Concepedia

Shared Learnings on the New EMA First-in-Human and Early Clinical Trial Guideline: Proceedings From a DIAlogue Session at DIA Europe 2018

Jan Willem van der Laan, Charles Benson, Walter Janssens, Jeroen Bos, Elke Stahl, Joseph T. Brady, Ulla Wändel‐Liminga, Solange Corriol‐Rohou, Roy Forster, Andreas Hartmann,

Therapeutic Innovation & Regulatory Science · 2020 · 25 citations · 2 references

Concepts

PharmacyMedical EducationEvidence-based PracticeGood Clinical PracticeMedical EthicsClinical Trial DocumentationClinical Trial EthicsClinical Trial PhasesClinical Trial Protocol ReviewClinical TrialsShared Decision-makingClinical Guideline ImplementationClinical Guideline RecommendationClinical LearningEarly-phase Clinical TrialsFirst-in-human Trial ApprovalImplementation Of Shared Decision-making

References

2

Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412

Ganesh Suntharalingam, Meghan Perry, Stephen Ward et al. · New England Journal of Medicine · 2006 · 2.1K citations

Veterinary Medicine, Immunology, Pharmacology +16

Current nonclinical testing paradigms in support of safe clinical trials: An IQ Consortium DruSafe perspective

Lynne Butler, Peggy Guzzie‐Peck, James Hartke et al. · Regulatory Toxicology and Pharmacology · 2017 · 44 citations

Public Health, Biostatistics, Clinical Research Regulation +11