|
|
IIR PTI
|
|
|
| |
|
 |
|
|
|
|
| |
Wed 03 Mar 2010
- Thu 04 Mar 2010
Regus Trafalgar Square, London, England
|
|
Tue 13 Jul 2010
- Wed 14 Jul 2010
To be confirmed, Amsterdam, Netherlands
|
|
|
|
Dissolution testing poses a major challenge to the pharmaceutical, biotech and generics industries both in terms of method development and regulatory compliance.
This two-day interactive training course will explain the history, benefits, importance and role of dissolution testing in drug development today. Using practical examples and case studies throughout, delegates will gain a thorough understanding of setting and establishing specifications for optimum dissolution testing.
-
Clarify global regulatory requirements
-
Assess new scientific developments and trends
-
Design optimum method development strategies
-
Identify the factors affecting dissolution
-
Drive product performance and quality control
-
Study design considerations for IVIVC Studies
|
|
|
Who Will Attend?
This course is designed for professionals working in the following areas:
|
Course Leader
Dr Malcolm Ross, Industry Consultant, Generapharm-Training and Consultancy
Dr Malcolm Ross has over 25 years experience in the pharmaceutical industry specializing in development of finished dosage forms. Malcolm has been responsible for setting up and running R&D in several companies in different international environments, with experience ranging from small CRO style to large corporate structures with multilevel reporting.
- Dosage forms experience in solids [tablets and capsules including modified release], topical products [creams and ointments] and liquid dosage forms including solutions and suspensions.
- Excellent knowledge of QA issues in R&D and QC environments and a good knowledge of cGMP having worked in both European and FDA environments.
- Considerable experience in Project Management including introduction of such into classic hierarchical structures as found in CEE countries. Malcolm has excellent teaching, presentation and mentoring skills in both technical and soft skill areas. In particular he has a good analytical approach to problem solving.
Dr Malcom Ross has provided some useful comments about the course:
The assay of a pharmaceutical dosage form is only a part of the demonstration of its ability to deliver the drug substance to the patient. A drug product that does not release the drug substance is of the same value as a drug product that does not contain the drug substance at all! Dissolution testing was introduced officially almost 40 years ago, and for the majority of dosage forms requiring such testing, little has changed in the mechanics of the test. However the understanding and interpretation of such testing has remained an area of much dispute with considerable over interpretation of the results both by the industry and the regulatory authorities.
The course looks at the history of the dissolution test in order to understand how we have arrived at today’s situation. It will review the test methods, both official and unofficial and discuss the development and validation of dissolution tests.
Although the main emphasis of the course will concern solid dosage forms, both instant and modified release there will be consideration of other forms requiring some form of release testing.
The course is designed to bring together aspects of the subject both from the analytical and the formulation development areas and will be illustrated with practical tips and examples.
Attention will be given to the regulatory aspects of dissolution particularly as related to regulatory submissions.
|
|
|
|
|
|
|
|
|