Download or read book Specification of Drug Substances and Products written by Christopher M. Riley and published by Elsevier. This book was released on 2020-07-23 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, 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. 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. - Presents a critical assessment of the application of ICH guidelines on method validation and specification setting - Written by subject-matter experts involved in the development and application of the guidelines - Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products - Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction

Download or read book Introductory Finite Difference Methods for PDEs written by and published by Bookboon. This book was released on with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Mathematics of Diffusion written by John Crank and published by Oxford University Press. This book was released on 1979 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: Though it incorporates much new material, this new edition preserves the general character of the book in providing a collection of solutions of the equations of diffusion and describing how these solutions may be obtained.

Download or read book Mutagenic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2022-02-15 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.

Download or read book Applied Numerical Methods Using MATLAB written by Won Y. Yang and published by John Wiley & Sons. This book was released on 2005-05-20 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, with the introduction of new media products, there has been a shift in the use of programming languages from FORTRAN or C to MATLAB for implementing numerical methods. This book makes use of the powerful MATLAB software to avoid complex derivations, and to teach the fundamental concepts using the software to solve practical problems. Over the years, many textbooks have been written on the subject of numerical methods. Based on their course experience, the authors use a more practical approach and link every method to real engineering and/or science problems. The main benefit is that engineers don't have to know the mathematical theory in order to apply the numerical methods for solving their real-life problems. An Instructor's Manual presenting detailed solutions to all the problems in the book is available online.

Download or read book Differential Equations with Boundary value Problems written by Dennis G. Zill and published by . This book was released on 2005 with total page 619 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now enhanced with the innovative DE Tools CD-ROM and the iLrn teaching and learning system, this proven text explains the "how" behind the material and strikes a balance between the analytical, qualitative, and quantitative approaches to the study of differential equations. This accessible text speaks to students through a wealth of pedagogical aids, including an abundance of examples, explanations, "Remarks" boxes, definitions, and group projects. This book was written with the student's understanding firmly in mind. Using a straightforward, readable, and helpful style, this book provides a thorough treatment of boundary-value problems and partial differential equations.

Download or read book Applied Genetic Algorithms written by Sam Jones and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic Algorithms (GA) are one of the various methods in the family of evolutionary algorithms that seek answers to developing questions by providing better solutions. Its applications can be observed in science, engineering, business and social sciences. In this book, the reader will get introduced to some applications in automatic control, scheduling of resources, electrical and electronics engineering. It also demonstrates various examples of character recognition and multi-criteria categorization, as well as trading systems. Therefore, this book will be useful to engineers and scientists belonging to different fields of specialization who need some evolutionary techniques in their work and for those readers who may be using Genetic Algorithms in their work for the first time.

Download or read book Shape Analysis in Medical Image Analysis written by Shuo Li and published by Springer Science & Business Media. This book was released on 2014-01-28 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book contains thirteen contributions from invited experts of international recognition addressing important issues in shape analysis in medical image analysis, including techniques for image segmentation, registration, modelling and classification and applications in biology, as well as in cardiac, brain, spine, chest, lung and clinical practice. This volume treats topics such as for example, anatomic and functional shape representation and matching; shape-based medical image segmentation; shape registration; statistical shape analysis; shape deformation; shape-based abnormity detection; shape tracking and longitudinal shape analysis; machine learning for shape modeling and analysis; shape-based computer-aided-diagnosis; shape-based medical navigation; benchmark and validation of shape representation, analysis and modeling algorithms. This work will be of interest to researchers, students and manufacturers in the fields of artificial intelligence, bioengineering, biomechanics, computational mechanics, computational vision, computer sciences, human motion, mathematics, medical imaging, medicine, pattern recognition and physics.

