Near Infrared Spectroscopic Assay Transfer For Active Pharmaceutical Ingredients In Intact Tablets

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Analytical Techniques in the Pharmaceutical Sciences

Author : Anette Müllertz
Publisher : Springer
ISBN 13 : 1493940295
Total Pages : 829 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Analytical Techniques in the Pharmaceutical Sciences by : Anette Müllertz

Download or read book Analytical Techniques in the Pharmaceutical Sciences written by Anette Müllertz and published by Springer. This book was released on 2016-08-30 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.

Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy, Second Edition

Author : Emil W. Ciurczak
Publisher : CRC Press
ISBN 13 : 1420084143
Total Pages : 188 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy, Second Edition by : Emil W. Ciurczak

Download or read book Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy, Second Edition written by Emil W. Ciurczak and published by CRC Press. This book was released on 2014-12-15 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the completion of the first edition of this book, major developments have occurred in the pharmaceutical industry that have shaped the field of near-infrared (NIR) spectroscopy. A new initiative from the U.S. Food and Drug Administration (FDA) to modernize regulations of pharmaceutical manufacturing and drug quality has helped position NIR spectroscopy as an effective tool for pharmaceutical testing. Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy: Second Edition reflects these developments and brings readers an up-to-date summary of how this technique is being applied to pharmaceutical manufacturing. Topics include: The origins and principles of NIR spectroscopy, including early instrumentation, spectroscopic theory, and light-particle interaction The physics of each instrument type, the strengths and weaknesses of each, and the manufacturers that produce them The possible advantages of using NIR methods for monitoring or controlling blending, as well as practical concerns for mixing processes NIR spectroscopy as applied to traditional granulation, drug layering, and film coating of beads or granules Pharmaceutical assays, including qualitative analysis, quantitative analysis, determination of actives in tablets and capsules, and considerations for intact dosage form analysis Steps involved in the validation and acceptance of an NIR spectroscopy method, including quality assurance, qualification and verification of instruments, and the International Conference on Harmonization (ICH) guidelines Medical applications, including those related to blood glucose measurements, tissue and major organ analysis, fetal analysis, and cancer research Providing comprehensive coverage of NIR spectroscopy, from theory, mathematics, application, and mechanics of NIR analysis, the book supplies ample references to facilitate further research into this burgeoning field.

Handbook of Near-Infrared Analysis

Author : Emil W. Ciurczak
Publisher : CRC Press
ISBN 13 : 1351269860
Total Pages : 1308 pages
Book Rating : 4.3/5 (512 download)

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Book Synopsis Handbook of Near-Infrared Analysis by : Emil W. Ciurczak

Download or read book Handbook of Near-Infrared Analysis written by Emil W. Ciurczak and published by CRC Press. This book was released on 2021-05-20 with total page 1308 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rapid, inexpensive, and easy-to-deploy, near-infrared (NIR) spectroscopy can be used to analyze samples of virtually any composition, origin, and condition. The Handbook of Near Infrared Analysis, Fourth Edition, explores the factors necessary to perform accurate and time- and cost-effective analyses across a growing spectrum of disciplines. This updated and expanded edition incorporates the latest advances in instrumentation, computerization, chemometrics applied to NIR spectroscopy, and method development in NIR spectroscopy, and underscores current trends in sample preparation, calibration transfer, process control, data analysis, instrument performance testing, and commercial NIR instrumentation. This work offers readers an unparalleled combination of theoretical foundations, cutting-edge applications, and practical experience. Additional features include the following: Explains how to perform accurate as well as time- and cost-effective analyses. Reviews software-enabled chemometric methods and other trends in data analysis. Highlights novel applications in pharmaceuticals, polymers, plastics, petrochemicals, textiles, foods and beverages, baked products, agricultural products, biomedicine, nutraceuticals, and counterfeit detection. Underscores current trends in sample preparation, calibration transfer, process control, data analysis, and multiple aspects of commercial NIR instrumentation. Offering the most complete single-source guide of its kind, the Handbook of Near Infrared Analysis, Fourth Edition, continues to offer practicing chemists and spectroscopists an unparalleled combination of theoretical foundations, cutting-edge applications, and detailed practical experience provided firsthand by more than 50 experts in the field.

Light Propagation Through Biological Tissue and Other Diffusive Media

Author : Fabrizio Martelli
Publisher : Society of Photo Optical
ISBN 13 : 9780819476586
Total Pages : 274 pages
Book Rating : 4.4/5 (765 download)

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Book Synopsis Light Propagation Through Biological Tissue and Other Diffusive Media by : Fabrizio Martelli

Download or read book Light Propagation Through Biological Tissue and Other Diffusive Media written by Fabrizio Martelli and published by Society of Photo Optical. This book was released on 2010 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides foundational information on modeling light propagation through diffusive media, with special emphasis on biological tissue. A summary of the theoretical background on light propagation through diffusive media is provided with the aid of easy-to-use software designed to calculate the solutions of the diffusion equation. The book also provides: the basic theory of photon transport with the analytical solutions of the diffusion equation for several geometries; detailed coverage of the radiative transfer equation and the diffusion equation; the theories and the formulae based on the diffusion equation that have been widely used for biomedical applications; the general concepts and the physical quantities necessary to describe light propagation through absorbing and scattering media; and, a description of the software provided on the CD-ROM, along with the accuracy of the presented solutions. Although the theoretical and computational tools provided with this book and CD-ROM have their primary use in the field of biomedical optics, there are many other applications in which they can be used, including agricultural products, forest products, food products, plastic materials, pharmaceutical products, and many others.

