Book Description
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Customer Reviews:
Limited scope.......2007-09-30
I have to admit being a bit disappointed with this book. The content is sound, based to a large extent on ICH guidance, and for the most part, applies concepts to HPLC analysis. The actual text begins on p17 and ends on p 83, with an average words/page
<250 (there are likely less than 16000 words in the entire text). So my rating is biased by what I consider a poor value in terms of cost/content. By way of comparison, the ICH Q2A and Q2B comprise almost 3700 words.
Although the book focuses on HPLC, the title concept also applies to other analytical methods (immunoassays, bioassays, mass spec., flow cytometry, etc.) There is clearly more to be learned on this topic. This text may be considered an intorductory primer, or a concise summary.
In retrospect, I would preferred to have spent more money to receive a more thorough text with applications in more diverse methods.
Great Introduction.......2006-10-12
This book is a very good basic (and comparatively inexpensive) introduction to the terms and definitions of method validation. Certainly worth the price until the next edition comes out in early 2007.
Protocol sugestions, and the bibliography are worth the price alone.
Analytical Method Development and Validation.......2006-07-24
Very general description of the method validation process. This book could only be the first step in undestanding of the general requirements for the method validation process. To deepen one's knowledge, the reader should choose the books (e.g. Development and Validation of Analytical Methods by Christopher Riley) which are focused on explaining the concept from the scientific prospective.
Average customer rating:
- development and validation of analytical methods
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Development and Validation of Analytical Methods (Progress in Pharmaceutical and Biomedical Analysis)
C.M. Riley , and
T.W. Rosanske
Manufacturer: Pergamon
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Analytical Method Development and Validation
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Analytical Method Validation and Instrument Performance Verification
ASIN: 0080427928 |
Book Description
The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations.
The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.
Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples.
Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.
This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
Customer Reviews:
development and validation of analytical methods.......2001-10-05
Really a very well organized manual. Very helpfull both for new labs and labs that should be in compliance with the regulatory requirements.
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Validation of Analytical Methods for Food Control: Report of a Joint Fao/Iaea Expert Consultation, Vienna, Austria, 2-4 December 1997 (Food and Nutrition Papers , No 68)
Manufacturer: Food & Agriculture Organization of the UN (FA
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Binding: Paperback
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ASIN: 9251041318 |
Book Description
This digital document is a journal article from Analytica Chimica Acta, published by Elsevier in 2006. The article is delivered in HTML format and is available in your Amazon.com Media Library immediately after purchase. You can view it with any web browser.
Description:
A simple, fast, sensitive and robust analytical method using gas chromatography (GC)-isotope dilution mass spectrometry (MS) was developed and validated for the identification and quantification of 1,4-dichlorobenzene (p-DCB) residues in honey samples. The proposed methodology is based on steam-distillation using a Clevenger-type apparatus followed by gas chromatography-mass spectrometry (GC-MS) in the selected ion monitoring (SIM) mode employing the isotopically labeled analogue d"4-1,4-dichlorobenzene (d"4-p-DCB) as internal standard (IS). Validation of the method was performed in two different GC-MS systems, using quadrupole MS (QMS) and ion-trap MS (ITMS) detectors, with no statistically significant differences between two. Recoveries were better than 91% with percent relative standard deviations lower than 12%. The instrumental limits of detection were 1@mgkg^-^1 in the GC-ITMS system and 0.6@mgkg^-^1 in the GC-QMS system. The expanded uncertainty was estimated as 17% at the currently accepted ''action level'' of 10@mgkg^-^1. The method was applied to the analysis of 310 honey samples in an extensive national monitoring study. A quality control (QC) system applied during the assays has demonstrated a good performance and long-term stability over a period of more than 8 months of continuous operation.
Book Description
This digital document is a journal article from Analytica Chimica Acta, published by Elsevier in 2006. The article is delivered in HTML format and is available in your Amazon.com Media Library immediately after purchase. You can view it with any web browser.
