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Riley - Spec of Drug Substances and Products, 2e, Riley, Christopher M.


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Автор: Riley, Christopher M.
Название:  Riley - Spec of Drug Substances and Products, 2e
ISBN: 9780081028247
Издательство: Elsevier Science
Классификация:




ISBN-10: 0081028245
Обложка/Формат: Paperback
Страницы: 712
Вес: 1.50 кг.
Дата издания: 01.08.2019
Язык: English
Издание: 2 ed
Размер: 234 x 188 x 41
Основная тема: Chemistry
Подзаголовок: Development and validation of analytical methods
Ссылка на Издательство: Link
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Поставляется из: Европейский союз
Описание:

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 books 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



Vibrational Spectra of Organometallic

Автор: Maslowsky
Название: Vibrational Spectra of Organometallic
ISBN: 1119404657 ISBN-13(EAN): 9781119404651
Издательство: Wiley
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Описание:

A comprehensive compilation of the available experimental and theoretical vibrational data for organometallic compounds and its role in evaluating the structures, bonding, and properties of these key compounds

This unique book offers a thorough review of the literature dealing with vibrational data obtained using various phases, including matrices, reported for organometallic compounds from infrared spectra, Raman spectra, and several other techniques. It is the only one that compiles the available experimental and theoretical vibrational data on these compounds, and which discusses the importance of this information and its role in evaluating structures, bonding, and other important properties. It also treats the use of DFT and other theoretical calculations to analyze the vibrational data and to predict properties associated with these compounds. The book also includes vibrational data for organic species that form on metal and other surfaces.

Vibrational Spectra of Organometallics: Theoretical and Experimental Data offers complete coverage of: Carbide, Alkylidyne, Alkylidene, Alkyl, and Alkane Derivatives; Noncyclic Carbon Clusters and Unsaturated Hydrocarbon Derivatives; and Cyclic, Unsaturated Organometallic Derivatives. By summarizing work that has already been done on organometallic compounds, it serves as an important reference for those studying their vibrational spectra and will, in the end, lead to a clearer understanding of other research that needs to be done in order to help researchers determine new research directions.

  • An important reference for those studying the vibrational spectra of organometallic compounds
  • Gathers the existing experimental and theoretical vibrational data and discusses its significance in assessing structures, bonding, and other principle properties
  • Includes DFT methods for the interpretation of spectra, which has been one of the major developments of the last two decades

Vibrational Spectra of Organometallics: Theoretical and Experimental Data is an important reference for researchers and practitioners in the areas of inorganic, organometallic, organic, and surface chemistry who have an interest in using vibrational data to characterize the bonding, composition, reactions, and structures of organometallic compounds, and organic species that are formed on various surfaces.

Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s dans la Chimie des Substances Organiques Naturelles

Автор: L. Zechmeister
Название: Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s dans la Chimie des Substances Organiques Naturelles
ISBN: 3709171555 ISBN-13(EAN): 9783709171554
Издательство: Springer
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Описание: Diese Ubersieht soll die wesentliche Literatur uber Ubichinon und einige chemisch nahe v: erwandte naturliche Chinone bis etwa Oktober 1961 referieren. Der Name Ubichinon (englisch Ubiquinone) wurde von MORTON und Mitarb. (II3) fUr eine Substanzgruppe der allgemeinen Formel (I) vorgeschlagen. In MORTONS Arbeitskreis wurde die betreffende Substanz anfanglich als "Substanz SA" bezeichnet (Io8). Wie sieh aus spateren o II H3CO", / CH3 3112 4 116 CH 3 /"'/'" I H3CO III (CH2-CH=C-CH2)n-H o (1.) Untersuchungen ergeben hat, waren nicht aIle als SA bezeichneten Substanzen untereinander identisch; die verschiedenen Praparate unter- schieden sich in der Lange der Polyisopren-seitenkette oder durch Ersatz einer der beiden Methoxylgruppen durch Athoxyl (vgl. SS. 78 und 101 ff.). Nach einem Vorschlag von MORTON und Mitarb. (III) sollen die ver- schiedenen von (I) sieh ableitenden naturlichen und synthetischen Ubichinone, die sich nur in der Anzahl der Isoprenreste in der Seiten- kette unterscheiden, in Anlehnung an die in der Vitamin-K-Reihe ubliche Nomenklatur, dadurch gekennzeichnet werden, daB die Anzahl der C-Atome in der Seitenkette hinter dem Namen Ubichinon in Klammern angegeben wird; z. B. Ubiehinon-(50} fUr das Derivat mit IoIsopren- resten usw. Bisher wurden in der Natur die Glieder mit n = 6, 7, 8, 9 und 10 aufgefunden.

Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s dans la Chimie des Substances Organiques Naturelles

Автор: J. Engel; W. Grassmann; K. Hannig; H. H?rmann; L.M
Название: Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s dans la Chimie des Substances Organiques Naturelles
ISBN: 3709171415 ISBN-13(EAN): 9783709171417
Издательство: Springer
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Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s dans la Chimie des Substances Organiques Naturelles

Автор: J. Bonner; K. Freudenberg; H. Kuhn; E.E. Van Tamel
Название: Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s dans la Chimie des Substances Organiques Naturelles
ISBN: 370918049X ISBN-13(EAN): 9783709180495
Издательство: Springer
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Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s dans la Chimie des Substances Organiques Naturelles