ICH Quality Guidelines

Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 1118971132
Total Pages : 624 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis ICH Quality Guidelines by : Andrew Teasdale

Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-09-29 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Index to Theses with Abstracts Accepted for Higher Degrees by the Universities of Great Britain and Ireland and the Council for National Academic Awards

Download Index to Theses with Abstracts Accepted for Higher Degrees by the Universities of Great Britain and Ireland and the Council for National Academic Awards PDF Online Free

Author :
Publisher :
ISBN 13 :
Total Pages : 356 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Index to Theses with Abstracts Accepted for Higher Degrees by the Universities of Great Britain and Ireland and the Council for National Academic Awards by :

Download or read book Index to Theses with Abstracts Accepted for Higher Degrees by the Universities of Great Britain and Ireland and the Council for National Academic Awards written by and published by . This book was released on 2006 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Advances in Near Infrared Spectroscopy and Related Computational Methods

Author : Christian Huck
Publisher : MDPI
ISBN 13 : 303928052X
Total Pages : 496 pages
Book Rating : 4.0/5 (392 download)

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Book Synopsis Advances in Near Infrared Spectroscopy and Related Computational Methods by : Christian Huck

Download or read book Advances in Near Infrared Spectroscopy and Related Computational Methods written by Christian Huck and published by MDPI. This book was released on 2020-01-03 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the last few decades, near-infrared (NIR) spectroscopy has distinguished itself as one of the most rapidly advancing spectroscopic techniques. Mainly known as an analytical tool useful for sample characterization and content quantification, NIR spectroscopy is essential in various other fields, e.g. NIR imaging techniques in biophotonics, medical applications or used for characterization of food products. Its contribution in basic science and physical chemistry should be noted as well, e.g. in exploration of the nature of molecular vibrations or intermolecular interactions. One of the current development trends involves the miniaturization and simplification of instrumentation, creating prospects for the spread of NIR spectrometers at a consumer level in the form of smartphone attachments—a breakthrough not yet accomplished by any other analytical technique. A growing diversity in the related methods and applications has led to a dispersion of these contributions among disparate scientific communities. The aim of this Special Issue was to bring together the communities that may perceive NIR spectroscopy from different perspectives. It resulted in 30 contributions presenting the latest advances in the methodologies essential in near-infrared spectroscopy in a variety of applications.

Handbook of Stability Testing in Pharmaceutical Development

Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
ISBN 13 : 0387856277
Total Pages : 389 pages
Book Rating : 4.3/5 (878 download)

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Book Synopsis Handbook of Stability Testing in Pharmaceutical Development by : Kim Huynh-Ba

Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

Nanopharmaceuticals: Principles and Applications Vol. 3

Author : Vinod Kumar Yata
Publisher : Springer Nature
ISBN 13 : 3030471209
Total Pages : 352 pages
Book Rating : 4.0/5 (34 download)

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Book Synopsis Nanopharmaceuticals: Principles and Applications Vol. 3 by : Vinod Kumar Yata

Download or read book Nanopharmaceuticals: Principles and Applications Vol. 3 written by Vinod Kumar Yata and published by Springer Nature. This book was released on 2020-08-19 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the third volume on this subject and focuses on the recent advances of nanopharmaceuticals in cancer, dental, dermal and drug delivery applications and presents their safety, toxicity and therapeutic efficacy. The book also includes the transport phenomenon of nanomaterials and important pathways for drug delivery applications. It goes on to explain the toxicity of nanoparticles to different physiological systems and methods used to assess this for different organ systems using examples of in vivo systems.

Practical NIR Spectroscopy with Applications in Food and Beverage Analysis

Author : B. G. Osborne
Publisher : Prentice Hall
ISBN 13 : 9780582099463
Total Pages : 227 pages
Book Rating : 4.0/5 (994 download)

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Book Synopsis Practical NIR Spectroscopy with Applications in Food and Beverage Analysis by : B. G. Osborne

Download or read book Practical NIR Spectroscopy with Applications in Food and Beverage Analysis written by B. G. Osborne and published by Prentice Hall. This book was released on 1993 with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a complete and up-to-date introduction to the technique, taking account of developments in instrumentation for remote and non-invasive measurements and significant advances in calibration and mathematics. The clear explanation of practical and theoretical aspects of the techniques and mathematical treatments available will be essential reading for those working in the food industry and for anyone approaching NIR for the first time.

