Evidence map›Paper›PMID 42752822›Full record

ArticleClinical pharmacology and therapeutics2026

Perspective on Pharmacokinetic Comparability for Biologics Development.

Fei Tang, Yifei Zhang, Mohamed Elmeliegy, Janki Mihir Desai, Yow-Ming Wang, Zhenhua Xu

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical pharmacology and therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Fei TangGenentech, Inc., South San Francisco, California, USA.ORCID https://orcid.org/0000-0002-4517-7569
Yifei ZhangOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration (OCP/CDER/FDA), Silver Spring, Maryland, USA.ORCID https://orcid.org/0009-0001-6517-7160
Mohamed ElmeliegyPfizer, Inc., San Diego, California, USA.ORCID https://orcid.org/0000-0002-9825-5890
Janki Mihir DesaiClinical Pharmacology, AbbVie, Inc., North Chicago, Illinois, USA.ORCID https://orcid.org/0000-0002-8673-1327
Yow-Ming WangOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration (OCP/CDER/FDA), Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0002-0663-7358
Zhenhua XuClinical Pharmacology and Pharmacometrics, Johnson & Johnson, Spring House, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-3415-0133

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Comparability assessment of biologics is essential to support manufacturing changes throughout drug development life cycle. Centering on pharmacokinetic comparability for biologics, this manuscript summarizes current and emerging insights drawing from a webinar hosted by the American Society for Clinical Pharmacology and Therapeutics Life Cycle Management Community. The common theme across industry and regulatory experiences is the use of risk-based, hierarchical approaches to bridge pre- and post-change products, ranging from foundational analytical comparability to clinical pharmacokinetic comparability studies.

Identifiers

PMID42752822
PMCPMC13584805

What OpenQuestion holds

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Registered trials

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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 OpenQuestion graph.