Development of Generic Solid Immediate Release Dosage Forms / Formulation and Analytical Method Development

Summary

This 2.5-day in-house training course focuses on particular challenges of generic solid immediate release dosage forms development. It will help formulators to learn the ways of minimizing their experiments in a way to remove the analytical burden from the R&D analytical.

Who should attend?

Heads of R&D, Formulation Development Scientists, Formulation Technician, Analytical Scientists, R&D Analytical Chemists, R&D Associates, Principal Scientists – Pre-Formulation, Senior Research Scientists

Learning Objectives

Learning & Key Takeaways

• Establishing an effective and cooperative relationship between the formulation development department and analytical research
• The value of pre-formulation work – formulation development starts in the analytical laboratory
• The importance of technology transfer which may become a rate limiting step in the completion of a project

Key Topics

• Establishing an effective generic drug development program
• The importance of API in the development of solid oral dosage forms
• Excipients as important as the API for the formulator
• Where do we start? – The pre-formulation laboratory
• Fitting the pieces together for instant release solid oral dosage forms
• De-risking your product – The challenge of QbD
• The formulation report – Common errors regarding establishment of specifications