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Categorizes subjects into FDA-defined age groups for pediatric and geriatric drug development studies.

Usage

agec(age)

Arguments

age

Numeric vector of baseline age in years

Value

Integer vector of age categories (1-6). Returns -999 for missing values. Includes a category_standard attribute set to "FDA".

Details

FDA age categories:

  • 1: Neonate: 0 to <28 days

  • 2: Infant: 28 days to <2 years

  • 3: Child: 2 to <12 years

  • 4: Adolescent: 12 to <18 years

  • 5: Adult: 18 to <65 years

  • 6: Elderly Adult: ≥65 years

References

Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act Guidance for Industry

Guideline for Industry Studies in Support of Special Populations: Geriatrics

Examples

age_cat <- agec(24)

df <- data.frame(
  ID = 1:12,
  AGE = c(0.07, 28 / 365, 0.25, 1, 2, 4, 12, 16, 18, 24, 65, 70)
)
dplyr::mutate(df, AGEC = agec(AGE))
#> Age near Neonate boundary (28 days)
#> Warning: There was 1 warning in `dplyr::mutate()`.
#>  In argument: `AGEC = agec(AGE)`.
#> Caused by warning in `agec()`:
#> ! Neonate ages detected. Confirm assignment.
#>    ID         AGE AGEC
#> 1   1  0.07000000    1
#> 2   2  0.07671233    2
#> 3   3  0.25000000    2
#> 4   4  1.00000000    2
#> 5   5  2.00000000    3
#> 6   6  4.00000000    3
#> 7   7 12.00000000    4
#> 8   8 16.00000000    4
#> 9   9 18.00000000    5
#> 10 10 24.00000000    5
#> 11 11 65.00000000    6
#> 12 12 70.00000000    6