The March/April issue of the PDA Journal of Pharmaceutical Science and Technology features a PDA Points to Consider paper from members of the Post-Approval Change: Innovation for Availability of Medicines (PAC iAM) technical report team.

Research

Alberto Biavati, Michele Poncini, Arianna Ferrarini, “Complexing Agents and pH Influence on Chemical Durability of Type I Molded Glass Containers”

Dennis Jenke, et al., “Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products”

Paul Faya, James D. Stamey, John W. Seaman Jr., “A Bayesian Approach to Determination of F, D, and Z Values Used in Steam Sterilization Validation”

Kurt Brorson, et al., “Mycoplasma Clearance and Risk Analysis in a Model Bioprocess”

Technology/Application

Harry Yang, et al., “Characterizing the Overall Derivatization of Conjugated Oligomeric Proteins”

Eric Hilario, et al., “An Improved Method of Predicting Extinction Coefficients for the Determination of Protein Concentration”

Commentary

Raja Mazumder, Vahan Simonyan, Jeremy Goecks, “Biocompute Objects—A Step towards Evaluation and Validation of Biomedical Scientific Computations“

Klaus Wuchner, et al., “Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry“

PDA Paper

Emma Ramnarine, et al., “PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities“