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Analysis of drug impurities [[electronic resource] /] / edited by Richard J. Smith and Michael L. Webb
| Analysis of drug impurities [[electronic resource] /] / edited by Richard J. Smith and Michael L. Webb |
| Pubbl/distr/stampa | Oxford ; ; Ames, Iowa, : Blackwell, 2007 |
| Descrizione fisica | 1 online resource (290 p.) |
| Disciplina |
615.1901
615/.1901 |
| Altri autori (Persone) |
SmithRichard J
WebbMichael L |
| Collana | Analytical chemistry series |
| Soggetto topico |
Drugs - Analysis
Materia medica |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-281-32024-2
9786611320249 0-470-98874-6 0-470-99422-3 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| 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 |
| Record Nr. | UNINA-9910145261903321 |
| Oxford ; ; Ames, Iowa, : Blackwell, 2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Analysis of drug impurities [[electronic resource] /] / edited by Richard J. Smith and Michael L. Webb
| Analysis of drug impurities [[electronic resource] /] / edited by Richard J. Smith and Michael L. Webb |
| Pubbl/distr/stampa | Oxford ; ; Ames, Iowa, : Blackwell, 2007 |
| Descrizione fisica | 1 online resource (290 p.) |
| Disciplina |
615.1901
615/.1901 |
| Altri autori (Persone) |
SmithRichard J
WebbMichael L |
| Collana | Analytical chemistry series |
| Soggetto topico |
Drugs - Analysis
Materia medica |
| ISBN |
1-281-32024-2
9786611320249 0-470-98874-6 0-470-99422-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| 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 |
| Record Nr. | UNISA-996218619503316 |
| Oxford ; ; Ames, Iowa, : Blackwell, 2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
| ||
Analysis of drug impurities [[electronic resource] /] / edited by Richard J. Smith and Michael L. Webb
| Analysis of drug impurities [[electronic resource] /] / edited by Richard J. Smith and Michael L. Webb |
| Pubbl/distr/stampa | Oxford ; ; Ames, Iowa, : Blackwell, 2007 |
| Descrizione fisica | 1 online resource (290 p.) |
| Disciplina |
615.1901
615/.1901 |
| Altri autori (Persone) |
SmithRichard J
WebbMichael L |
| Collana | Analytical chemistry series |
| Soggetto topico |
Drugs - Analysis
Materia medica |
| ISBN |
1-281-32024-2
9786611320249 0-470-98874-6 0-470-99422-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| 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 |
| Record Nr. | UNINA-9910830641003321 |
| Oxford ; ; Ames, Iowa, : Blackwell, 2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Analysis of drug impurities [[electronic resource] /] / edited by Richard J. Smith and Michael L. Webb
| Analysis of drug impurities [[electronic resource] /] / edited by Richard J. Smith and Michael L. Webb |
| Pubbl/distr/stampa | Oxford ; ; Ames, Iowa, : Blackwell, 2007 |
| Descrizione fisica | 1 online resource (290 p.) |
| Disciplina |
615.1901
615/.1901 |
| Altri autori (Persone) |
SmithRichard J
WebbMichael L |
| Collana | Analytical chemistry series |
| Soggetto topico |
Drugs - Analysis
Materia medica |
| ISBN |
1-281-32024-2
9786611320249 0-470-98874-6 0-470-99422-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| 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 |
| Record Nr. | UNINA-9910840949003321 |
| Oxford ; ; Ames, Iowa, : Blackwell, 2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision making / / Filip Mussen, Sam Salek, Stuart Walker
| Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision making / / Filip Mussen, Sam Salek, Stuart Walker |
| Autore | Mussen Filip |
| Pubbl/distr/stampa | Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 |
| Descrizione fisica | 1 online resource (306 p.) |
| Disciplina |
615.19
615/.1901 |
| Altri autori (Persone) |
SalekSam
WalkerStuart R. <1944-> |
| Soggetto topico |
Drugs - Testing
Pharmaceutical policy - Decision making |
| ISBN |
1-282-25949-0
