Výsledky vyhledávání

The Effect of Food on the Absorption of Abiraterone Acetate from a Fine Particle Dosage Form: A Randomized Crossover Trial in Healthy Volunteers

Autor: Cy A. Stein, Bill Bosch, Paul Nemeth, Alexander Papangelou, Anthony J. Olszanski

Publikováno v: Oncology and Therapy. 5:161-170

Abiraterone acetate (AA) is approved for treatment of metastatic castration-resistant prostate cancer. The originator AA (OAA) formulation has been associated with AUC and C max increases of 10- and 17-fold, respectively, when administered following

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::0dce0fd4653bac503a9b3f5a0793c336
https://doi.org/10.1007/s40487-017-0054-2

Zobrazit plný text záznamu

Impact of an alternative steroid on the relative bioavailability and bioequivalence of a novel versus the originator formulation of abiraterone acetate

Autor: Bill Bosch, Anthony J. Olszanski, Paul Nemeth, Azra Hussaini, Cy A. Stein

Publikováno v: Cancer Chemotherapy and Pharmacology

The originator abiraterone acetate (OAA) formulation is used for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This study evaluated the bioavailability and bioequivalence of a novel formulation, abiraterone acetate fine pa

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eb45c326859ceb548f82e37a66f61dc0
https://doi.org/10.1007/s00280-017-3360-3

Zobrazit plný text záznamu

Comparison of a Novel Formulation of Abiraterone Acetate vs. the Originator Formulation in Healthy Male Subjects: Two Randomized, Open-Label, Crossover Studies

Autor: Bill Bosch, Ronald Goldwater, Azra Hussaini, Paul Nemeth

Publikováno v: Clinical Pharmacokinetics

Background and Objective Abiraterone acetate is approved for the treatment of metastatic castration-resistant prostate cancer. The originator abiraterone acetate (OAA) formulation is poorly absorbed and exhibits large pharmacokinetic variability in a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9448f68bb1e8a13961d2f6994ba5f98e
https://doi.org/10.1007/s40262-017-0536-2

Zobrazit plný text záznamu

Randomized phase 2 therapeutic equivalence study of abiraterone acetate fine particle formulation vs. originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer: The STAAR study

Autor: Paul Nemeth, Celestia S. Higano, Bill Bosch, Cy A. Stein, Jillian Chapas-Reed, Robert Dreicer, Robert Given, Richard Levin

Publikováno v: Urologic oncology. 36(2)

This multicenter, randomized, open-label, active-controlled study evaluated therapeutic equivalence, steady-state pharmacokinetics, and safety of a novel abiraterone acetate fine particle formulation (AAFP) 500mg plus methylprednisolone vs. the origi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::613765e98903bd22d50a400260231c23
https://pubmed.ncbi.nlm.nih.gov/29150328

Zobrazit plný text záznamu

Pharmacokinetic (PK) subgroup results from the phase 2 pharmacodynamic and bioequivalence study of abiraterone acetate fine particle formulation (AAFP) in patients with metastatic castration-resistant prostate cancer (mCRPC): The STAAR study

Autor: Bill Bosch, Curtis Dunshee, Paul Nemeth, Robert Dreicer, Cy A. Stein, Jillian Chapas-Reed

Publikováno v: Journal of Clinical Oncology. 36:176-176

176 Background: AAFP, a novel formulation, showed therapeutic equivalence to originator abiraterone acetate (OAA) in the Phase 2 STAAR study (Stein et al. Urologic Oncol). A patient-subgroup analysis compared steady-state PK parameters between AAFP a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::3e86706ae8e8da056a16805281b9d655
https://doi.org/10.1200/jco.2018.36.6_suppl.176

Zobrazit plný text záznamu

Multicenter extension and switch study evaluating the safety of long-term treatment with abiraterone acetate fine particle formulation (AAFP) in patients with metastatic castration-resistant prostate cancer (mCRPC): The STAAR-E study

Autor: Bill Bosch, William Oh, Richard Levin, Jillian Chapas-Reed, Robert Given, Paul Nemeth

Publikováno v: Journal of Clinical Oncology. 36:181-181

181 Background: The STAAR-study results showed novel AAFP 500 mg is therapeutically equivalent to originator abiraterone acetate (OAA) 1000 mg in men with mCRPC (Stein et al. Urologic Oncol). This STAAR-extension study evaluates the safety of ≤ 1 y

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::81e6ad4eb6de2fb79cc1162f9d99594e
https://doi.org/10.1200/jco.2018.36.6_suppl.181

Zobrazit plný text záznamu

Relative bioavailability (BA) and bioequivalence (BE) study of abiraterone acetate (AA) fine particle (AAFP) with methylprednisolone (MP) and a reference formulation with prednisone (PN) in healthy male subjects

Autor: Paul Nemeth, Azra Hussaini, Bill Bosch, Anthony J. Olszanski, Cy A. Stein

Publikováno v: Journal of Clinical Oncology. 35:e16538-e16538

e16538 Background: AA is approved for treatment of metastatic castration-resistant prostate cancer when taken in combination with PN. The originator AA (OAA) formulation is poorly absorbed and exhibits large pharmacokinetic (PK) variability. AAFP is

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::a4a51980a7fb8b3168d2504a85f2319d
https://doi.org/10.1200/jco.2017.35.15_suppl.e16538

Zobrazit plný text záznamu

Absorption of a novel formulation of abiraterone acetate (AA) fine particle (AAFP) under fed and fasted conditions

Autor: Anthony J. Olszanski, Alexander Papangelou, Bill Bosch, Cy A. Stein, Paul Nemeth, Yuxin Zhang

Publikováno v: Journal of Clinical Oncology. 35:e606-e606

e606 Background: AA is approved for treatment of metastatic castration-resistant prostate cancer (mCRPC). In healthy subjects administered the originator AA (OAA) formulation, AUC and Cmaxincreased by 10- and 17-fold, respectively, when administered

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::a15fd23c715ec51d882adcf674420b02
https://doi.org/10.1200/jco.2017.35.6_suppl.e606

Zobrazit plný text záznamu

Single-dose, four-way crossover, open-label, relative bioavailability (BA) studies of a novel formulation of abiraterone acetate (AA) versus the reference formulation under fasted conditions in healthy male subjects

Autor: Ronald Goldwater, Bill Bosch, Paul Nemeth, Yuxin Zhang, Azra Hussaini

Publikováno v: Journal of Clinical Oncology. 35:e605-e605

e605 Background: AA is approved for treatment of metastatic castration-resistant prostate cancer. The originator AA (OAA) formulation is poorly absorbed and exhibits large pharmacokinetic variability in abiraterone exposure in healthy subjects. AA fi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::a862dbc776fc4004610cb115ae2c9662
https://doi.org/10.1200/jco.2017.35.6_suppl.e605

Zobrazit plný text záznamu

Vyhledávací nástroje:

Upřesnit hledání