Specification of Drug Substances and Products: Development and Validation of Analytical Methods

Skoog, Douglas A

MacKenzie, Kenneth J D

Jeffrey Aube

<p>Nuclear magnetic resonance (NMR) is an analytical tool used by chemists and physicists to study the structure and dynamics of molecules. In recent years, no other technique has gained such significance as NMR spectroscopy. It is used in all branches of science in which precise structural determination is required and in which the nature of interactions and reactions in solution is being studied. <i>Annual Reports on NMR Spectroscopy</i> has established itself as a premier means for the specialist and non-specialist alike to become familiar with new techniques and applications of NMR spectroscopy.</p><br>Editor of about 150 volumes, mostly dealing with aspects of NMR. Retired Professor of Chemistry from the University of Surrey.<br>An eclectic and timely collection of reviews on recent advances and hot topics in nuclear magnetic resonance spectroscopy. ...faithful in citing seminal literature and past reviews, while including most, if not all, recent work in the past 10 years. For those who have an interest in NMR spectroscopy, this book would be an excellent resource.--<b><i>Journal of American Chemical Society</i></b><br>

<p><i>Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, </i> presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. <p/>The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.</p>

<p><i>Advances in Biomembranes and Lipid Self-Assembly, Volume 29</i>, formerly titled <i>Advances in Planar Lipid Bilayers and Liposomes</i>, provides a global platform for the study of cell membranes, lipid model membranes, and lipid self-assemblies, from the micro- to the nanoscale. As planar lipid bilayers are widely studied due to their ubiquity in nature, this book presents research on their application in the formulation of biomimetic model membranes, and in the design of artificial dispersion of liposomes. Moreover, the book discusses how lipids self-assemble into a wide range of other structures, including micelles and the liquid crystalline hexagonal and cubic phases.</p> <p>Chapters in this volume present both original research and comprehensive reviews written by world leading experts and young researchers.</p>