9786612259494 0-470-74811-7 0-470-74812-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Benefit-Risk Appraisal of Medicines; Contents; Foreword; Preface; 1 Concept and Scope of Benefit-Risk Evaluation of Medicines; 1.1 Historical background; 1.2 The regulatory systems for assessing medicines; 1.3 Benefit-risk assessment: definitions; 1.4 Views and perceptions of benefits and risks of medicines; 1.5 Stages and concepts in benefit-risk assessment; 1.6 Benefit-risk assessment: the current regulatory environment; 1.7 Benefit-risk assessment in other disciplines; 1.8 Specific methods and models for benefit-risk assessment
1.9 Discussions with stakeholders on the concepts and models for benefit-risk evaluation2 Criteria for a Benefit-Risk Model: a Conceptual Framework; 2.1 Introduction; 2.2 Regulatory guidelines on benefit and risk criteria; 2.3 Identification, definition and rationale of relevant benefit and risk criteria; 2.4 Verification of the list of benefit and risk criteria by means of a survey; 3 Review of the Current Benefit-Risk Assessment Models; 3.1 Background; 3.2 Evaluation of the existing benefit-risk assessment models; 3.3 Review of models in single clinical trials and for specific medicines 3.4 Conclusion3.5 Newer models; 4 Defining a Systematic Approach to Decision Making; 4.1 Introduction; 4.2 Objectives and features of the ideal model for benefit-risk assessment; 4.3 The use of decision-analysis techniques for the development of the new model; 5 Development and Application of a Benefit-Risk Assessment Model Based on Multi-Criteria Decision Analysis; 5.1 Introduction; 5.2 Conceptualization of the new model; 5.3 Reasons for using decision analysis techniques in the new model; 5.4 The use of MCDA in the new model; 5.5 Development of the new model 5.6 Applicability of the new model5.7 Summary; 5.8 Review of the MCDA model; 6 A Future Framework for Benefit-Risk Appraisal of Medicines; 6.1 Background; 6.2 Development of a benefit-risk framework for regulatory review of new medicines; 6.3 Prerequisites of a benefit-risk framework for the registration of a new medicine; 6.4 Current status of benefit-risk assessment among companies and agencies; 6.5 Constructing a benefit-risk framework; 6.6 Conclusion; Appendices Appendix 1 Summary Reports of the CMR International Institute for Regulatory Science March 2004 and June 2005 Workshops on Benefit-RiskAppendix 2 Office of Health Economics Briefing: Challenges and Opportunities for Improving Benefit-risk Assessment of Pharmaceuticals from an Economic Perspective - James Cross and Louis Garrison (August 2008); Appendix 3 Reflection Paper on Benefit-risk Assessment Methods in the Context of the Evaluation of Marketing Authorisation Applications of Medicinal Products for Human Use - Committee for Medicinal Products for Human Use (March 2008) Appendix 4 Commentaries on 'A Quantitative Approach to Benefit-risk Assessment of Medicines' Pharmacoepidemiology and Drug Safety, 2007, 16 |
| Record Nr. | UNINA-9910139929703321 |
Mussen Filip
|
||
| Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision-making / / Filip Mussen, Sam Salek, Stuart Walker
| Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision-making / / Filip Mussen, Sam Salek, Stuart Walker |
| Autore | Mussen Filip |
| Pubbl/distr/stampa | Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 |
| Descrizione fisica | 1 online resource (306 p.) |
| Disciplina |
615.19
615/.1901 |
| Altri autori (Persone) |
SalekSam
WalkerStuart R. <1944-> |
| Soggetto topico |
Drugs - Testing
Pharmaceutical policy - Decision making |
| ISBN |
1-282-25949-0
9786612259494 0-470-74811-7 0-470-74812-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Benefit-Risk Appraisal of Medicines; Contents; Foreword; Preface; 1 Concept and Scope of Benefit-Risk Evaluation of Medicines; 1.1 Historical background; 1.2 The regulatory systems for assessing medicines; 1.3 Benefit-risk assessment: definitions; 1.4 Views and perceptions of benefits and risks of medicines; 1.5 Stages and concepts in benefit-risk assessment; 1.6 Benefit-risk assessment: the current regulatory environment; 1.7 Benefit-risk assessment in other disciplines; 1.8 Specific methods and models for benefit-risk assessment
