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Adverse drug event reporting [[electronic resource] ] : the roles of consumers and health-care professionals : workshop summary / / Jeffrey M. Drazen ... [et al], rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy ; Institute of Medicine of the National Academies
| Adverse drug event reporting [[electronic resource] ] : the roles of consumers and health-care professionals : workshop summary / / Jeffrey M. Drazen ... [et al], rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy ; Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2007 |
| Descrizione fisica | 1 online resource (82 p.) |
| Disciplina | 362.29 |
| Altri autori (Persone) | DrazenJeffrey M. <1946-> |
| Soggetto topico |
Drugs - Side effects
Drug monitoring |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-84426-4
9786610844265 0-309-66330-X |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Contents""; ""Summary""; ""1 Introduction""; ""2 Current Adverse Event Reporting Systems""; ""3 Active Surveillance Systems""; ""4 Consumer Involvement in Reporting Adverse Events""; ""5 Drug-Drug Interactions""; ""6 Drug Labels""; ""References""; ""Appendixes""; ""A Workshop Agenda""; ""B Speaker Biographies"" |
| Record Nr. | UNINA-9910454633303321 |
| Washington, D.C., : National Academies Press, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Adverse drug event reporting [[electronic resource] ] : the roles of consumers and health-care professionals : workshop summary / / Jeffrey M. Drazen ... [et al], rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy ; Institute of Medicine of the National Academies
| Adverse drug event reporting [[electronic resource] ] : the roles of consumers and health-care professionals : workshop summary / / Jeffrey M. Drazen ... [et al], rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy ; Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2007 |
| Descrizione fisica | 1 online resource (82 p.) |
| Disciplina | 362.29 |
| Altri autori (Persone) | DrazenJeffrey M. <1946-> |
| Soggetto topico |
Drugs - Side effects
Drug monitoring |
| ISBN |
0-309-17979-3
1-280-84426-4 9786610844265 0-309-66330-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Contents""; ""Summary""; ""1 Introduction""; ""2 Current Adverse Event Reporting Systems""; ""3 Active Surveillance Systems""; ""4 Consumer Involvement in Reporting Adverse Events""; ""5 Drug-Drug Interactions""; ""6 Drug Labels""; ""References""; ""Appendixes""; ""A Workshop Agenda""; ""B Speaker Biographies"" |
| Record Nr. | UNINA-9910782032203321 |
| Washington, D.C., : National Academies Press, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Adverse drug event reporting [[electronic resource] ] : the roles of consumers and health-care professionals : workshop summary / / Jeffrey M. Drazen ... [et al], rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy ; Institute of Medicine of the National Academies
| Adverse drug event reporting [[electronic resource] ] : the roles of consumers and health-care professionals : workshop summary / / Jeffrey M. Drazen ... [et al], rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy ; Institute of Medicine of the National Academies |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2007 |
| Descrizione fisica | 1 online resource (82 p.) |
| Disciplina | 362.29 |
| Altri autori (Persone) | DrazenJeffrey M. <1946-> |
| Soggetto topico |
Drugs - Side effects
Drug monitoring |
| ISBN |
0-309-17979-3
