1.

Record Nr.

UNINA9910783619903321

Autore

McLoughlin Ian.

Titolo

Creative technological change : the shaping of technology and organisations / / Ian McLoughlin

Pubbl/distr/stampa

London ; ; New York : , : Routledge, , 1999

ISBN

1-134-68015-5

1-134-68016-3

9786612876318

1-282-87631-7

0-203-01987-3

Descrizione fisica

1 online resource (201 p.)

Collana

Management of technology and innovation

Disciplina

658.5/14

Soggetti

Technological innovations - Management

Technological innovations - Economic aspects

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references (p. [166]-182) and index.

Nota di contenuto

Book Cover; Title; Contents; List of illustrations; Acknowledgements; Introduction: shaping technology and organisation; The problem of technology and technological determinism; What is technology and what does it do?; Metaphors, technology and organisation; Creative technological change; book structure; Machines, organisms and virtual realities; The evolution of the innovative organisation; Fordism, post-Fordism and the electronic panopticon; Organisational choice politics and the outcomes of technological change; Inside the black box: social constructivism and technology

Transforming the organisation? Technology as 'text'Outside the black box: the socio-economic shaping of technology; Conclusion: creative technological change; References; Index

Sommario/riassunto

Creative Technological Change draws upon a wide range of thinking from organisational theory, innovation studies and the sociology of technology. It explores the different ways in which these questions have been framed and answered, especially in relation to new 'virtual' technologies. The idea of metaphor is used to capture the differences between, and strengths and weaknesses of various ways of



conceptualising the technology/organisation relationship. This approach offers the possibility of developing new ways of thinking about, viewing and ultimately responding creatively to the or

2.

Record Nr.

UNINA9910830641003321

Titolo

Analysis of drug impurities [[electronic resource] /] / edited by Richard J. Smith and Michael L. Webb

Pubbl/distr/stampa

Oxford ; ; Ames, Iowa, : Blackwell, 2007

ISBN

1-281-32024-2

9786611320249

0-470-98874-6

0-470-99422-3

Descrizione fisica

1 online resource (290 p.)

Collana

Analytical chemistry series

Altri autori (Persone)

SmithRichard J

WebbMichael L

Disciplina

615.1901

615/.1901

Soggetti

Drugs - Analysis

Materia medica

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

Analysis of Drug Impurities; Contents; Preface; List of contributors; 1 Organic impurities in drug substance: origin, control, and measurement; 1.1 Introduction; 1.2 Origin of impurities; 1.2.1 Process impurities; 1.2.2 Degradation impurities; 1.2.3 Contamination impurities; 1.2.4 Other impurities; 1.3 Control of drug substance impurities; 1.3.1 Control of residual solvents; 1.3.2 Control of synthetic impurities; 1.3.3 Control of impurities in biological and botanical products; 1.3.4 Purification processes; 1.3.5 Control of impurities from packaging; 1.3.6 Control of contamination impurities

1.3.7 Control of degradants on stability1.4 Measurement of drug substance impurities; 1.4.1 HPLC; 1.4.2 GC; 1.4.3 CE; 1.4.4 General considerations; 1.5 Conclusions; Disclaimer; References; 2 Organic



impurities in drug products: origin, control and measurement; 2.1 Introduction; 2.2 Analytical methodology; 2.3 Drug-excipient compatibility experimental design; 2.4 Degradation mechanisms; 2.5 Excipients' role in drug product destabilisation; 2.6 Processing as a source of moisture; 2.7 Hydrolysis; 2.8 Oxidation; 2.9 Photolysis; 2.10 Impact of processing on photostability

2.11 Miscellaneous reactions2.12 Container-closure systems; References; 3 Stereochemical impurities; 3.1 Introduction; 3.2 Separation techniques: direct resolution; 3.2.1 HPLC using CSPs; 3.2.2 HPLC using chiral mobile-phase additives; 3.2.3 Capillary electrophoresis using chiral selectors; 3.2.4 Supercritical fluid chromatography using chiral stationary phases; 3.2.5 Gas chromatography using chiral stationary phases; 3.3 Separation techniques: indirect resolution; 3.4 Non-separation techniques; 3.4.1 Chiroptical spectroscopy; 3.4.2 Nuclear magnetic resonance spectroscopy; 3.5 Conclusions

AcknowledgementsReferences; 4 Low-level measurement of potent toxins; 4.1 Introduction; 4.2 Classes of genotoxic impurity; 4.2.1 Alkylating agents; 4.2.2 Reactive amines; 4.2.3 Fused tricyclics; 4.2.4 Substituted purines and pyrimidines; 4.2.5 Hydroperoxides; 4.3 The analytical challenge of genetic; 4.4 Gas chromatography; 4.4.1 Sample introduction techniques; 4.4.2 Detectors; 4.5 High-performance liquid chromatography; 4.5.1 Separation modes; 4.5.2 Detection techniques; 4.6 Supercritical fluid chromatography; 4.7 Thin-layer chromatography; 4.8 Sample pre-concentration

4.8.1 Liquid-liquid extraction4.8.2 Solid-phase extraction; 4.8.3 Solid-phase microextraction; 4.8.4 Liquid-phase microextraction; 4.9 Other techniques; 4.9.1 Electrochemical measurements; 4.9.2 Derivatisation methods; 4.10 Adapting analytical methods from fields beyond pharmaceuticalsimpurities analysis; 4.10.1 Antineoplastic agents; 4.10.2 Other fields; 4.11 Validation of trace analytical methods; 4.11.1 Sensitivity; 4.11.2 Specificity; 4.11.3 Accuracy; 4.11.4 Solution stability; 4.11.5 Linearity and precision; 4.12 Conclusions; References; 5 A systematic approach to impurity identification

5.1 Introduction

Sommario/riassunto

A key component of the overall quality of a pharmaceutical is control of impurities, as their presence, even in small amounts, may affect drug safety and efficacy. The identification and quantification of impurities to acceptable standards presents a significant challenge to the analytical chemist. Analytical science is developing rapidly and provides increasing opportunity to identify the structure, and therefore the origin and safety implications of these impurities, and the challenges of their measurement drives the development of modern quantitative methods.Written for both practic