1.9 Discussions with stakeholders on the concepts and models for benefit-risk evaluation2 Criteria for a Benefit-Risk Model: a Conceptual Framework; 2.1 Introduction; 2.2 Regulatory guidelines on benefit and risk criteria; 2.3 Identification, definition and rationale of relevant benefit and risk criteria; 2.4 Verification of the list of benefit and risk criteria by means of a survey; 3 Review of the Current Benefit-Risk Assessment Models; 3.1 Background; 3.2 Evaluation of the existing benefit-risk assessment models; 3.3 Review of models in single clinical trials and for specific medicines 3.4 Conclusion3.5 Newer models; 4 Defining a Systematic Approach to Decision Making; 4.1 Introduction; 4.2 Objectives and features of the ideal model for benefit-risk assessment; 4.3 The use of decision-analysis techniques for the development of the new model; 5 Development and Application of a Benefit-Risk Assessment Model Based on Multi-Criteria Decision Analysis; 5.1 Introduction; 5.2 Conceptualization of the new model; 5.3 Reasons for using decision analysis techniques in the new model; 5.4 The use of MCDA in the new model; 5.5 Development of the new model 5.6 Applicability of the new model5.7 Summary; 5.8 Review of the MCDA model; 6 A Future Framework for Benefit-Risk Appraisal of Medicines; 6.1 Background; 6.2 Development of a benefit-risk framework for regulatory review of new medicines; 6.3 Prerequisites of a benefit-risk framework for the registration of a new medicine; 6.4 Current status of benefit-risk assessment among companies and agencies; 6.5 Constructing a benefit-risk framework; 6.6 Conclusion; Appendices Appendix 1 Summary Reports of the CMR International Institute for Regulatory Science March 2004 and June 2005 Workshops on Benefit-RiskAppendix 2 Office of Health Economics Briefing: Challenges and Opportunities for Improving Benefit-risk Assessment of Pharmaceuticals from an Economic Perspective - James Cross and Louis Garrison (August 2008); Appendix 3 Reflection Paper on Benefit-risk Assessment Methods in the Context of the Evaluation of Marketing Authorisation Applications of Medicinal Products for Human Use - Committee for Medicinal Products for Human Use (March 2008) Appendix 4 Commentaries on 'A Quantitative Approach to Benefit-risk Assessment of Medicines' Pharmacoepidemiology and Drug Safety, 2007, 16 |
| Record Nr. | UNINA-9910643711703321 |
|
Mussen Filip
|
||
| Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision-making / / Filip Mussen, Sam Salek, Stuart Walker
| Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision-making / / Filip Mussen, Sam Salek, Stuart Walker |
| Autore | Mussen Filip |
| Pubbl/distr/stampa | Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 |
| Descrizione fisica | 1 online resource (306 p.) |
| Disciplina |
615.19
615/.1901 |
| Altri autori (Persone) |
SalekSam
WalkerStuart R. <1944-> |
| Soggetto topico |
Drugs - Testing
Pharmaceutical policy - Decision making |
| ISBN |
1-282-25949-0
9786612259494 0-470-74811-7 0-470-74812-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Benefit-Risk Appraisal of Medicines; Contents; Foreword; Preface; 1 Concept and Scope of Benefit-Risk Evaluation of Medicines; 1.1 Historical background; 1.2 The regulatory systems for assessing medicines; 1.3 Benefit-risk assessment: definitions; 1.4 Views and perceptions of benefits and risks of medicines; 1.5 Stages and concepts in benefit-risk assessment; 1.6 Benefit-risk assessment: the current regulatory environment; 1.7 Benefit-risk assessment in other disciplines; 1.8 Specific methods and models for benefit-risk assessment
1.9 Discussions with stakeholders on the concepts and models for benefit-risk evaluation2 Criteria for a Benefit-Risk Model: a Conceptual Framework; 2.1 Introduction; 2.2 Regulatory guidelines on benefit and risk criteria; 2.3 Identification, definition and rationale of relevant benefit and risk criteria; 2.4 Verification of the list of benefit and risk criteria by means of a survey; 3 Review of the Current Benefit-Risk Assessment Models; 3.1 Background; 3.2 Evaluation of the existing benefit-risk assessment models; 3.3 Review of models in single clinical trials and for specific medicines 3.4 Conclusion3.5 Newer models; 4 Defining a Systematic Approach to Decision Making; 4.1 Introduction; 4.2 Objectives and features of the ideal model for benefit-risk assessment; 