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Biblioteca

MARC Lista (tabellare)
Scientific communications strategy and the value creation in pharmaceutical firms : dynamics and evolution trends in Italian market / Ascensionato Raffaello Carnà
Scientific communications strategy and the value creation in pharmaceutical firms : dynamics and evolution trends in Italian market / Ascensionato Raffaello Carnà
Autore CARNÀ, Ascensionato Raffaello
Pubbl/distr/stampa Milano : Giuffrè, 2010
Descrizione fisica 27 p. ; 24 cm
Disciplina 338.476151
Collana Series of paper
Soggetto topico Industria farmaceutica - Gestione
ISBN 88-14-15383-3
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Record Nr. UNISA-990003517420203316
CARNÀ, Ascensionato Raffaello  
Milano : Giuffrè, 2010
Materiale a stampa
Lo trovi qui: Univ. di Salerno
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Settore farmaceutico e sistema Paese : contributi ed esigenze per uno sviluppo sostenibile : GlaxoSmithKline : il valore di un investimento duraturo / Nomisma
Settore farmaceutico e sistema Paese : contributi ed esigenze per uno sviluppo sostenibile : GlaxoSmithKline : il valore di un investimento duraturo / Nomisma
Autore Nomisma
Pubbl/distr/stampa Bologna : Il Mulino, 2007
Descrizione fisica 147 p. : ill. ; 22 cm
Disciplina 338.476151
Collana Percorsi
Soggetto non controllato Industria farmaceuticaSviluppoItalia
ISBN 97888-15-12222-3
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione ita
Titolo uniforme
Record Nr. UNIPARTHENOPE-000029096
Nomisma  
Bologna : Il Mulino, 2007
Materiale a stampa
Lo trovi qui: Univ. Parthenope
Opac: Controlla la disponibilità qui
Settore farmaceutico e sistema paese : contributi ed esigenze per uno sviluppo sostenibile / Nomisma : GlazoSmithKline, il valore di un investimento duraturo
Settore farmaceutico e sistema paese : contributi ed esigenze per uno sviluppo sostenibile / Nomisma : GlazoSmithKline, il valore di un investimento duraturo
Autore Nomisma
Pubbl/distr/stampa Bologna : Il Mulino, 2007
Descrizione fisica 147 p. : graf., tab. ; 21 cm
Disciplina 338.476151
Collana Percorsi
Soggetto non controllato Industria farmaceuticaInnovazione tecnologicaItalia
ISBN 978-88-15-12222-3
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione ita
Titolo uniforme
Record Nr. UNIPARTHENOPE-000028357
Nomisma  
Bologna : Il Mulino, 2007
Materiale a stampa
Lo trovi qui: Univ. Parthenope
Opac: Controlla la disponibilità qui
Settore farmaceutico e sistema paese : contributi ed esigenze per uno sviluppo sostenibile : GlaxoSmithKline, il valore di un investimento duraturo / Nomisma
Settore farmaceutico e sistema paese : contributi ed esigenze per uno sviluppo sostenibile : GlaxoSmithKline, il valore di un investimento duraturo / Nomisma
Autore Nomisma
Pubbl/distr/stampa Bologna : il Mulino, c2007
Descrizione fisica 147 p. ; 22 cm
Disciplina 338.476151
Collana Percorsi
Soggetto non controllato Industria farmaceutica - Sviluppo tecnologico - Italia
ISBN 978-88-15-12222-3
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione ita
Record Nr. UNINA-990008803390403321
Nomisma  
Bologna : il Mulino, c2007
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Sources of contamination in medicinal products and medical devices [[electronic resource] /] / Denise Bohrer
Sources of contamination in medicinal products and medical devices [[electronic resource] /] / Denise Bohrer
Autore Bohrer Denise
Pubbl/distr/stampa Hoboken, N.J., : Wiley, 2012
Descrizione fisica 1 online resource (593 p.)
Disciplina 338.4/76151
338.476151
Soggetto topico Microbial contamination
Pharmaceutical industry - Quality control
Pharmaceutical technology - Standards
ISBN 1-118-44905-3
1-283-64526-2
1-118-44906-1
1-118-44908-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Title page; Copyright page; Contents; Preface; Acknowledgments; 1: Introduction; Reference; 2: Directives for Contamination Control; PART I: Chemical Contamination; 3: Raw Materials; 3.1 Water; 3.2 Inorganic Impurities; 3.3 Organic Impurities; 3.3.1 By-products; 3.3.2 Genotoxic Impurities (GTIs); 3.3.3 Degradation Products; 3.4 Additives; 3.5 Residual Solvents; Concluding Remarks; References; 4: Medicinal Gases and Volatile Anesthetics; 4.1 Medicinal Gases; 4.2 Volatile Anesthetics; Concluding Remarks; References; 5: Diagnostic Imaging Agents; 5.1 Radiopharmaceuticals
5.1.1 Technetium-Based Products5.1.2 Iodine-Based Products; 5.1.3 Fluorine-Based Products; 5.2 Contrast Agents; 5.2.1 Gadolinium-Based Products; 5.2.2 Iodine-Based Products; 5.2.3 Barium Sulfate; Concluding Remarks; References; 6: Containers; 6.1 Glass Containers; 6.2 Plastic Containers; 6.2.1 Polymer Formation; 6.2.2 PVC Containers; 6.2.3 Other Plastic Containers; 6.3 Metal Containers; Concluding Remarks; References; 7: Closures; Concluding Remarks; References; 8: Delivery Systems and Filters; 8.1 Delivery Systems Made of PVC; 8.2 Delivery Systems Made of Other Plastic Materials; 8.3 Filters
Concluding RemarksReferences; 9: Medical Devices; 9.1 General Use Devices; 9.1.1 Medical Gloves; 9.1.2 Syringes; 9.2 Extracorporeal Circuits; 9.3 Devices for Administration of Aerosolized Drugs; 9.4 Reprocessed Medical Devices; 9.5 Tissue Substitutes; 9.5.1 Skin Substitutes and Surgical Dressings; 9.5.2 Hard Tissue Substitutes; 9.5.3 Soft Tissue Substitutes; Concluding Remarks; References; PART II: Physical Contamination; 10: Particulate Matter; Concluding Remarks; References; PART III: Microbiological Contamination; 11: Microbiological and Endotoxin Contamination; 11.1 Water
11.2 Raw Materials11.3 Sterile Products; 11.3.1 Single- and Multiple-Dose Products; 11.3.2 Parenteral Nutrition (PN); 11.3.3 Propofol; 11.3.4 Ophthalmic Products; 11.4 Medicinal Gases; 11.5 Medical Devices; 11.5.1 Syringes; 11.5.2 Endoscopes; 11.5.3 Other Devices; 11.6 Biofilms; 11.7 Dialysis Circuits; 11.8 Nosocomial Infections; Concluding Remarks; References; PART IV: Miscellaneous; 12: Contamination from Sterilization Procedures; 12.1 Residuals from Radiation Sterilization; 12.1.1 Radiolysis of Water; 12.1.2 Effect of Ionizing Radiation on Drug Products; 12.1.3 Polymers in Drug Delivery
12.1.4 Radiolysis of Selected Nondrug Components12.1.5 Effect of Ionizing Radiation on Materials Used in Packaging and in Medical Devices; 12.2 Heat Sterilization; 12.3 Residuals from Chemical Disinfection and Sterilization Agents; 12.3.1 Ethylene Oxide (EtO); 12.3.2 Peracetic Acid and Hydrogen Peroxide; 12.3.3 Formaldehyde; Concluding Remarks; References; 13: Biotechnological Products; 13.1 DNA and HCP Residuals; 13.2 Viruses and Mycoplasma; 13.3 Endotoxin; 13.4 Protein Degradation; 13.5 Protein Aggregation; Concluding Remarks; References
Appendix Polymeric Materials: Components, Additives, Extractables, and Degradation Products
Record Nr. UNINA-9910141378403321
Bohrer Denise  
Hoboken, N.J., : Wiley, 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Sources of contamination in medicinal products and medical devices [[electronic resource] /] / Denise Bohrer
Sources of contamination in medicinal products and medical devices [[electronic resource] /] / Denise Bohrer
Autore Bohrer Denise
Pubbl/distr/stampa Hoboken, N.J., : Wiley, 2012
Descrizione fisica 1 online resource (593 p.)
Disciplina 338.4/76151
338.476151
Soggetto topico Microbial contamination
Pharmaceutical industry - Quality control
Pharmaceutical technology - Standards
ISBN 1-118-44905-3
1-283-64526-2
1-118-44906-1
1-118-44908-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Title page; Copyright page; Contents; Preface; Acknowledgments; 1: Introduction; Reference; 2: Directives for Contamination Control; PART I: Chemical Contamination; 3: Raw Materials; 3.1 Water; 3.2 Inorganic Impurities; 3.3 Organic Impurities; 3.3.1 By-products; 3.3.2 Genotoxic Impurities (GTIs); 3.3.3 Degradation Products; 3.4 Additives; 3.5 Residual Solvents; Concluding Remarks; References; 4: Medicinal Gases and Volatile Anesthetics; 4.1 Medicinal Gases; 4.2 Volatile Anesthetics; Concluding Remarks; References; 5: Diagnostic Imaging Agents; 5.1 Radiopharmaceuticals