Karl Fischer Titration

Author : Eugen Scholz
Publisher : Springer Science & Business Media
ISBN 13 : 3642699898
Total Pages : 142 pages
Book Rating : 4.6/5 (426 download)

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Book Synopsis Karl Fischer Titration by : Eugen Scholz

Download or read book Karl Fischer Titration written by Eugen Scholz and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Karl Fischer titration is used in many different ways following its publication in 1935 and further applications are continually being explored. At the present time we are experiencing another phase of expansion, as shown by the development of new titration equipment and new reagents. KF equipment increasingly incorporates microprocessors which enable the course of a titration to be programmed thus sim plifying the titration. Coulometric titrators allow water determinations in the micro gram-range: the KF titration has become a micro-method. The new pyridine-free re agents make its application significantly more pleasant and open up further possibili ties on account of their accuracy. To make the approach to Karl Fischer titrations easier, we have summarized the present knowledge in this monograph and we have complemented it with our own studies and practical experience. As this book should remain "readable", we have tried to keep the fundamentals to a minimum. Historical developments are only mentioned if they seem to be necessary for understanding the KF reaction. The ap plications are described more fully. Specific details which may interest a particular reader can be found in the original publications cited. The referenced literature is in chronological order as the year of publication may also prove informative. Thus, [6902] for example denotes 69 for 1969 being the year of publication and 02 is a non-recurring progressive number. The referenced litera ture includes summaries which we hope will be of help to find the "right" publica tion easily.

Method Validation in Pharmaceutical Analysis

Author : Joachim Ermer
Publisher : John Wiley & Sons
ISBN 13 : 3527604472
Total Pages : 418 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Method Validation in Pharmaceutical Analysis by : Joachim Ermer

Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

Near-infrared Technology in the Agricultural and Food Industries

Author : Phil Williams
Publisher :
ISBN 13 :
Total Pages : 352 pages
Book Rating : 4.:/5 (89 download)

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Book Synopsis Near-infrared Technology in the Agricultural and Food Industries by : Phil Williams

Download or read book Near-infrared Technology in the Agricultural and Food Industries written by Phil Williams and published by . This book was released on 1987 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceutical Excipients

Author : Otilia M. Y. Koo
Publisher : John Wiley & Sons
ISBN 13 : 1118992423
Total Pages : 369 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis Pharmaceutical Excipients by : Otilia M. Y. Koo

Download or read book Pharmaceutical Excipients written by Otilia M. Y. Koo and published by John Wiley & Sons. This book was released on 2016-10-03 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients

Multivariate Calibration

Author : Harald Martens
Publisher : John Wiley & Sons
ISBN 13 : 9780471930471
Total Pages : 444 pages
Book Rating : 4.9/5 (34 download)

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Book Synopsis Multivariate Calibration by : Harald Martens

Download or read book Multivariate Calibration written by Harald Martens and published by John Wiley & Sons. This book was released on 1992-08-07 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: Multivariate Calibration Harald Martens, Chemist, Norwegian Food Research Institute, Aas, Norway and Norwegian Computing Center, Oslo, Norway Tormod Næs, Statistician, Norwegian Food Research Institute, Aas, Norway The aim of this inter-disciplinary book is to present an up-to-date view of multivariate calibration of analytical instruments, for use in research, development and routine laboratory and process operation. The book is intended to show practitioners in chemistry and technology how to extract the quantitative and understandable information embedded in non-selective, overwhelming and apparently useless measurements by multivariate data analysis. Multivariate calibration is the process of learning how to combine data from several channels, in order to overcome selectivity problems, gain new insight and allow automatic outlier detection. Multivariate calibration is the basis for the present success of high-speed Near-Infrared (NIR) diffuse spectroscopy of intact samples. But the technique is very general: it has shown similar advantages in, for instance, UV, Vis, and IR spectrophotometry, (transmittance, reflectance and fluorescence), for x-ray diffraction, NMR, MS, thermal analysis, chromatography (GC, HPLC) and for electrophoresis and image analysis (tomography, microscopy), as well as other techniques. The book is written at two levels: the main level is structured as a tutorial on the practical use of multivariate calibration techniques. It is intended for university courses and self-study for chemists and technologists, giving one complete and versatile approach, based mainly on data compression methodology in self-modelling PLS regression, with considerations of experimental design, data pre-processing and model validation. A second, more methodological, level is intended for statisticians and specialists in chemometrics. It compares several alternative calibration methods, validation approaches and ways to optimize the models. The book also outlines some cognitive changes needed in analytical chemistry, and suggests ways to overcome some communication problems between statistics and chemistry and technology.

Countering the Problem of Falsified and Substandard Drugs

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309269393
Total Pages : 377 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Countering the Problem of Falsified and Substandard Drugs by : Institute of Medicine

Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Handbook of Pharmaceutical Manufacturing Formulations

Author : Safaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1420081314
Total Pages : 458 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Pharmaceutical Manufacturing Formulations by : Safaraz K. Niazi

Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Safaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster