Risk Assessment Scorecard Improves Efficiency & Reduces Potential Risks in Drug Development Programs
SAN DIEGO, Calif. – October 13, 2011 – Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry has created a Drug Development Risk Assessment Scorecard to help in assessing the risk in oral drug development programs . Pharmatek will officially launch the scorecard at the AAPS Annual Meeting and Exposition in Washington D.C., October 24-27. The Scorecard is a tool designed to help project managers identify drug program risks and provides them a dashboard view of critical areas in the drug development process.
Pharmatek’s Drug Development Risk Assessment Scorecard is defined by 8 key categories: BCS Classification, API Supply, API Stability, Safety/Toxicity, Dosage Strength, Formulation, Quality of CMC Leadership, and Timing. Each category is given a numeric score of 0, 1, or 2, based on its assessed risk within the drug development process. A low risk category receives a 0, a standard risk category receives a 1, and a high risk category receives a 2. Based on the score given to the specific categories on the Scorecard, the total score is calculated and then used to assess the overall project risk.
“Our scorecard is a quantitative approach to assessing risk in oral drug development programs with respect to Chemistry, Manufacturing, and Controls (CMC) activities,” stated Bryan Knox, Director of Pharmaceutics at Pharmatek Laboratories. “It is based on evaluations of 100’s of different drug candidates by Pharmatek scientists over the last 12 years. Once the components of risk are understood, strategies can be implemented to mitigate the risk going forward.”
For further information on Pharmatek’s Drug Development Risk Assessment Scorecard, or for help scoring compounds in development, please contact Pharmatek at email@example.com.Leave a reply →