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Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design
| Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design |
| Edizione | [Third edition.] |
| Pubbl/distr/stampa | Chichester, England : , : Wiley Blackwell, , 2014 |
| Descrizione fisica | 1 online resource (876 p.) |
| Disciplina | 363.19/463 |
| Soggetto topico |
Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions Internationality Pharmacoepidemiology Product Surveillance, Postmarketing |
| ISBN |
1-118-82018-5
1-118-82014-2 1-118-82017-7 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Title page; Copyright page; Contents; Contributors; Foreword; 1: Introduction: Updated from Second Edition; Background; Diagnosing Adverse Drug Reactions; Current Methods of Pharmacovigilance; Hypothesis-Generating Methods; Spontaneous Adverse Drug Reaction Reporting; Prescription-Event Monitoring; Other Hypothesis-Generating Methods; Hypothesis-Testing Methods; Conclusion; References; 2: History of Pharmacovigilance; Early History of Drug Safety; Recent History; Pre-1962; Turning Point: The Federal Food, Drug and Cosmetics Act; Gradual Increase in Regulatory Authority
Tectonic Shift: ThalidomidePost-Thalidomide Evolution of Regulation; United States of America; United Kingdom; Germany; Scandinavia; Japan; World Health Organization; France; Special Issues in Pharmacovigilance; Examples of Drugs that were Withdrawn from the Market; Bendectin; Thalidomide: Today's Approved Uses; Pharmacovigilance is Not Just for Regulators; References; Part I: The Regulatory Basis of Pharmacovigilance; 3: Legal Basis: European Union; Introduction; Reorganization of the European Union Regulatory System Obligations of being a Marketing Authorization Holder and being Granted a Marketing AuthorizationSignal Detection and Risk Management; Reporting Requirements; Transparency and Communication; Pharmacovigilance Enforcement; Further Information about Proposed New Legislation and Guidelines; 4: Ethical Oversight, Consent, and Confidentiality; Introduction; Practical Implications of Ethical Oversight; The Privacy and Security of Health Data; The Linkage of Electronic Health Data; The Conduct of Scientifically Sound Studies; Ethical Oversight and Privacy Law and Resulting Dilemmas; The Common Rule State LawsThe Health Insurance Portability and Accountability Act; Dilemmas Arising from the Health Insurance Portability and Accountability Act; Directions for Future Ethical Oversight and Privacy Provisions; References; 5: Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation1; Introduction; The International Conference on Harmonisation Step Process; ICH Step 1: Development of Draft Consensus ICH Guideline or Recommendations; ICH Step 2: Confirmation of Six Party Consensus; ICH Step 3: Regulatory Consultation ICH Step 4: Adoption of Tripartite ICH Guideline or RecommendationsICH Step 5: Implementation of ICH Guideline or Recommendations; Pharmacovigilance-Related International Conference on Harmonisation Topics; Topic ICH-E2A: Clinical Safety Data Management - Definitions and Standards for Expedited Reporting; ICH-E2D Topic: Post-Approval Safety Management - Definitions and Standards for Expedited Reporting; ICH-E2B Topic: Clinical Safety Data Management - Data Elements for Transmission of Individual Case Safety Reports ICH-E2C Topic: Clinical Safety Data Management - Periodic Benefit-Risk Evaluation Report (PBRER) |
| Record Nr. | UNINA-9910139125403321 |
| Chichester, England : , : Wiley Blackwell, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design
| Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design |
| Edizione | [Third edition.] |
| Pubbl/distr/stampa | Chichester, England : , : Wiley Blackwell, , 2014 |
| Descrizione fisica | 1 online resource (876 p.) |
| Disciplina | 363.19/463 |
| Soggetto topico |
Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions Internationality Pharmacoepidemiology Product Surveillance, Postmarketing |
| ISBN |
1-118-82018-5