1-280-84426-4 9786610844265 0-309-66330-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Contents""; ""Summary""; ""1 Introduction""; ""2 Current Adverse Event Reporting Systems""; ""3 Active Surveillance Systems""; ""4 Consumer Involvement in Reporting Adverse Events""; ""5 Drug-Drug Interactions""; ""6 Drug Labels""; ""References""; ""Appendixes""; ""A Workshop Agenda""; ""B Speaker Biographies"" |
| Record Nr. | UNINA-9910820009703321 |
| Washington, D.C., : National Academies Press, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Bioresearch monitoring alert
| Bioresearch monitoring alert |
| Pubbl/distr/stampa | Rockville, MD, : Washington Information Source Co., 2001- |
| Disciplina | 616 |
| Soggetto topico | Drug monitoring |
| Soggetto genere / forma | Periodicals. |
| ISSN | 1541-0668 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNISA-996216633303316 |
| Rockville, MD, : Washington Information Source Co., 2001- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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Clinical challenges in therapeutic drug monitoring : special populations, physiological conditions, and pharmacogenomics / / edited by William Clarke, PhD, MBA, Associate Professor of Pathology, Johns Hopkins University, Baltimore, MD, Amitava Dasgupta, Professor of Pathology and Laboratory Medicine, University of Texas Medical School at Houston, Houston, TX
| Clinical challenges in therapeutic drug monitoring : special populations, physiological conditions, and pharmacogenomics / / edited by William Clarke, PhD, MBA, Associate Professor of Pathology, Johns Hopkins University, Baltimore, MD, Amitava Dasgupta, Professor of Pathology and Laboratory Medicine, University of Texas Medical School at Houston, Houston, TX |
| Pubbl/distr/stampa | Amsterdam : , : Elsevier, , [2016] |
| Descrizione fisica | 1 online resource (xvi, 360 pages) : illustrations (some color) |
| Disciplina | 615.7 |
| Collana | Gale eBooks |
| Soggetto topico | Drug monitoring |
| ISBN |
0-12-802052-0
0-12-802025-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Clinical Challenges in Therapeutic Drug Monitoring; Copyright Page; Contents; List of Contributors; Preface; 1 Overview of Therapeutic Drug Monitoring; 1.1 Introduction; 1.2 Principles of TDM; 1.3 Clinical Areas in Which TDM is Routine Practice; 1.3.1 Epilepsy; 1.3.2 Organ Transplantation; 1.3.3 Cardiology (Antiarrhythmic Drugs); 1.3.4 Psychiatry; 1.3.5 Infectious Disease; 1.3.6 Oncology; 1.4 Conclusions; References; 2 Immunoassays and Issues With Interference in Therapeutic Drug Monitoring; 2.1 Introduction; 2.2 Immunoassay Platforms Used in TDM
2.3 Interference of Bilirubin, Hemolysis, and Lipemia2.4 Interferences in Digoxin Immunoassays; 2.4.1 DLIS Interferences in Digoxin Immunoassays; 2.4.2 Effect of Digibind and DigiFab on Digoxin Immunoassays; 2.4.3 Potassium-Sparing Diuretics and Digoxin Immunoassays; 2.4.4 Herbal Supplements and Digoxin Immunoassays; 2.5 Issues of Interferences With Immunoassays for Immunosuppressants; 2.5.1 Metabolite Interferences in Cyclosporine Immunoassays; 2.5.2 Metabolite Interferences in Tacrolimus Immunoassays; 2.5.3 Metabolite Interferences in Sirolimus and Everolimus Immunoassays 2.5.4 Metabolite Interferences in Mycophenolic Acid Immunoassays2.6 Interferences in Immunoassays for Anticonvulsants; 2.6.1 Interferences in Phenytoin Immunoassays; 2.6.2 Interferences in Carbamazepine Immunoassays; 2.6.3 Interferences in Phenobarbital and Valproic Acid Immunoassays; 2.6.4 Interferences in Immunoassays for Newer Anticonvulsants; 2.7 Interferences in Immunoassays for TCAs; 2.7.1 Interference of Phenothiazines and Their Metabolites in Immunoassays for TCAs; 2.7.2 Interference of Carbamazepine in Immunoassays for TCAs 2.7.3 Interference of Cyproheptadine and Quetiapine With Immunoassays for TCAs2.7.4 Interference of Miscellaneous