FDA BRIEF: Week on May 23, 2016

fda guidances

COPD.JPG

INDICATION: Whole spectrum or defined entities

TYPES OF DRUGS:

  • Improving airflow obstruction .
  • Providing symptom relief
  • Modifying or preventing exacerbations
  • Altering disease progression
  •  Modifying lung structure

DOSE SELECTION:  To optimize benefit/risk

EFFICACY ASSESSMENT:

  • Objective: Pulmonary function tests,  Exercise capacity,
  • Patient Reported Outcomes: Symptom scores, Activity scales, Health-related quality-of-life instruments
  • Biomarkers, Surrogate Endpoints:: lung function test parameters, such as FEV1,

PRIMARY EFFICACY ENDPOINT:

  • Improving airflow obstruction
  • Providing symptom relief
  • Modifying or preventing exacerbations
  • Altering disease progression.
  • Modifying lung structure.

DURATION: 3 mo. – several years,  dependent on endpoint

DRUGS ADMINISTERED VIA INHALED ROUTE: Assessment of delivery systems on safety/efficacy

COMBINATION DRUGS: Compare product to each of its constituents to demonstrate combination product superior to each constituent

READ


 

histo.JPG

 

SCOPE: Biomarker qualification using histopathology as reference standard

BIOMARKER PERFORMANCE:

  • Performance characteristics
  • Sensitivity and Temporal Correlation
  • Specificity
  • Reversibility/Resolution
  • Alternative Testing Models.

HISTOPATHOLOGIC METHODS:

  • General Planning
  • Slide examination
  • Timing of Sample Collection
  • Controls
  • Fixation
  • Number of Sections and Sampling Location (at Necropsy)
  • Staining
  • Special methodology

OTHER CONSIDERATIONS: Digital Pathology and Slide Sharing, Lexicons, Filtering

OTHER FACTORS: Diagnostic Drift, Chronological Bias

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