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    Front QBD Book

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    of 8

    AAPS Introductions in the Pharmaceutical

    Sciences
    Founding Editor
    Robin Zavod, Chicago College of Pharmacy Midwestern University, Downers
    Grove, IL, USA

    Series Editor
    Claudio Salomon, National University of Rosario, Rosario, Argentina
    The AAPS Introductions in the Pharmaceutical Sciences book series is designed to
    support pharmaceutical scientists at the point of knowledge transition. Springer and
    the American Association of Pharmaceutical Scientists (AAPS) have partnered again
    to produce a second series that juxtaposes the AAPS Advances in the Pharmaceutical
    Sciences series. Whether shifting between positions, business models, research
    project objectives, or at a crossroad in professional development, scientists need to
    retool to meet the needs of the new scientific challenges ahead of them. These
    educational pivot points require the learner to develop new vocabulary in order to
    effectively communicate across disciplines, appreciate historical evolution within
    the knowledge area with the aim of appreciating the current limitations and potential
    for growth, learn new skills and evaluation metrics so that project planning and
    subsequent evolution are evidence-based, as well as to simply “dust the rust off”
    content learned in previous educational or employment settings, or utilized during
    former scientific explorations. The Introductions book series will meet these needs
    and serve as a quick and easy-to-digest resource for contemporary science.
    Márcia C. Breitkreitz • Hector C. Goicoechea
    Editors

    Introduction to Quality by
    Design in Pharmaceutical
    Manufacturing and Analytical
    Development
    Editors
    Márcia C. Breitkreitz Hector C. Goicoechea
    Laboratory of Pharmaceutical Research Laboratorio de Desarrollo Analítico y
    and Chemometrics (LABFARQUI), Quimiometría (LADAQ), Cátedra de Química
    Institute of Chemistry Analítica I, Facultad de Bioquímica y Ciencias
    University of Campinas (UNICAMP) Biológicas
    Campinas, SP, Brazil Universidad Nacional del Litoral, Ciudad
    Universitaria, Santa Fe
    Santa Fe, Argentina
    Consejo Nacional de Investigaciones Científicas
    y Técnicas (CONICET)
    Ciudad Autónoma de Buenos Aires, Buenos
    Aires, Argentina

    Jointly published with American Association of Pharmaceutical Scientists


    ISSN 2522-834X ISSN 2522-8358 (electronic)
    AAPS Introductions in the Pharmaceutical Sciences
    ISBN 978-3-031-31504-6 ISBN 978-3-031-31505-3 (eBook)
    https://doi.org/10.1007/978-3-031-31505-3

    © American Association of Pharmaceutical Scientists 2023


    This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether
    the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of
    illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and
    transmission or information storage and retrieval, electronic adaptation, computer software, or by
    similar or dissimilar methodology now known or hereafter developed.
    The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication
    does not imply, even in the absence of a specific statement, that such names are exempt from the relevant
    protective laws and regulations and therefore free for general use.
    The publishers, the authors, and the editors are safe to assume that the advice and information in this
    book are believed to be true and accurate at the date of publication. Neither the publishers nor the
    authors or the editors give a warranty, expressed or implied, with respect to the material contained
    herein or for any errors or omissions that may have been made. The publishers remain neutral with
    regard to jurisdictional claims in published maps and institutional affiliations.

    This Springer imprint is published by the registered company Springer Nature Switzerland AG
    The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
    Preface