5.1.1 Technetium-Based Products5.1.2 Iodine-Based Products; 5.1.3 Fluorine-Based Products; 5.2 Contrast Agents; 5.2.1 Gadolinium-Based Products; 5.2.2 Iodine-Based Products; 5.2.3 Barium Sulfate; Concluding Remarks; References; 6: Containers; 6.1 Glass Containers; 6.2 Plastic Containers; 6.2.1 Polymer Formation; 6.2.2 PVC Containers; 6.2.3 Other Plastic Containers; 6.3 Metal Containers; Concluding Remarks; References; 7: Closures; Concluding Remarks; References; 8: Delivery Systems and Filters; 8.1 Delivery Systems Made of PVC; 8.2 Delivery Systems Made of Other Plastic Materials; 8.3 Filters
Concluding RemarksReferences; 9: Medical Devices; 9.1 General Use Devices; 9.1.1 Medical Gloves; 9.1.2 Syringes; 9.2 Extracorporeal Circuits; 9.3 Devices for Administration of Aerosolized Drugs; 9.4 Reprocessed Medical Devices; 9.5 Tissue Substitutes; 9.5.1 Skin Substitutes and Surgical Dressings; 9.5.2 Hard Tissue Substitutes; 9.5.3 Soft Tissue Substitutes; Concluding Remarks; References; PART II: Physical Contamination; 10: Particulate Matter; Concluding Remarks; References; PART III: Microbiological Contamination; 11: Microbiological and Endotoxin Contamination; 11.1 Water
11.2 Raw Materials11.3 Sterile Products; 11.3.1 Single- and Multiple-Dose Products; 11.3.2 Parenteral Nutrition (PN); 11.3.3 Propofol; 11.3.4 Ophthalmic Products; 11.4 Medicinal Gases; 11.5 Medical Devices; 11.5.1 Syringes; 11.5.2 Endoscopes; 11.5.3 Other Devices; 11.6 Biofilms; 11.7 Dialysis Circuits; 11.8 Nosocomial Infections; Concluding Remarks; References; PART IV: Miscellaneous; 12: Contamination from Sterilization Procedures; 12.1 Residuals from Radiation Sterilization; 12.1.1 Radiolysis of Water; 12.1.2 Effect of Ionizing Radiation on Drug Products; 12.1.3 Polymers in Drug Delivery
12.1.4 Radiolysis of Selected Nondrug Components12.1.5 Effect of Ionizing Radiation on Materials Used in Packaging and in Medical Devices; 12.2 Heat Sterilization; 12.3 Residuals from Chemical Disinfection and Sterilization Agents; 12.3.1 Ethylene Oxide (EtO); 12.3.2 Peracetic Acid and Hydrogen Peroxide; 12.3.3 Formaldehyde; Concluding Remarks; References; 13: Biotechnological Products; 13.1 DNA and HCP Residuals; 13.2 Viruses and Mycoplasma; 13.3 Endotoxin; 13.4 Protein Degradation; 13.5 Protein Aggregation; Concluding Remarks; References
Appendix Polymeric Materials: Components, Additives, Extractables, and Degradation Products
Record Nr. UNINA-9910830989003321
Bohrer Denise  
Hoboken, N.J., : Wiley, 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Statistical thinking for non-statisticians in drug regulation / / Richard Kay
Statistical thinking for non-statisticians in drug regulation / / Richard Kay
Autore Kay R (Richard), <1949->
Edizione [Third edition.]
Pubbl/distr/stampa Hoboken, New Jersey : , : Wiley-Blackwell, , [2023]
Descrizione fisica 1 online resource (435 pages)
Disciplina 338.476151
Soggetto topico Drug approval
ISBN 9781119867395
9781119867388
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cover -- Title Page -- Copyright Page -- Contents -- Preface to the third edition -- Preface to the second edition -- Preface to the first edition -- Abbreviations -- CHAPTER 1 Basic ideas in clinical trial design -- 1.1 Historical perspective -- 1.2 Control groups -- 1.3 Placebos and blinding -- 1.4 Randomisation -- 1.4.1 Unrestricted randomisation -- 1.4.2 Block randomisation -- 1.4.3 Unequal randomisation -- 1.4.4 Stratified randomisation -- 1.4.5 Central randomisation -- 1.4.6 Dynamic allocation and minimisation -- 1.4.7 Cluster randomisation -- 1.5 Bias and precision -- 1.6 Between- and within-patient designs -- 1.7 Crossover trials -- 1.8 Signal, noise and evidence -- 1.8.1 Signal -- 1.8.2 Noise -- 1.8.3 Signal-to-noise ratio -- 1.9 Confirmatory and exploratory trials -- 1.10 Superiority, equivalence and non-inferiority trials -- 1.11 Endpoint types -- 1.12 Choice of endpoint -- 1.12.1 Primary endpoints -- 1.12.2 Secondary endpoints -- 1.12.3 Surrogate endpoints -- 1.12.4 Global assessment endpoints -- 1.12.5 Composite endpoints -- 1.12.6 Categorisation -- CHAPTER 2 Sampling and inferential statistics -- 2.1 Sample and population -- 2.2 Sample statistics and population parameters -- 2.2.1 Sample and population distribution -- 2.2.2 Median and mean -- 2.2.3 Standard deviation -- 2.2.4 Notation -- 2.2.5 Box plots -- 2.3 The normal distribution -- 2.4 Sampling and the standard error of the mean -- 2.5 Standard errors more generally -- 2.5.1 The standard error for the difference between two means -- 2.5.2 Standard errors for proportions -- 2.5.3 The general setting -- CHAPTER 3 Confidence intervals and p-values -- 3.1 Confidence intervals for a single mean -- 3.1.1 The 95% confidence interval -- 3.1.2 Changing the confidence coefficient -- 3.1.3 Changing the multiplying constant -- 3.1.4 The role of the standard error.
