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. |
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| 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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| ISSN: | 2163-8306 |
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| DOI: | 10.1002/psp4.70157 |