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The regulatory state of nonalcoholic steatohepatitis and metabolism

Omokaro, Stephanie O. ; Golden, Julie K.

Endocrinology, diabetes & metabolism, 2020-10, Vol.3 (4), p.e00113-n/a [Periódico revisado por pares]

England: John Wiley & Sons, Inc

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  • Título:
    The regulatory state of nonalcoholic steatohepatitis and metabolism
  • Autor: Omokaro, Stephanie O. ; Golden, Julie K.
  • Assuntos: Biomarkers ; Biopsy ; Clinical trials ; Drugs ; FDA approval ; Histology ; Liver diseases ; Metabolic disorders ; Mortality ; Patients ; Pediatrics ; Regulatory approval ; Transplants & implants
  • É parte de: Endocrinology, diabetes & metabolism, 2020-10, Vol.3 (4), p.e00113-n/a
  • Notas: SourceType-Other Sources-1
    ObjectType-Editorial-2
    ObjectType-Commentary-1
    The content of this paper represents the considerations and reflections of the authors, and not the views of the U.S. Food and Drug Administration.
  • Descrição: FDA DRAFT NONCIRRHOTIC NASH WITH LIVER FIBROSIS GUIDANCE—EFFICACY AND SAFETY CONSIDERATIONS FDA draft guidance regarding drug development in noncirrhotic NASH with liver fibrosis was published in 2018 with primary aims to facilitate clinical development of drugs for the treatment of noncirrhotic NASH patients with liver fibrosis who are at risk for liver‐related adverse outcomes. Phase 4 (post‐market) confirmatory trials verifying the clinical benefit of these histological end‐points and using composite outcome end‐points of progression of cirrhosis, reduction of decompensation events, changes in model for end‐stage liver disease (MELD) score, liver transplant and all‐cause mortality, should generally be underway at the time of submission of the marketing application for accelerated approval. While it is not yet known whether the effect of any particular drug will be precisely and comprehensively characterized by the inflammatory and fibrotic components of NASH injury as assessed by the histological method or whether the current 12‐18 months duration of clinical trials will be sufficiently long to allow detection of treatment effects, what is known is that the fibrosis component of the NASH pattern of injury is the strongest predictor for adverse outcomes in patients. DGIEP has employed the recommendation of a much smaller alpha (ie probability of concluding that there is a treatment effect, when in fact there is none) to achieve statistical significance for biopsy‐based NASH end‐point(s) in phase 3 trials and allow greater certainty in predicting the relationship between histology and clinical benefit.
  • Editor: England: John Wiley & Sons, Inc
  • Idioma: Inglês
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