Cargando…

Does GLP enhance the quality of toxicological evidence for regulatory decisions?

There is debate over whether the requirements of GLP are appropriate standards for evaluating the quality of toxicological data used to formulate regulations. A group promoting the importance of non-monotonic dose responses for endocrine disruptors contend that scoring systems giving primacy to GLP...

Descripción completa

Detalles Bibliográficos
Autores principales:	Borgert, Christopher J., Becker, Richard A., Carlton, Betsy D., Hanson, Mark, Kwiatkowski, Patricia L., Sue Marty, Mary, McCarty, Lynn S., Quill, Terry F., Solomon, Keith, Van Der Kraak, Glen, Witorsch, Raphael J., Don Yi, Kun
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Oxford University Press 2016
Materias:	Forum: Value of GLP for Regulatory Decisions
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4880141/ https://www.ncbi.nlm.nih.gov/pubmed/27208076 http://dx.doi.org/10.1093/toxsci/kfw056

Ejemplares similares

Principles of dose-setting in toxicology studies: the importance of kinetics for ensuring human safety
por: Borgert, C. J., et al.
Publicado: (2021)

A Survey of Systematic Evidence Mapping Practice and the Case for Knowledge Graphs in Environmental Health and Toxicology
por: Wolffe, Taylor A M, et al.
Publicado: (2020)

Oral nicotine pouches with an aftertaste? Part 1: screening and initial toxicological assessment of flavorings and other ingredients
por: Mallock-Ohnesorg, Nadja, et al.
Publicado: (2023)

Practical application of the interim internal threshold of toxicological concern (iTTC): a case study based on clinical data
por: Najjar, Abdulkarim, et al.
Publicado: (2022)

Crítica de la decisión
por: Sfez, Lucien
Publicado: (1984)

Evaluation of the Inherent Toxicity Concept in Environmental Toxicology and Risk Assessment
por: McCarty, L.S., et al.
Publicado: (2020)

Drug Lag and Key Regulatory Barriers in the Emerging Markets
por: Wileman, Harriet, et al.
Publicado: (2010)

Regulations and guidelines governing stem cell based products: Clinical considerations
por: George, Bobby
Publicado: (2011)

Regulatory Considerations for Biosimilars
por: Nellore, Ranjani
Publicado: (2010)

Registration of Medical Devices
por: George, Bobby
Publicado: (2010)

Implications of ICH-E5: Assessment of drug's sensitivity to ethnic factors and necessity of a bridging study for global drug development
por: Gupta, Sandeep Kumar
Publicado: (2011)

Regulatory requirements for marketing fixed dose combinations
por: Jayasheel, B. G.
Publicado: (2010)

Injury and death in clinical trials and compensation: Rule 122 DAB
por: Ghooi, Ravindra. B.
Publicado: (2013)

Key points of technical review for the registration of SARS-CoV-2 antigen/antibody tests
por: Li, Hongran, et al.
Publicado: (2021)

China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody test reagents in the process of emergency approval
por: Lv, Yunfeng, et al.
Publicado: (2020)

Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China
por: Li, Hongran, et al.
Publicado: (2021)

China's NMPA perspective on the clinical performance of SARS-CoV-2 antigen test reagents
por: Lv, Yunfeng, et al.
Publicado: (2022)

Analysis of health concerns not addressed by REACH for low tonnage chemicals and opportunities for new approach methodology
por: Botham, Philip, et al.
Publicado: (2023)

How Adverse Outcome Pathways Can Aid the Development and Use of Computational Prediction Models for Regulatory Toxicology
por: Wittwehr, Clemens, et al.
Publicado: (2017)

Accelerating the Development of 21st-Century Toxicology: Outcome of a Human Toxicology Project Consortium Workshop
por: Stephens, Martin L., et al.
Publicado: (2012)

250 Defining Developmentally High-Risk Full Term and Late Preterm Infants in the Neonatal Intensive Care Unit
por: Carlton, Katherine, et al.
Publicado: (2022)

95347 Examining the Impact of the BPCA: Promoting Pediatric Inclusion in Clinical Trials and Pediatric-Specific Drug Information
por: Ly, Annie, et al.
Publicado: (2021)

397 Regulations and Marketing of Energy Drinks in the United States: A Survey of University Student Beliefs about Caffeine Consumption
por: Chung, Christian, et al.
Publicado: (2023)

393 Disposable Electronic Nicotine Delivery Systems (ENDS) and Underage Nicotine Addiction–A Survey of College Students
por: Riggs, Griffin, et al.
Publicado: (2023)

390 A Mixed Methods Review of Endpoint Measures Utilized in Adult ADHD Medication Clinical Trial Design
por: Davies, Claire, et al.
Publicado: (2023)

Science and Decisions: Advancing Toxicology to Advance Risk Assessment
por: Rodricks, Joseph V., et al.
Publicado: (2013)

Brain GLP‐1 and the regulation of food intake: GLP‐1 action in the brain and its implications for GLP‐1 receptor agonists in obesity treatment
por: Trapp, Stefan, et al.
Publicado: (2021)

369 The impact of asymmetric lung injury on gas and pressures distribution in a mechanical ventilation model with implementation of compartmentalized inspiratory hold
por: Meyerowitz, Glen, et al.
Publicado: (2022)

Application of a Rat Liver Drug Bioactivation Transcriptional Response Assay Early in Drug Development That Informs Chemically Reactive Metabolite Formation and Potential for Drug-induced Liver Injury
por: Monroe, James J, et al.
Publicado: (2020)

A Next-Generation Risk Assessment Case Study for Coumarin in Cosmetic Products
por: Baltazar, Maria T, et al.
Publicado: (2020)

Physiologically Based Pharmacokinetic Modeling in Risk Assessment: Case Study With Pyrethroids
por: Mallick, Pankajini, et al.
Publicado: (2020)

Decontamination and Management of Contaminated Hair following a CBRN or HazMat Incident
por: Matar, Hazem, et al.
Publicado: (2019)

Bioelution, Bioavailability, and Toxicity of Cobalt Compounds Correlate
por: Danzeisen, Ruth, et al.
Publicado: (2020)

Potential of ToxCast Data in the Safety Assessment of Food Chemicals
por: Punt, Ans, et al.
Publicado: (2020)

Multiorgan Crystal Deposition of an Amphoteric Drug in Rats Due to Lysosomal Accumulation and Conversion to a Poorly Soluble Hydrochloride Salt
por: Lenz, Barbara, et al.
Publicado: (2021)

Reliability of the AR-CALUX(®)In Vitro Method Used to Detect Chemicals with (Anti)Androgen Activity: Results of an International Ring Trial
por: Milcamps, Anne, et al.
Publicado: (2021)

Application of a Framework for Grouping and Mixtures Toxicity Assessment of PFAS: A Closer Examination of Dose-Additivity Approaches
por: Goodrum, Philip E, et al.
Publicado: (2020)

Gut-Selective Design of Orally Administered Izencitinib (TD-1473) Limits Systemic Exposure and Effects of Janus Kinase Inhibition in Nonclinical Species
por: Hardwick, Rhiannon N, et al.
Publicado: (2022)

Are Non-animal Systemic Safety Assessments Protective? A Toolbox and Workflow
por: Middleton, Alistair M, et al.
Publicado: (2022)

Manganese relative oral bioavailability in electric arc furnace steel slag is influenced by high iron content and low bioaccessibility
por: Proctor, Deborah M, et al.
Publicado: (2023)

Cannot write session to /tmp/vufind_sessions/sess_46ktcblur9hgekror7o7ofjjdt