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Author : Roger E. Schirmer
Publisher : CRC Press
Page : 416 pages
File Size : 49,9 Mb
Release : 1990-11-30
Category : Medical
ISBN : 0849352665
Author : Roger E. Schirmer
Publisher : Springer
Page : 296 pages
File Size : 48,8 Mb
Release : 1982-01-05
Category : Medical
ISBN : UOM:39015000816523
Vols. -3: Edited by Roger E. Schirmer.
Author : Roger E. Schirmer
Publisher : CRC-Press
Page : 456 pages
File Size : 55,7 Mb
Release : 1990-12-19
Category : Medical
ISBN : 0849352673
This book reviews several of the newer methods that find wide application in pharmaceutical analysis, as well as several older methods of unique importance. The principle of each technique is discussed with emphasis on factors that directly affect its proper application to analytical problems .
Author : Roger E. Schirmer
Publisher : Unknown
Page : 264 pages
File Size : 41,5 Mb
Release : 1982
Category : Drugs
ISBN : UOM:39015000816549
Author : Satinder Ahuja,Stephen Scypinski
Publisher : Academic Press
Page : 604 pages
File Size : 54,5 Mb
Release : 2010-11-11
Category : Medical
ISBN : 9780123759818
Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS
Author : Stig Pedersen-Bjergaard,Bente Gammelgaard,Trine G. Halvorsen
Publisher : John Wiley & Sons
Page : 722 pages
File Size : 51,5 Mb
Release : 2019-02-11
Category : Science
ISBN : 9781119362753
The definitive textbook on the chemical analysis of pharmaceutical drugs – fully revised and updated Introduction to Pharmaceutical Analytical Chemistry enables students to gain fundamental knowledge of the vital concepts, techniques and applications of the chemical analysis of pharmaceutical ingredients, final pharmaceutical products and drug substances in biological fluids. A unique emphasis on pharmaceutical laboratory practices, such as sample preparation and separation techniques, provides an efficient and practical educational framework for undergraduate studies in areas such as pharmaceutical sciences, analytical chemistry and forensic analysis. Suitable for foundational courses, this essential undergraduate text introduces the common analytical methods used in quantitative and qualitative chemical analysis of pharmaceuticals. This extensively revised second edition includes a new chapter on chemical analysis of biopharmaceuticals, which includes discussions on identification, purity testing and assay of peptide and protein-based formulations. Also new to this edition are improved colour illustrations and tables, a streamlined chapter structure and text revised for increased clarity and comprehension. Introduces the fundamental concepts of pharmaceutical analytical chemistry and statistics Presents a systematic investigation of pharmaceutical applications absent from other textbooks on the subject Examines various analytical techniques commonly used in pharmaceutical laboratories Provides practice problems, up-to-date practical examples and detailed illustrations Includes updated content aligned with the current European and United States Pharmacopeia regulations and guidelines Covering the analytical techniques and concepts necessary for pharmaceutical analytical chemistry, Introduction to Pharmaceutical Analytical Chemistry is ideally suited for students of chemical and pharmaceutical sciences as well as analytical chemists transitioning into the field of pharmaceutical analytical chemistry.
Author : James W. Munson
Publisher : CRC Press
Page : 496 pages
File Size : 43,8 Mb
Release : 1984-11-30
Category : Medical
ISBN : 0824772512
Author : Joachim Ermer,John H. McB. Miller
Publisher : John Wiley & Sons
Page : 418 pages
File Size : 52,9 Mb
Release : 2006-03-06
Category : Science
ISBN : 9783527604470
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.
Author : Joachim Ermer,Phil W. Nethercote
Publisher : John Wiley & Sons
Page : 451 pages
File Size : 40,5 Mb
Release : 2014-11-10
Category : Medical
ISBN : 9783527335633
This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.
Author : David G. Watson
Publisher : Elsevier Health Sciences
Page : 480 pages
File Size : 41,8 Mb
Release : 2015-12-24
Category : Medical
ISBN : 9780702069888
Pharmaceutical analysis determines the purity, concentration, active compounds, shelf life, rate of absorption in the body, identity, stability, rate of release etc. of a drug. Testing a pharmaceutical product involves a variety of chemical, physical and microbiological analyses. It is reckoned that over £10 billion is spent annually in the UK alone on pharmaceutical analysis, and the analytical processes described in this book are used in industries as diverse as food, beverages, cosmetics, detergents, metals, paints, water, agrochemicals, biotechnological products and pharmaceuticals. This is the key textbook in pharmaceutical analysis, now revised and updated for its fourth edition. Worked calculation examples Self-assessment Additional problems (self tests) Practical boxes Key points boxes New chapter on Biotech products. New chapter on electrochemical methods in diagnostics. Greatly extended chapter on molecular emission spectroscopy to accommodate developments and innovations in the area. Now on StudentConsult
Author : David G. Watson
Publisher : Elsevier Health Sciences
Page : 441 pages
File Size : 41,7 Mb
Release : 2012
Category : Medical
ISBN : 9780702046216
This introductory text highlights the most important aspects of a wide range of techniques used in the control of the quality of pharmaceuticals. Written with the needs of the student in mind, this clear, practical guide includes self-testing sections with arithmetical examples and tests to help students brush up on their arithmetical skills in an applied context.
Author : John Kenkel
Publisher : CRC Press
Page : 620 pages
File Size : 51,9 Mb
Release : 1994-07-22
Category : Science
ISBN : 0873719662
The second edition of Analytical Chemistry for Technicians provides the "nuts and bolts" of analytical chemistry and focuses on the practical aspects for training a technician-level laboratory worker. This edition presents new and expanded chapters, innumerable questions and problems, and modified experiments that present a fresh and challenging approach. Some of the topics that have been expanded include chemical equilibrium, chromatography, Kjeldahl method, and molarity and moles where EDTA and water hardness calculations are concerned. New discussions of the Ag/AgCl and combination pH electrodes have been added, while the discussion of ion-selective electrodes has been expanded. The chapter introducing instrumental analysis and computers now includes discussions of "y = mx + b" and the method of least squares. The book also includes discussions of FTIR, topics of NMR, and mass spectrometry, which are found in the new infrared spectrometry chapter.
Author : Ashutosh Kar
Publisher : New Age International
Page : 558 pages
File Size : 43,7 Mb
Release : 2005-12
Category : Medical
ISBN : 8122415822
About the Book: During the past two decades, there have been magnificent and significant advances in both analytical instrumentation and computerized data handling devices across the globe. In this specific context the remarkable proliferation of windows
Author : Allen Cato,Lynda Sutton,Allen Cato III
Publisher : CRC Press
Page : 451 pages
File Size : 51,6 Mb
Release : 2002-03-26
Category : Medical
ISBN : 9780824744809
Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.
Author : David G. Watson
Publisher : Churchill Livingstone
Page : 400 pages
File Size : 46,5 Mb
Release : 2005
Category : Medical
ISBN : UOM:39015060575084
This introductory text highlights the most important aspects of a wide range of techniques used in the control of the quality of pharmaceuticals. Written with the needs of the student in mind, this clear, practical guide includes self-testing sections with arithmetical examples and tests to help students brush up on their arithmetical skills in an applied context.