3.2 Confidence intervals for other parameters -- 3.2.1 Difference between two means -- 3.2.2 Confidence interval for proportions -- 3.2.3 General case -- 3.2.4 Bootstrap confidence interval -- 3.3 Hypothesis testing -- 3.3.1 Interpreting the p-value -- 3.3.2 Calculating the p-value -- 3.3.3 A common process -- 3.3.4 The language of statistical significance -- 3.3.5 One-sided and two-sided tests -- CHAPTER 4 Tests for simple treatment comparisons -- 4.1 The unpaired t-test -- 4.2 The paired t-test -- 4.3 Interpreting the t-tests -- 4.4 The chi-square test for binary endpoints -- 4.4.1 Pearson chi-square -- 4.4.2 The link to a ratio of the signal to the standard error -- 4.5 Measures of treatment benefit -- 4.5.1 Odds ratio -- 4.5.2 Relative risk -- 4.5.3 Relative and absolute risk reduction -- 4.5.4 Number needed to treat -- 4.5.5 Confidence intervals -- 4.5.6 Interpretation -- 4.6 Fisher's exact test -- 4.7 Tests for categorical and ordered categorical endpoints -- 4.7.1 Categorical endpoints -- 4.7.2 Ordered categorical (ordinal) endpoints -- 4.7.3 Measures of treatment benefit -- 4.8 Count endpoints -- 4.9 Extensions for multiple treatment groups -- 4.9.1 Continuous endpoints -- 4.9.2 Binary, categorical and ordered categorical endpoints -- 4.9.3 Dose-ranging studies -- 4.9.4 Further discussion -- CHAPTER 5 Adjusting the analysis -- 5.1 Objectives for adjusted analysis -- 5.2 Comparing treatments for continuous endpoints -- 5.3 Least squares means -- 5.4 Evaluating the homogeneity of the treatment effect -- 5.4.1 Treatment-by-factor interactions -- 5.4.2 Quantitative and qualitative interactions -- 5.5 Methods for binary and ordered categorical endpoints -- 5.6 Multi-centre trials -- 5.6.1 Adjusting for centre -- 5.6.2 Significant treatment-by-centre interactions -- 5.6.3 Combining centres -- CHAPTER 6 Regression and analysis of covariance.
6.1 Adjusting for baseline factors -- 6.2 Simple linear regression -- 6.3 Multiple regression -- 6.4 Logistic regression for binary endpoints -- 6.4.1 Negative binomial regression for count endpoints -- 6.5 Analysis of covariance for continuous outcomes -- 6.5.1 Main effect of treatment -- 6.5.2 Treatment-by-covariate interactions -- 6.5.3 A single model -- 6.5.4 Connection with adjusted analyses -- 6.5.5 Advantages of ANCOVA -- 6.5.6 Least squares means -- 6.5.7 Random element -- 6.6 Other endpoint types -- 6.6.1 Binary endpoints and extensions -- 6.6.2 Count endpoints -- 6.7 Mixed models -- 6.8 Regulatory aspects of the use of covariates -- 6.9 Baseline testing -- 6.10 Correlation and regression -- CHAPTER 7 Intention-to-treat, analysis sets and missing data -- 7.1 The principle of intention-to-treat -- 7.2 The practice of intention-to-treat -- 7.2.1 Full analysis set -- 7.2.2 Per-protocol set -- 7.2.3 Further aspects of ITT -- 7.3 Missing data -- 7.3.1 Introduction -- 7.3.2 Complete cases analysis -- 7.3.3 Last observation carried forward (LOCF) -- 7.3.4 Baseline observation carried forward (BOCF) -- 7.3.5 Success/failure classification -- 7.3.6 Worst-case/best-case classification -- 7.3.7 Sensitivity -- 7.3.8 Avoidance of missing data -- 7.3.9 Classification of missing data -- 7.3.10 Multiple imputation -- 7.4 Intention-to-treat and time-to-event data -- 7.5 General questions and considerations -- CHAPTER 8 Estimands -- 8.1 ICH E9 (R1) -- 8.2 Attributes of an estimand -- 8.2.1 Population -- 8.2.2 Variable -- 8.2.3 Intercurrent event (ICE) -- 8.2.4 Statistic for treatment effect -- 8.3 Estimand strategies -- 8.3.1 Five strategies -- 8.3.2 Treatment policy, composite and hypothetical strategies -- 8.3.3 While on treatment -- 8.3.4 Principal stratification -- 8.4 Sensitivity and supplementary analyses -- 8.4.1 Main estimator.
8.4.2 Sensitivity analyses -- 8.4.3 Supplementary analyses -- CHAPTER 9 Power, sample size and clinical relevance -- 9.1 Type I and type II errors -- 9.2 Power -- 9.3 Calculating sample size -- 9.4 Impact of changing the parameters -- 9.4.1 Standard deviation -- 9.4.2 Event rate in the control group -- 9.4.3 Clinically relevant difference -- 9.5 Regulatory aspects -- 9.5.1 Power 80% -- 9.5.2 Sample size adjustment -- 9.6 Reporting the sample size calculation -- 9.7 Post hoc power -- 9.8 Link between p-values and confidence intervals -- 9.9 Confidence intervals for clinical importance -- 9.10 Misinterpretation of the p-value -- 9.10.1 Conclusions of similarity -- 9.10.2 The problem with 0.05 -- 9.11 Single pivotal trial and 0.05 -- CHAPTER 10 Multiple testing -- 10.1 Inflation of the type I error -- 10.1.1 False positives -- 10.1.2 A simulated trial -- 10.2 How does multiplicity arise? -- 10.3 Regulatory and scientific view -- 10.4 Methods for adjustment -- 10.4.1 Bonferroni correction -- 10.4.2 Holm correction -- 10.4.3 Hochberg correction -- 10.4.4 Interim analyses -- 10.5 Avoiding adjustment -- 10.5.1 Co-primary endpoints -- 10.5.2 Composite endpoints -- 10.5.3 Hierarchical testing -- 10.6 Fallback procedure -- 10.7 Multiple comparisons of treatments -- 10.8 Subgroup testing -- 10.9 Other aspects of multiplicity -- 10.9.1 Using different statistical tests -- 10.9.2 Different analysis sets and methods for missing data -- 10.9.3 Pre-planning -- 10.9.4 Nominal significance -- CHAPTER 11 Non-parametric and related methods -- 11.1 Assumptions underlying the t-tests and their extensions -- 11.2 Homogeneity of variance -- 11.3 The assumption of normality -- 11.4 Non-normality and transformations -- 11.5 Non-parametric tests -- 11.5.1 The Mann-Whitney U-test -- 11.5.2 The Wilcoxon signed rank test -- 11.5.3 General comments.
11.6 Advantages and disadvantages of non-parametric methods -- 11.7 Outliers -- CHAPTER 12 Equivalence and non-inferiority -- 12.1 Demonstrating similarity -- 12.2 Confidence intervals for equivalence -- 12.3 Confidence intervals for non-inferiority -- 12.4 A p-value approach -- 12.5 Assay sensitivity -- 12.6 Analysis sets -- 12.7 The choice of -- 12.7.1 Bioequivalence -- 12.7.2 Therapeutic equivalence, biosimilars -- 12.7.3 Non-inferiority -- 12.7.4 The 10% rule for cure rates -- 12.7.5 The synthesis method -- 12.8 Biocreep and constancy -- 12.9 Sample size calculations -- 12.10 Switching between non-inferiority and superiority -- 12.11 Biosimilars -- CHAPTER 13 The analysis of survival data -- 13.1 Time-to-event data and censoring -- 13.2 Kaplan-Meier curves -- 13.2.1 Plotting Kaplan-Meier curves -- 13.2.2 Event rates and relative risk -- 13.2.3 Median event times -- 13.3 Treatment comparisons -- 13.4 The hazard ratio -- 13.4.1 The hazard rate -- 13.4.2 Constant hazard ratio -- 13.4.3 Non-constant hazard ratio -- 13.4.4 Link to survival curves -- 13.4.5 Calculating Kaplan-Meier curves -- 13.5 Restricted mean survival time -- 13.6 Adjusted analyses -- 13.6.1 Stratified methods -- 13.6.2 Proportional hazards regression -- 13.6.3 Accelerated failure time model -- 13.7 Independent censoring -- 13.8 Crossover -- 13.8.1 Rank Preserving Structural Failure Time Model -- 13.8.2 Regulatory position -- 13.9 Composite time-to-event endpoints -- 13.9.1 Cumulative incidence functions -- 13.9.2 Regulatory position -- 13.10 Sample size calculations -- CHAPTER 14 Interim analysis and data monitoring committees -- 14.1 Stopping rules for interim analysis -- 14.2 Stopping for efficacy and futility -- 14.2.1 Efficacy -- 14.2.2 Futility and conditional power -- 14.2.3 Some practical issues -- 14.2.4 Point estimates and confidence intervals -- 14.3 Monitoring safety.
14.4 Data monitoring committees.
Record Nr. UNINA-9910678187803321
Kay R (Richard), <1949->  
Hoboken, New Jersey : , : Wiley-Blackwell, , [2023]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Sterile processing of pharmaceutical products : engineering practice, validation, and compliance in regulated environments / / Sam A. Hout
Sterile processing of pharmaceutical products : engineering practice, validation, and compliance in regulated environments / / Sam A. Hout
Autore Hout Sam A.
Pubbl/distr/stampa Hoboken, NJ : , : John Wiley & Sons, Inc., , 2022
Descrizione fisica 1 online resource (371 pages)
Disciplina 338.476151
Soggetto topico Pharmaceutical industry
Soggetto genere / forma Electronic books.
ISBN 1-119-80234-2
1-119-80235-0
1-119-80233-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cover -- Title Page -- Copyright -- Contents -- Preface -- Acknowledgments -- Chapter 1 Introduction -- Chapter 2 Sterilization -- Steam Sterilization -- Flash Sterilization -- Low‐Temperature Sterilization Technologies -- Ethylene Oxide Gas Sterilization -- Hydrogen Peroxide Gas Plasma -- Disinfection and Surface Sterilization Using Peracetic Acid -- Ionizing Radiation -- Dry‐Heat Sterilizers -- Filtration -- Microwave -- Vaporized Hydrogen Peroxide (VHP®) -- Ozone -- Formaldehyde Steam -- Gaseous Chlorine Dioxide -- Vaporized Peracetic Acid -- Infrared Radiation -- Sterilization Cycle Verification -- Monitoring -- Chapter 3 Sterile Manufacturing Facilities -- Chapter 4 Sanitary Process Piping and Equipment -- QA Procedures -- Standard Operating Procedures - cGMP Installations -- Heat Exchangers -- Sanitary Pumps -- Sanitary Tanks -- Instruments -- Pressure Transmitter (Various Sources) -- Temperature Transmitter (Various Sources) -- Standard Operating Procedures - cGMP Installations -- Surface Finish -- Welding -- Applicability -- Process/Procedure -- Records (General) -- Records -- Automatic Orbital Welding -- Weld Acceptance Criteria for Automatic Orbital Weld Qualifications -- Chapter 5 Passivation -- In‐house Passivation Using Vats -- Spot Passivation -- Astro Pak UltraPass Gel Passivation -- Alternative Process -- Control of Passivated Items -- Preparing, Testing, and Adjusting Cleaning and Passivation Chemicals (Passivation in Vats) -- Chapter 6 Chilled Water System -- Process Description -- Commissioning of HVAC -- Installation Verification - X Ton Chiller System -- System Startup - X Ton Chiller -- Functional Testing - X Ton Chiller -- Chapter 7 Clean‐In‐Place (CIP) Systems -- Life Cycle Requirements -- Product and Process User Requirements -- Process Quality Requirements -- Process Parameter Requirements.
Installation User Requirements -- Operational Requirements -- Chapter 8 Computerized Automated Systems -- Functional Requirement Specification -- Process Automation System -- EMS User Requirement Specification -- Automation Overview -- Software -- Hardware -- SCADA -- Control Panels -- Main Control Panel -- Remote I/O Panels -- Power Distribution Panels -- Instrumentation Panels -- System Functions -- System Overview -- Control Modules -- Interfaces -- User Interface (SCADA) -- PAS System Overview -- Graphical Screen Navigation -- Client EMS Area Graphical Screens -- Graphical Control Screens -- Interfaces to Equipment -- Interfaces to Other Systems -- Ethernet Network -- Nonfunctional Attributes -- Power Failure Recovery -- PLC Only Failure -- HMI Only Failure -- Network Only Failure -- Maintainability -- Backup and Recovery -- Functional Requirement Specification -- GLC Environmental Monitoring System -- Automation Overview -- System Components -- Software -- Hardware -- Control Panels -- Gateways -- System Functions -- System Overview -- Control Modules -- Interfaces -- User Interface (SCADA) -- GLC EMS Area Graphical Screen -- Global Logistics Center (GLC) Environmental Monitoring System -- Interfaces to Equipment -- Interfaces to Other Systems -- Ethernet Network -- Wireless Connections -- Nonfunctional Attributes -- Power Failure Recovery -- PLC Only Failure -- HMI Only Failure -- Network Only Failure -- Maintainability -- Backup and Recovery -- Software Module Design Specification -- Functional Requirement Specification -- Process Automation System -- Automation Overview -- System Components -- Software -- Hardware -- Control Panels -- System Functions -- System Overview -- Control Modules -- Interfaces -- User Interface (SCADA) -- PAS System Overview Screen -- Graphical Screen Navigation -- Graphical Control Screens -- Interfaces to Equipment.
Interfaces to Other Systems -- Ethernet Network -- Nonfunctional Attributes -- Power Failure Recovery -- PLC Only Failure -- HMI Only Failure -- Network Only Failure -- Maintainability -- Backup and Recovery -- Software Design Specification -- Prosoft Configuration -- Enabling and Disabling of the Gateway Default Server Interface -- Temperature Sensor Settings -- Humidity Sensor Settings -- Software Design Specification -- Continuous Logic -- Module Classes and Control Modules -- Virtual Differential Pressure Alarm Disable -- Room Condition Indication -- Navigation Links -- Alarm Daily Report -- WFI Still Equipment Module Class -- WFI Silo Equipment Module Class -- EM& -- uscore -- SILO -- WFI Primary Loop Equipment Module Class -- EM& -- uscore -- PRIM& -- uscore -- LOOP -- WFI Supply Header Equipment Module Class -- EM& -- uscore -- HEADER -- Electrical - Controls Equipment Specifications -- Documentation -- Drives/Motors -- Chapter 9 Personal Protective Equipment (PPE) and Process Flow -- Chapter 10 Sterile Aseptic Processing -- Chapter 11 Integrated Facility Design -- Case Study -- Issue -- Root Cause -- Corrective Action -- Preventive Actions -- Chapter 12 Barriers and Isolators -- Isolator Design Considerations -- Chapter 13 Guidelines for Statistical Procedure -- Process Capability Analysis -- Long‐term Studies -- Acceptance Sampling -- Attribute and Variable Sampling Plans -- Variable Sampling Plans - ANSI Z1.9 -- Normality -- Transformation of Non‐normal Data (Normalization) -- Protocol Sampling -- Failure Mode and Effect Analysis (FMEA) -- Calculating or Recalculating Control Limits -- Chapter 14 Calibration -- Contingency Plan/Disaster Recovery -- Chapter 15 Cleaning Validation -- New Products and Product Changes -- Cleaning Processes and Changes -- Risk Assessment/Matrix Approach -- Matrix Development.
Cleaning Processes (Manual and Automated) -- CPP/CQA -- Cleaning Validation Life Cycle - Cleaning Method Development -- Strategy for Process Controls -- Worst‐Case Identification - Product/Component -- Equipment -- Validation Tests/Inspections - Visual Inspection -- Chemical Testing -- Microbiological Testing -- Endotoxin Testing -- Sampling Methods -- Direct Swab Sampling -- Rinse Sampling -- Coupon Testing -- Sampling Sites -- Acceptance Criteria -- Residual Levels -- Endotoxin Levels -- Microbiological Levels -- Cleaning Agents/Sanitizer Validation Studies -- Hold Time Development -- Dirty Hold Time -- Clean Hold Time -- Additional Hold Times/Cleaning Frequencies -- Continuous Process Verification -- Failure Investigations -- Chapter 16 Validation of Filling Equipment -- Chapter 17 Manufacturing Process Validation -- Stage 2 - Process Qualification -- Appendix A Installation Test Plans -- Appendix B Operational Tests Plans -- Appendix C WFI Turbulence Flow Requirements -- Appendix D Water For Injection (WFI) - Design Requirements -- Process Description -- Specifications -- Life Cycle Requirements -- Product and Process User Requirements -- Product Description -- Operating Ranges -- Material of Construction -- Metallics -- Plastics -- Elastomers -- Glass -- Welding Requirements -- Construction Requirements -- Lubrication Requirements -- Electrical Requirements -- Safety Requirements -- Operational Requirements -- Process Constraints and Limitations -- Process Control System -- Operator Interface -- Power Loss and Recovery -- Cleaning and Sanitizing -- Maintenance Requirements -- Training and Documentation Requirements -- Appendix E Solution Transfer System (STS) - Design Requirements -- System Description -- Bulk Powder Handling System -- Glossary -- Nomenclature -- References -- Further Reading -- Index -- EULA.
Record Nr. UNINA-9910554859503321
Hout Sam A.  
Hoboken, NJ : , : John Wiley & Sons, Inc., , 2022
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Sterile processing of pharmaceutical products : engineering practice, validation, and compliance in regulated environments / / Sam A. Hout
Sterile processing of pharmaceutical products : engineering practice, validation, and compliance in regulated environments / / Sam A. Hout
Autore Hout Sam A.
Pubbl/distr/stampa Hoboken, NJ : , : John Wiley & Sons, Inc., , 2022
Descrizione fisica 1 online resource (371 pages)
Disciplina 338.476151
Soggetto topico Pharmaceutical industry
ISBN 1-119-80234-2
1-119-80235-0
1-119-80233-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cover -- Title Page -- Copyright -- Contents -- Preface -- Acknowledgments -- Chapter 1 Introduction -- Chapter 2 Sterilization -- Steam Sterilization -- Flash Sterilization -- Low‐Temperature Sterilization Technologies -- Ethylene Oxide Gas Sterilization -- Hydrogen Peroxide Gas Plasma -- Disinfection and Surface Sterilization Using Peracetic Acid -- Ionizing Radiation -- Dry‐Heat Sterilizers -- Filtration -- Microwave -- Vaporized Hydrogen Peroxide (VHP®) -- Ozone -- Formaldehyde Steam -- Gaseous Chlorine Dioxide -- Vaporized Peracetic Acid -- Infrared Radiation -- Sterilization Cycle Verification -- Monitoring -- Chapter 3 Sterile Manufacturing Facilities -- Chapter 4 Sanitary Process Piping and Equipment -- QA Procedures -- Standard Operating Procedures - cGMP Installations -- Heat Exchangers -- Sanitary Pumps -- Sanitary Tanks -- Instruments -- Pressure Transmitter (Various Sources) -- Temperature Transmitter (Various Sources) -- Standard Operating Procedures - cGMP Installations -- Surface Finish -- Welding -- Applicability -- Process/Procedure -- Records (General) -- Records -- Automatic Orbital Welding -- Weld Acceptance Criteria for Automatic Orbital Weld Qualifications -- Chapter 5 Passivation -- In‐house Passivation Using Vats -- Spot Passivation -- Astro Pak UltraPass Gel Passivation -- Alternative Process -- Control of Passivated Items -- Preparing, Testing, and Adjusting Cleaning and Passivation Chemicals (Passivation in Vats) -- Chapter 6 Chilled Water System -- Process Description -- Commissioning of HVAC -- Installation Verification - X Ton Chiller System -- System Startup - X Ton Chiller -- Functional Testing - X Ton Chiller -- Chapter 7 Clean‐In‐Place (CIP) Systems -- Life Cycle Requirements -- Product and Process User Requirements -- Process Quality Requirements -- Process Parameter Requirements.
Installation User Requirements -- Operational Requirements -- Chapter 8 Computerized Automated Systems -- Functional Requirement Specification -- Process Automation System -- EMS User Requirement Specification -- Automation Overview -- Software -- Hardware -- SCADA -- Control Panels -- Main Control Panel -- Remote I/O Panels -- Power Distribution Panels -- Instrumentation Panels -- System Functions -- System Overview -- Control Modules -- Interfaces -- User Interface (SCADA) -- PAS System Overview -- Graphical Screen Navigation -- Client EMS Area Graphical Screens -- Graphical Control Screens -- Interfaces to Equipment -- Interfaces to Other Systems -- Ethernet Network -- Nonfunctional Attributes -- Power Failure Recovery -- PLC Only Failure -- HMI Only Failure -- Network Only Failure -- Maintainability -- Backup and Recovery -- Functional Requirement Specification -- GLC Environmental Monitoring System -- Automation Overview -- System Components -- Software -- Hardware -- Control Panels -- Gateways -- System Functions -- System Overview -- Control Modules -- Interfaces -- User Interface (SCADA) -- GLC EMS Area Graphical Screen -- Global Logistics Center (GLC) Environmental Monitoring System -- Interfaces to Equipment -- Interfaces to Other Systems -- Ethernet Network -- Wireless Connections -- Nonfunctional Attributes -- Power Failure Recovery -- PLC Only Failure -- HMI Only Failure -- Network Only Failure -- Maintainability -- Backup and Recovery -- Software Module Design Specification -- Functional Requirement Specification -- Process Automation System -- Automation Overview -- System Components -- Software -- Hardware -- Control Panels -- System Functions -- System Overview -- Control Modules -- Interfaces -- User Interface (SCADA) -- PAS System Overview Screen -- Graphical Screen Navigation -- Graphical Control Screens -- Interfaces to Equipment.