4.3 The use of decision-analysis techniques for the development of the new model; 5 Development and Application of a Benefit-Risk Assessment Model Based on Multi-Criteria Decision Analysis; 5.1 Introduction; 5.2 Conceptualization of the new model; 5.3 Reasons for using decision analysis techniques in the new model; 5.4 The use of MCDA in the new model; 5.5 Development of the new model 5.6 Applicability of the new model5.7 Summary; 5.8 Review of the MCDA model; 6 A Future Framework for Benefit-Risk Appraisal of Medicines; 6.1 Background; 6.2 Development of a benefit-risk framework for regulatory review of new medicines; 6.3 Prerequisites of a benefit-risk framework for the registration of a new medicine; 6.4 Current status of benefit-risk assessment among companies and agencies; 6.5 Constructing a benefit-risk framework; 6.6 Conclusion; Appendices Appendix 1 Summary Reports of the CMR International Institute for Regulatory Science March 2004 and June 2005 Workshops on Benefit-RiskAppendix 2 Office of Health Economics Briefing: Challenges and Opportunities for Improving Benefit-risk Assessment of Pharmaceuticals from an Economic Perspective - James Cross and Louis Garrison (August 2008); Appendix 3 Reflection Paper on Benefit-risk Assessment Methods in the Context of the Evaluation of Marketing Authorisation Applications of Medicinal Products for Human Use - Committee for Medicinal Products for Human Use (March 2008) Appendix 4 Commentaries on 'A Quantitative Approach to Benefit-risk Assessment of Medicines' Pharmacoepidemiology and Drug Safety, 2007, 16 |
| Record Nr. | UNINA-9910830138703321 |
|
Mussen Filip
|
||
| Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision-making / / Filip Mussen, Sam Salek, Stuart Walker
| Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision-making / / Filip Mussen, Sam Salek, Stuart Walker |
| Autore | Mussen Filip |
| Pubbl/distr/stampa | Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 |
| Descrizione fisica | 1 online resource (306 p.) |
| Disciplina |
615.19
615/.1901 |
| Altri autori (Persone) |
SalekSam
WalkerStuart R. <1944-> |
| Soggetto topico |
Drugs - Testing
Pharmaceutical policy - Decision making |
| ISBN |
1-282-25949-0
9786612259494 0-470-74811-7 0-470-74812-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Benefit-Risk Appraisal of Medicines; Contents; Foreword; Preface; 1 Concept and Scope of Benefit-Risk Evaluation of Medicines; 1.1 Historical background; 1.2 The regulatory systems for assessing medicines; 1.3 Benefit-risk assessment: definitions; 1.4 Views and perceptions of benefits and risks of medicines; 1.5 Stages and concepts in benefit-risk assessment; 1.6 Benefit-risk assessment: the current regulatory environment; 1.7 Benefit-risk assessment in other disciplines; 1.8 Specific methods and models for benefit-risk assessment
1.9 Discussions with stakeholders on the concepts and models for benefit-risk evaluation2 Criteria for a Benefit-Risk Model: a Conceptual Framework; 2.1 Introduction; 2.2 Regulatory guidelines on benefit and risk criteria; 2.3 Identification, definition and rationale of relevant benefit and risk criteria; 2.4 Verification of the list of benefit and risk criteria by means of a survey; 3 Review of the Current Benefit-Risk Assessment Models; 3.1 Background; 3.2 Evaluation of the existing benefit-risk assessment models; 3.3 Review of models in single clinical trials and for specific medicines 3.4 Conclusion3.5 Newer models; 4 Defining a Systematic Approach to Decision Making; 4.1 Introduction; 4.2 Objectives and features of the ideal model for benefit-risk assessment; 4.3 The use of decision-analysis techniques for the development of the new model; 5 Development and Application of a Benefit-Risk Assessment Model Based on Multi-Criteria Decision Analysis; 5.1 Introduction; 5.2 Conceptualization of the new model; 5.3 Reasons for using decision analysis techniques in the new model; 5.4 The use of MCDA in the new model; 5.5 Development of the new model 5.6 Applicability of the new model5.7 Summary; 5.8 Review of the MCDA model; 6 A Future Framework for Benefit-Risk Appraisal of Medicines; 6.1 Background; 6.2 Development of