    This book was inspired by the demand of modern pharmaceutical development to


    incorporate quality into their products, processes and methods in the early stages of
    development. This is the goal of Quality by Design and Analytical Quality by
    Design approaches, in which Design of Experiments plays a central role, together
    with the risk assessment. At this moment we are facing a paradigm change regarding
    quality – from final product testing to building the quality into the products. As any
    paradigm change, it requires studying, training and learning from examples. There-
    fore, solid materials are needed for the present and future generations and this is the
    major goal of this book: to organize in a single volume the most important topics,
    including both theory and examples, on QbD and AQbD, with special attention to
    our favorite part: DOE. We can say this material is the result of our passion for
    applied research and the use of DOE to fully understand the systems we study. Over
    the years we have become enthusiastics about it and therefore we are really glad to
    contribute to the spread of this magnificent tool within a modern applied scenario.
    Another important aspect we would like to highlight is the so-needed bound of
    Academia, Industry and Pharmacopeias we have reached when building the content
    of this book. More than ever, the academic knowledge is very welcome into the
    industrial scenario in order to promote quality to products and methods. Pharmaco-
    peias play an important role in providing guidance to this process.
    We do hope this book helps the readers to walk towards the understanding of the
    importance of QbD, AQbD and the implementation of DOE in routine for product
    and method development. We hope you enjoy reading as much as we enjoyed
    organizing it.

    Campinas, São Paulo, Brazil Márcia C. Breitkreitz


    Santa Fe, Santa Fé, Argentina Hector C. Goicoechea

    v
    Acknowledgments

    To Prof. Roy Edward Bruns for the careful revision of the text, for his willingness to
    teach DOE and for being an inspiring example to all of us.
    To all the authors who, in spite of their hectic routine of work, went on board with
    us on this knowledge endeavour and contributed to the final result of this book.

    vii
    Contents

    Part 1 Quality by Design (QbD)


    1 Pharmaceutical Quality by Design (QbD) Overview
    and Major Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
    Ana Vanessa Dutra Silva and Márcia C. Breitkreitz
    2 Fundamentals of Design of Experiments and Optimization:
    Designs for Factor Screening and Data Analysis in
    Pre-Response Surface Methodology . . . . . . . . . . . . . . . . . . . . . . . . . 29
    Fabricio A. Chiappini, Carla M. Teglia, Silvana M. Azcarate,
    and Hector C. Goicoechea
    3 Fundamentals of Design of Experiments and Optimization:
    Experimental Designs in Response Surface Methodology . . . . . . . . 47
    Silvana M. Azcarate, Carla M. Teglia, Fabricio A. Chiappini,
    and Hector C. Goicoechea
    4 Fundamentals of Design of Experiments and Optimization:
    Data Modeling in Response Surface Methodology . . . . . . . . . . . . . . 67
    Fabricio A. Chiappini, Silvana M. Azcarate, Carla M. Teglia,
    and Hector C. Goicoechea
    5 Quality by Design in Pharmaceutical Product and
    Process Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
    Marília Medeiros and Márcia C. Breitkreitz
    6 A Quality by Design Update on Nano-drug
    Delivery Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
    Darío Leonardi, María Celina Lamas,
    and Claudio Javier Salomon

    ix
    x Contents

    7 Control Strategies of Solid Dosage Forms by PAT Tools . . . . . . . . . 141


    Pierre-Yves Sacré, Charlotte De Bleye, Philippe Hubert,
    and Eric Ziemons

    Part 2 Analytical Quality by Design (AQbD)


    8 Analytical Quality by Design Fundamentals and
    Compendial and Regulatory Perspectives . . . . . . . . . . . . . . . . . . . . 165
    Amanda Guiraldelli Mahr, Felipe Rebello Lourenço,
    Phil Borman, Jane Weitzel, and Jean-Marc Roussel
    9 Analytical Target Profile (ATP) and Method Operable
    Design Region (MODR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
    Amanda Guiraldelli Mahr, Felipe Rebello Lourenço,
    Phil Borman, Jane Weitzel, and Jean-Marc Roussel
    10 Quality by Design Applications to Development of
    Analytical Methods for Quality Control of Pharmaceuticals . . . . . . 223
    Yamile Soledad Caro, María Silvia Cámara,
    and María Mercedes De Zan
    11 Design of Experiments Applied to the Extraction
    of Active Compounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
    Ieda Spacino Scarminio and Roy Edward Bruns

    Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265

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