Автор: D.H.R. Barton; J.E. Courtois; L. Crombie; M. Ellio
Название: Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s dans la Chimie des Substances Organiques Naturelles
ISBN: 370917158X ISBN-13(EAN): 9783709171585
Издательство: Springer
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Fortschritte der Chemie organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s Dans La Chimie Des Substances Organiques Naturelles

Автор: G.W. Beadle; F.E. Brauns; V. Deulofeu; M. Doudorof
Название: Fortschritte der Chemie organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s Dans La Chimie Des Substances Organiques Naturelles
ISBN: 3709171814 ISBN-13(EAN): 9783709171813
Издательство: Springer
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Fortschritte der Chemie Organischer Naturstoffe/Progress in the Chemistry of Organic Natural Products/Progres dans la Chimie des Substances Organiques Naturel?es

Автор: G.W. Beadle; A.J. Haagen-Smit; T.G Halsall; F.T. H
Название: Fortschritte der Chemie Organischer Naturstoffe/Progress in the Chemistry of Organic Natural Products/Progres dans la Chimie des Substances Organiques Naturel?es
ISBN: 3709171687 ISBN-13(EAN): 9783709171684
Издательство: Springer
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Описание: Substances belonging to this group of organic compounds are wi, lely distributed in Nature, being found in plants, both higher and lower fungi and, upto the present time, in one animal source, sheep wool-fat. For a long- time no real differentiation was possible between the tetra- and penta- cyclic triterpenes and the sterols. Then the two latter became disting- uishable by their selenium. -dehydrogenation products, i. e., picene and naphthalene derivatives from the pentacyclic triterpenes and DIELS' hydrocarbon from the sterols. It is now apparent that those compounds yielding predominantly I: 2: 8-trimethylphenanthrene on dehydro- genation represent yet another class, and this property is regarded as typical of the tetracyclic triterpenes. The group contains both C and C 30 3l compounds and, although the latter fall outside RUZICKA'S strict definition of triterpenes (I42), it seems desirable to permit this deviation. Members with thirty-two carbon atoms may well be discovered in due course. In a most- valuable account of the triterpenes written in I949, JEGER. (II3) was able to summarize all that was known about the tetra- cyclic group in a very small compass. Most of the work discussed in the present article has been published during the last five years and in that time the structures of some twenty compounds have been elucidated. Of outstanding importance is the revelation of close structural relation- ships tQ the steroids, and the presence of C and C side-chains, skeletally 8 9 identical with those of cholesterol and ergosterol.

Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progres dans La Chimie des Substances Organiques Naturelles

Автор: K. Alder; J. Asselineau; A. Chatterjee; L. Feinste
Название: Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progres dans La Chimie des Substances Organiques Naturelles
ISBN: 3709180058 ISBN-13(EAN): 9783709180051
Издательство: Springer
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Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s Dans la Chimie des Substances Organiques Naturelles

Автор: Y. Asahina; R.B. Corey; A. Frey-Wyssling; F. Galin
Название: Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s Dans la Chimie des Substances Organiques Naturelles
ISBN: 3709171741 ISBN-13(EAN): 9783709171745
Издательство: Springer
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Описание: In agreement with SCHLENK (I78) "nucleotide" is here taken to mean a phosphoric ester of an N-glycoside of a heterocyclic base. Although they fall outside the scope of this definition, phosphorylated derivatives of riboflavin are added in recognition of their close relation to the main body of nucleotides. A complete review of even the organic chemistry of nucleotides and their derivatives would now form a substantial monograph. The smaller and less characteristic fragments of the nucleotides, namely the hetero- cyclic bases, the component sugars and the derived sugar phosphates, are therefore excluded from this article. * Their chemistry is of longer standing and is covered in standard works. On the other hand knowledge of the "nucleosides", the N-glycosides of heterocyclic bases, has expanded very considerably in recent years and an account of the relevant work is therefore included. With regard to the nucleotides themselves attention is focussed on work published in the last few years leading to improved characterisation, more exact structural knowledge and increased availa- biIity. Only such enzymatic experiments as bear direct1y on structural problems are discussed and therefore much fascinating work by KALCKAR, FRIEDKIN et al. and by KORN BERG has been omitted. I t would be unthinkable to present a review on nucleotides without mentioning that the foundations of the subject were laid by P. A. LEVENE. His monograph with BASS (I36) was published in 1931 and two reviews by LYTHGOE (I50, I5I) cover the intervening period until 1944.

Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s dans la Chimie des Substances Organiques Naturelles

Автор: A. Albert; K. Br?ckner; R.B. Corey; K. Freudenberg
Название: Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s dans la Chimie des Substances Organiques Naturelles
ISBN: 3709180163 ISBN-13(EAN): 9783709180167
Издательство: Springer
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Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s dans la Chimie des Substances Organiques Naturelles

Автор: P.H. Abelson; H. Barkemeyer; K. Bernauer; A.E. Dim
Название: Fortschritte der Chemie Organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products / Progr?s dans la Chimie des Substances Organiques Naturelles
ISBN: 3709180546 ISBN-13(EAN): 9783709180549
Издательство: Springer
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In Vitro Drug Release Testing of Special Dosage Forms

Автор: Fotaki
Название: In Vitro Drug Release Testing of Special Dosage Forms
ISBN: 1118341473 ISBN-13(EAN): 9781118341476
Издательство: Wiley
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Цена: 18366.00 р.
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Описание:

Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms

In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms' performances and describes the different techniques required for each one.

In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects.

  • Covers both oral and non-oral dosage forms
  • Describes current regulatory conditions for in vitro drug release testing
  • Features contributions from well respected global experts in dissolution testing

In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.


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