Drugs With Immunoassays for TCAs; 2.8 Conclusions; References; 3 Application of Chromatography Combined With Mass Spectrometry in Therapeutic Drug Monitoring; 3.1 Introduction; 3.2 Liquid Chromatography; 3.3 Mass Spectrometry; 3.3.1 Ion Source; 3.3.2 Mass Analyzers; 3.3.2.1 Quadrupole Analyzers; 3.3.2.2 Ion Trap Analyzers; 3.3.2.3 TOF Analyzers; 3.3.3 Detectors; 3.4 Preanalytical Stage; 3.5 Application of LC-MS/MS Methods in TDM; 3.5.1 Immunosuppressants; 3.5.2 Anticonvulsants 3.5.3 Antidepressants3.5.4 Antifungal Drugs; 3.5.5 Others Drug Classes; 3.6 LC-MS/MS Limitations; 3.7 Conclusions; References; 4 Monitoring Free Drug Concentration: Clinical Usefulness and Analytical Challenges; 4.1 Introduction; 4.2 Drug-Protein Binding; 4.3 Drugs Requiring Free Drug Monitoring; 4.4 Conditions in Which Monitoring Free Anticonvulsants is Necessary; 4.4.1 Clinical Utility of Monitoring Free Phenytoin Concentrations; 4.4.2 Clinical Utility of Monitoring Free Valproic Acid Concentration; 4.4.3 Clinical Utility of Monitoring Free Carbamazepine Concentrations 4.5 Mechanisms of Elevated Free Anticonvulsant Levels in Various Pathophysiological Conditions |
| Record Nr. | UNINA-9910583388103321 |
| Amsterdam : , : Elsevier, , [2016] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Drug safety evaluation / / Shayne Cox Gad, Dexter W. Sullivan
| Drug safety evaluation / / Shayne Cox Gad, Dexter W. Sullivan |
| Autore | Gad Shayne C. <1948-> |
| Edizione | [Fourth edition.] |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : John Wiley & Sons, , [2023] |
| Descrizione fisica | 1 online resource (995 pages) |
| Disciplina | 615/.19 |
| Collana | Pharmaceutical Development |
| Soggetto topico |
Drug monitoring
Drugs - Side effects - Reporting |
| ISBN |
1-119-75588-3
1-119-75586-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover -- Title Page -- Copyright Page -- Acknowledgment -- Contents -- Preface -- About the Authors -- Chapter 1 The Drug Development Process and The Global Pharmaceutical Marketplace -- 1.1 Introduction -- 1.2 The Marketplace -- 1.3 History of Modern Therapeutics -- 1.4 The Drug Development Process -- 1.5 Strategies For Development: Large Versus Small Company or The Short Versus Long Game -- 1.5.1 Do Only What You Must (The Short Game) -- 1.5.2 Minimize the Risk of Subsequent Failure -- 1.6 Safety Assessment And The Evolution Of Drug Safety -- 1.7 The Three Stages of Drug Safety Evaluation In The General Case -- References -- Chapter 2 Regulation of Human Pharmaceutical Safety: Routes To Human Use and Market -- 2.1 Introduction -- 2.2 Brief History of Us Pharmaceutical Law -- 2.2.1 1906: Pure Food and Drug Act -- 2.2.2 1938: Food, Drug, and Cosmetic Act -- 2.2.3 1962: Major Amendment -- 2.2.4 1992, 1997, 2002, 2007, 2012, and 2017: PDUFA, FDAMA, and FDARA -- 2.2.5 PREA: The Pediatric Research Equity Act -- 2.2.6 ICH: International Conference on Harmonization -- 2.2.7 Electronic Recordings: Electronic Submissions Impact -- 2.2.8 COVID-19 -- 2.3 Fdama Summary: Consequences and Other Regulations -- 2.4 Overview of us Regulations -- 2.4.1 Regulations: General Considerations -- 2.4.2 Regulations: Human Pharmaceuticals -- 2.4.3 Regulations: Environmental Impact -- 2.4.4 Regulations: Antibiotics -- 2.4.5 Regulations: Biologics -- 2.4.6 Regulations Versus Law -- 2.5 Organizations Regulating Drug And Device Safety In The United States -- 2.6 Process Of Pharmaceutical Product Development and Approval -- 2.7 Testing Guidelines -- 2.7.1 Toxicity Testing: Traditional Pharmaceuticals -- 2.7.2 General or Systematic Toxicity Assessment -- 2.7.3 Genetic Toxicity Assessment -- 2.7.4 Safety Pharmacology -- 2.7.5 Local Tissue Tolerance.
2.7.6 Reproductive and Developmental -- 2.7.7 Carcinogenicity -- 2.7.8 Toxicity Testing: Biotechnology Products -- 2.8 Toxicity/Safety Testing: Cellular And Gene Therapy Products -- 2.8.1 Cellular Therapies -- 2.8.2 Gene Therapies -- 2.8.3 ex vivo -- 2.8.4 in vivo -- 2.8.5 Preclinical Safety Evaluation -- 2.8.6 Basic Principles for Preclinical Safety Evaluation of Cellular and Gene Therapies -- 2.8.7 Additional Considerations for Cellular Therapies -- 2.8.8 Additional Considerations for Gene Therapies -- 2.9 Toxicity Testing: Special Cases -- 2.9.1 Oral Contraceptives -- 2.9.2 Life-Threatening Diseases (Compassionate Use) -- 2.9.3 Vaccines -- 2.9.4 Oncology Drugs and Imaging Agents -- 2.9.5 Optical Isomers -- 2.9.6 Special Populations: Pediatric and Geriatric Claims -- 2.9.7 Orphan Drugs -- 2.9.8 Expedited and Augmented Routes to Approval (Once you have an IND) -- 2.9.9 Botanical Drug Products -- 2.9.10 Types of New Drug Applications (NDAs) -- 2.10 International Pharmaceutical Regulation and Registration -- 2.10.1 International Council for Harmonization -- 2.10.2 Other International Considerations -- 2.10.3 Safety Pharmacology -- 2.11 Combination Products -- 2.11.1 Device Programs That Are CDER and CBRH Each Will Administer -- 2.11.2 Coordination -- 2.11.3 Submissions -- 2.12 Meetings And Submissions To Fda Toxicologists -- 2.13 Conclusion -- References -- Further Reading -- Chapter 3 Data Mining: Sources of Information For Consideration In Study And Program Design and In Safety Evaluation -- 3.1 Introduction -- 3.1.1 Claims -- 3.1.2 Time and Economies -- 3.1.3 Prior Knowledge -- 3.1.4 Miscellaneous Reference Sources -- 3.1.5 Search Procedure -- 3.1.6 Monitoring Published Literature and Other Research in Progress -- 3.1.7 Kinds of Information -- 3.1.8 Toxic Release Inventory (TRI) -- 3.1.9 Material Safety Data Sheets (MSDS). 3.1.10 Canadian Centre for Occupational Health and Safety (CCINFO) -- 3.1.11 Pollution and Toxicology (POLTOX) -- 3.1.12 Medline -- 3.2 Pc-Based Information Products: Laser Disc -- 3.2.1 International Veterinary Pathology Slide Bank (IVPSB) -- 3.3 Conclusion -- References -- Further Reading -- Chapter 4 Electronic Records, Reporting, and Submission: eCTD and Send -- 4.1 Introduction -- 4.2 Submission of Send Data In Module 4 of The eCTD -- 4.3 Send Background -- 4.4 Send Regulatory -- 4.5 Send Features -- 4.6 Send Study Submission Package -- 4.7 Determination of Studies That Need Data To Be Submitted As Send Files -- 4.7.1 FDA Center -- 4.7.2 Type of Application -- 4.7.3 Study Start Date -- 4.8 Storage of Files At The FDA -- 4.9 Recommended Regulatory Resources -- References -- Chapter 5 Screens in Safety and Hazard Assessment -- 5.1 Introduction -- 5.2 Characteristics of Screens -- 5.3 Uses of Screens -- 5.4 Types of Screens -- 5.4.1 Single Stage -- 5.4.2 Sequential -- 5.4.3 Tier (or Multistage) -- 5.5 Criterion: Development And Use -- 5.6 Analysis Of Screening Data -- 5.7 Univariate Data -- 5.7.1 Control Charts -- 5.7.2 Central Tendency Plots -- 5.7.3 Multivariate Data -- 5.7.4 The Analog Plot -- References -- Chapter 6 Formulations, Routes, and Dosage Regimens -- 6.1 Introduction -- 6.2 Mechanisms -- 6.2.1 Local Effects -- 6.2.2 Absorption and Distribution -- 6.2.3 Metabolism -- 6.3 Common Routes -- 6.3.1 Dermal Route -- 6.3.2 Parenteral Routes -- 6.3.3 Bolus versus Infusion -- 6.3.4 Oral Route -- 6.3.5 Minor Routes -- 6.3.6 Route Comparisons and Contrasts -- 6.4 Formulation Of Test Materials -- 6.4.1 Preformulation -- 6.4.2 Dermal Formulations -- 6.4.3 Interactions Between Skin, Vehicle, and Test Chemical -- 6.4.4 Oral Formulations -- 6.4.5 Parenteral Formulations -- 6.5 Dosing Calculations -- 6.6 Calculating Material Requirements. 6.7 Excipients -- 6.7.1 Regulation of Excipients -- References -- Chapter 7 Mechanisms And End Points Of Drug Toxicity -- 7.1 Manifestations -- 7.2 Mechanisms Of Toxicity -- 7.3 End Points Measured In General Toxicity Studies -- 7.3.1 Clinical Observations -- 7.3.2 Body Weights -- 7.3.3 Food and Water Consumption -- 7.3.4 Clinical Signs -- 7.3.5 Clinical Chemistry and Pathology -- 7.3.6 Hematology -- 7.3.7 Gross Necropsy and Organ Weights -- 7.3.8 Histopathology -- 7.3.9 Ophthalmology -- 7.3.10 Cardiovascular Function -- 7.3.11 Neurotoxicology -- 7.3.12 Immunotoxicology -- 7.3.13 Imaging and Telemetry -- 7.4 Complications -- References -- Chapter 8 Pilot Toxicity Testing In Drug Safety Evaluation: MTD and DRF -- 8.1 Introduction -- 8.2 RangeFinding Studies -- 8.2.1 Lethality Testing -- 8.2.2 Using Range-Finding Lethality Data in Drug Development: The Minimum Lethal Dose -- 8.3 Acute Systemic Toxicity Characterization -- 8.3.1 Minimal Acute Toxicity Test -- 8.3.2 Complete Acute Toxicity Testing -- 8.3.3 Acute Toxicity Testing with Non -- 8.3.4 Factors that Can Affect Acute Tests -- 8.3.5 Selection of Dosages -- 8.4 Screens -- 8.4.1 General Toxicity Screens -- 8.4.2 Specific Toxicity Screening -- 8.5 Pilot And DRF Studies -- References -- Chapter 9 RepeatDose Toxicity Studies -- 9.1 Objectives -- 9.2 Regulatory Considerations -- 9.2.1 Good Laboratory Practices -- 9.2.2 Animal Welfare Act -- 9.2.3 Regulatory Requirements for Study Design -- 9.3 Study Design and Conduct -- 9.3.1 Animals -- 9.3.2 Routes and Setting Doses -- 9.3.3 Parameters to Measure -- 9.3.4 Study Designs -- 9.4 Study Interpretation and Reporting -- 9.5 Read Across For Program Wide Evaluation -- References -- Chapter 10 Genotoxicity -- 10.1 ICH Test Profile -- 10.2 DNA Structure -- 10.2.1 Transcription -- 10.2.2 Translation -- 10.2.3 Gene Regulation -- 10.2.4 DNA Repair. 10.2.5 Error-Prone Repair -- 10.2.6 Mismatch Repair -- 10.2.7 The Adaptive Repair Pathway -- 10.2.8 Plasmids -- 10.2.9 Plasmids and DNA Repair -- 10.2.10 Nature of Point Mutations -- 10.2.11 Suppressor Mutations -- 10.2.12 Adduct Formation -- 10.2.13 Mutations Due to Insertion Sequences -- 10.2.14 The Link Between Mutation and Cancer -- 10.2.15 Genotoxic Versus Nongenotoxic Mechanisms of Carcinogenesis -- 10.2.16 Genetic Damage and Heritable Defects -- 10.2.17 Reproductive Effects -- 10.3 Cytogenetics -- 10.3.1 Cytogenetic Damage and Its Consequences -- 10.3.2 Individual Chromosomal Damage -- 10.3.3 Chromosome Set Damage -- 10.3.4 Test Systems -- 10.3.5 in vitro Test Systems -- 10.3.6 Bacterial Mutation Tests -- 10.3.7 Controls -- 10.3.8 Plate Incorporation Assay -- 10.3.9 Eukaryotic Mutation Tests -- 10.3.10 In vitro Tests for the Detection of Mammalian Mutation -- 10.3.11 in vivo Mammalian Mutation Tests -- 10.4 In vitro Cytogenetic Assays -- 10.4.1 Cell Types -- 10.4.2 Chinese Hamster Cell Lines -- 10.4.3 Human Peripheral Blood Lymphocytes -- 10.4.4 Positive and Negative Controls -- 10.4.5 Treatment of Cells -- 10.4.6 Scoring Procedures -- 10.4.7 Data Recording -- 10.4.8 Presentation of Results -- 10.5 In vivo Cytogenetic Assays -- 10.5.1 Somatic Cell Assays -- 10.5.2 Germ Cell Assays -- 10.5.3 Heritable Chromosome Assays -- 10.5.4 Germ Cell Cytogenetic Assays -- 10.6 Sister Chromatid Exchange Assays -- 10.6.1 Relevance of SCE in Terms of Genotoxicity -- 10.6.2 Experimental Design -- 10.7 How to Deal with Positive Test Results -- References -- Chapter 11 QSAR Tools For Drug Safety -- 11.1 Structure-Activity Relationships -- 11.1.1 Basic Assumptions -- 11.1.2 Molecular Parameters of Interest -- 11.2 Sar Modeling Methods -- 11.3 Applications In Toxicology -- 11.3.1 Metabolism -- 11.3.2 Reproductive -- 11.3.3 Eye Irritation -- 11.3.4 Lethality. 11.3.5 Carcinogenicity. |
| Record Nr. | UNINA-9910678179503321 |
Gad Shayne C. <1948->
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| Hoboken, New Jersey : , : John Wiley & Sons, , [2023] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Drug target insights
| Drug target insights |
| Pubbl/distr/stampa | Auckland, N.Z., : Libertas Academica, 2007- |
| Soggetto topico |
Drug targeting
Drug monitoring Chemotherapy Clinical pharmacology Drug Therapy Pharmacological Phenomena Pharmacology, Clinical |
| Soggetto genere / forma |
Periodical
Fulltext Internet Resources. Periodicals. |
| ISSN | 1177-3928 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | DTI |
| Record Nr. | UNISA-996212896503316 |
| Auckland, N.Z., : Libertas Academica, 2007- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
| ||
Drug target insights
| Drug target insights |
| Pubbl/distr/stampa | Auckland, N.Z., : Libertas Academica, 2007- |
| Soggetto topico |
Drug targeting
Drug monitoring Chemotherapy Clinical pharmacology Drug Therapy Pharmacological Phenomena Pharmacology, Clinical |
| Soggetto genere / forma |
Periodical
Fulltext Internet Resources. Periodicals. |
| ISSN | 1177-3928 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | DTI |
| Record Nr. | UNINA-9910146639303321 |
| Auckland, N.Z., : Libertas Academica, 2007- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter [[electronic resource]]
| Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter [[electronic resource]] |
| Pubbl/distr/stampa | [Rockville, Md.?] : , : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research] |
| Descrizione fisica | 10 pages : digital, PDF file |
| Soggetto topico |
Drug monitoring
Drugs - Microbiology - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
ICH regions on Sterility Test General Chapter
Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions |
| Record Nr. | UNINA-9910698136903321 |
| [Rockville, Md.?] : , : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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An introduction to pharmacovigilance / / Patrick Waller, Mira Harrison-Woolrych
| An introduction to pharmacovigilance / / Patrick Waller, Mira Harrison-Woolrych |
| Autore | Waller Patrick <1957 January 30-> |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Chichester, West Sussex, UK ; ; Hoboken, NJ : , : John Wiley & Sons Incorporated, , 2017 |
| Descrizione fisica | 1 online resource (193 pages) : illustrations |
| Disciplina | 615/.7042 |
| Collana | THEi Wiley ebooks |
| Soggetto topico |
Drug monitoring
Drugs - Side effects |
| ISBN |
1-119-28978-5
1-119-28975-0 1-119-28977-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | What is pharmacovigilance and how has it developed? -- Basic concepts -- Types and sources of data -- The process of pharmacovigilance -- Regulatory aspects of pharmacovigilance -- International collaboration -- Clinical aspects of adverse drug reactions -- Ethical and societal considerations -- Future directions -- Learning more about pharmacovigilance. |
| Record Nr. | UNINA-9910165027303321 |
|
Waller Patrick <1957 January 30->
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| Chichester, West Sussex, UK ; ; Hoboken, NJ : , : John Wiley & Sons Incorporated, , 2017 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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