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Bioequivalence

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https://www.readbyqxmd.com/read/28443391/atazanavir-sulfate-cobicistat-for-the-treatment-of-hiv-infection
#1
Francisco Antunes
The life expectancy of patients living with HIV has increased significantly in the last two decades, as a result of the great progress in treatment of HIV infection. During this time, several drugs were developed to offer long-term benefits in terms of virologic efficacy, favourable tolerability and toxicity profiles. Pharmacokinetic boosting of protease inhibitors allows a higher genetic barrier, as few or no drug-resistant mutations are detected in patients with virologic failure. Areas covered: Atazanavir sulfate + cobicistat (ATV/c) was recently approved in the United States of America and in the European Union for the treatment of HIV-1 infection...
April 26, 2017: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/28442892/bioequivalence-study-of-a-new-sildenafil-100-mg-orodispersible-film-compared-to-the-conventional-film-coated-100-mg-tablet-administered-to-healthy-male-volunteers
#2
Milko Radicioni, Chiara Castiglioni, Andrea Giori, Irma Cupone, Valeria Frangione, Stefano Rovati
A new orodispersible film formulation of the phosphodiesterase type 5 inhibitor, sildenafil, has been developed to examine the advantages of an orally disintegrating film formulation and provide an alternative to the current marketed products for the treatment of erectile dysfunction. The pharmacokinetics of the sildenafil 100 mg orodispersible film (IBSA) was compared to that of the conventional marketed 100 mg film-coated tablet (Viagra(®)) after single-dose administration to 53 healthy male volunteers (aged 18-51 years) in a randomized, open, two-way crossover bioequivalence study...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28440049/analytical-based-methodologies-for-examining-the-in-vitro-absorption-distribution-metabolism-and-elimination-adme-of-silver-nanoparticles
#3
Sesha L A Paluri, John D Ryan, Nhi H Lam, Dhriti Nepal, Ioana E Sizemore
The clinical applications of silver nanoparticles (AgNPs) remain limited due to the lack of well-established methodologies for studying their nanokinetics. Hereby, the primary goal is to adapt a suite of analytical-based methodologies for examining the in vitro absorption, distribution, metabolism, and elimination of AgNPs. Vero 76 and HEK 293 cells are exposed to ≈10-nm spherical AgNPs(+) and AgNPs(-) at relevant concentrations (0-300 µg mL(-1) ) and times (4-48 h). Absorption: Inductively coupled plasma optical emission spectroscopy (ICP-OES) demonstrates that the two AgNP formulations are not bioequivalent...
April 25, 2017: Small
https://www.readbyqxmd.com/read/28440004/safety-and-effectiveness-of-room-temperature-stable-recombinant-factor-viia-in-patients-with-haemophilia-a-or-b-and-inhibitors-results-of-a-multinational-prospective-observational-study
#4
K Kavakli, F Demartis, M Karimi, P Eshghi, D Neme, H Chambost, L Sommer, M Zak, G Benson
INTRODUCTION: A room temperature stable formulation of recombinant activated factor VII (NovoSeven(®) ), allowing convenient storage and therefore improved treatment access, has been developed. Bioequivalence to the previous NovoSeven(®) was demonstrated in healthy humans, leading to European approval (2008). Although no confirmed cases of neutralising antibodies to rFVIIa in patients with haemophilia A or B have been observed with the original formulation, changes in formulation or storage condition may alter immunogenicity...
April 24, 2017: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/28438257/pharmacokinetics-and-relative-bioavailability-of-two-allopurinol-tablets-in-healthy-chinese-volunteers%C3%A2
#5
Zhen-Yan Hou, Hua-Lin Cai, Yang Deng, Zhi-Hua Li, Si-Si Cao, Ying Chen, Yao Li, Miao Yan, Bi-Kui Zhang
OBJECTIVE: To evaluate the pharmacokinetics and relative bioavailability of two allopurinol tablets in healthy Chinese volunteers. METHODS: A single-center, randomized, cross-over, two-period study design was conducted in healthy male subjects who were identified as not carrying the HLA-B*58:01 allele. Under fasting conditions, a single oral dose of 300 mg test or reference tablets was given with a 1-week washout period. The blood samples were collected for up to 12 hours after the administration and the plasma concentrations of allopurinol were determined by high performance liquid chromatography...
April 25, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28435140/biowaiver-monographs-for-immediate-release-solid-oral-dosage-forms-enalapril
#6
REVIEW
Roger K Verbeeck, Isadore Kanfer, Raimar Löbenberg, Bertil Abrahamsson, Rodrigo Cristofoletti, D W Groot, Peter Langguth, James E Polli, Alan Parr, Vinod P Shah, Mehul Mehta, Jennifer B Dressman
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence testing for the marketing authorization of immediate release, solid oral dosage forms containing enalapril maleate are reviewed. Enalapril, a prodrug, is hydrolyzed by carboxylesterases to the active angiotensin-converting enzyme inhibitor enalaprilat. Enalapril as the maleate salt is shown to be highly soluble, but only 60 to 70% of an orally administered dose of enalapril is absorbed from the gastrointestinal tract into the enterocytes...
April 20, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28432741/pharmacokinetic-and-pharmacodynamic-effects-of-two-omeprazole-formulations-on-stomach-ph-and-gastric-ulcer-scores
#7
S Raidal, F M Andrews, S G Nielsen, G Trope
REASONS FOR PERFORMING THE STUDY: Limited data are available on the relative pharmacokinetics and pharmacodynamics of different omeprazole formulations. OBJECTIVES: To compare pharmacokinetic and pharmacodynamic effects of a novel omeprazole formulation against a currently registered product. STUDY DESIGN: Masked two period, two treatment crossover. METHODS: Twelve clinically healthy horses were studied over two 6-day treatment periods...
April 22, 2017: Equine Veterinary Journal
https://www.readbyqxmd.com/read/28432051/impact-of-study-outcome-on-submission-and-acceptance-metrics-for-peer-reviewed-medical-journals-six-year-retrospective-review-of-all-completed-glaxosmithkline-human-drug-research-studies
#8
Gary Evoniuk, Bernadette Mansi, Barbara DeCastro, Jennie Sykes
Objectives To determine whether the outcome of drug studies influenced submission and/or acceptance rates for publication in peer reviewed medical journals.Design A six year retrospective review of publication status by study outcome for all human drug research studies conducted by a single industry sponsor (GlaxoSmithKline) that completed from 1 January 2009 to 30 June 2014 and were therefore due for manuscript submission (per the sponsor's policy) to peer reviewed journals within 18 months of study completion-that is, 31 December 2015...
April 21, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28425029/comparison-of-a-novel-formulation-of-abiraterone-acetate-vs-the-originator-formulation-in-healthy-male-subjects-two-randomized-open-label-crossover-studies
#9
Ronald Goldwater, Azra Hussaini, Bill Bosch, Paul Nemeth
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 abiraterone exposure. Abiraterone acetate fine particle (AAFP) is a proprietary formulation (using SoluMatrix Fine Particle Technology™) designed to increase the oral bioavailability of abiraterone acetate. Here, we report on two phase I studies in healthy male subjects aged 18-50 years...
April 19, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28414137/novel-dabigatran-etexilate-hemisuccinate-loaded-polycap-physicochemical-characterisation-and-in-vivo-evaluation-in-beagle-dogs
#10
Jung Hyun Cho, Jin Cheul Kim, Hyung-Seo Kim, Dong Shik Kim, Kyeong Soo Kim, Yong Il Kim, Chul Soon Yong, Jong Oh Kim, Yu Seok Youn, Kyung Taek Oh, Jong Soo Woo, Han-Gon Choi
The purpose of this study was to develop a novel dabigatran etexilate hemisuccinate (DEH) salt-loaded polycap with bioequivalence to the dabigatran etexilate mesylate (DEM)-loaded commercial product. DEH prepared with dabigatran etexilate base (DE) and succinic acid was less hygroscopic but less soluble than DEM. Numerous micronized DEHs and DEH-loaded solid dispersions were prepared employing the spiral jet-milling and spray-drying techniques, respectively. Among the formulations prepared, a micronized DEH prepared with the injection air at 1...
April 13, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28412689/simple-rapid-and-highly-sensitive-hplc-method-for-measurement-of-lamotrigine-in-human-plasma-and-its-clinical-applications
#11
Abdul Sami Shaikh, Wenlong Li, Guiyan Yuan, Meimei Gao, Chunmei Geng, Nan Guo, Ruichen Guo
Spikes in Lamotrigine concentrations levels and associated clinical toxicity may occur unpredictably. This study describes the development and validation of a simple, more rapid, highly sensitive and economical method for measuring Lamotrigine (LTG) concentration levels in human plasma using HPLC-UV and its clinical applications. Analyte from plasma was extracted with methanol (protein precipitation) and separated on the analytical column Diamonsil C18 (150mm×4.6mm, 5μm) Waters-Milford, MA, United States...
November 2016: Pakistan Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28410800/superparamagnetic-graphene-oxide-based-dispersive-solid-phase-extraction-for-preconcentration-and-determination-of-tamsulosin-hydrochloride-in-human-plasma-by-high-performance-liquid-chromatography-ultraviolet-detection
#12
Yaser Pashaei, Fatemeh Ghorbani-Bidkorbeh, Maryam Shekarchi
In the present study, superparamagnetic graphene oxide-Fe3O4 nanocomposites were successfully prepared by a modified impregnation method (MGOmi) and their application as a sorbent in the magnetic-dispersive solid phase extraction (M-dSPE) mode to the preconcentration and determination of tamsulosin hydrochloride (TMS) in human plasma was investigated by coupling with high performance liquid chromatography-ultraviolet detection (HPLC-UV). The structure, morphology and magnetic properties of the prepared nanocomposites were characterized using X-ray diffraction (XRD), Fourier transform infrared spectroscopy (FT-IR), scanning electron microscopy (SEM), energy dispersive X-ray spectroscopy (EDX), and vibrating sample magnetometry (VSM)...
March 19, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/28406090/pharmacokinetic-comparison-using-two-tablets-of-an-evogliptin-metformin-xr-2-5-500%C3%A2-mg-fixed-dose-combination-vs-1-tablet-each-of-evogliptin-5-mg-and-metformin-xr-1-000-mg%C3%A2
#13
Sumin Yoon, Su-Jin Rhee, Sang-In Park, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, SeungHwan Lee, Kyung-Sang Yu
OBJECTIVES: The aim of this study was to compare the pharmacokinetic (PK) characteristics of evogliptin and metformin following the administration of 2 evogliptin/metformin extended-release (XR) 2.5/500 mg FDC tablets with the coadministration of separate evogliptin 5-mg and metformin XR 1,000-mg tablets (separate formulations). METHODS: A randomized, two-period, two-sequence crossover study was conducted. Subjects were randomly assigned to receive 2 FDC tablets or the individual tablets, followed by a 14-day washout period and the administration of the alternate treatment...
April 13, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28398400/-bioequivalence-and-excipients-the-case-of-tirofiban-a-warning-from-the-italian-society-of-interventional-cardiology-sici-gise
#14
Marianna Adamo, Roberto Bonmassari, Guglielmo Bernardi, Paola Colombo, Giovanni Esposito, Marco Ferlini, Alessio Gaetano La Manna, Ugo Limbruno, Alfredo Marchese, Ciro Mauro, Alberto Menozzi, Antonino Nicosia, Stefano Rigattieri, Giuseppe Tarantini, Fabio Tarantino, Marco Valgimigli, Ferdinando Varbella, Giuseppe Musumeci
No abstract text is available yet for this article.
February 2017: Giornale Italiano di Cardiologia
https://www.readbyqxmd.com/read/28392509/bioequivalence-and-pharmacokinetic-profiles-of-agomelatine-25-mg-tablets-in-healthy-chinese-subjects-a-four-way-replicate-crossover-study-demonstrating-high-intra-and-inter-individual-variations
#15
Cuiyun Li, Jing Xu, Yan Zheng, Guiling Chen, Jianmeng Wang, Liying Ma, Yan Qiao, Junqi Niu, Min Wu, Hong Zhang, Xiaojiiao Li, Hong Chen, Xiaoxue Zhu, Chengjiao Liu, Yanhua Ding
The present study was designed to assess the bioequivalence of two agomelatine formulations (25-mg tablets) in healthy Chinese male subjects. This single-dose, open-label, randomized, four-way replicate study with a 1-week washout period was conducted in 60 healthy Chinese male volunteers under fasting conditions. Blood samples were collected over a 12-h period after a single dose of the 25-mg agomelatine test (T) formulation or a reference (R) formulation, and the drug concentrations were assayed by liquid chromatography tandem mass spectrometry (LC-MS/MS)...
