Bioequivalence study with lapatinib powder for oral suspension and the original tablet formulation in cancer patients

2014 ◽  
Vol 4 (3) ◽  
pp. 203-209
Author(s):  
Kevin M. Koch ◽  
Geraldine Ferron-Brady ◽  
Colleen Lemmon ◽  
Leanne Cartee ◽  
Hedy Hollyfield ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Bioequivalence Study ◽  
Tablet Formulation ◽  
Oral Suspension

scholarly journals The tablet formulation of posaconazole: clinical pharmacology and the use in patients with hematologic malignancies

2020 ◽  
Vol 22 (2) ◽  
pp. 96-117
Author(s):  
Alexander V. Veselov
Keyword(s):  
Clinical Studies ◽  
Fungal Infections ◽  
Plasma Concentrations ◽  
Pharmacokinetic Profile ◽  
Hematologic Malignancies ◽  
Tablet Formulation ◽  
Oral Suspension ◽  
Tolerability Profile ◽  
Hematopoietic Stem ◽  
Release Tablet

Posaconazole is a broad-spectrum triazole antifungal agent with potent activity against various fungi, including yeast and molds, including Mucorales, what makes a key difference with itraconazole and voriconazole. Clinical studies have demonstrated his efficacy for prophylaxis against invasive fungal infections in hematological patients at high risk (with acute myeloid leukemia, myelodysplastic syndrome, aplastic anemia, and in patients after hematopoietic stem cell transplantation, especially with graft versus host disease). Posaconazole also use as salvage therapy against invasive aspergillosis, mucormycosis and some other systemic mycoses. For today there are 3 posaconazole formulations – oral suspension, modify release tablet and intravenous solution (not registered in Russia at the time of writing this paper). As far as bioavailability of posaconazole following administration by oral suspension is highly variable with low unstable plasma concentrations and there are number of factors with negatively influence to the pharmacokinetic profile of suspension a delayed-release tablet was developed using hot-melt extrusion technology with a pH-sensitive polymer. The tablet formulation releases the drug in the intestine, and this leads to the enhanced bioavailability and increased posaconazole exposure parameters and, as a result, to a higher efficacy. This was demonstrated in pre-clinical, early phase clinical studies and confirmed with data from real practice. The tablet formulation has well tolerability profile with a low incidence of clinically significant adverse events. For today posaconazole included in all relevant clinical recommendations with high levels of evidence, including prophylaxis of invasive mycoses and therapy of their refractory forms, while the authors agree that for the oral therapy a preference should be given to the tablet formulation of posaconazole.

A Pharmacokinetic Bioequivalence Study Comparing Sublingual Riluzole (BHV‐0223) and Oral Tablet Formulation of Riluzole in Healthy Volunteers

2019 ◽  
Vol 9 (4) ◽  
pp. 476-485
Author(s):  
Irfan Qureshi ◽  
Meghan Lovegren ◽  
Victoria Wirtz ◽  
Richard Larouche ◽  
Mario Tanguay ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Bioequivalence Study ◽  
Tablet Formulation ◽  
Oral Tablet

scholarly journals Pharmacokinetic and bioequivalence study between two formulations of S-1 in Korean gastric cancer patients

2019 ◽  
Vol Volume 13 ◽  
pp. 3127-3136 ◽  
Author(s):  
Hae Won Lee ◽  
Sook Jin Seong ◽  
Woo Youl Kang ◽  
Boram Ohk ◽  
Mi-Ri Gwon ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Cancer Patients ◽  
Bioequivalence Study ◽  
Gastric Cancer Patients

Bioequivalence study of a new tablet formulation of triamterene and hydrochlorothiazide

1984 ◽  
Vol 77 (5) ◽  
pp. 59-61 ◽  
Author(s):  
Cheryl D. Blume ◽  
Roger L. Williams ◽  
Robert A. Upton ◽  
Emil T. Lin ◽  
Leslie Z. Benet
Keyword(s):  
Bioequivalence Study ◽  
Tablet Formulation

Pharmacokinetic and bioequivalence study of new S-1 capsule in Chinese cancer patients

2020 ◽  
Vol 151 ◽  
pp. 105384
Author(s):  
Yong Chen ◽  
Yun Jiang ◽  
Jingjing Qu ◽  
Qiming Wang ◽  
Yuxian Bai ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Bioequivalence Study ◽  
Chinese Cancer Patients

Pharmacokinetics and Bioequivalence Study of a Generic Amlodipine Tablet Formulation in Healthy Male Volunteers

2011 ◽  
Vol 57 (07) ◽  
pp. 462-466
Author(s):  
Reinhard Sailer ◽  
Peter Arnold ◽  
Aydin Erenmemişoğlu ◽  
Wolfgang Martin ◽  
Uygur Tamur ◽  
...  
Keyword(s):  
Bioequivalence Study ◽  
Tablet Formulation ◽  
Healthy Male ◽  
Healthy Male Volunteers ◽  
Male Volunteers
Sign in / Sign up

Export Citation Format

Share Document