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In this work the development of a method to determine semicarbazide (SEM) in fresh whole egg and in whole egg and egg white powders as those used in the food industry, by using LC-MS/MS is described. The method is based on a recently validated one for the determination of SEM in baby food. SEM is extracted from egg with 0.2molL^-^1 hydrochloric acid and derivatised with 2-nitrobenzaldehyde. The extract is neutralised and purified by passing through a solid phase extraction (SPE) cartridge. The 2-nitrobenzaldehyde derivative is eluted with ethyl acetate. The eluate is evaporated to dryness and the residue re-dissolved in methanol:water mobile phase. SEM is determined by reversed-phase LC-MS/MS. The ''in-house'' validation of this method has been performed taking into account the ''Harmonized guidelines for single-laboratory validation of methods of analysis'' (IUPAC Technical report) and the Commission Decision (2002/657/EC). The performance characteristics of the method were established by in-house validation procedures employing assays with standard solutions, sample blanks and spiked samples. Linearity, matrix effect, trueness, precision, selectivity, limits of detection and of quantification were determined. The fitness for purpose of this method was assessed based on its performance characteristics. LOD's of 0.15 and 0.4@mgkg^-^1 for whole fresh egg and industrial egg powders, respectively, were obtained. The LOQ for fresh whole egg was 0.2@mgkg^-^1 and for industrial egg powders 0.8@mgkg^-^1. Linear calibration curves were obtained in the ranges 1-100 and 0.8-400@mgkg^-^1 for fresh whole egg and the egg powders, respectively.
Book Description
This digital document is a journal article from Analytica Chimica Acta, published by Elsevier in . The article is delivered in HTML format and is available in your Amazon.com Media Library immediately after purchase. You can view it with any web browser.
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Novel HPLC methods were developed for the analytical and semipreparative resolution of new antidepressant drug mirtazapine enantiomers. At analytical scale, the separation of the mirtazapine enantiomers was investigated using both cellulose and amylose tris(3,5-dimethylphenylcarbamate) (CDMPC and ADMPC) chiral stationary phases under normal-phases and polar organic modes. Good baseline enantioseparation was achieved using cellulose tris(3,5-dimethylphenylcarbamate) chiral stationary phases under both normal-phases and polar organic modes. Furthermore, the elution order of mirtazapine enantiomic pairs was found reversed by changing the stationary phase from the amylose-based ADMPC-CSPs to its cellulose-based counterpart, CDMPC-CSPs. The validation of the analytical methods including linearity, limit of detection (LOD), limit of quantification (LOQ), recovery and precision, together with the semipreparative resolution of mirtazapine racemate were carried out using cellulose tris(3,5-dimethylphenylcarbamate) chiral stationary phases and methanol as mobile phase without any basic additives under polar organic mode. At analytical scale, the elution times of both enantiomers were less than 6min at normal temperature and 1.0ml/min, with the separation factor (@a) 1.99 and the resolution factor (Rs) 3.56. Then, the analytical methods were scaled up to semipreparative loading to obtain small quantities of both mirtazapine enantiomers. At semipreparative scale, about 16mg/h enantiomers could be isolated and elution times of both enantiomers were less than 10min at 2.0ml/min. To increase the throughput, the technique of boxcar injections was used. One enantiomer ((-)-(R)-mirtazapine) was isolated with purity of >99.9% e.e. and >98.0% yield and another ((+)-(S)-mirtazapine) was isolated with purity of >97.0% e.e. and >99.0% yield. In addition, optical rotation and circular dichroism (CD) spectroscopy of both mirtazapine enantiomers isolated were also investigated.
