(607f) Implementation of QbD In the Development of a CR Dosage Form

Use of QbD in characterization and development of a modified release dosage form will be discussed.  Special emphasis will be placed on the early stages of development and the utilization of material sparing, strategic experimental design to ascertain the critical parameters affecting the performance of the dosage unit.  Lab to Pilot to Commercial scale transfer will be discussed in terms of a QbD based approach.  In addition to formulation development, opportunities for QbD in analytical method development will also be presented.

Additional information will be provided upon legal approval - End of May.