21st-Century Oncology Drug Safety via New-Age Regulatory Standards and Practices.
Ther Innov Regul Sci
; 53(5): 701-705, 2019 09.
Article
em En
| MEDLINE
| ID: mdl-30392396
ABSTRACT
There is no such thing as a drug that is 100% safe or effective. Determining whether or not a new oncology treatment (or an additional indication for an existing medicine) should be approved by a regulatory licensing authority is, ultimately, as much regulatory science as public health art and nuance. There are many dynamic shifts in regulatory science (expedited review pathways, biomarker validation, use of real-world evidence, expanded off-label usage, etc) interpreted and expressed within the context of 21st-century oncology drug development, and these new tools and the learnings gleaned from them are helping to advance patient care. They are also helping us to carefully reconsider the levels of uncertainty we find in benefit-risk data and clinical calculations. New-Age Pharmacovigilance can be a tool in product development, regulatory review, postmarketing surveillance and enhanced clinical outcomes.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Aprovação de Drogas
/
Legislação de Medicamentos
/
Antineoplásicos
Tipo de estudo:
Etiology_studies
/
Guideline
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article