Development Of Quantitative Assays For The Actives In Intact Pharmaceutical Capsules Using Near Infrared Spectroscopy

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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 : Donald A. Burns
Publisher : CRC Press
ISBN 13 : 1420007378
Total Pages : 836 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Near-Infrared Analysis by : Donald A. Burns

Download or read book Handbook of Near-Infrared Analysis written by Donald A. Burns and published by CRC Press. This book was released on 2007-09-07 with total page 836 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fast, inexpensive, and easy-to-use, near-infrared (NIR) spectroscopy can be used to analyze small samples of virtually any composition. The Handbook of Near Infrared Analysis, Third Edition explains how to perform accurate as well as time- and cost-effective analyses across a growing spectrum of disciplines. Presenting nearly 50% new and re

Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy

Author : Emil W. Ciurczak
Publisher : CRC Press
ISBN 13 : 1498704468
Total Pages : 180 pages
Book Rating : 4.4/5 (987 download)

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

Download or read book Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy written by Emil W. Ciurczak and published by CRC Press. This book was released on 2014-12-15 with total page 180 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 sp

Physico Chemical Methods in Drug Discovery and Development

Author : Zoran Mandic
Publisher : IAPC Publishing
ISBN 13 : 9535694200
Total Pages : 500 pages
Book Rating : 4.5/5 (356 download)

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Book Synopsis Physico Chemical Methods in Drug Discovery and Development by : Zoran Mandic

Download or read book Physico Chemical Methods in Drug Discovery and Development written by Zoran Mandic and published by IAPC Publishing. This book was released on 2012 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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.

ICH Quality Guidelines

Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 1118971124
Total Pages : 737 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 737 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)

Handbook of Modern Pharmaceutical Analysis

Author : Satinder Ahuja
Publisher : Elsevier
ISBN 13 : 0080488927
Total Pages : 587 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis Handbook of Modern Pharmaceutical Analysis by : Satinder Ahuja

Download or read book Handbook of Modern Pharmaceutical Analysis written by Satinder Ahuja and published by Elsevier. This book was released on 2001-08-02 with total page 587 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories.No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

Applied Spectroscopy

Author : Jerry Workman Jr.
Publisher : Academic Press
ISBN 13 : 0080527493
Total Pages : 557 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis Applied Spectroscopy by : Jerry Workman Jr.

Download or read book Applied Spectroscopy written by Jerry Workman Jr. and published by Academic Press. This book was released on 1998-06-08 with total page 557 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book delineates practical, tested, general methods for ultraviolet, visible, and infrared spectrometry in clear language for novice users, and serves as a reference resource for advanced spectroscopists. Applied Spectroscopy includes important information and equations which will be referred to regularly. The book emphasizes reflectance and color measurements due to their common usage in todays spectroscopic laboratories, and contains methods for selectinga measurement technique as well as solar and color measurements. Written by experts in the field, this text covers spectrometry of new materials, ceramics, and textiles, and provides an appendix of practical reference data for spectrometry. - Book topics include: Practical aspects of spectrometers and spectrometry; Sample preparation; Chemometrics and calibration practices; Reflectance measurements; Standard materials measurements - An emphasis is placed on reflectance and color measurements due to their common usage in today's spectroscopic laboratories - Methods for selecting a measurement technique are included as well as solar measurements and reference information on sources, detectors, optical fiber and window materials

Process Analytical Technology

Author : Katherine A. Bakeev
Publisher : John Wiley & Sons
ISBN 13 : 140517319X
Total Pages : 472 pages
Book Rating : 4.4/5 (51 download)

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Book Synopsis Process Analytical Technology by : Katherine A. Bakeev

Download or read book Process Analytical Technology written by Katherine A. Bakeev and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of real or near real time measurement of chemical production process parameters as the basis for achieving control or optimisation of a manufacturing process has wide application in the petrochemical, food and chemical industries. Process analytical chemistry (PAC), or process analytical technology (PAT) as it has recently been called, is now being deployed in the pharmaceutical industry, where it is seen as a technology that can help companies to improve their conformity with manufacturing compliance regulations. The objective of this book is to provide a starting point for implementing process analytical chemistry tools in process monitoring applications or as part of a total quality management system. Written from the perspective of the spectroscopist required to implant PAT tools in a process environment, attention is focussed on measurements that are made "in process" at-line or off-line, providing data on product during manufacture. With chapters covering the key spectroscopic tools, their applications in the pharmaceutical and chemical industries and basic chemometrics, the novice can quickly develop a sound understanding of the most practical technologies and applications. Implementation strategies are fully covered and address some of the critical issues that need to be tackled when setting up a PAT project – including choosing a project with a sound business justification in the first place.