Download or read book The Optimal Homotopy Asymptotic Method written by Vasile Marinca and published by Springer. This book was released on 2015-04-02 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book emphasizes in detail the applicability of the Optimal Homotopy Asymptotic Method to various engineering problems. It is a continuation of the book “Nonlinear Dynamical Systems in Engineering: Some Approximate Approaches”, published at Springer in 2011 and it contains a great amount of practical models from various fields of engineering such as classical and fluid mechanics, thermodynamics, nonlinear oscillations, electrical machines and so on. The main structure of the book consists of 5 chapters. The first chapter is introductory while the second chapter is devoted to a short history of the development of homotopy methods, including the basic ideas of the Optimal Homotopy Asymptotic Method. The last three chapters, from Chapter 3 to Chapter 5, are introducing three distinct alternatives of the Optimal Homotopy Asymptotic Method with illustrative applications to nonlinear dynamical systems. The third chapter deals with the first alternative of our approach with two iterations. Five applications are presented from fluid mechanics and nonlinear oscillations. The Chapter 4 presents the Optimal Homotopy Asymptotic Method with a single iteration and solving the linear equation on the first approximation. Here are treated 32 models from different fields of engineering such as fluid mechanics, thermodynamics, nonlinear damped and undamped oscillations, electrical machines and even from physics and biology. The last chapter is devoted to the Optimal Homotopy Asymptotic Method with a single iteration but without solving the equation in the first approximation.

Download or read book Simulation of ODE PDE Models with MATLAB OCTAVE and SCILAB written by Alain Vande Wouwer and published by Springer. This book was released on 2014-06-07 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Simulation of ODE/PDE Models with MATLAB®, OCTAVE and SCILAB shows the reader how to exploit a fuller array of numerical methods for the analysis of complex scientific and engineering systems than is conventionally employed. The book is dedicated to numerical simulation of distributed parameter systems described by mixed systems of algebraic equations, ordinary differential equations (ODEs) and partial differential equations (PDEs). Special attention is paid to the numerical method of lines (MOL), a popular approach to the solution of time-dependent PDEs, which proceeds in two basic steps: spatial discretization and time integration. Besides conventional finite-difference and element techniques, more advanced spatial-approximation methods are examined in some detail, including nonoscillatory schemes and adaptive-grid approaches. A MOL toolbox has been developed within MATLAB®/OCTAVE/SCILAB. In addition to a set of spatial approximations and time integrators, this toolbox includes a collection of application examples, in specific areas, which can serve as templates for developing new programs. Simulation of ODE/PDE Models with MATLAB®, OCTAVE and SCILAB provides a practical introduction to some advanced computational techniques for dynamic system simulation, supported by many worked examples in the text, and a collection of codes available for download from the book’s page at www.springer.com. This text is suitable for self-study by practicing scientists and engineers and as a final-year undergraduate course or at the graduate level.

Download or read book Introduction to Pharmaceutical Chemical Analysis written by Steen Honoré Hansen and published by John Wiley & Sons. This book was released on 2011-10-18 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook is the first to present a systematic introduction to chemical analysis of pharmaceutical raw materials, finished pharmaceutical products, and of drugs in biological fluids, which are carried out in pharmaceutical laboratories worldwide. In addition, this textbook teaches the fundamentals of all the major analytical techniques used in the pharmaceutical laboratory, and teaches the international pharmacopoeias and guidelines of importance for the field. It is primarily intended for the pharmacy student, to teach the requirements in “analytical chemistry” for the 5 years pharmacy curriculum, but the textbook is also intended for analytical chemists moving into the field of pharmaceutical analysis. Addresses the basic concepts, then establishes the foundations for the common analytical methods that are currently used in the quantitative and qualitative chemical analysis of pharmaceutical drugs Provides an understanding of common analytical techniques used in all areas of pharmaceutical development Suitable for a foundation course in chemical and pharmaceutical sciences Aimed at undergraduate students of degrees in Pharmaceutical Science/Chemistry Analytical Science/Chemistry, Forensic analysis Includes many illustrative examples

Download or read book Extractables and Leachables written by Dennis Jenke and published by John Wiley & Sons. This book was released on 2022-08-02 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.

Download or read book Numerical Partial Differential Equations Finite Difference Methods written by J.W. Thomas and published by Springer Science & Business Media. This book was released on 2013-12-01 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: What makes this book stand out from the competition is that it is more computational. Once done with both volumes, readers will have the tools to attack a wider variety of problems than those worked out in the competitors' books. The author stresses the use of technology throughout the text, allowing students to utilize it as much as possible.

Download or read book Computational Mathematics with SageMath written by P. Zimmermann and published by SIAM. This book was released on 2018-12-10 with total page 459 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fantastic and deep book about how to use Sage for learning and doing mathematics at all levels perfectly complements the existing Sage documentation. It is filled with many carefully thought through examples and exercises, and great care has been taken to put computational functionality into proper mathematical context. Flip to almost any random page in this amazing book, and you will learn how to play with and visualize some beautiful part of mathematics. --- William A. Stein, CEO, SageMath, and professor of mathematics, University of Washington SageMath, or Sage for short, is an open-source mathematical software system based on the Python language and developed by an international community comprising hundreds of teachers and researchers, whose aim is to provide an alternative to the commercial products Magma, Maple, Mathematica, and MATLAB. To achieve this, Sage relies on many open-source programs, including GAP, Maxima, PARI, and various scientific libraries for Python, to which thousands of new functions have been added. Sage is freely available and is supported by all modern operating systems. Sage provides a wonderful scientific and graphical calculator for high school students, and it efficiently supports undergraduates in their computations in analysis, linear algebra, calculus, etc. For graduate students, researchers, and engineers in various mathematical specialties, Sage provides the most recent algorithms and tools, which is why several universities around the world already use Sage at the undergraduate level.

Download or read book An Introduction to Financial Option Valuation written by Desmond J. Higham and published by Cambridge University Press. This book was released on 2004-04-15 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a lively textbook providing a solid introduction to financial option valuation for undergraduate students armed with a working knowledge of a first year calculus. Written in a series of short chapters, its self-contained treatment gives equal weight to applied mathematics, stochastics and computational algorithms. No prior background in probability, statistics or numerical analysis is required. Detailed derivations of both the basic asset price model and the Black–Scholes equation are provided along with a presentation of appropriate computational techniques including binomial, finite differences and in particular, variance reduction techniques for the Monte Carlo method. Each chapter comes complete with accompanying stand-alone MATLAB code listing to illustrate a key idea. Furthermore, the author has made heavy use of figures and examples, and has included computations based on real stock market data.

Download or read book Superbases for Organic Synthesis written by Tsutomu Ishikawa and published by John Wiley & Sons. This book was released on 2009-01-26 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guanidines, amidines and phosphazenes have been attracting attention in organic synthesis due to their potential functionality resulting from their extremely strong basicity. They are also promising catalysts because of their potential for easy molecular modification, possible recyclability, and reduced or zero toxicity. Importantly, these molecules can be derived as natural products – valuable as scientists move towards “sustainable chemistry”, where reagents and catalysts are derived from biomaterial sources. Superbases for Organic Synthesis is an essential guide to these important molecules for preparative organic synthesis. Topics covered include the following aspects: an introduction to organosuperbases physicochemical properties of organic superbases amidines and guanidines in organic synthesis phosphazene: preparation, reaction and catalytic role polymer-supported organosuperbases application of organosuperbases to total synthesis related organocatalysts: proton sponges and urea derivatives amidines and guanidines in natural products and medicines Superbases for Organic Synthesis is a comprehensive, authoritative and up-to-date guide to these important reagents for organic chemists, drug discovery researchers and those interested in the chemistry of natural products.

Download or read book Subdivision Methods for Geometric Design written by Joe Warren and published by Morgan Kaufmann. This book was released on 2002 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: Subdivision Methods for Geometric Design provides computer graphics students and designers with a comprehensive guide to subdivision methods, including the background information required to grasp underlying concepts, techniques for manipulating subdivision algorithms to achieve specific effects, and a wide array of digital resources on a dynamic companion Web site. Subdivision Methods promises to be a groundbreaking book, important for both advanced students and working professionals in the field of computer graphics.