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Bioequivalence

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https://www.readbyqxmd.com/read/28645021/development-a-validated-highly-sensitive-lc-ms-ms-method-for-simultaneous-quantification-of-ledipasvir-sofosbuvir-and-its-major-metabolite-gs-331007-in-human-plasma-application-to-a-human-pharmacokinetic-study
#1
Ola M Abdallah, Ahmed M Abdel-Megied, Amira S Gouda
A highly sensitive and rapid LC-MS/MS method was developed, fully optimized and validated for the simultaneous determination of Ledipasvir (LED) and Sofosbuvir (SOF) in the presence of its major metabolite GS-331007 in human plasma using Daclatasvir as internal standard (IS). The extraction of analytes and IS from plasma was performed using liquid-liquid extraction with ethyl acetate. The chromatographic separation of these prepared samples was achieved on Xterra MS C8 column (4.6×50mm,5μm) using gradient elution with a mobile phase of ammonium formate buffer (pH 3...
June 20, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28639216/biocomparison-study-of-adult-and-paediatric-dose-strengths-of-the-prostacyclin-receptor-agonist-selexipag
#2
Margaux Boehler, Shirin Bruderer, Ivan Ulč, Jasper Dingemanse
BACKGROUND AND OBJECTIVES: Selexipag is an oral, non-prostanoid, selective prostacyclin receptor agonist recently marketed for the treatment of pulmonary arterial hypertension (PAH) in adults. Selexipag may also be an effective treatment in children with PAH. The aim of this study was to compare the pharmacokinetics of selexipag and its active metabolite ACT-333679 following single oral administration of one tablet of 200 µg selexipag (Treatment A) vs. 4 paediatric tablets of 50 µg (Treatment B) in healthy adult male subjects...
June 21, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/28639119/a-pharmacokinetic-drug-drug-interaction-study-between-selexipag-and-midazolam-a-cyp3a4-substrate-in-healthy-male-subjects
#3
Pierre-Eric Juif, Margaux Boehler, Yves Donazzolo, Shirin Bruderer, Jasper Dingemanse
PURPOSE: In vitro data showed that selexipag and its active metabolite (ACT-333679) have an inductive effect on CYP3A4, CYP2B6, and CYP2C9 at concentrations approximately 100-fold higher than the maximum plasma concentration (C max) measured under steady-state conditions. In order to confirm in vivo the lack of induction at the enterocyte level, we assessed the effect of selexipag on midazolam, a substrate of hepatic and intestinal CYP3A4. METHODS: This study was conducted according to an open-label, randomized, two-way crossover design...
June 21, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28637670/a-randomised-double-blind-trial-to-demonstrate-bioequivalence-of-gp2013-and-reference-rituximab-combined-with-methotrexate-in-patients-with-active-rheumatoid-arthritis
#4
Josef S Smolen, Stanley B Cohen, Hans-Peter Tony, Morton Scheinberg, Alan Kivitz, Andra Balanescu, Juan Gomez-Reino, Liyi Cen, Peijuan Zhu, Tamas Shisha
OBJECTIVES: The aim of this report is to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence as well as similar efficacy, safety and immunogenicity between GP2013, a biosimilar rituximab, and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate response or intolerance to tumour necrosis factor inhibitor (TNFi) treatment. METHODS: In this multinational, randomised, double-blind, parallel-group study, 312 patients with active disease despite prior TNFi therapy were randomised to receive GP2013 or either the EU (RTX-EU) or the US (RTX-US) reference product, along with methotrexate (MTX) and folic acid...
June 21, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28636828/pharmacokinetic-drug-evaluation-of-extended-release-lorcaserin-for-the-treatment-of-obesity
#5
Kathryn Hurren, Marissa W Dunham
Lorcaserin is a serotonin 2C receptor antagonist that was FDA approved in 2012. Lorcaserin is recently available as an extended-release (ER) formulation for the treatment of obesity as an adjunct to lifestyle modification. Areas covered: The pharmacokinetics, pharmacodynamics, efficacy, and safety of lorcaserin ER will be reviewed. Expert opinion: Lorcaserin ER 20mg daily provides drug exposure bioequivalent to lorcaserin immediate release (IR) 10mg twice daily. Lorcaserin IR is associated with 3.3% and 3.0% placebo-subtracted weight loss in patients without and with diabetes, respectively...
