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Pharmaceutical Process Engineering and Scale-up Principles [[electronic resource] /] / edited by Anil B. Jindal
| Pharmaceutical Process Engineering and Scale-up Principles [[electronic resource] /] / edited by Anil B. Jindal |
| Autore | Jindal Anil B |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (226 pages) |
| Disciplina | 615.19 |
| Collana | AAPS Introductions in the Pharmaceutical Sciences |
| Soggetto topico |
Pharmaceutical chemistry
Pharmacology Pharmacy Pharmacovigilance Pharmaceutics Drug Safety and Pharmacovigilance |
| ISBN | 3-031-31380-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Part I: Physical properties of solids -- Part II: Mixing -- Rapid Mixer Granulator -- Fluid bed processing technology -- Drying -- Compression -- Pan coating -- Size reduction -- Part III: Mixing and filtration -- Scale-up of liquid mixing process -- Manufacturing process of nanoparticles -- Scale-up of nanoparticle manufacturing process -- Part 4: Manufacturing and scale-up of biotechnology-derived products. . |
| Record Nr. | UNINA-9910734849803321 |
Jindal Anil B
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| Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Pharmacogenomics in Clinical Practice [[electronic resource] /] / edited by Dragan Primorac, Wolfgang Höppner, Lidija Bach-Rojecky
| Pharmacogenomics in Clinical Practice [[electronic resource] /] / edited by Dragan Primorac, Wolfgang Höppner, Lidija Bach-Rojecky |
| Autore | Primorac Dragan |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (484 pages) |
| Disciplina | 610 |
| Altri autori (Persone) |
HöppnerWolfgang
Bach-RojeckyLidija |
| Soggetto topico |
Medicine
Pharmacology Medical genetics Practice of medicine Hospitals - Administration Pharmacovigilance Pharmacogenetics Genetics, Medical Clinical Medicine Medical Genetics Practice and Hospital Management Drug Safety and Pharmacovigilance |
| ISBN | 3-031-45903-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Contents -- Contributors -- Introduction -- Principles of Pharmacogenomics -- Principles of xenobiotic metabolism (Biotransformation) -- Pharmacogenomics of drug-metabolizing enzymes -- Role of membrane transporters in pharmacogenomics -- Role of drug receptors in pharmacogenomics -- Role of drug targets and other proteins important in pharmacogenomics -- Pharmacogenomics algorithms in clinical practice -- Pharmacogenomics in pain treatment -- Pharmacogenomics in psychiatric diseases -- Pharmacogenomics in anesthesia -- Pharmacogenomics in cardiovascular diseases -- Pharmacogenomics in gastroenterology -- Pharmacogenomics in cancer therapeutics -- Pharmacogenomics on immunosuppressive drugs in solid organ transplantation -- Pharmacogenomics and big data -- Public health issues in Pharmacogenomics -- Ethical Issues in Pharmacogenomics -- Economic evaluation of Pharmacogenomic Testing -- Role of public data bases for pharmacogenomics -- Pharmacogenomics education at University -- Pharmacogenomics in drug research development -- Future perspectives -- Index. |
| Record Nr. | UNINA-9910799226603321 |
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Primorac Dragan
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Pharmacotherapeutic Potential of Natural Products in Neurological Disorders [[electronic resource] /] / by Amritpal Singh Saroya, Jaswinder Singh
| Pharmacotherapeutic Potential of Natural Products in Neurological Disorders [[electronic resource] /] / by Amritpal Singh Saroya, Jaswinder Singh |
| Autore | Saroya Amritpal Singh |
| Edizione | [1st ed. 2018.] |
| Pubbl/distr/stampa | Singapore : , : Springer Singapore : , : Imprint : Springer, , 2018 |
| Descrizione fisica | 1 online resource (XV, 191 p. 233 illus.) |
| Disciplina | 612.8 |
| Soggetto topico |
Neurosciences
Pharmaceutical technology Pharmacy Pharmaceutical Sciences/Technology Drug Safety and Pharmacovigilance |
| ISBN |
981-13-0289-8
978-981-13-0289-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Introduction to Herbal Medicine -- 2. Medicinal Herbs Used in Herbal Medicine for Nervous Disorders -- 3. Neuropharmacology of Genus Hypericum, Hypericin and Hyperforin -- 4. Neuropharmacology of Lavender, Rosemary and Salvia -- 5. Neuropharmacology of Passiflora Genus -- 6. Neuropharmacology of Scutellaria baicalensis Georgi -- 7. Piper methysticum G.Forst - A Potent Anti-anxiety Agent -- 8. Neuropharmacology of Melissa officinalis L. -- 9. Neuropharmacology of Chamomiles -- 10. Neuropharmacology of Bacopa monnieri with reference to Bacosides -- 11. Neuropharmacology of Acorus calamus L. -- 12. Neuropharmacology of Celastrus paniculatus Willd -- 13. Phytopharmacology of Indian Nootropic Convolvulus plauricaulis -- 14. Neuropharmacology of Rhodiola rosea L. -- 15. Neuropharmacology of Salvia miltiorrhiza Bunge (Danshen) -- 16. Neuropharmacology of Withania somnifera Dunal -- 17. Neuropharmacology of Nardostachys jatamansi DC -- 18. Neuropharmacology of Nutritional Supplements -- 19. Neuropharmacology of Valeriana Genus -- 20. Neuropharmacology of Curcumin. |
| Record Nr. | UNINA-9910298434803321 |
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Saroya Amritpal Singh
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| Singapore : , : Springer Singapore : , : Imprint : Springer, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Pharmacovigilance [[electronic resource] ] : Critique and Ways Forward / / edited by I. Ralph Edwards, Marie Lindquist
| Pharmacovigilance [[electronic resource] ] : Critique and Ways Forward / / edited by I. Ralph Edwards, Marie Lindquist |
| Edizione | [1st ed. 2017.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Adis, , 2017 |
| Descrizione fisica | 1 online resource (XXXI, 205 p. 16 illus., 3 illus. in color.) |
| Disciplina | 353.998 |
| Soggetto topico |
Pharmacy
Drug Safety and Pharmacovigilance |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. How to learn Pharmacovigilance, now and in the Future -- 2. Lost in Regulation -- 3. What is the Future of Pharmacovigilance and how can we Make it as Good as Possible? -- 4. Some Other Ideas About the Future of Pharmacovigilance -- 5. Best Safety Practices now and in the Future -- 6. Is There a Benefit from the Medical Literature Monitoring Service of the EMA? -- 7. The Unified Drug Safety-Clinical Database -- 8. Behind the Scenes – ‘Silent Factors’ Influencing Pharmacovigilance Practice and Decisions -- 9. Shaking up Culture and Communication in PV [V6] -- 10. Broadening the Scope of Pharmacovigilance -- 11. Effective Treatment Matters: Revitalizing Pharmacoviglance -- 12. There are More Weber-Effects -- 13. Herbal and Traditional Medicines, Now and Future -- 14. The Concept of ‘Health’ -- 15. Impact of Referral Procedures on the Interaction of RMP and PSUR -- 16. Other Sources of Information for Monitoring Drug Safety: Now and in the Future -- 17. Ecopharmacovigilance. |
| Record Nr. | UNINA-9910148857703321 |
| Cham : , : Springer International Publishing : , : Imprint : Adis, , 2017 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Pharmacovigilance in Psychiatry [[electronic resource] /] / edited by Edoardo Spina, Gianluca Trifirò
| Pharmacovigilance in Psychiatry [[electronic resource] /] / edited by Edoardo Spina, Gianluca Trifirò |
| Edizione | [1st ed. 2016.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Adis, , 2016 |
| Descrizione fisica | 1 online resource (320 p.) |
| Disciplina | 610 |
| Soggetto topico |
Psychopharmacology
Pharmacy Drug Safety and Pharmacovigilance |
| ISBN | 3-319-24741-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Introduction: History of pharmacovigilance in psychiatry -- 2. Adverse drug reactions: definition and pathogenesis -- 3. Methodologies for pharmacovigilance monitoring of psychotropic drugs -- 4. The role of prescription event monitoring in pharmacovigilance of psychotropic drugs -- 5. The role of healthcare databases in pharmacovigilance of psychotropic drugs -- 6. Monitoring of plasma concentrations of psychotropic drugs in pharmacovigilance -- 7. The role of pharmacogenetics in pharmacovigilance of psychotropic drugs -- 8. Safety and tolerability of antidepressants -- 9. Safety and tolerability of antipsychotics -- 10. Safety and tolerability of anxiolytics/sedative hypnotics -- 11. Safety and tolerability of mood stabilizers -- 12. Safety and tolerability of medications for ADHD -- 13. Safety of psychotropic drugs in children and adolescents -- 14. Safety of psychotropic drugs in the elderly(Safety of psychotropic drugs in the elderly -- 15. Safety of psychotropic drugs in pregnancy and breastfeeding. |
| Record Nr. | UNINA-9910254517603321 |
| Cham : , : Springer International Publishing : , : Imprint : Adis, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Pharmacovigilance in the European Union [[electronic resource] ] : Practical Implementation across Member States / / by Michael Kaeding, Julia Schmälter, Christoph Klika
| Pharmacovigilance in the European Union [[electronic resource] ] : Practical Implementation across Member States / / by Michael Kaeding, Julia Schmälter, Christoph Klika |
| Autore | Kaeding Michael |
| Edizione | [1st ed. 2017.] |
| Pubbl/distr/stampa | Wiesbaden : , : Springer Fachmedien Wiesbaden : , : Imprint : Springer, , 2017 |
| Descrizione fisica | 1 online resource (XIV, 124 p. 13 illus., 12 illus. in color.) |
| Disciplina | 320 |
| Soggetto topico |
Comparative politics
Political economy European Union Pharmacy Comparative Politics International Political Economy European Union Politics Drug Safety and Pharmacovigilance |
| ISBN | 3-658-17276-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Intro -- Contents -- Abbreviations -- List of Tables, Figures and Boxes -- Preface -- 1 Introduction -- 1.1 Background and Terms of Reference -- 1.2 Methodology: Selection of Countries -- 1.3 Methodology: Research Strategy -- 1.4 Summary of Evidence -- 1.5 Implementation Assessment Structure -- References -- 2 Pharmacovigilance -- 2.1 Fundamentals of Pharmacovigilance -- 2.2 Importance of Pharmacovigilance for Biologicals -- References -- 3 The EU Pharmacovigilance System -- 3.1 EU Institutions and Pharmacovigilance Actors -- 3.2 Legislative Developments -- 3.3 The Pharmacovigilance Reform: Directive 2010/84/EU and Article 102 -- References -- 4 Timely and Correct Transposition of Pharmacovigilance across Member States -- 4.1 Timely Transposition of Directive 2010/84/EU across Member States -- 4.2 Correct Transposition of Directive 2010/84/EU across Member States -- 4.2.1 Correct Transposition - Processes and Actors -- 4.2.2 Correct Transposition - Quality and Content -- References -- 5 Practical Implementation in Six Member States -- 5.1 ADR Reporting in the United Kingdom -- 5.1.1 The System -- 5.1.2 Perceived Challenges -- 5.1.3 Perceived Best Practices -- 5.2 ADR Reporting in Finland -- 5.2.1 The System -- 5.2.2 Perceived Challenges -- 5.2.3 Perceived Best Practices -- 5.3 ADR Reporting in Poland -- 5.3.1 The System -- 5.3.2 Perceived Challenges -- 5.3.3 Perceived Best Practices -- 5.4 ADR Reporting in France -- 5.4.1 The System -- 5.4.2 Perceived Challenges -- 5.4.3 Perceived Best Practices -- 5.5 ADR Reporting in Portugal -- 5.5.1 The System -- 5.5.2 Perceived Challenges -- 5.5.3 Perceived Best Practices -- 5.6 ADR Reporting in Germany -- 5.6.1 The System -- 5.6.2 Perceived Challenges -- 5.6.3 Perceived Best Practices -- References -- 6 Challenges and Best Practices in Perspective -- 6.1 Pharmacovigilance Systems -- 6.2 Major Challenges.
