Predictability Assessment (FDA 1997)

Cmax %PE

{{ pe_cmax }}%

limit <= 15%

AUCinf %PE

{{ pe_auc }}%

limit <= 15%

Cross-form Mean Abs %PE

{% if mean_abs_pe == 'N/A' %}N/A{% else %}{{ mean_abs_pe }}%{% endif %}

limit <= 10% per metric (multi-form)

{% if overall_pass is none %} N/A -- single-formulation %PE only {% else %} {{ 'PASS' if overall_pass else 'FAIL' }} -- IVIVC Predictability {% endif %}

IVIVC Plots

Levy Plot Regression

Slope	{{ levy_slope }}
Intercept	{{ levy_intercept }}
R-squared	{{ levy_r_squared }}
N points (0.05-0.95)	{{ levy_n }}

Study Info

Method	{{ method }}
In vivo time points	{{ n_iv_timepoints }}
Dissolution time points	{{ n_ivt_timepoints }}

In Vivo Fraction Absorbed

{% for row in data_rows %} {% endfor %}

Time (h)	Conc	F_a
{{ row.time }}	{{ row.conc }}	{{ row.fa }}

Predicted vs Observed

{% for row in pred_rows %} {% endfor %}