June 21, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28633956/a-time-adjustable-pulsatile-release-system-for-ketoprofen-in-vitro-and-in-vivo-investigation-in-a-pharmacokinetic-study-and-an-ivivc-evaluation
#6
Haiying Wang, Lizhen Cheng, Haoyang Wen, Caiyan Li, Yuenan Li, Xiaoyu Zhang, Yongfei Wang, Yanyan Wang, Tuanjie Wang, Weisan Pan, Xinggang Yang
A time-adjustable pulsatile release system (TAPS) containing ketoprofen (KF) as an active pharmaceutical agent was developed having been designed for bedtime dosing and releasing drug in the early morning to control the symptoms of rheumatoid arthritis (RA). The formulation involved a tablet core (KF) and a control-release layer, and the coating membrane was composed of EC and Eudragit L100. A single-factor study, a central composite design and a response surface method were selected to optimize the formula and the optimum prescription was as follows: tablet core (KF 50mg, MCC 70mg, lactose 40mg, L-HPC 38mg), and film (EC 7...
June 17, 2017: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/28628269/effect-of-food-intake-on-the-pharmacokinetics-of-a-novel-methylphenidate-extended-release-oral-suspension-for-attention-deficit-hyperactivity-disorder
#7
Floyd R Sallee, Donna R Palumbo, Richat Abbas, Sally A Berry, Shivanand P Puthli, Kalyan K Kathala
We conducted an open-label, single-dose, randomized, crossover study in healthy adults to assess the impact of food on the bioavailability of 60 mg methylphenidate extended-release oral suspension (MEROS; Quillivant XR™)-a long-acting stimulant for the treatment of attention deficit hyperactivity disorder-by comparing the pharmacokinetic parameters under fed and fasting conditions. When MEROS 60 mg was administered under fed conditions compared with fasting conditions, the exposure of methylphenidate (d enantiomer) was higher, with a mean area under the plasma concentration-vs-time curve (AUC)0-t of 160...
June 19, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28625505/bioequivalence-study-of-a-new-fixed-dose-combination-tablet-containing-s-amlodipine-nicotinate-and-olmesartan-medoxomil-in-healthy-korean-male-subjects
#8
Mi Jin Oh, Hyun Hwan Hwang, Hyun Gyu Kim, Geun Hyeog Lee, Yun-Seok Cho, Sun Young Lee, Soo Yeon Kang, Kyung Hee Cho, Yun Young Lee, Yun Jeong Lee, Choon-Gon Jang, Seok-Yong Lee
PURPOSE: A fixed-dose combination (FDC) pill of amlodipine (relatively old calcium channel blocker as dihydropyridine) and olmesartan (relatively new angiotensin II receptor blocker) is used for hypertension that is not adequately controlled with a single-formulation drug. Because the FDC is a one-pill formulation, and amlodipine and olmesartan have different mechanisms of action, it is expected to improve patients' medication compliance and have an increased blood pressure-lowering efficacy...
June 15, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28620937/testing-for-bioequivalence-of-highly-variable-drugs-from-tr-rt-crossover-designs-with-heterogeneous-residual-variances
#9
Qing Kang, Christopher I Vahl
Traditional bioavailability studies assess average bioequivalence (ABE) between the test (T) and reference (R) products under the crossover design with TR and RT sequences. With highly variable (HV) drugs whose intrasubject coefficient of variation in pharmacokinetic measures is 30% or greater, assertion of ABE becomes difficult due to the large sample sizes needed to achieve adequate power. In 2011, the FDA adopted a more relaxed, yet complex, ABE criterion and supplied a procedure to assess this criterion exclusively under TRR-RTR-RRT and TRTR-RTRT designs...
