FORMULATION DEVELOPMENT for GENERICS

Venue: Istanbul

Location: Istanbul, Turkey

Event Date/Time: May 09, 2007 End Date/Time: May 10, 2007
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Description

Day One starts with some general considerations regarding the legal and regulatory basis for Generic Medicines. There will be a brief review of the regulatory approval process and emphasis on the need for the formulation development process to be intimately linked to the regulatory process. A brief consideration of how Project Management can prevent serious delays in achieving a timely regulatory filing.

The first part of this overview will finish with a look at the patent and supplementary protection certificates situation as it affects generics in Europe and the strategies of Ever-greening that are employed by the Branded Industry.

This will be followed by a detailed analysis of Formulation Development as mainly illustrated by Solid Dosage Forms including instant release and modified release products. This type of formulation has been selected for detailed analysis as some 90% of Generic products fall into this category.

As the Drug Substance is critical in the development of this type of product the remainder of Day One will concentrate on the Active Pharmaceutical Ingredient [API]

Day Two will complete the consideration of the API and with then look at the possibilities of Preformulation study techniques together with some examples.

This is followed by some generally applicable guidance as to how the steps in formulation development and some indications as to how to avoid problems in technology transfer.

The major part of Day Two will be devoted to a consideration of solid dosage forms relying on much of the information already learned. Because of the special nature of solid dosage forms and their economic significance subjects such as dissolution, biowaivers and biostudies will be included.

The course will end with a brief look at the new regulations related to Product Development such as QbD and the requirements of ICH8 in terms of development reports.

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