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# Guide on PK-Based Criteria for PD1/PD-L1 Alt Dosing
- URL: https://www.fdaweb.com/guide-on-pk-based-criteria-for-pd1-pd-l1-alt-dosing/
- Published: 2022-12-06T12:00:00.000Z
- Updated: 2026-09-14T18:08:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153330

FDA has released a [final guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacokinetic-based-criteria-supporting-alternative-dosing-regimens-programmed-cell-death-receptor?ref=fdaweb.com) entitled “Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer.”

The document provides recommendations on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for PD-1 or PD-L1 blocking antibodies, which are used for various cancer indications. “These alternative \[intravenous\] IV dosing regimens are typically designed to change doses and dosing intervals,” the guidance says. “Longer dosing intervals can minimize patient burden and reduce risks associated with more frequent administration (e.g., infusion reactions), as well as exposure to communicable diseases (e.g., SARS-CoV-2) associated with visits to hospitals or infusion centers.”

The guidance recommends a PK-based approach that relies on population-PK (Pop-PK) modeling and simulation to support alternative dosing regimens. “The Pop-PK model should be established with sufficient PK data from all indicated patient populations over a wide range of dosing regimens (i.e., different from the alternative dosing regimens),” it says. “The model itself should be well validated and determined to be fit for the purpose.” 

The agency also references its Population Pharmacokinetics [guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/population-pharmacokinetics?ref=fdaweb.com) for recommendations about Pop-PK models.