6.3 Comparison of Factors Contributing to Underreporting -- 6.3.1 Lack of Awareness -- 6.3.2 Complexity of ADR Reporting -- 6.3.3 Lack of Cooperation -- 6.3.4 Interconnectivity Problems -- References -- 7 Conclusions and Recommendations -- 7.1 Specific Recommendations in Relation to Article 102 -- 7.2 General Recommendations: National Healthcare Systems and Policy Options for Pharmacovigilance -- References. |
| Record Nr. | UNINA-9910168748003321 |
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Kaeding Michael
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| Wiesbaden : , : Springer Fachmedien Wiesbaden : , : Imprint : Springer, , 2017 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Polymer Nanoparticles for Nanomedicines [[electronic resource] ] : A Guide for their Design, Preparation and Development / / edited by Christine Vauthier, Gilles Ponchel
| Polymer Nanoparticles for Nanomedicines [[electronic resource] ] : A Guide for their Design, Preparation and Development / / edited by Christine Vauthier, Gilles Ponchel |
| Edizione | [1st ed. 2016.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2016 |
| Descrizione fisica | 1 online resource (XXIX, 641 p. 115 illus., 80 illus. in color.) |
| Disciplina | 615.19 |
| Soggetto topico |
Pharmaceutical technology
Pharmacy Proteomics Biomedical engineering Pharmaceutical Sciences/Technology Drug Safety and Pharmacovigilance Biomedical Engineering/Biotechnology |
| ISBN | 3-319-41421-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Preface -- Introduction Part I: Polymer nanoparticles for in vivo applications: Progress on preparation methods and future challenges -- Nanoprecipitation process: From particlepreparation to in vivo applications -- Targeted Theragnostic Nanoparticles via Flash Nanoprecipitation: Principles of Materials Selection -- Preparation of polymer nanoparticles by the emulsification-solvent evaporation method: from Vanderhoff´s pioneer approach to recent adaptations -- Methods for the preparation of nanoparticles by polymerization -- Shape-controlled nanoparticles for drug delivery and targeting applications -- Physicochemical characterization of polymer nanoparticles: Challenges and present limitations -- Imaging polymer nanoparticles by means of transmission and scanning electron microscopy techniques -- Evaluating the interactions between proteins and components of the immune system with polymer nanoparticles -- Investigating interactions between nanoparticles and cells: internalization and intracellular trafficking -- Characterization of mucoadhesive interactions between nanoparticles and epithelial membranes -- Designing polymer nanoparticle nanomedicines: potential applications and challenges -- Selecting and designing polymers suitable for nanoparticles manufacturing -- Associating Drugs with Polymer Nanoparticles: A Challenge -- Drug delivery by nanoparticles: The Challenge of Controlled Release and Evaluation -- Interaction between nanoparticles and plasma proteins: effects on nanoparticle biodistribution and toxicity -- Toxicological aspects of polymer nanoparticles -- Theranostics: In Vivo -- Nanomedicines –A scientific toy or an emerging market? -- Regulatory perspective on the development of polymeric nanomaterials. |
| Record Nr. | UNINA-9910158730903321 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Practical Considerations for Adaptive Trial Design and Implementation [[electronic resource] /] / edited by Weili He, José Pinheiro, Olga M. Kuznetsova
| Practical Considerations for Adaptive Trial Design and Implementation [[electronic resource] /] / edited by Weili He, José Pinheiro, Olga M. Kuznetsova |
| Edizione | [1st ed. 2014.] |
| Pubbl/distr/stampa | New York, NY : , : Springer New York : , : Imprint : Springer, , 2014 |
| Descrizione fisica | 1 online resource (420 p.) |
| Disciplina | 610.724 |
| Collana | Statistics for Biology and Health |
| Soggetto topico |
Statistics
Biostatistics Pharmacy Statistics for Life Sciences, Medicine, Health Sciences Drug Safety and Pharmacovigilance Statistical Theory and Methods |
| ISBN | 1-4939-1100-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Preface -- The Need for and the Future of Adaptive Designs in Clinical Development -- Regulatory Guidance Documents on Adaptive Designs: an Industry Perspective -- A Commentary on the U.S. FDA Adaptive Design Draft Guidance and EMA Reflection Paper from a Regulatory Perspective and Regulatory Experiences -- Considerations and optimization of adaptive trial design in clinical development programs -- Optimal Cost-effective Go-No Go Decisions in Clinical Development -- Timing and frequency of interim analyses in confirmatory trials -- Approaches for optimal dose selection for adaptive design trials -- A Review of Available Software and Capabilities for Adaptive Designs -- Randomization Challenges in Adaptive Design Studies -- Response-adaptive randomization for clinical trials -- Implementing Adaptive Designs: Operational Considerations, Putting it all together -- Implementation Issues