Interfaces to Other Systems -- Ethernet Network -- Nonfunctional Attributes -- Power Failure Recovery -- PLC Only Failure -- HMI Only Failure -- Network Only Failure -- Maintainability -- Backup and Recovery -- Software Design Specification -- Prosoft Configuration -- Enabling and Disabling of the Gateway Default Server Interface -- Temperature Sensor Settings -- Humidity Sensor Settings -- Software Design Specification -- Continuous Logic -- Module Classes and Control Modules -- Virtual Differential Pressure Alarm Disable -- Room Condition Indication -- Navigation Links -- Alarm Daily Report -- WFI Still Equipment Module Class -- WFI Silo Equipment Module Class -- EM& -- uscore -- SILO -- WFI Primary Loop Equipment Module Class -- EM& -- uscore -- PRIM& -- uscore -- LOOP -- WFI Supply Header Equipment Module Class -- EM& -- uscore -- HEADER -- Electrical - Controls Equipment Specifications -- Documentation -- Drives/Motors -- Chapter 9 Personal Protective Equipment (PPE) and Process Flow -- Chapter 10 Sterile Aseptic Processing -- Chapter 11 Integrated Facility Design -- Case Study -- Issue -- Root Cause -- Corrective Action -- Preventive Actions -- Chapter 12 Barriers and Isolators -- Isolator Design Considerations -- Chapter 13 Guidelines for Statistical Procedure -- Process Capability Analysis -- Long‐term Studies -- Acceptance Sampling -- Attribute and Variable Sampling Plans -- Variable Sampling Plans - ANSI Z1.9 -- Normality -- Transformation of Non‐normal Data (Normalization) -- Protocol Sampling -- Failure Mode and Effect Analysis (FMEA) -- Calculating or Recalculating Control Limits -- Chapter 14 Calibration -- Contingency Plan/Disaster Recovery -- Chapter 15 Cleaning Validation -- New Products and Product Changes -- Cleaning Processes and Changes -- Risk Assessment/Matrix Approach -- Matrix Development.
Cleaning Processes (Manual and Automated) -- CPP/CQA -- Cleaning Validation Life Cycle - Cleaning Method Development -- Strategy for Process Controls -- Worst‐Case Identification - Product/Component -- Equipment -- Validation Tests/Inspections - Visual Inspection -- Chemical Testing -- Microbiological Testing -- Endotoxin Testing -- Sampling Methods -- Direct Swab Sampling -- Rinse Sampling -- Coupon Testing -- Sampling Sites -- Acceptance Criteria -- Residual Levels -- Endotoxin Levels -- Microbiological Levels -- Cleaning Agents/Sanitizer Validation Studies -- Hold Time Development -- Dirty Hold Time -- Clean Hold Time -- Additional Hold Times/Cleaning Frequencies -- Continuous Process Verification -- Failure Investigations -- Chapter 16 Validation of Filling Equipment -- Chapter 17 Manufacturing Process Validation -- Stage 2 - Process Qualification -- Appendix A Installation Test Plans -- Appendix B Operational Tests Plans -- Appendix C WFI Turbulence Flow Requirements -- Appendix D Water For Injection (WFI) - Design Requirements -- Process Description -- Specifications -- Life Cycle Requirements -- Product and Process User Requirements -- Product Description -- Operating Ranges -- Material of Construction -- Metallics -- Plastics -- Elastomers -- Glass -- Welding Requirements -- Construction Requirements -- Lubrication Requirements -- Electrical Requirements -- Safety Requirements -- Operational Requirements -- Process Constraints and Limitations -- Process Control System -- Operator Interface -- Power Loss and Recovery -- Cleaning and Sanitizing -- Maintenance Requirements -- Training and Documentation Requirements -- Appendix E Solution Transfer System (STS) - Design Requirements -- System Description -- Bulk Powder Handling System -- Glossary -- Nomenclature -- References -- Further Reading -- Index -- EULA.
Record Nr. UNINA-9910830350803321
Hout Sam A.  
Hoboken, NJ : , : John Wiley & Sons, Inc., , 2022
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Strategies to Enhance Drug Permeability across Biological Barriers / / Jingyuan Wen, Yuan Huang, editors
Strategies to Enhance Drug Permeability across Biological Barriers / / Jingyuan Wen, Yuan Huang, editors
Pubbl/distr/stampa Basel : , : MDPI - Multidisciplinary Digital Publishing Institute, , 2023
Descrizione fisica 1 online resource (278 pages)
Disciplina 338.476151
Soggetto topico Pharmaceutical industry
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Record Nr. UNINA-9910729785603321
Basel : , : MDPI - Multidisciplinary Digital Publishing Institute, , 2023
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui