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Safe and effective medicines for children [[electronic resource] ] : pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act / / Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA); Board on Health Sciences Policy; Marilyn J. Field and Thomas F. Boat, editors
| Safe and effective medicines for children [[electronic resource] ] : pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act / / Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA); Board on Health Sciences Policy; Marilyn J. Field and Thomas F. Boat, editors |
| Pubbl/distr/stampa | Washington, : National Academies Press, 2012 |
| Descrizione fisica | 1 online resource (432 p.) |
| Disciplina | 615.1083 |
| Altri autori (Persone) |
FieldMarilyn J (Marilyn Jane)
BoatThomas F |
| Soggetto topico |
Pediatric pharmacology
Drugs - Safety measures |
| ISBN |
1-283-63634-4
0-309-22550-7 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""Front Matter""; ""Acknowledgments""; ""Reviewers""; ""Preface""; ""Contents""; ""Boxes, Figures, and Tables""; ""Abbreviations and Acronyms""; ""Summary""; ""1 Introduction""; ""2 Children's Growth and Development and Pediatric Drug Studies""; ""3 Policy Framework for BPCA and PREA""; ""4 Ethical Issues in Pediatric Drug Studies""; ""5 Safety and Efficacy Assessments in Studies Conducted Under BPCA and PREA""; ""6 BPCA, PREA, and Drug Studies with Neonates""; ""7 Outcomes of Written Requests, Requirements, Studies, and Labeling Changes""; ""8 Pediatric Studies of Biologics""; ""References""
""Appendix A: Study Activities, Methods, and Public Meetings""""Appendix B: Dissemination of Information from Pediatric Studies Conducted Under BPCA and PREA""; ""Appendix C: Biologics in Pediatrics""; ""Appendix D: Biologics Studied and Not Studied in Children""; ""Appendix E: Written Requests for Studies of Pediatric Hypertension: Longitudinal Changes in FDA Specifications""; ""Appendix F: Committee and Staff Biographies""; ""Index"" |
| Record Nr. | UNINA-9910785912203321 |
| Washington, : National Academies Press, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Safe and effective medicines for children [[electronic resource] ] : pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act / / Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA); Board on Health Sciences Policy; Marilyn J. Field and Thomas F. Boat, editors
| Safe and effective medicines for children [[electronic resource] ] : pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act / / Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA); Board on Health Sciences Policy; Marilyn J. Field and Thomas F. Boat, editors |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, : National Academies Press, 2012 |
| Descrizione fisica | 1 online resource (432 p.) |
| Disciplina | 615.1083 |
| Altri autori (Persone) |
FieldMarilyn J (Marilyn Jane)
BoatThomas F |
| Soggetto topico |
Pediatric pharmacology
Drugs - Safety measures |
| ISBN |
1-283-63634-4
0-309-22550-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""Front Matter""; ""Acknowledgments""; ""Reviewers""; ""Preface""; ""Contents""; ""Boxes, Figures, and Tables""; ""Abbreviations and Acronyms""; ""Summary""; ""1 Introduction""; ""2 Children's Growth and Development and Pediatric Drug Studies""; ""3 Policy Framework for BPCA and PREA""; ""4 Ethical Issues in Pediatric Drug Studies""; ""5 Safety and Efficacy Assessments in Studies Conducted Under BPCA and PREA""; ""6 BPCA, PREA, and Drug Studies with Neonates""; ""7 Outcomes of Written Requests, Requirements, Studies, and Labeling Changes""; ""8 Pediatric Studies of Biologics""; ""References""
""Appendix A: Study Activities, Methods, and Public Meetings""""Appendix B: Dissemination of Information from Pediatric Studies Conducted Under BPCA and PREA""; ""Appendix C: Biologics in Pediatrics""; ""Appendix D: Biologics Studied and Not Studied in Children""; ""Appendix E: Written Requests for Studies of Pediatric Hypertension: Longitudinal Changes in FDA Specifications""; ""Appendix F: Committee and Staff Biographies""; ""Index"" |
| Record Nr. | UNINA-9910823344203321 |
| Washington, : National Academies Press, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Safeguarding Therapeutics Act : report (to accompany H.R. 5663)
| Safeguarding Therapeutics Act : report (to accompany H.R. 5663) |
| Pubbl/distr/stampa | [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2020] |
| Descrizione fisica | 1 online resource (31 pages) |
| Collana | Report / 116th Congress, 2d session, House of Representatives |
| Soggetto topico |
Medical supplies - Protection - United States
Drugs - United States - Safety measures Drugs - Law and legislation - United States Product counterfeiting - United States - Prevention Consumer protection - Law and legislation - United States Consumer protection - Law and legislation Drugs - Law and legislation Drugs - Safety measures |
| Soggetto genere / forma | Legislative materials. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Safeguarding Therapeutics Act |
| Record Nr. | UNINA-9910715155903321 |
| [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2020] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Securing the U.S. drug supply chain : oversight of FDA's foreign inspection program : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Sixteenth Congress, first session, December 10, 2019
| Securing the U.S. drug supply chain : oversight of FDA's foreign inspection program : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Sixteenth Congress, first session, December 10, 2019 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2021 |
| Descrizione fisica | 1 online resource (v, 136 pages) : color illustrations, color map |
| Soggetto topico |
Imports - Inspection - United States
Drugs - Inspection - United States Drugs - Standards - United States Drugs - Quality control Drugs - Safety measures Foreign trade regulation - United States |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Securing the U.S. Drug Supply Chain |
| Record Nr. | UNINA-9910717501203321 |
| Washington : , : U.S. Government Publishing Office, , 2021 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Sepa cómo tomar sus medicamentos
| Sepa cómo tomar sus medicamentos |
| Pubbl/distr/stampa | [Rockville, MD] : , : FDA Office of Women's Health, , 2013 |
| Descrizione fisica | 1 online resource (2 unnumbered pages) : color illustrations |
| Soggetto topico | Drugs - Safety measures |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Record Nr. | UNINA-9910702706903321 |
| [Rockville, MD] : , : FDA Office of Women's Health, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Zebrafish [[electronic resource] ] : methods for assessing drug safety and toxicity / / edited by Patricia McGrath
| Zebrafish [[electronic resource] ] : methods for assessing drug safety and toxicity / / edited by Patricia McGrath |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, 2011 |
| Descrizione fisica | 1 online resource (362 p.) |
| Disciplina | 597/.482 |
| Altri autori (Persone) | McGrathPatricia <1949-> |
| Soggetto topico |
Logperch - Genetics
Drugs - Safety measures Toxicology - Animal models Fish as laboratory animals Animal models in research |
| ISBN |
1-283-39799-4
9786613397997 1-118-10214-2 1-118-10213-4 1-118-10216-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Zebrafish: Methods for Assessing Drug Safety and Toxicity; Contents; Preface; Contributors; Acknowledgments; 1. The Reproductive Biology and Spawning of Zebrafish in Laboratory Settings; 1.1 Introduction; 1.2 Overview of Zebrafish Reproductive Biology and Behavior; 1.3 Spawning Techniques and Technology; 1.4 Determining Factors for Reproduction in Laboratory Stocks of Zebrafish; 1.5 Conclusions; References; 2. Developmental Toxicity Assessment in Zebrafish; 2.1 Introduction; 2.2 Methods; 2.3 Results; 2.4 Discussion; References; 3. Use of Emerging Models for Developmental Toxicity Testing
3.1 Importance of Assessing Developmental Toxicity3.2 Current Methods for Assessing Developmental Toxicity; 3.3 Use of Emerging Models for Developmental Toxicity Testing; 3.4 New Guidelines for Chemical Testing Using Zebrafish; 3.5 Conclusions; References; 4. Assessment of Drug-Induced Cardiotoxicity in Zebrafish; 4.1 Introduction; 4.2 Zebrafish Heart; 4.3 Summary of Cardiotoxicity Study Design and Results; 4.4 Materials and Methods; 4.5 Results; 4.6 Conclusions; References; 5. Cardiotoxicity Studies in Zebrafish; 5.1 Introduction; 5.2 Repolarization Toxicity 5.3 Initial Screening: Bradycardia5.4 High-Resolution Assays of Repolarization; 5.5 Future Directions; References; 6. In Vivo Recording of the Adult Zebrafish Electrocardiogram; 6.1 Introduction; 6.2 Optimization of Zebrafish Electrocardiogram Recording; 6.3 Basic Intervals; 6.4 Drug Effects; 6.5 Conclusions; References; 7. Hematopoietic and Vascular System Toxicity; 7.1 Introduction; 7.2 Hematopoiesis and Vascular Development in the Zebrafish; 7.3 Morphological and Functional Assays to Assess Toxicity; 7.4 Summary; Acknowledgment; References; 8. Hepatotoxicity Testing in Larval Zebrafish 8.1 Introduction: The Larval Zebrafish Model8.2 Liver Development; 8.3 Hepatic Gene Knockdown and Mutation; 8.4 Hepatotoxicity Testing in Drug Discovery; 8.5 Phenotypic-Based Larval Zebrafish Hepatotoxicity Screens; 8.6 Secondary and Mechanistic Liver Assays; 8.7 Conclusions; References; 9. Whole Zebrafish Cytochrome P450 Assay for Assessing Drug Metabolism and Safety; 9.1 Introduction; 9.2 Background and Significance; 9.3 Materials and Methods; 9.4 Results; 9.5 Conclusions; Acknowledgment; References; 10. Methods for Assessing Neurotoxicity in Zebrafish; 10.1 Introduction 10.2 Limitations of Current Neurotoxicity Testing10.3 Assessing Neurotoxicity in Zebrafish; 10.4 Summary; Acknowledgments; References; 11. Zebrafish: A Predictive Model for Assessing Cancer Drug-Induced Organ Toxicity; 11.1 Introduction; 11.2 Materials and Methods; 11.3 Results; 11.4 Conclusions; Reference; 12. Locomotion and Behavioral Toxicity in Larval Zebrafish: Background, Methods, and Data; 12.1 Introduction; 12.2 Background; 12.3 Locomotion; 12.4 Zebrafish Models; 12.5 Analyzing Larval Locomotion; 12.6 Chemical Effects on Larval Locomotion; 12.7 Conclusions; Acknowledgments; References 13. Zebrafish: A Predictive Model for Assessing Seizure Liability |
| Record Nr. | UNINA-9910141196203321 |
| Hoboken, N.J., : John Wiley & Sons, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Zebrafish [[electronic resource] ] : methods for assessing drug safety and toxicity / / edited by Patricia McGrath
| Zebrafish [[electronic resource] ] : methods for assessing drug safety and toxicity / / edited by Patricia McGrath |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, 2011 |
| Descrizione fisica | 1 online resource (362 p.) |
| Disciplina | 597/.482 |
| Altri autori (Persone) | McGrathPatricia <1949-> |
| Soggetto topico |
Logperch - Genetics
Drugs - Safety measures Toxicology - Animal models Fish as laboratory animals Animal models in research |
| ISBN |
1-283-39799-4
9786613397997 1-118-10214-2 1-118-10213-4 1-118-10216-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Zebrafish: Methods for Assessing Drug Safety and Toxicity; Contents; Preface; Contributors; Acknowledgments; 1. The Reproductive Biology and Spawning of Zebrafish in Laboratory Settings; 1.1 Introduction; 1.2 Overview of Zebrafish Reproductive Biology and Behavior; 1.3 Spawning Techniques and Technology; 1.4 Determining Factors for Reproduction in Laboratory Stocks of Zebrafish; 1.5 Conclusions; References; 2. Developmental Toxicity Assessment in Zebrafish; 2.1 Introduction; 2.2 Methods; 2.3 Results; 2.4 Discussion; References; 3. Use of Emerging Models for Developmental Toxicity Testing
3.1 Importance of Assessing Developmental Toxicity3.2 Current Methods for Assessing Developmental Toxicity; 3.3 Use of Emerging Models for Developmental Toxicity Testing; 3.4 New Guidelines for Chemical Testing Using Zebrafish; 3.5 Conclusions; References; 4. Assessment of Drug-Induced Cardiotoxicity in Zebrafish; 4.1 Introduction; 4.2 Zebrafish Heart; 4.3 Summary of Cardiotoxicity Study Design and Results; 4.4 Materials and Methods; 4.5 Results; 4.6 Conclusions; References; 5. Cardiotoxicity Studies in Zebrafish; 5.1 Introduction; 5.2 Repolarization Toxicity 5.3 Initial Screening: Bradycardia5.4 High-Resolution Assays of Repolarization; 5.5 Future Directions; References; 6. In Vivo Recording of the Adult Zebrafish Electrocardiogram; 6.1 Introduction; 6.2 Optimization of Zebrafish Electrocardiogram Recording; 6.3 Basic Intervals; 6.4 Drug Effects; 6.5 Conclusions; References; 7. Hematopoietic and Vascular System Toxicity; 7.1 Introduction; 7.2 Hematopoiesis and Vascular Development in the Zebrafish; 7.3 Morphological and Functional Assays to Assess Toxicity; 7.4 Summary; Acknowledgment; References; 8. Hepatotoxicity Testing in Larval Zebrafish 8.1 Introduction: The Larval Zebrafish Model8.2 Liver Development; 8.3 Hepatic Gene Knockdown and Mutation; 8.4 Hepatotoxicity Testing in Drug Discovery; 8.5 Phenotypic-Based Larval Zebrafish Hepatotoxicity Screens; 8.6 Secondary and Mechanistic Liver Assays; 8.7 Conclusions; References; 9. Whole Zebrafish Cytochrome P450 Assay for Assessing Drug Metabolism and Safety; 9.1 Introduction; 9.2 Background and Significance; 9.3 Materials and Methods; 9.4 Results; 9.5 Conclusions; Acknowledgment; References; 10. Methods for Assessing Neurotoxicity in Zebrafish; 10.1 Introduction 10.2 Limitations of Current Neurotoxicity Testing10.3 Assessing Neurotoxicity in Zebrafish; 10.4 Summary; Acknowledgments; References; 11. Zebrafish: A Predictive Model for Assessing Cancer Drug-Induced Organ Toxicity; 11.1 Introduction; 11.2 Materials and Methods; 11.3 Results; 11.4 Conclusions; Reference; 12. Locomotion and Behavioral Toxicity in Larval Zebrafish: Background, Methods, and Data; 12.1 Introduction; 12.2 Background; 12.3 Locomotion; 12.4 Zebrafish Models; 12.5 Analyzing Larval Locomotion; 12.6 Chemical Effects on Larval Locomotion; 12.7 Conclusions; Acknowledgments; References 13. Zebrafish: A Predictive Model for Assessing Seizure Liability |
| Record Nr. | UNINA-9910824873503321 |
| Hoboken, N.J., : John Wiley & Sons, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
