Solid Oral Dose Process Validation / AAPS Introductions in the Pharmaceutical Sciences (PDF)

approaches for solid dose products from traditional to novel manufacturing technologies and approaches across the organization. She was the lead author of AAPS PharmSciTech journal article Assessment Methodology for Process Validation Lifecycle Stage 3A. She is a contributing member of PDA Post Approval Change Innovation for Availability of Medicines Program and is involved in developing PDA Technical Report on ICH Q12 tools.





Dr. Emilija Fredro-Kumbaradzi is Manager of Biowaivers & Biocorrelation team within the Formulation Development Department at Apotex Inc, Toronto responsible for Biopharmaceutical aspects of drug product. She has extensive experience in formulation development of generic formulations for immediate and modified release products intended for various markets. Prior to Apotex, she has held a position of Professor of Pharmaceutical Technology at Faculty of Pharmacy at University of Skopje, Macedonia. She has received herB.Sc. degree in Pharmacy from the University of Skopje, MSc. Degree from the University of Belgrade, Serbia and Ph D. degree in Pharmaceutical Sciences from the University of Skopje, Macedonia. Her current research interests include solid dosage forms of low soluble drugs and various approaches and technologies in drug formulation to remediate solubility and stability issues, Selection of bio indicative dissolution and in silico modelling.









Dr. Jordan Collins is Senior Solutions Architect at Privacy Analytics, an IQVIA Company, responsible for leading client engagements assessing the risk of re-identification of individuals and supplying guidance on anonymization for data sets shared for secondary purposes. He also currently provides statistical consulting services, primarily to healthcare researchers and pharmaceutical companies. He has extensive experience in performing statistical analyses across a wide variety of industries. Prior to Privacy Analytics,he held the position of Manager, Statistical Support at Apotex Inc. He received his B. Sc. (Honours) degree in Mathematics from Mount Allison University, MSc. degree in Mathematics from McMaster University, M.A. degree in Applied Statistics from York University, and PhD. degree in Philosophy from the University of Auckland, New Zealand. His current research interests include the application of Bayesian statistics to industrial decision making and the development of machine learning techniques for use in process optimization.