handbook of modern pharmaceutical analysis separation science and technology

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Handbook Of Modern Pharmaceutical Analysis

Author : Satinder Ahuja
ISBN : 0120455552
Genre : Medical
File Size : 65. 32 MB
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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.

Handbook Of Pharmaceutical Analysis By Hplc

Author : Satinder Ahuja
ISBN : 0080455182
Genre : Medical
File Size : 40. 11 MB
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High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling

Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals

Author : Satinder Ahuja
ISBN : 9780080507767
Genre : Medical
File Size : 38. 40 MB
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The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product. This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements. It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.

Hplc Method Development For Pharmaceuticals

Author : Satinder Ahuja
ISBN : 9780080554198
Genre : Medical
File Size : 51. 97 MB
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High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge. Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities) Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase

Pharmaceutical Analysis For Small Molecules

Author : Behnam Davani
ISBN : 9781119425038
Genre : Science
File Size : 89. 18 MB
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A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

Pharmakologie F R Den Rettungsdienst

Author : Henner Bechtold
ISBN : 9783437485534
Genre : Medical
File Size : 51. 57 MB
Format : PDF, ePub
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So versteht man Pharmakologie - speziell angepasst für die Bedürfnisse im Rettungsdienst Alles, was Sie im Rettungsdienst über Pharmakologie wissen müssen, absolut lernfreundlich und verständlich dargestellt: die Grundlagen zur Pharmakologie einfach und dennoch ausführlich erklärt profundes Wissen über Notfallmedikamente, Applikation und Wirkungsweisen spezieller Nachschlageteil für häufig verschriebene Medikamente, sortiert nach den wichtigsten Erkrankungen der Organsysteme Kapitel zur Prüfungsvorbereitung mit 200 Übungsfragen und Antwortteil zahlreiche Abbildungen zur Erklärung der Grundlagen sowie Medikamentenfotos Neu in der 2. Auflage: Aktualisierung aller Inhalte gemäß der aktuellen Leitlinien und ERC-Guidelines 2015 Ausführliche Darstellung der Medikamente des Pyramidenprozesses Erweiterung der rechtlichen Rahmenbedingungen Aktuelle Fotos der Präparate und Notfallmedikamente

Subject Guide To Books In Print

Author :
ISBN : STANFORD:36105025888517
Genre : American literature
File Size : 77. 64 MB
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Handbuch Der Spurenanalyse

Author : Othmar G. Koch
ISBN : 9783642654237
Genre : Science
File Size : 64. 33 MB
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Allgemeine Bedeutung der Spurenelemente und der Spurenanalyse Man weiß schon seit langem, daß die uns bekannten Elemente allgegenwärtig sind und als Verunreinigungen in kleinen und kleinsten Mengen praktisch überall vorkommen. Im allgemeinen stören diese weder bei den gewöhnlichen Arbeits- und Lebensprozessen noch bei den zur Ermittlung der von Haupt- und Nebenbestandteilen der Stoffe ein gesetzten V erfahren der analytischen Chemie. Kleine Mengen bestimmter Elemente (Spurenelemente, s. S. 9) aber üben einerseits in vielen Fällen einen großen Einfluß aus auf Stoffeigenschaften und chemische Reaktionen. Andererseits lassen sie sich mit Hilfe empfindlicher Reaktionen, wie sie die Spurenanalyse verwendet, nachweisen und quantitativ bestimmen, weshalb sie bei bestimmten Spurenanalysen auch stören können. Die wissenschaftliche und technische Entwicklung der neueren Zeit verlangt nun in zunehmendem Maße die Anwendung verfeinerter Analysenverfahren, die es gestatten, Spurenelemente quantitativ zu bestimmen. Daran sind, wie später ausgeführt wird, zahlreiche Wissensgebiete interessiert, so daß sich zwangsläufig die Entwicklung einer eigenen Arbeitstechnik zur Durchführung von Spurenanalysen ergab.

Handbook Of Nuclear Chemistry

Author : Attila Vértes
ISBN : 9781441907196
Genre : Science
File Size : 78. 78 MB
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This revised and extended 6 volume handbook set is the most comprehensive and voluminous reference work of its kind in the field of nuclear chemistry. The Handbook set covers all of the chemical aspects of nuclear science starting from the physical basics and including such diverse areas as the chemistry of transactinides and exotic atoms as well as radioactive waste management and radiopharmaceutical chemistry relevant to nuclear medicine. The nuclear methods of the investigation of chemical structure also receive ample space and attention. The international team of authors consists of scores of world-renowned experts - nuclear chemists, radiopharmaceutical chemists and physicists - from Europe, USA, and Asia. The Handbook set is an invaluable reference for nuclear scientists, biologists, chemists, physicists, physicians practicing nuclear medicine, graduate students and teachers - virtually all who are involved in the chemical and radiopharmaceutical aspects of nuclear science. The Handbook set also provides further reading via the rich selection of references.

Haare

Author : Ralph M. Trüeb
ISBN : 9783642574481
Genre : Medical
File Size : 63. 5 MB
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Haare haben einen hohen gesellschaftlichen Stellenwert. Seit jeher sind die Bemühungen groß, Haarverlust zu verhindern oder rückgängig zu machen bzw. unerwünschte Haare zu entfernen. Das Haar ist in das Visier der Grundlagenforschung und des klinischen Interesses gerückt, was zum vertieften Verständnis der Biologie des Haarwachstums und seiner pathologischen Abweichungen geführt hat. Die Trichologie hat sich zur Aufgabe gemacht, mit Hilfe rationaler Pharmakotherapien und potenter Technologien die häufigsten Haarprobleme effektiv zu behandeln. Dieses Buch befasst sich mit Diagnostik und Therapie definierter Haarkrankheiten sowie der Psychologie und Psychopathologie der Haare und bietet jedem Interessierten das Fachwissen für eine rationale Praxis der medizinischen Trichologie.

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