June 16, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/28619129/randomized-two-way-crossover-bioequivalence-study-of-levamlodipine-besylate-tablets-in-healthy-chinese-subjects%C3%A2
#10
Su-Mei Xu, Yu-Lu Wang, Dan Li, Xiao-Min Li, Dai Li, Ping-Sheng Xu
OBJECTIVE: The present bioequivalence study was designed to compare the newly-developed levamlodipine besylate 2.5-mg tablet (test) with that of its 2.5-mg marketed counterpart (reference) in healthy Chinese adult male volunteers. METHODS: A single-dose, randomized, open-label, two-period, and two-treatment self-crossover study was conducted in healthy Chinese volunteers after informed consent was obtained. In each part of the study, the subjects were randomly assigned to receive the test or reference product (5 mg levamlodipine) in a 1 : 1 ratio, and then received the alternative product, following a 14-day washout period...
June 16, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28618191/a-proton-pump-inhibitor-in-the-reformulation-setting-bioequivalence-and-potential-implications-for-long-term-safety
#11
E Dubcenco, P M Beers-Block, L P Kim, P Schotland, J G Levine, C A McCloskey, E D Bashaw
Proton pump inhibitors (PPIs) have become known for both their therapeutic effect and good safety profile. An application was submitted to the US Food and Drug Administration for approval of a reformulated PPI product that failed bioequivalence testing, but was submitted on the basis of the long history of PPI use as a "surrogate" for equivalence. This review evaluates the safety data for PPIs, discuss variability of pharmacokinetic parameters of PPIs in the reformulation setting, and potential implications of those changes for long-term safety...
June 15, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28603636/make-up-a-missed-lesson-new-policy-to-ensure-the-interchangeability-of-generic-drugs-in-china
#12
Baobin Huang, Sarah L Barber, Mingzhe Xu, Shuanghong Cheng
Generic drugs should be interchangeable with originators in terms of quality and efficacy. With relative lower prices, generic drugs are playing an important role in controlling health expenditures and ensuring access. However, the widespread understanding of "cheap price equals low quality" has a negative impact on the acceptance of generic drugs. In China, medical doctors doubt the efficacy and quality of generic drugs manufactured domestically. To address these concerns, the Chinese State Council released a policy in 2016 to ensure the interchangeability by re-evaluating the quality and efficacy of generic drugs...
June 2017: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28597911/digitizing-medicines-for-remote-capture-of-oral-medication-adherence-using-co-encapsulation
#13
Sara H Browne, Charles Peloquin, Frank Santillo, Richard Haubrich, Leticia Muttera, Kathleen Moser, George Savage, Constance Benson, Terrence Blaschke
High-resolution measurement of medication adherence is essential to personalized drug therapy . An FDA-cleared device, using an edible ingestion sensor (IS), external wearable patch and paired mobile device, can detect and record ingestion events. Oral medications must be combined with an IS to generate precise 'digitized-medication' ingestion records. We developed a GMP-protocol to repackage oral medications with the IS within certified Capsugel® capsules, termed co-encapsulation (CoE). A randomized bioequivalence study of CoE-IS-Rifamate (Isoniazid/Rifampin 150/300mg) versus native-Rifamate was conducted in 12 patients with active Mycobacterium Tuberculosis (MTB) and demonstrated bioequivalence using the population method ratio test (95% CI)...
June 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28587612/lipodox%C3%A2-generic-doxorubicin-hydrochloride-liposome-injection-in-vivo-efficacy-and-bioequivalence-versus-caelyx%C3%A2-doxorubicin-hydrochloride-liposome-injection-in-human-mammary-carcinoma-mx-1-xenograft-and-syngeneic-fibrosarcoma-wehi-164-mouse-models
#14
Vinod Burade, Subhas Bhowmick, Kuntal Maiti, Rishit Zalawadia, Harry Ruan, Rajamannar Thennati
BACKGROUND: Doxorubicin (DXR) hydrochloride (HCl) liposome injection is an important part of the treatment armamentarium for a number of cancers. With growing needs for affordable and effective anticancer treatments, the development of generics is becoming increasingly important to facilitate patient access to vital medications. We conducted studies in relevant mouse models of cancer to compare the preclinical antitumour efficacy and plasma pharmacokinetic profile of a proposed generic DXR HCl liposome injection developed by Sun Pharmaceutical Industries Ltd...