1-118-82014-2 1-118-82017-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Title page; Copyright page; Contents; Contributors; Foreword; 1: Introduction: Updated from Second Edition; Background; Diagnosing Adverse Drug Reactions; Current Methods of Pharmacovigilance; Hypothesis-Generating Methods; Spontaneous Adverse Drug Reaction Reporting; Prescription-Event Monitoring; Other Hypothesis-Generating Methods; Hypothesis-Testing Methods; Conclusion; References; 2: History of Pharmacovigilance; Early History of Drug Safety; Recent History; Pre-1962; Turning Point: The Federal Food, Drug and Cosmetics Act; Gradual Increase in Regulatory Authority
Tectonic Shift: ThalidomidePost-Thalidomide Evolution of Regulation; United States of America; United Kingdom; Germany; Scandinavia; Japan; World Health Organization; France; Special Issues in Pharmacovigilance; Examples of Drugs that were Withdrawn from the Market; Bendectin; Thalidomide: Today's Approved Uses; Pharmacovigilance is Not Just for Regulators; References; Part I: The Regulatory Basis of Pharmacovigilance; 3: Legal Basis: European Union; Introduction; Reorganization of the European Union Regulatory System Obligations of being a Marketing Authorization Holder and being Granted a Marketing AuthorizationSignal Detection and Risk Management; Reporting Requirements; Transparency and Communication; Pharmacovigilance Enforcement; Further Information about Proposed New Legislation and Guidelines; 4: Ethical Oversight, Consent, and Confidentiality; Introduction; Practical Implications of Ethical Oversight; The Privacy and Security of Health Data; The Linkage of Electronic Health Data; The Conduct of Scientifically Sound Studies; Ethical Oversight and Privacy Law and Resulting Dilemmas; The Common Rule State LawsThe Health Insurance Portability and Accountability Act; Dilemmas Arising from the Health Insurance Portability and Accountability Act; Directions for Future Ethical Oversight and Privacy Provisions; References; 5: Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation1; Introduction; The International Conference on Harmonisation Step Process; ICH Step 1: Development of Draft Consensus ICH Guideline or Recommendations; ICH Step 2: Confirmation of Six Party Consensus; ICH Step 3: Regulatory Consultation ICH Step 4: Adoption of Tripartite ICH Guideline or RecommendationsICH Step 5: Implementation of ICH Guideline or Recommendations; Pharmacovigilance-Related International Conference on Harmonisation Topics; Topic ICH-E2A: Clinical Safety Data Management - Definitions and Standards for Expedited Reporting; ICH-E2D Topic: Post-Approval Safety Management - Definitions and Standards for Expedited Reporting; ICH-E2B Topic: Clinical Safety Data Management - Data Elements for Transmission of Individual Case Safety Reports ICH-E2C Topic: Clinical Safety Data Management - Periodic Benefit-Risk Evaluation Report (PBRER) |
| Record Nr. | UNINA-9910813194203321 |
| Chichester, England : , : Wiley Blackwell, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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 | ||
| ||
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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Technology for Drug Safety [[electronic resource] ] : Current Status and Future Developments / / by Yaser Mohammed Al-Worafi
| Technology for Drug Safety [[electronic resource] ] : Current Status and Future Developments / / by Yaser Mohammed Al-Worafi |
| Autore | Al-Worafi Yaser Mohammed |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (213 pages) |
| Disciplina | 615.7042 |
| Collana | Health Informatics |
| Soggetto topico |
Medical informatics
Pharmacovigilance Pharmacology Health Informatics Drug Safety and Pharmacovigilance |
| ISBN | 3-031-34268-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Importance of Technology for Drug Safety -- History of Drug Safety and Technology for Drug Safety -- Electronic Registration and Medical Records for Drug Safety -- Electronic Prescriptions and orders for Drug Safety -- Computer Technologies for Drug Safety -- Internet Technologies for Drug Safety -- Artificial intelligence & Machine Learning for Drug Safety -- Mobile technologies for Drug Safety -- Social-Media for Drug Safety -- Blockchain for Drug Safety -- Technology for Drug Safety: Challenges and Recommendations. |