April 8, 2017: Chemical & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28379643/integrating-in-vitro-modeling-and-in-vivo-approaches-to-investigate-warfarin-bioequivalence
#16
Xinyuan Zhang, Hong Wen, Jianghong Fan, Bradley Vince, Tonglei Li, Wei Gao, Minori Kinjo, Jill Brown, Wanjie Sun, Wenlei Jiang, Robert Lionberger
We demonstrate the use of modeling and simulation to investigate bioequivalence concerns raised about generic warfarin products. To test the hypothesis that the loss of isopropyl alcohol and slow dissolution in acidic pH have significant impact on the pharmacokinetics of warfarin sodium tablets, we conducted physiologically based pharmacokinetic absorption modeling and simulation using formulation factors, or in vitro dissolution profiles as input parameters. Sensitivity analyses indicated that warfarin pharmacokinetics was not sensitive to solubility, particle size and density, or dissolution rate in pH 4...
April 5, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28375032/pharmacodynamic-properties-and-bioequivalence-of-dalteparin-sodium-subcutaneous-injection-in-healthy-chinese-male-subjects
#17
Lijin Yu, Xin Guo, Sujie Jia, Yuanyuan Xiang, Zhigang Ding, Ren Guo
1. Dalteparin sodium (DS) is a low molecular weight heparin that is widely used in the treatment of thromboembolism. The purpose of this study was to compare the pharmacodynamic properties and bioequivalence of the two formulations of DS with subcutaneous injection in healthy Chinese male subjects. 2. In this randomized, open-label, two-period crossover study, a total of 24 male subjects were recruited to receive single subcutaneous doses of test and reference dalteparin sodium injection in 2 different sequences (12 subjects each) with a 7-day washout period...
April 4, 2017: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
https://www.readbyqxmd.com/read/28374622/pharmacokinetic-drug-evaluation-of-saxagliptin-plus-dapagliflozin-for-the-treatment-of-type-2-diabetes
#18
André J Scheen
Combining a dipeptidyl peptidase-4 inhibitor and a sodium-glucose cotransporter type 2 inhibitor is an attractive option to treat hyperglycaemia in type 2 diabetes. Areas covered: The saxagliptin plus dapagliflozin combination is carefully analysed, focusing on: 1) pharmacokinetic properties, 2) pharmacodynamics data, and 3) results of randomised controlled trials (dual combination versus either monotherapy, sequential therapy saxagliptin added to dapagliflozin or dapagliflozin added to saxagliptin). Expert opinion: Pharmacokinetic findings demonstrate the absence of drug-drug interaction and the bioequivalence of the FDC compared with separated tablets...
May 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28374512/pharmacokinetic-analysis-of-inhaled-salmeterol-in-asthma-patients-evidence-from-two-dry-powder-inhalers
#19
Konstantina Soulele, Panos Macheras, Vangelis Karalis
Salmeterol (SAL) is a long-acting β2-adrenergic agonist, which is widely used in the asthma therapy. The aim of this study was to investigate the pharmacokinetics (PK) of inhaled SAL in asthma patients using two different dry powder inhalers. This analysis was based on data from 45 subjects who participated in a two-sequence, four period crossover bioequivalence (BE) study after single administration of the test (T) and reference (R) products. In order to mimic more closely the real treatment conditions, activated charcoal was not co-administered...
April 3, 2017: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/28371488/bioequivalence-study-of-warfarin-in-healthy-chinese-volunteers-with-a-validated-high-performance-liquid-chromatography-mass-spectrometry-method
#20
Wenlong Li, Fanlong Bu, Rong Li, Benjie Wang, Abdul Sami Shaikh, Yunyun Zhang, Ruichen Guo, Rui Zhang
This study was designed to investigate the pharmacokinetics of an innovative film-coated warfarin sodium tablet and to compare it with the marketed sugar-coated warfarin sodium tablet in humans. A single-dose, open-label, randomized, two-way crossover study was performed in 24 healthy Chinese male volunteers. They were administered 2.5 mg of innovative film-coated warfarin sodium tablets or the marketed sugar-coated warfarin sodium tablets. Blood samples were collected at different time points after dosing for investigation of the pharmacokinetics of warfarin in human plasma...
April 3, 2017: Clinical Pharmacology in Drug Development
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