a benefit-risk framework for regulatory review of new medicines; 6.3 Prerequisites of a benefit-risk framework for the registration of a new medicine; 6.4 Current status of benefit-risk assessment among companies and agencies; 6.5 Constructing a benefit-risk framework; 6.6 Conclusion; Appendices Appendix 1 Summary Reports of the CMR International Institute for Regulatory Science March 2004 and June 2005 Workshops on Benefit-RiskAppendix 2 Office of Health Economics Briefing: Challenges and Opportunities for Improving Benefit-risk Assessment of Pharmaceuticals from an Economic Perspective - James Cross and Louis Garrison (August 2008); Appendix 3 Reflection Paper on Benefit-risk Assessment Methods in the Context of the Evaluation of Marketing Authorisation Applications of Medicinal Products for Human Use - Committee for Medicinal Products for Human Use (March 2008) Appendix 4 Commentaries on 'A Quantitative Approach to Benefit-risk Assessment of Medicines' Pharmacoepidemiology and Drug Safety, 2007, 16 |
| Record Nr. | UNINA-9910841543203321 |
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Mussen Filip
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| Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Biomedical chromatography [[electronic resource] /] / John T. Elwood, editor
| Biomedical chromatography [[electronic resource] /] / John T. Elwood, editor |
| Pubbl/distr/stampa | New York, : Nova Science, c2010 |
| Descrizione fisica | 1 online resource (190 p.) |
| Disciplina | 615/.1901 |
| Altri autori (Persone) | ElwoodJohn T |
| Collana | Chemical engineering methods and technology |
| Soggetto topico |
Drugs - Analysis
Chromatographic analysis Pharmaceutical chemistry |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-61668-470-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Bioanalysis in drug discovery and development : focus on pharmacokinetic studies / Gilberto Alves, Ana Fortuna, Amílcar Falcão -- Characterization of drug-plasmatic protein interactions by microseparation techniques / Maria Amparo Martínez-Gómez ... [et al.] -- Statistical approaches for bioequivalence of highly variable drugs and drug products / Alionka Citlali P. Angeles-Moreno, Gabriel Marcelín-Jiménez, Salvador Zamora-Muñoz -- New strategies of sample preparation in the analysis of pharmaceuticals and their determination using high performance liquid chromatography / Zoraida Sosa-Ferrera ... [et al.] -- Analysis of catecholamines with peroxyoxalate chemiluminescence reaction detection / Makoto Tsunoda -- Photoproducts of naproxen in alcoholic solvents / Hsin-Tsung Ho ... [et al.]. |
| Record Nr. | UNINA-9910465675903321 |
| New York, : Nova Science, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Biomedical chromatography / / John T. Elwood, editor
| Biomedical chromatography / / John T. Elwood, editor |
| Pubbl/distr/stampa | New York : , : Nova Science, , 2010 |
| Descrizione fisica | 1 online resource (190 pages) |
| Disciplina | 615/.1901 |
| Altri autori (Persone) | ElwoodJohn T |
| Collana | Chemical engineering methods and technology |
| Soggetto topico |
Drugs - Analysis
Chromatographic analysis Pharmaceutical chemistry |
| ISBN | 1-61668-470-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Bioanalysis in drug discovery and development : focus on pharmacokinetic studies / Gilberto Alves, Ana Fortuna, Amílcar Falcão -- Characterization of drug-plasmatic protein interactions by microseparation techniques / Maria Amparo Martínez-Gómez ... [et al.] -- Statistical approaches for bioequivalence of highly variable drugs and drug products / Alionka Citlali P. Angeles-Moreno, Gabriel Marcelín-Jiménez, Salvador Zamora-Muñoz -- New strategies of sample preparation in the analysis of pharmaceuticals and their determination using high performance liquid chromatography / Zoraida Sosa-Ferrera ... [et al.] -- Analysis of catecholamines with peroxyoxalate chemiluminescence reaction detection / Makoto Tsunoda -- Photoproducts of naproxen in alcoholic solvents / Hsin-Tsung Ho ... [et al.]. |
| Record Nr. | UNINA-9910791768403321 |
| New York : , : Nova Science, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
