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

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Title: Talazoparib Formulation Bridging in Cancer Patients-Challenges and the Critical Role of Model-Informed Drug Development in Approval Despite Failed Bioequivalence.
Authors: Wang D; Pfizer Inc., La Jolla, California, USA., Guo CC; Pfizer Inc., La Jolla, California, USA., Gao X; Pfizer Inc., La Jolla, California, USA., Wang Y; Pfizer Inc., La Jolla, California, USA., Yu Y; Pfizer Inc., La Jolla, California, USA., Plotka A; Pfizer Inc., Collegeville, Pennsylvania, USA., Elmeliegy M; Pfizer Inc., La Jolla, California, USA., Shi H; Pfizer Inc., Groton, Connecticut, USA., Johnson S; Pfizer R&D UK Ltd., Sandwich, Kent, UK., DeAnnuntis L; Pfizer Inc., Collegeville, Pennsylvania, USA., Hoffman J; Pfizer Inc., La Jolla, California, USA.
Source: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2026 Jan; Vol. 15 (1), pp. e70157. Date of Electronic Publication: 2025 Dec 11.
Publication Type: Clinical Trial, Phase I; Journal Article; Multicenter Study; Randomized Controlled Trial
Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2163-8306 (Electronic) Linking ISSN: 21638306 NLM ISO Abbreviation: CPT Pharmacometrics Syst Pharmacol Subsets: MEDLINE
Database: MEDLINE Ultimate
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Description
ISSN:2163-8306
DOI:10.1002/psp4.70157