Zobrazeno 1 - 10
of 32
pro vyhledávání: '"Balakrishna Hosmane"'
Autor:
Benoit You, Vasudha Sehgal, Balakrishna Hosmane, Xin Huang, Peter J. Ansell, Minh H. Dinh, Katherine Bell-McGuinn, Xizhi Luo, Gini F. Fleming, Michael Friedlander, Michael A. Bookman, Kathleen N. Moore, Karina D. Steffensen, Robert L. Coleman, Elizabeth M. Swisher
Publikováno v:
Journal of Clinical Oncology. 41:107-116
PURPOSE In VELIA trial, veliparib combined with carboplatin-paclitaxel, followed by maintenance (veliparib-throughout) was associated with improved progression-free survival (PFS) compared with carboplatin-paclitaxel alone in patients with high-grade
Autor:
Kelly E. Desino, Balakrishna Hosmane, Stella Doktor, Edward Price, David A. Degoey, J. Cory Kalvass
Publikováno v:
Journal of Medicinal Chemistry. 64:9389-9403
Models intended to predict intestinal absorption are an essential part of the drug development process. Although many models exist for capturing intestinal absorption, many questions still exist around the applicability of these models to drug types
Publikováno v:
Journal of biopharmaceutical statistics. 31(5)
According to the International Conference on Harmonisation E14 QAs R3, concentration-QTc analysis can serve as an alternative to the by-time-point analysis or intersection-union test as the primary basis for decisions to classify the QTc risk of a dr
Autor:
Edward, Price, J Cory, Kalvass, David, DeGoey, Balakrishna, Hosmane, Stella, Doktor, Kelly, Desino
Publikováno v:
Journal of medicinal chemistry. 64(13)
Models intended to predict intestinal absorption are an essential part of the drug development process. Although many models exist for capturing intestinal absorption, many questions still exist around the applicability of these models to drug types
Publikováno v:
Clinical Pharmacology and Therapeutics
Exposure-response analyses of QT data from early-stage clinical studies represent a valuable tool to assess the QT prolongation potential for drugs in development in lieu of standalone thorough QT (TQT) studies. However, demonstrating adequate electr
Autor:
Walid M. Awni, Haoyu Wang, Akshanth R. Polepally, Rajeev M. Menon, Daniel E. Cohen, Amit Khatri, Sven Mensing, Thomas Podsadecki, Patrick J. Marroum, Balakrishna Hosmane, Mukul Minocha
Publikováno v:
The AAPS Journal. 19:1523-1535
The triple direct-acting antiviral (3-DAA) regimen (two co-formulated tablets of ombitasvir/paritaprevir/ritonavir once daily and one tablet of dasabuvir twice daily) for patients with hepatitis C virus (HCV) genotype 1 infection has been reformulate
Autor:
Balakrishna Hosmane, Lois Larsen, Nael M. Mostafa, Kristof Chwalisz, Yi-Lin Chiu, Rajendra S. Pradhan
Publikováno v:
Clinical Drug Investigation. 34:441-448
A pharmacokinetic substudy was conducted within a phase 3 clinical trial that evaluated the efficacy and safety of two leuprolide acetate 3-month depot formulations in children with central precocious puberty (CPP), where the pharmacokinetics of leup
Publikováno v:
Journal of Biopharmaceutical Statistics. 23:804-817
We study the statistical efficiency for rising-dose designs in the context of first-in-human studies. Specifically, we identify a class of crossover designs that are appealing in terms of both subject safety and statistical efficiency and, for a thre
Publikováno v:
The AAPS Journal. 14:168-175
ABT-594, a neuronal nicotinic acetylcholine receptor ligand, is 30- to 100-fold more potent than morphine in animal models of nociceptive and neuropathic pain. Efficacy and safety of ABT-594 in subjects with painful diabetic polyneuropathy was evalua
Publikováno v:
Journal of Biopharmaceutical Statistics. 20:595-603
We developed analytical results for computing the power in a thorough QT/QTc study with a four-group parallel design in which the treatments are placebo, positive control, supratherapeutic dose of investigational drug, and therapeutic dose of investi