Author Description

QUALITY BY DESIGN- CONCEPT FOR DRUG PRODUCT DEVELOPMENT Multivariate data analysis (MVDA) is a form of statistics that helps to understand the relationships between variables, observations, and their relevance to each other using Principal component analysis (PCA) as well as relationships between independent variables and responses using Partial least squares (PLS).When coupled with process knowledge and criticality understanding, PLS and /PCA models can be used to construct multivariate statistical process control (MSPC) charts in order to identify deviations from targeted behavior. Criticality is determined by assessing the magnitude of impact a variable (parameter/ material attribute) has on a response (CQA). Hence, relationship between the parameter and CQA need to understand. MVDA uses established algorithms to create linear models comprising an approximation function and level of concomitant noise. MVDA models are designed to assess and ensure that progression of product is evolving within the defined design space during processing, thereby ultimately yielding material meeting predefined critical quality attributes. With this methodology, the process parameters are summarize