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Bioequivalence

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https://www.readbyqxmd.com/read/29786959/assessment-of-the-drug-interaction-potential-of-ertugliflozin-with-sitagliptin-metformin-glimepiride-or-simvastatin-in-healthy-subjects
#1
Vikas Kumar Dawra, David L Cutler, Susan Zhou, Rajesh Krishna, Haihong Shi, Yali Liang, Christine Alvey, Anne Hickman, Didier Saur, Steven G Terra, Vaishali Sahasrabudhe
Ertugliflozin, a sodium-glucose cotransporter 2 inhibitor for the treatment of adults with type 2 diabetes mellitus, is expected to be coadministered with sitagliptin, metformin, glimepiride, and/or simvastatin. Four separate open-label, randomized, single-dose, crossover studies were conducted in healthy adults to assess the potential pharmacokinetic interactions between ertugliflozin 15 mg and sitagliptin 100 mg (n = 12), metformin 1000 mg (n = 18), glimepiride 1 mg (n = 18), or simvastatin 40 mg (n = 18)...
May 22, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29780236/pharmacokinetic-comparison-of-a-fixed-dose-combination-versus-concomitant-administration-of-fimasartan-amlodipine-and-rosuvastatin-using-partial-replicated-design-in-healthy-adult-subjects
#2
Minkyung Oh, Jong-Lyul Ghim, Sung-Eun Park, Eun-Young Kim, Jae-Gook Shin
Objective: The aim of this study was to compare the pharmacokinetics (PK) and safety profiles of a fixed-dose combination (FDC) formulation of fimasartan, amlodipine, and rosuvastatin with the co-administration of the two products by using a replicated crossover study design in healthy male subjects. Results: This was an open-label, randomized, three-sequence, three-period replicated crossover study in healthy male subjects. The replicated crossover design was done because of high coefficient of variation of PK parameter for fimasartan, that is, >30%...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29777529/pharmacokinetics-of-ads-5102-amantadine-extended-release-capsules-administered-once-daily-at-bedtime-for-the-treatment-of-dyskinesia
#3
Robert A Hauser, Rajesh Pahwa, William A Wargin, Cindy J Souza-Prien, Natalie McClure, Reed Johnson, Jack T Nguyen, Rajiv Patni, Gregory T Went
BACKGROUND: Preclinical and clinical studies suggest amantadine immediate-release (IR) may reduce dyskinesia in Parkinson's disease (PD), although higher doses are associated with increased CNS adverse events (AEs). ADS-5102 is an extended release amantadine capsule formulation, designed for once-daily dosing at bedtime (qhs) to provide high concentrations upon waking and throughout the day, with lower concentrations in the evening. The pharmacokinetics (PK) of ADS-5102 were assessed in two phase I studies in healthy subjects, and a blinded, randomized phase II/III dose-finding study in PD patients...
May 18, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29771145/standard-curve-range-for-clinical-sample-analysis-of-oral-bioavailability-bioequivalence-studies-dilemma-introspection-and-strategies
#4
Prashant Tripathi, Harilal Patel, Tanuja Kulshrestha, Nuggehally R Srinivas
No abstract text is available yet for this article.
May 17, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29768717/pharmacokinetics-and-target-attainment-of-ceftobiprole-in-asian-and-non-asian-subjects
#5
A E Muller, N Punt, M Engelhardt, A H Schmitt-Hoffmann, J W Mouton
Ceftobiprole is a broad-spectrum cephalosporin. The objective of this study was to test the hypothesis that the pharmacokinetics (PK) and exposure of ceftobiprole in Asian subjects are similar to those in non-Asian subjects. Three approaches were followed. The first compared the individual PK estimates between the 2 subgroups derived from a population PK model previously built. Next, it was determined whether "Asian subject" was a significant covariate. Finally, a pharmacodynamic analysis was performed by comparing measures of exposure and target attainment...
May 16, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29765386/design-of-a-type-1-diabetes-vaccine-candidate-using-edible-plants-expressing-a-major-autoantigen
#6
Edoardo Bertini, Matilde Merlin, Elisa Gecchele, Andrea Puggia, Annalisa Brozzetti, Mauro Commisso, Alberto Falorni, Vittorio Bini, Victor Klymyuk, Mario Pezzotti, Linda Avesani
Type-1 diabetes (T1D) is a metabolic disease involving the autoimmune destruction of insulin-producing pancreatic beta cells. It is often diagnosed by the detection of autoantibodies, typically those recognizing insulin itself or the 65-kDa isoform of glutamic acid decarboxylase (GAD65). Oral insulin can be used to induce systemic immunological tolerance and thus prevent or delay the onset of T1D, suggesting that combination treatments with other autoantigens such as GAD65 could be even more successful. GAD65 has induced oral tolerance and prevented T1D in preclinical studies but it is difficult to produce in sufficient quantities for clinical testing...
2018: Frontiers in Plant Science
https://www.readbyqxmd.com/read/29758344/the-effects-of-three-absorption-modifying-critical-excipients-on-the-in-vivo-intestinal-absorption-of-six-model-compounds-in-rats-and-dogs
#7
Dahlgren David, Roos Carl, Johansson Pernilla, Tannergren Christer, Lundqvist Anders, Langguth Peter, Sjöblom Markus, Sjögren Erik, Lennernäs Hans
Pharmaceutical excipients that may affect gastrointestinal (GI) drug absorption are called critical pharmaceutical excipients (CPEs), or absorption-modifying excipients (AMEs) if they act by altering the integrity of the intestinal epithelial cell membrane. Some of these excipients increase intestinal permeability, and subsequently the absorption and bioavailability of the drug. This could have implications for both the assessment of bioequivalence and the efficacy of the absorption-enhancing drug delivery system...
May 11, 2018: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29758343/the-effect-of-the-composition-of-a-fixed-dose-combination-on-bioequivalence-results
#8
Šalandová Jana, Franc Aleš, Hofmann Jiří, Dumicic Aleksandra, Kukačková Lenka, Červená Tereza, Beránek Josef, Srbek Jan, Repický Andrej, Vladovičová Beata, Vetchý David
The purpose of this work was to develop a new supergeneric product Meloxicam/Omeprazole. Such a combination brings a benefit in terms of decreasing side effects for the patients using meloxicam. The new combination is composed of a meloxicam powder blend (MPB) and omeprazole gastro-resistant pellets (OAP) in hard gelatin capsules. The main tasks were to select the excipients to keep the functional layer of OAP active and to prove the bioequivalence to the original products of meloxicam tablets together with omeprazole capsules...
May 11, 2018: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29749718/bioequivalence-evaluation-of-two-oral-formulations-of-acetaminophen-in-healthy-subjects-results-from-a-randomized-single-blind-crossover-study
#9
Luis García Aguirre, Carlos Bohorquez Nassar, Isabel Ruiz Olmedo, Lara Dennie, Araceli G Medina Nolasco
Despite widespread availability of acetaminophen in Mexico, data on its pharmacokinetic properties in Mexican populations are limited. This single-center, single-blind, randomized, 2-period, 2-treatment, crossover, single-dose-per-period, 2-sequence study evaluated the bioequivalence of a test acetaminophen product available in Mexico compared with a reference 500-mg acetaminophen product in 28 healthy adults under fasting conditions. Blood samples were collected predose and at specified intervals across a 16-hour period following administration and were analyzed for acetaminophen using a validated reverse-phase high-performance liquid chromatography method...
May 11, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29749716/comparative-randomized-single-dose-two-way-crossover-open-label-study-to-determine-the-bioequivalence-of-two-formulations-of-dalfampridine-tablets
#10
Abdel Qader Al Bawab, Bashar A Alkhalidi, Esra'a Albarahmieh, Sami M A Qassim, Mohammad A D Al-Saifi
Dalfampridine is a medication that is approved by the US Food and Drug Administration to improve walking impairments in patients with multiple sclerosis (MS). The branded dalfampridine is enormously expensive; hence, the availability of generic dalfampridine will provide better access to the medication, especially for uninsured patients with MS. Bioequivalence studies are demanded by the regulatory authorities to allow the marketing of new generics of dalfampridine. The aim of this study was to assess the bioavailability of the generic (test) and branded (reference) formulations of 10 mg dalfampridine of extended-release tablets after oral administration to healthy adults under fed conditions...
May 11, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29747311/-study-of-bioequiavailability-of-paclitaxel-for-injection-albumin-bound-and-abraxane-and-the-efficacy-of-extension-treatments-in-patients-with-metastatic-breast-cancer
#11
L Bian, C Z Geng, Q C Ouyang, X C Hu, Y Y Peng, J Y Xiao, M X Wang, N Yang, J Yuan, Y M Wang, Z F Jiang
Objective: To compare the bioequiavailability of paclitaxel for injection (albumin bound) (PAB) and reference listed drug abraxane in the patients with metastatic breast cancer, and to investigate the safety and efficacy in the extension treatments of PAB. Methods: This study was random, two cycles, self-crossover control study in the bioequiavailability stage. PAB was the investigational drug T and Abraxane was the reference drug R. Patients were randomly assigned to two cycles therapy of either R→T or T→R(260 mg/m(2)/21d)...
April 24, 2018: Zhonghua Yi Xue za Zhi [Chinese medical journal]
https://www.readbyqxmd.com/read/29746726/formulation-and-in-vitro-in-vivo-correlation-between-two-candesartan-cilexetil-tablets
#12
Abdel Naser Zaid, Asma Radwan, Nidal Jaradat, Ayman Mousa, Nadia Ghazal, Rana Bustami
In this study, the in vitro and in vivo interchangeability between generic candesartan 16 mg and the branded formulation was assessed. The in vitro release of these products was conducted in 3 pH media (1.2, 5.0, and 6.8), and similarity factors (f2 ) were calculated. This bioequivalence study was a randomized, 2-period crossover study that included 42 healthy adult male subjects under fasting conditions with a 9-day washout. The pharmacokinetic (PK) parameters AUC0-last , AUC0-∞ , and Cmax , tmax , and the elimination half-life time were assessed based on the plasma concentrations of candesartan, using a newly developed and validated liquid chromatography-tandem mass spectrometry bioanalytical method with acceptable degrees of linearity, sensitivity, precision, and accuracy...
May 10, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29746133/in-vitro-dissolution-as-a-tool-for-formulation-selection-telmisartan-two-step-ivivc
#13
Alejandro Ruiz-Picazo, Mª Teresa Martinez-Martinez, Sarin Colon-Useche, Ramon Iriarte, Barbara Sanchez-Dengra, Marta Gonzalez-Alvarez, Alfredo Garcia-Arieta, Isabel Gonzalez Alvarez, Marival Bermejo
The main objective of this investigation was to develop an exploratory two-step level A IVIVC for three Telmisartan oral immediate release formulations, the reference product Micardis and two generic formulations (X1 and X2). Correlation was validated with a third test formulation Y1. Experimental solubility and permeability data was obtained to confirm that Telmisartan is a class II compound under the Biopharmaceutic Classification System. BE studies plasma profiles were combined using a previously published reference scaling procedure...
May 10, 2018: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/29742934/drug-information-association-pharmacovigilance-and-risk-management-strategies-2017-overview-of-the-generic-drug-program-and-surveillance
#14
Howard D Chazin, John R Peters, Debra M Catterson, James L Osterhout, Linda M Forsyth, Jung E Lee, Edward K Kim, Karen B Feibus
The US Food and Drug Administration's (FDA's) generic drug program has dramatically increased the availability of affordable, high quality generic drugs. The foundation of generic drug approvals is a two-tiered regulatory framework of pharmaceutical equivalence and bioequivalence. Intrinsic to both of these is consideration of the clinical relevance of formulation and bioequivalence data to support an inference of therapeutic equivalence, based on clear evidence that there are no significant differences between the generic drug and the brand name drug...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29737100/-lc-ms-ms-determination-of-tenofovir-in-human-plasma-and-its-bioequivalence
#15
Zhi-Hui Chen, Shi-Yin Feng, Feng Nan, Qin Yu, Mao-Zhi Liang
OBJECTIVE: To develop a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for detecting tenofovir in human plasma. METHODS: Twenty four healthy male volunteers received a single oral dose of 300 mg tenofovir disoproxil fumarate tablets under fasting and high-fat diet conditions in a randomized four-way crossover bioequivalence study with two preparations of tablets. Plasma samples were taken and analyzed using the LC-MS/MS method. The pharmacokinetic parameters of the two preparations were calculated and compared statistically to evaluate their bioequivalence using Phoenix Winnonlin6...
January 2018: Sichuan da Xue Xue Bao. Yi Xue Ban, Journal of Sichuan University. Medical Science Edition
https://www.readbyqxmd.com/read/29737099/-determination-of-voriconazole-in-human-plasma-and-its-bioequivalence-by-hplc-ms-ms
#16
Jin Xiang, Qin Yu, Mao-Zhi Liang, Yong-Ping Qin, Feng Nan
OBJECTIVE: To develop a high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method for the determination of voriconazole in human plasma and its bioequivalence. METHODS: 48 healthy male volunteers received a single dose of 200 mg voriconazole tablets in a two period (with two preparations) and randomized crossover bioequivalence study. Their plasma voriconazole was determined using HPLC-MS/MS. The pharmacokinetic parameters and bioequivalence of the two preparations were calculated with WinNonlin® 6...
January 2018: Sichuan da Xue Xue Bao. Yi Xue Ban, Journal of Sichuan University. Medical Science Edition
https://www.readbyqxmd.com/read/29726096/design-and-inference-for-3-stage-bioequivalence-testing-with-serial-sampling-data
#17
Fangrong Yan, Huihong Zhu, Junlin Liu, Liyun Jiang, Xuelin Huang
A bioequivalence test is to compare bioavailability parameters, such as the maximum observed concentration (Cmax ) or the area under the concentration-time curve, for a test drug and a reference drug. During the planning of a bioequivalence test, it requires an assumption about the variance of Cmax or area under the concentration-time curve for the estimation of sample size. Since the variance is unknown, current 2-stage designs use variance estimated from stage 1 data to determine the sample size for stage 2...
May 3, 2018: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/29719976/common-filing-deficiencies-in-abbreviated-new-drug-applications-containing-clinical-endpoint-studies
#18
Lewis J Fermaglich, Ru Chen, Carol Y Kim, Eunjung Esther Chuh, Teena Thomas, Daiva Shetty, Julia Lee, Johnny Young, Ying Fan
BACKGROUND: The objective of this report is to summarize common deficiencies identified in the filing reviews of abbreviated new drug applications (ANDAs) with clinical endpoint bioequivalence studies and skin irritation, sensitization, and adhesion (I/S/A) studies received by the US Food and Drug Administration (FDA) between 2007 and 2017, to help applicants avoid common deficiencies, minimize "refuse-to-receive" (RTR) actions, "information requests," and ANDA approval delays...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29708281/pharmacokinetics-safety-and-tolerability-of-obe022-a-selective-prostaglandin-f2%C3%AE-receptor-antagonist-tocolytic-a-first-in-human-trial-in-healthy-post-menopausal-women
#19
Oliver Pohl, Line Marchand, Jean-Pierre Gotteland, Simon Coates, Jörg Täubel, Ulrike Lorch
AIMS: Preterm birth remains a significant risk for later disability. The selective inhibition of the prostaglandin F2α receptor (FP) has significant advantages for a tocolytic. The pro-drug OBE022 and its metabolite OBE002 are novel FP antagonists under development for treating preterm labour. METHODS: We performed a prospective, first in human, Phase I, dose escalation, placebo-controlled, randomised trial at a clinical trial site in the UK. Placebo, single ascending doses (SAD) of 10, 30, 100, 300, 1000 or 1300 mg, and multiple ascending doses (MAD) over seven days of 100, 300 or 1000 mg per day; were administered to post-menopausal female volunteers...
April 30, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29707043/development-and-10-year-history-of-a-biosimilar-the-example-of-binocrit-%C3%A2
#20
REVIEW
Matti Aapro, Andriy Krendyukov, Nadja Höbel, Andreas Seidl, Pere Gascón
Patent expirations for several biological products have prompted the development of alternative versions, termed 'biosimilars', which have comparable quality, safety and efficacy to a licensed biological medicine (also referred to as the 'reference' medicine). The first biosimilars developed in oncology were the supportive-care agents filgrastim and epoetin. Binocrit® (HX575) is a biosimilar version of epoetin alfa, indicated in the oncology setting for the treatment of chemotherapy-induced anemia (CIA). The process for development and approval of Binocrit® as a biosimilar included extensive analytical characterization and comparison with the reference epoetin alfa...
2018: Therapeutic Advances in Medical Oncology
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