Chemometrics-based Spectroscopy for Pharmaceutical and Biomedical Analysis

Author : Hoang Vu Dang
Publisher : Frontiers Media SA
ISBN 13 : 2889458458
Total Pages : 177 pages
Book Rating : 4.8/5 (894 download)

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Book Synopsis Chemometrics-based Spectroscopy for Pharmaceutical and Biomedical Analysis by : Hoang Vu Dang

Download or read book Chemometrics-based Spectroscopy for Pharmaceutical and Biomedical Analysis written by Hoang Vu Dang and published by Frontiers Media SA. This book was released on 2019-04-17 with total page 177 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chemometrics is the application of mathematics and statistics to chemical data in order to design or select optimal experimental procedures, to provide maximum relevant information, and to obtain knowledge about systems under study. This chemical discipline has constantly developed to become a mature field of Analytical Chemistry after its inception in the 1970s. The utility and versatility of chemometric techniques enable spectroscopists to perform multidimensional classification and/or calibration of spectral data that make identification and quantification of analytes in complex mixtures possible.Wavelets are mathematical functions that cut up data into different frequency components, and then study each component with a resolution matched to its scale. They are now being adapted for a vast number of signal processing due to their unprecedented success in terms of asymptotic optimality, spatial adaptivity and computational efficiency. In analytical chemistry, they have increasingly shown great applicability and have been preferred over existing signal processing algorithms in noise removal, resolution enhancement, data compression and chemometrics modeling in chemical studies.The aim of this Research Topic is to present state-of-the-art applications of chemometrics, in the field of spectroscopy, with special attention to the use of wavelet transform. Both reviews and original research articles on pharmaceutical and biomedical analysis are welcome in the specialty section Analytical Chemistry.

Encyclopedia of Pharmaceutical Technology

Author : James Swarbrick
Publisher : CRC Press
ISBN 13 : 1439808236
Total Pages : 880 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Encyclopedia of Pharmaceutical Technology by : James Swarbrick

Download or read book Encyclopedia of Pharmaceutical Technology written by James Swarbrick and published by CRC Press. This book was released on 2013-07-01 with total page 880 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the pharmaceutical specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and constant companion for years to com

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)

Development of a Multiplex Bandpass Near-infrared Spectrometer Utilizing Molecular Filters

Author : Michele Rene Fischer
Publisher :
ISBN 13 :
Total Pages : 134 pages
Book Rating : 4.3/5 ( download)

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Book Synopsis Development of a Multiplex Bandpass Near-infrared Spectrometer Utilizing Molecular Filters by : Michele Rene Fischer

Download or read book Development of a Multiplex Bandpass Near-infrared Spectrometer Utilizing Molecular Filters written by Michele Rene Fischer and published by . This book was released on 1995 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Sample Preparation of Pharmaceutical Dosage Forms

Author : Beverly Nickerson
Publisher : Springer Science & Business Media
ISBN 13 : 1441996311
Total Pages : 400 pages
Book Rating : 4.4/5 (419 download)

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Book Synopsis Sample Preparation of Pharmaceutical Dosage Forms by : Beverly Nickerson

Download or read book Sample Preparation of Pharmaceutical Dosage Forms written by Beverly Nickerson and published by Springer Science & Business Media. This book was released on 2011-08-05 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms. • Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods. • Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.

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 : 398 pages
Book Rating : 4.F/5 ( 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 2009 with total page 398 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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.

Oral Formulation Roadmap from Early Drug Discovery to Development

Author : Elizabeth Kwong
Publisher : John Wiley & Sons
ISBN 13 : 1118907906
Total Pages : 268 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis Oral Formulation Roadmap from Early Drug Discovery to Development by : Elizabeth Kwong

Download or read book Oral Formulation Roadmap from Early Drug Discovery to Development written by Elizabeth Kwong and published by John Wiley & Sons. This book was released on 2017-01-03 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing