dissolution testing of semisolids -
researcher’s points of view
• Evaluation of dissolution data in marketing authorization dossiers -
regulatory requirements and their fulfilment
• Methodology, equipment selection and data evaluation

Dr habil. Ildikó Csóka
Associate Professor
Head, Institute of Drug Regulatory Affairs
University of Szeged

12:30 Improving hydrophobic drug dissolution via
lyophilization and excipients
• Formulation strategies for oral delivery biopharmaceutics Class 2 drugs
• Lyophilisation - extending formulation capability and facilitating the
product development cycle?
• Lyophilisation - out of the frying pan and into the fi re?

Dr Alexander Mullen
Strathclyde Institute of Pharmacy and Biomedical Sciences

• What are the dissolution equipment parameters which may contribute to
the high variability in dissolution results?
• How USP Prednisone Tablets RS indicate a not “well controlled”
dissolution equipment?
• What are the USP standards for performance verifi cation test?

Dr Erika Stippler
Director of Dosage Form Performance Laboratory
United States Pharmacopeia

14:50 Automated dissolution testing: Choosing the
right equipment for your company

• Benefits of automated dissolution testing equipment
• Designing parameters of dissolution testing equipment
according to Ph.Eur/USP
• Qualifi cation of automated dissolution equipment including
on-line analysis
• Understanding the capability requirements of the dissolution
method throughout the life cycle

Kevin Deane
Managing Consultant, Product and Process Engineering
PA Consulting Group

• USP 4: History of a unique technique.
• Novel dosage forms and dissolution Testing: where are the limits?
• Using the same instrument for API characterization in Preformulation
and batch release in QC: is it possible?
• USP 4, an R&D tool: pH changes, small volumes Elution profi les on Low
dosage forms, larger volumes Dissolution profi les on poorly soluble
compounds -Diffusion/convection Flow-Through cells: a new approach.
• Outsourcing dissolution expertise: why?

Michel Magnier
Product Manager, USP IV
Sotax

• The harmonized Ph.Eur monograph 2.9.3
• Regulatory requirements
• Analytical validation of dissolution
• Pro and contra 3rd stage testing

Federal Institute for Drugs and Medical Devices

• Providing a global perspective on laboratory management
and quality control

Dr Janja Luksa
Head of Pharmacokinetic Studies, R&D
Lek Pharmaceuticals

Day 2
DISSOLUTION TESTING, BIOEQUIVALENCE & BIOAVAILABILITY STRATEGIES
FRIDAY 27TH JUNE 2008

Strathclyde Institute of Pharmacy and Biomedical Sciences

• Relationships between permeability and fraction absorbed/reabsorbed
in the human intestine, liver, kidneys and brain
• The Permeability-based Classiifi cation System (PCS)
• PCS vs BDDCS
• Interplay between permeability and metabolism in the human
intestine and liver
• Evaluation and suggested improvements of the BCS

Dr Urban Fagerholm
Clinical Pharmacology
AstraZeneca

• Signifi cance of direct compression of microspheres for industry
• Choice of excipients and their physical properties for
compression of microcapsules
• The placebo pellet approach for compression
• Dissoluion testing and similarity function for evaluation of
degree of damage to active microspheres
• Examples of directly compressed microspheres from the
pharmaceutical industry

Dr Idris M. El-Mahdi
Associate professor of Pharmaceutics
Arab Medical Sciences University

• Defi ning study objectives
• Protocol development
• Ethical considerations
• Assessing clinical, laboratory, and analytical facilities
• Selecting subjects
• Adhering to guidelines

Director

12:30 How to do dissolution in the view of IVIVC
• Goals of in vitro drug performance testing
• Validation of an IVIVC
• Mimicking GI physiology
• Choice of an appropriate apparatus for in vitro drug release testing
• Concept and fi ne tuning of methods

CEO

14:30 Using the statistical “one step” approach to
establish a Level A IVIVC
• Introduction and defi nitions
• Basic considerations when using the convoluted based “one step”
IVIVC approach
• Application for “a dual component release system”: an example

Dr Stefaan Rossenu
PK/PD Scientist
Johnson & Johnson Research & Development

15:10 The role of hydrodynamics in dissolution testing
• Use of computational fl uid dynamics (CFD) to investigate
hydrodynamics in commonly used dissolution testing apparatuses
• Estimates of In Vivo velocity magnitudes
• The effect of natural convection in areas of low forced velocity

Dr Deirdre D’Arcy
School of Pharmacy and Pharmaceutical Sciences
Trinity College

• The challenge of sample size
• PK variability in children
• Healthy volunteers vs. patients

Dr Carlos R. Camozzi
Medical Director
Orphan Europe

• Evaluating sources of variability in current methodologies and
evaluating new technologies for characterising inhalation products
• Understanding of the sources of variations in in vitro testing of
inhalation products
• Understanding the limitations and capabilities of new techniques for
PSD measurements
• Ensure quality and equivalency of inhalation products

Dr Jason T McConville
Assistant Professor, College of Pharmacy
University of Texas