Evidence map›Paper›PMID 40908395›Full record

ReviewThe AAPS journal2025

Recent Advances in Bioanalytical Methods for Quantification and Pharmacokinetic Analyses of Antibody-Drug Conjugates.

R M Naseer Khan, Yi Zeng, Abdul-Azeez A Lanihun, Oluwatobi T Arisa, Jessica L Horner, William D Figg

Abstract readReview
In one paragraph

Review in The AAPS journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

R M Naseer KhanClinical Pharmacology Laboratory, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 5A03, Bethesda, Maryland, 20892, USA.
Yi ZengClinical Pharmacology Laboratory, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 5A03, Bethesda, Maryland, 20892, USA.
Abdul-Azeez A LanihunClinical Pharmacology Laboratory, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 5A03, Bethesda, Maryland, 20892, USA.
Oluwatobi T ArisaClinical Pharmacology Laboratory, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 5A03, Bethesda, Maryland, 20892, USA.
Jessica L HornerClinical Pharmacology Program, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA.
William D FiggClinical Pharmacology Laboratory, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 5A03, Bethesda, Maryland, 20892, USA. wdfigg@helix.nih.gov.ORCID 0000-0003-2428-5613

Funding

Using Clinical Pharmacology Principles to Develop New TherapeuticsZIACL090115 · CLC · CLINICAL CENTER · PI FIGG, WILLIAM · 2025 to 2025
$0k
Intramural NIH HHS ZIA CL090115
6 · The paper itself

Abstract

Antibody-drug conjugates (ADCs) represent a rapidly expanding class of therapeutics, uniquely combining the specificity of monoclonal antibodies with the potency of cytotoxic small-molecule payloads. Due to their inherent structural complexity and heterogeneous composition, accurate characterization and quantification of ADCs pose significant bioanalytical challenges. This review discusses recent advancements in bioanalytical methodologies, including ligand binding assays (LBAs), liquid chromatography-tandem mass spectrometry (LC-MS/MS)-based approaches, and emerging hybrid LBA-LC-MS/MS platforms. In addition, this review will discuss pharmacokinetic (PK) modeling approaches essential to ADC development, ranging from population PK models to mechanistic frameworks, including physiologically based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP) models. These modeling strategies allow detailed characterization of ADC absorption, distribution, metabolism, and elimination processes while also accounting for complexities introduced by payload deconjugation and drug-to-antibody ratio variability. By integrating robust bioanalytical methods with advanced modeling techniques, this review provides researchers with essential insights to enhance ADC characterization, inform experimental design, and ultimately facilitate the development of safer, more effective therapeutic candidates.

Indexed as

Antibodies, MonoclonalImmunoconjugatesAnimalsChromatography, LiquidHumansModels, BiologicalTandem Mass SpectrometryAntibodies, MonoclonalImmunoconjugatesanalytical chemistryantibody–drug conjugatebioanalyticalcancerclinical PharmacologyECLIAELISAFT-ICRLC–MS/MSpharmacokinetic

Identifiers

PMID40908395
PMCPMC12493022

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.