Average customer rating:
- Please inform us when this book is available
- Please inform us when this book is available
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Sedimentographica
Franco Ricci Lucchi
Manufacturer: Columbia University Press
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ASIN: 0231100183 |
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-- B. Charlotte Schreiber, Queens College, City University of New York
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Please inform us when this book is available.......1999-06-26
Please inform us when this book is availabl
Please inform us when this book is available.......1999-06-26
Please inform us when this book is availabl
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Particles at Fluid Interfaces and Membranes (Studies in Interface Science)
Manufacturer: Elsevier Science
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ASIN: 0444502343 |
Book Description
In the small world of micrometer to nanometer scale many natural and industrial processes include attachment of colloid particles (solid spheres, liquid droplets, gas bubbles or protein macromolecules) to fluid interfaces and their confinement in liquid films. This may lead to the appearance of lateral interactions between particles at interfaces, or between inclusions in phospholipid membranes, followed eventually by the formation of two-dimensional ordered arrays. The book is devoted to the description of such processes, their consecutive stages, and to the investigation of the underlying physico-chemical mechanisms.
The first six chapters give a concise but informative introduction to the basic knowledge in surface and colloid science, which includes both traditional concepts and some recent results. Chapters 1 and 2 are devoted to the basic theory of capillarity, kinetics of surfactant adsorption, shapes of axisymmetric fluid interfaces, contact angles and line tension. Chapters 3 and 4 present a generalization of the theory of capillarity to the case, in which the variation of the interfacial (membrane) curvature contributes to the total energy of the system. The generalized Laplace equation is applied to determine the configurations of free and adherent biological cells. Chapters 5 and 6 are focused on the role of thin liquid films and hydrodynamic factors in the attachment of solid and fluid particles to an interface. Surface forces of various physical nature are presented and their relative importance is discussed. Hydrodynamic interactions of a colloidal particle with an interface (or another particle) are also considered.
Chapters 7 to 10 are devoted to the theoretical foundation of various kinds of capillary forces. When two particles are attached to the same interface (membrane), capillary interactions, mediated by the interface or membrane, appear between them. Two major kinds of capillary interactions are described: (i) capillary immersion force related to the surface wettability (Chapter 7), (ii) capillary flotation force originating from interfacial deformations due to particle weight (Chapter 8). Special attention is paid to the theory of capillary immersion forces between particles entrapped in spherical liquid films (Chapter 9). A generalization of the theory of immersion forces allows one to describe membrane-mediated interactions between protein inclusions into a lipid bilayer (Chapter 10).
Chapter 11 is devoted to the theory of the capillary bridges and the capillary-bridge forces, whose importance has been recognized in phenomena like consolidation of granules and soils, wetting of powders, capillary condensation, long-range hydrophobic attraction, etc. The nucleation of capillary bridges is also examined.
Chapter 12 considers solid particles, which have an irregular wetting perimeter upon attachment to a fluid interface. The undulated contact line induces interfacial deformations, which engender a special lateral capillary force between the particles. The latter contributes to the dilatational and shear elastic moduli of particulate adsorption monolayers.
Chapter 13 describes how lateral capillary forces, facilitated by convective flows and some specific and non-specific interactions, can lead to the aggregation and ordering of various particles at fluid interfaces or in thin liquid films. Recent results on fabricating two-dimensional (2D) arrays from micrometer and sub-micrometer latex particles, as well as 2D crystals from proteins and protein complexes, are reviewed.
Chapter 14 presents applied aspects of the particle-surface interaction in antifoaming and defoaming. The mechanisms of antifoaming action involve as a necessary step the entering of an antifoam particle at the air-water interface. The considered mechanisms indicate the factors for control of foaminess.
