T-DM1 and T-DXd conditional intact-ADC pharmacokinetics

T-DM1 0.3 mg/kg, fixed cycle-1 PK

Single specified 90-minute infusion followed through day 21; fixed intact-ADC PK coefficients and zero log deviations.

Readouts

Central conc · ng/mL

Fixed-context physical amount, concentration, rate or nonfeedback accounting quantity.

Exposure (AUC) · ng*day/mL

Fixed-context physical amount, concentration, rate or nonfeedback accounting quantity.

Accounted ADC · mg

Fixed-context physical amount, concentration, rate or nonfeedback accounting quantity.

Fixed coefficient terminal half-life · day

Fixed-matrix slow-phase half-life; not a clinical population estimate.

Study purpose

• How do the model's key biological readouts change under t-dm1 0.3 mg/kg, fixed cycle-1 pk?

Assumptions

• Deterministic fixed infusion histories only; no original meta-analysis fitting, sampled population, response prediction or clinical dose selection.
• Intact ADC serum is the modeled analyte. The apparent peripheral pool is unmeasured; no receptor, payload or binding mechanism is represented.
• T-DM1 and T-DXd use separate reported fixed PK coefficients. Fixed study-level log deviations remain zero in every preset; they are not sampled patient effects.
• Reference body weight converts mg/kg to mg only; kinetic coefficients have no weight covariate.
• AUC, elapsed day and eliminated amount are nonfeedback observers. Physical day-based AUC units remain unchanged under an hour display.
• The terminal half-life readout belongs to the fixed two-compartment coefficient matrix, not a clinical population distribution.