in Adaptive Design Trials -- Implementing Adaptive Designs; Using Technology to Protect Trial Integrity, Reduce Operational Bias, and Build Regulatory Trust -- Considerations for Interim Analyses in Adaptive Trials, and Perspectives on the Use of DMCs -- Approaches for Clinical Supply Modelling and Simulation -- Approaches for Patient Recruitment Modeling and Simulation -- A case study for adaptive trial design consideration and implementation -- Design Considerations for a Phase Ib Randomized, Placebo-Controlled, 4-Period Cross-over Adaptive Dose-Finding Clinical Trial -- Continual Reassessment Method for a First-In-Human Trial: From Design to Trial Implementation -- Practical Considerations for a Two-Stage Confirmatory Adaptive Clinical Trial Design and its Implementation: ADVENT Trial. |
| Record Nr. | UNINA-9910299977903321 |
| New York, NY : , : Springer New York : , : Imprint : Springer, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Quantitative Decisions in Drug Development [[electronic resource] /] / by Christy Chuang-Stein, Simon Kirby
| Quantitative Decisions in Drug Development [[electronic resource] /] / by Christy Chuang-Stein, Simon Kirby |
| Autore | Chuang-Stein Christy |
| Edizione | [1st ed. 2017.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2017 |
| Descrizione fisica | 1 online resource (XV, 248 p. 27 illus., 11 illus. in color.) |
| Disciplina | 519.5 |
| Collana | Springer Series in Pharmaceutical Statistics |
| Soggetto topico |
Statistics
Biostatistics Pharmacy Pharmaceutical technology Quality control Reliability Industrial safety Statistics for Life Sciences, Medicine, Health Sciences Drug Safety and Pharmacovigilance Pharmaceutical Sciences/Technology Quality Control, Reliability, Safety and Risk |
| ISBN | 3-319-46076-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Clinical Testing of a New Drug -- A Frequentist Decision-making Framework -- Characteristics of a Diagnostic Test -- The Parallel Between Clinical Trials and Diagnostic Tests -- Incorporating Information from Completed Trials in Future Trial Planning -- Choosing Metrics Appropriate for Different Stages of Drug Development -- Designing Proof-of-Concept Trials with Desired Characteristics -- Designing Dose-response Studies with Desired Characteristics -- Designing Confirmatory Trials with Desired Characteristics -- Designing Phase 4 Trials -- Other Metrics That Have Been Proposed to Optimize Drug Development Decisions -- Discounting Prior Results to Account for Selection Bias -- Index -- Appendix. |
| Record Nr. | UNINA-9910254282103321 |
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Chuang-Stein Christy
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2017 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Quick Guide to Good Clinical Practice [[electronic resource] ] : How to Meet International Quality Standard in Clinical Research / / by Cemal Cingi, Nuray Bayar Muluk
| Quick Guide to Good Clinical Practice [[electronic resource] ] : How to Meet International Quality Standard in Clinical Research / / by Cemal Cingi, Nuray Bayar Muluk |
| Autore | Cingi Cemal |
| Edizione | [1st ed. 2017.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2017 |
| Descrizione fisica | 1 online resource (XVIII, 237 p.) |
| Disciplina | 353.998 |
| Soggetto topico |
Pharmacy
Statistics Surgery Medical education Drug Safety and Pharmacovigilance Statistics for Life Sciences, Medicine, Health Sciences General Surgery Medical Education |
| ISBN | 3-319-44344-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1 Clinical Trials: Historical Aspects and Importance and New Drug Developments -- 2 The Definition of GCP -- 3 The Principles of GCP -- 4 The Drug Development Process and Evolution of Regulations -- 5 Planning Clinical Research -- 6 Preparation of Ethics Committee (IRB) Proposal -- 7 Preparation of Informed Consent -- 8 Preparation of Findings Tables -- 9 Setting the Ideal Statistical Methods -- 10 The Duties of a Clinical Research Coordinator -- 11 The Duties of Clinical Researchers -- 12 The Phases of Clinical Studies -- 13 Safety in Clinical Trials -- 14 Setting the Size -- 15 Setting the Ideal Method -- 16 Ethics of Clinical Research -- 17 Recruitment and Enrolment -- 18 Why we need Clinical Consent and Other Documentation -- 19 Monitoring the Trial -- 20 Inspection -- 21 Ethics - Institutional Review Board/Independent Ethics Committee(IRB/IEC) -- 22 Responsibilities of the Investigator -- 23 Responsibilities of the Sponsor -- 24.Clinical Trial Protocols. |
| Record Nr. | UNINA-9910151663203321 |
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Cingi Cemal
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2017 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Soggetto topico
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Drug Safety and Pharmacovigilance
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- Pharmacy (44)
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- Pharmacology/Toxicology (9)
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