Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development

Márcia Cristina Breitkreitz has worked since 2014 as Professor in the Chemistry Institute of the University of Campinas (UNICAMP), coordinating the Laboratory of Pharmaceutical Research and Chemometrics (LabFarQui). She was a researcher in Chemometrics from 2006-2007 at the International Institute of Pharmaceutical Research (IIPF, Brazil) and coordinator of Research and Development (R&D) from 2007 to 2009, where she started the implementation of chemometrics methods for pharmaceutical development.  She received her PhD (2013) degree from UNICAMP, with a project aimed at using hyperspectral imaging  (NIR/Raman) and multivariate analysis to develop stable pharmaceutical formulations.  Her major research interests are related to Chemometrics applied to the development of pharmaceutical products and processes according to the strategy of Quality by Design (QbD); development of analytical methods based Analytical Quality by Design (AQbD) and the use of vibrational spectroscopy (IR, NIR and Raman, point and imaging) for pharmaceutical development and troubleshooting. In addition to her research work and teaching (graduate and undergraduate levels), Prof. Marcia is dedicated to courses and consultancy on relevant topics to the pharmaceutical industry, especially related to Chemometrics within the context of Quality by Design.

Héctor C. Goicoechea was born in Santa Fe, Argentina, on May 15, 1961. He received his Ph.D. (2000) from the National University of Rosario. After a postdoctoral research at North Dakota State University, USA, he joined the University of Litoral, Santa Fe (2004), where he is Full Professor of Analytical Chemistry/Chemometrics. He is fellow (Senior Researcher) of the National Research Council of Argentina (CONICET), and has founded a research group (LADAQ). His works in the development of analytical methods based on spectroscopy, separations and electrochemistry coupled to chemometrics. He published more than 220 papers in well-known international journals, two books, 8 book chapters and has supervised thirteen Ph.D. Theses.

Part 1: Quality by Design (QbD).- Chapter 1. Pharmaceutical Quality by Design (QbD) overview and major elements.- Chapter 2. Fundamentals of design of experiments and optimization: designs for factor screening and data analysis in pre-response surface methodology.- Chapter 3. Fundamentals of design of experiments and optimization: experimental designs in response surface methodology.- Chapter 4. Fundamentals of design of experiments and optimization: data modeling in response surface methodology.- Chapter 5. Quality by Design in pharmaceutical product and process development.- Chapter 6. A Quality by Design update on nano-drug delivery systems.- Chapter 7. Control strategies of solid dosage forms by PAT tools.- Part 2: Analytical Quality by Design (AQbD).- Chapter 8. Analytical Quality by Design Fundamentals, Compendial and Regulatory Perspectives.- Chapter 9. Analytical Target Profile (ATP) and Method Operable Design Region (MODR).- Chapter 10: Quality by Design applications to development of analytical methods for quality control of pharmaceuticals.- Chapter 11. Design of Experiments Applied to the Extraction of Active Compounds.