| Record Nr. | UNINA-9910735400203321 |
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Al-Worafi Yaser Mohammed
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Technology Transfer [[electronic resource] ] : Drug Product Manufacturing Process / / by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram
| Technology Transfer [[electronic resource] ] : Drug Product Manufacturing Process / / by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram |
| Autore | Pazhayattil Ajay Babu |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (158 pages) |
| Disciplina | 615.1 |
| Altri autori (Persone) |
SharmaSanjay
PhilipJoe Paul Gischewski-SilvaMichelle IngramMarzena |
| Collana | AAPS Introductions in the Pharmaceutical Sciences |
| Soggetto topico |
Pharmacy
Pharmaceutical chemistry Pharmacology Drug delivery systems Pharmacovigilance Pharmaceutics Drug Delivery Drug Safety and Pharmacovigilance |
| ISBN | 3-031-32192-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Chapter 1: Current Status of Technology Transfer -- Chapter 2: Quality by Design (QbD) Process Design -- Chapter 3: Quality Risk Management (QRM) -- Chapter 4: Technology Transfer Process -- Chapter 5: Scaling-Up of Solid Orals: Granulation, Drying, Size Reduction, Blending, Compression, and Coating Technologies -- Chapter 6: Qualification, Continued Process Verification, and Lifecycle Management -- Chapter 7: Continuous Improvement Case Study: Transforming Legacy Products. |
| Record Nr. | UNINA-9910731465203321 |
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Pazhayattil Ajay Babu
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Understanding Allergic Airway Diseases : Contemporary Treatment Paradigm / / edited by Parteek Prasher, Mousmee Sharma, Sachin Kumar Singh, Ronan MacLoughlin, Kavita Pabreja, Kamal Dua
| Understanding Allergic Airway Diseases : Contemporary Treatment Paradigm / / edited by Parteek Prasher, Mousmee Sharma, Sachin Kumar Singh, Ronan MacLoughlin, Kavita Pabreja, Kamal Dua |
| Autore | Prasher Parteek |
| Edizione | [1st ed. 2024.] |
| Pubbl/distr/stampa | Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2024 |
| Descrizione fisica | 1 online resource (271 pages) |
| Disciplina | 616.202 |
| Altri autori (Persone) |
SharmaMousmee
SinghSachin Kumar MacLoughlinRonan PabrejaKavita DuaKamal |
| Soggetto topico |
Pharmacology
Pharmaceutical chemistry Pharmacovigilance Immunology Nanotechnology Quantum dots Pharmaceutics Drug Safety and Pharmacovigilance Quantum Dots |
| ISBN |
9789819719532
9789819719525 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Chapter 1. Introduction to Allergic Airway Diseases -- Chapter 2. Pathophysiology of Allergic airway diseases -- Chapter 3. Immunology of Allergic Airway Diseases -- Chapter 4. Epidemiology of Allergic Airway Diseases -- Chapter 5. Nanotechnology in the Diagnosis of Allergic Airway Diseases -- Chapter 6. Metal and metal oxide Nanoparticles for the Management of Allergic Airway Diseases -- Chapter 7.-Nanomicelles for the Management of Allergic Airway Diseases -- Chapter 8 -- Carbon nanotubes (CNTs): A novle therapeutic approach in the management of allergic airway disease -- Chapter 9. Liposomes for the Management of Allergic Airway Diseases -- Chapter 10. Nanoparticles Solutions for Allergic Airway Disorders: Current Trends and Future Prospects -- Chapter 11. Solid lipid nanoparticles for the Management of Allergic Airway Diseases -- Chapter 12. Role of Dendrimers in Management of Allergic Airway Diseases -- Chapter 13. Nanofibers for the Management of Allergic Airway Diseases -- Chapter 14. Quantum dots for the Management of Allergic Airway Diseases -- Chapter 15. Future Directions in Allergic Airway Diseases. |
| Record Nr. | UNINA-9910869168903321 |
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Prasher Parteek
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| Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2024 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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