June 6, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28581645/effects-of-a-nutritional-protein-rich-drink-on-the-pharmacokinetics-of-elvitegravir-cobicistat-emtricitabine-tenofovir-alafenamide-and-tenofovir-compared-with-a-standard-meal-in-healthy-japanese-male-subjects
#15
REVIEW
Hiroyuki Yamada, Ippei Ikushima, Takanori Nemoto, Tomohiro Ishikawa, Noriko Ninomiya, Shin Irie
This study investigated the effects of ingested meal types on the pharmacokinetics of elvitegravir (EVG), cobicistat (COBI), emtricitabine (FTC), tenofovir alafenamide (TAF), and tenofovir (TFV) following a single administration of the single-tablet regimen (STR) of EVG/COBI/FTC/TAF (150/150/200/10 mg) in Japanese HIV-negative healthy subjects (n = 12). In this open-label, randomized, 3-way crossover study, the bioequivalence of the EVG/COBI/FTC/TAF STR following ingestion of a nutritional protein-rich drink with a reference treatment of taking a standard breakfast was evaluated...
June 5, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28578848/study-on-pharmacokinetics-and-bioequivalence-of-vonoprazan-pyroglutamate-in-rats-by-liquid-chromatography-with-tandem-mass-spectrometry
#16
Yuan Qiao, Jun Zhao, Xuanfeng Yue, Yang Zhang, Ruitao Zhang, Yuan Xu, Xiuling Tang, Xueying Liu, Qingwei Wang
Vonoprazan Fumarate (TAK-438F) is a new and effective drug approved in Japan in 2014 for treatment and prevention of acid-related diseases (ARDs), which exhibits many advantages compared with traditional proton-pump inhibitors (PPIs). However, the clinical applications of TAK0-438F suffers limitation due to the lack of injection dosage form. Efforts to overcome this limitation lead to the systhesis of Vonoprazan pyroglutamate (TAK-438P) for its high water solubility and more potent antisecretory effect. This was the first report to establish and validate a reliable and sensitive LC-MS/MS method for the quantification of TAK-438P in rat plasma and tissues (heart, liver, spleen, liver, kidney, rain, stomach and small intestine)...
August 1, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28578191/determination-of-quetiapine-in-human-plasma-by-lc-ms-ms-and-its-application-in-a-bioequivalence-study
#17
Min Li, Shuo Zhang, Aixin Shi, Wenyuan Qi, Yao Liu
A selective, sensitive and simple high performance liquid chromatography tandem mass spectrometric (HPLC-MS/MS) method for determining quetiapine in human plasma was developed and validated. One-step protein precipitation with acetonitrile was used to pretreat plasma samples. Carbamazepine was used as internal standard. An automated liquid handling workstation with 96-well protein precipitate plate was used to facilitate the process. The chromatographic separation was achieved on a Waters Xbridge C18 column (3...
May 29, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28577294/comparison-of-generic-drug-reviews-for-marketing-authorization-between-japan-and-canada
#18
Ryosuke Kuribayashi, Scott Appleton
PURPOSE: Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. OBJECTIVE: The objective of this study was to examine generic drug reviews in Japan and Canada. METHODS: We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms...
June 2, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28571121/mechanistic-oral-absorption-modeling-and-simulation-for-formulation-development-and-bioequivalence-evaluation-report-of-an-fda-public-workshop
#19
EDITORIAL
Xinyuan Zhang, John Duan, Filippos Kesisoglou, Jasmina Novakovic, Gordon Amidon, Masoud Jamei, Viera Lukacova, Thomas Eissing, Eleftheria Tsakalozou, Liang Zhao, Robert Lionberger
No abstract text is available yet for this article.
June 1, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28566743/pharmacokinetic-evaluation-of-empagliflozin-in-healthy-egyptian-volunteers-using-lc-ms-ms-and-comparison-with-other-ethnic-populations
#20
Bassam M Ayoub, Shereen Mowaka, Eman S Elzanfaly, Nermeen Ashoush, Mohamed M Elmazar, Shaker A Mousa
The present study considered the pharmacokinetic evaluation of empagliflozin after administration to Egyptian volunteers, and the results were compared with other ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies and to assess potential subgroup differences. The design of the study was as an open labeled, randomized, one treatment, one period, single dose pharmacokinetic study. The main pharmacokinetic parameters estimated were Cmax, Tmax, t1/2, elimination rate constant, AUC0-t and AUC0-inf...
May 31, 2017: Scientific Reports
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