Evidence map›Paper›PMID 41379622›Full record

Trial reportCPT: pharmacometrics & systems pharmacology2026

Talazoparib Formulation Bridging in Cancer Patients-Challenges and the Critical Role of Model-Informed Drug Development in Approval Despite Failed Bioequivalence.

Diane Wang, Cathy Cen Guo, Xizhe Gao, Yibo Wang, Yanke Yu, Anna Plotka, Mohamed Elmeliegy, Haihong Shi, Samantha Johnson, Liza DeAnnuntis and 1 more

Abstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in CPT: pharmacometrics & systems pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Trial
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

11 authors.

Diane WangPfizer Inc., La Jolla, California, USA.
Cathy Cen GuoPfizer Inc., La Jolla, California, USA.ORCID https://orcid.org/0000-0001-6850-1045
Xizhe GaoPfizer Inc., La Jolla, California, USA.
Yibo WangPfizer Inc., La Jolla, California, USA.
Yanke YuPfizer Inc., La Jolla, California, USA.
Anna PlotkaPfizer Inc., Collegeville, Pennsylvania, USA.
Mohamed ElmeliegyPfizer Inc., La Jolla, California, USA.
Haihong ShiPfizer Inc., Groton, Connecticut, USA.
Samantha JohnsonPfizer R&D UK Ltd., Sandwich, Kent, UK.
Liza DeAnnuntisPfizer Inc., Collegeville, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-7974-2343
Justin HoffmanPfizer Inc., La Jolla, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Talazoparib is a poly(ADP-ribose) polymerase inhibitor approved for the treatment of breast and prostate cancer. Commercialization of a soft gelatin capsule (SGC) formulation developed post-approval required a bioequivalence (BE) and food effect (FE) study to bridge SGC with the initial commercial hard capsule (HC) formulation. Study execution and meeting BE criteria are challenging due to high variability in C

Indexed as

Antineoplastic AgentsModels, BiologicalNeoplasmsPhthalazinesPoly(ADP-ribose) Polymerase InhibitorsAdultAgedArea Under CurveBreast NeoplasmsCapsulesComputer SimulationDrug ApprovalDrug DevelopmentFemaleFood-Drug InteractionsHumansAntineoplastic AgentsCapsulesPhthalazinesPoly(ADP-ribose) Polymerase InhibitorstalazoparibbioequivalencecancerMIDDPARP inhibitorPK/PD modeling

Identifiers

PMID41379622
PMCPMC12823315

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.