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Murio por los Pelos
Manufacturer: Ediciones SM
ProductGroup: Book
Binding: Paperback
ASIN: 843484690X |
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Por Los Pelos
Marian Keyes
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ASIN: 8497593650 |
Book Description
This digital document is an article from Epoca, published by Thomson Gale on January 27, 2006. The length of the article is 508 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: Defensa por los pelos: Bono: la fragata no participó en operaciones bélicas: mientras el Roosevelt atacaba Irak, la fragata española formaba parte del grupo de combate. La fragata española se adiestraba, pero ni en el momento, ni en el lugar adecuados.(José Bono)(participación española en Guerra contra Irak)
Author: Ana del Paso
Publication:
Epoca (Magazine/Journal)
Date: January 27, 2006
Publisher: Thomson Gale
Issue: 1086
Page: 35(1)
Distributed by Thomson Gale
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This digital document is an article from Epoca, published by Difusora de Informacion Periodica, S.A. (DINPESA) on February 18, 2005. The length of the article is 540 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: Que no nos tomen el pelo.(apoyo socialista por Constitución europea)
Author: Enrique de Diego
Publication:
Epoca (Magazine/Journal)
Date: February 18, 2005
Publisher: Difusora de Informacion Periodica, S.A. (DINPESA)
Issue: 1040
Page: 25(1)
Distributed by Thomson Gale
Book Description
This digital document is an article from Semana, published by Thomson Gale on September 24, 2006. The length of the article is 747 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: Sin "pelos" en la lengua: Kinky Friedman: a primera vista sus argumentos disgustan, pero si los escucha con calma, la cosa cambia. Por ejemplo, está a favor de la legalización de los inmigrantes indocumentados, pero también a que se militarice la frontera. Entendiéndolo.(candidato a jefatura del estado de Tejas)(Entrevista)
Author: Don Juan Corzo
Publication:
Semana (Magazine/Journal)
Date: September 24, 2006
Publisher: Thomson Gale
Volume: 12
Issue: 708
Page: 6(1)
Article Type: Entrevista
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Book Description
This digital document is an article from Epoca, published by Difusora de Informacion Periodica, S.A. (DINPESA) on November 10, 1997. The length of the article is 1740 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: Teletiendas: aprobado por los pelos. (la Organización de Consumidores y Usuarios denuncia irregularidades en la venta a distancia; España; incluye artículo relacionado)(TT: Home shopping television: narrowly approved) (TA: the Consumers Organization denounces irregularities; Spain; includes related article)
Author: Silvia Nieto
Publication:
Epoca (Magazine/Journal)
Date: November 10, 1997
Publisher: Difusora de Informacion Periodica, S.A. (DINPESA)
Issue: n663
Page: p88(4)
Distributed by Thomson Gale
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This digital document is an article from Epoca, published by Thomson Gale on May 16, 2003. The length of the article is 1177 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: Votar por los pelos: son reacios a la hora de confesarlo, pero los politicos miman su cabellera, patillas, bigote, entrecejo, calva ... la calvicie reduce hasta en un 30% la intencion de voto del electorado. (Espana: politica).
Author: Maria Lopez Munoz
Publication:
Epoca (Magazine/Journal)
Date: May 16, 2003
Publisher: Thomson Gale
Page: 28(2)
Distributed by Thomson Gale
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22 por 22: A Semana de Arte Moderna vista pelos seus contemporaneos
Manufacturer: Edusp
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WORLD CLASS CLIMBER...WORLD CLASS READ..........2005-08-03
This is the Portuguese edition of "High Exposure: An Enduring Passion for Everest and Unforgiving Places", a terrific book that draws you into David Breashears' world. You follow his development from young rock climber to world class mountaineer and filmmaker. You also see his development as a person, all while drawing you into that exclusive club of mountaineers. He makes you feel his passion for the mountains he so loves. You learn how he combined that passion with the art of cinematography, making him an award winning filmmaker.
You live through the 1996 tragedy on Everest with him, and feel the compassion that he has for those who died on the mountain under such tragic circumstances. The narrative is always compelling and informative, making the book a hard one to put down. His compassion and sensitivity towards those who did not fare well on the ill-fated 1996 Everest climb is palpable, and for his assistance to those who needed it, even though it put him and his expedition in jeopardy, he is truly an unsung hero. This is, without a doubt, a man who leads by example.
David Breashears writes beautifully of his experiences and his book is a must read for all climbing enthusiasts, as well as for those simply interested in the human condition. This is a book that is simply too good to pass up.
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