Created by: Jennifer Lewis, Ph.D., Director, University of Rhode Island ICH-Q14_Takeaway-Tool-(Laboratory University)Download

Created by: Prafulla Kumar Sahua, Nageswara Rao Ramisetti b,∗, Teresa Cecchi c,∗, Suryakanta Swaind,Chandra Sekhar Patroa, Jagadeesh Panda Chemometric approaches have been increasingly viewed as precious complements to high performanceliquid chromatographic practices, since a large number of variables can be simultaneously controlledto achieve the desired separations. Moreover, their applications may efficiently identify and optimizethe significant […]

Created by: Breno M. Marsona, Victor Concentinoa, Allan M. Junkerta, Mariana M. Fachia, Raquel O. Vilhenaa and Roberto Pontarolo Analytical validation has fundamental importance in the scope of Good Manufacturing Practice (GMP) for pharmaceutical products since it establishes scientific evidence that an analytical procedure provides reliable results. However, even with validation guidelines available it is […]

Created by: Chris Latoz & Kim Huynh-ba Combination products are therapeutic and diagnostic products that include two or more of the following: drug, biologic, and device. These products are needed for enhanced clinical outcomes and have more than one Mode of Action (MOA). Therefore, they require a more complex regulatory pathway and compliance with a […]