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Bioequivalence

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https://www.readbyqxmd.com/read/28712940/efficacy-pharmacokinetics-and-safety-of-the-biosimilar-ct-p10-compared-with-rituximab-in-patients-with-previously-untreated-advanced-stage-follicular-lymphoma-a-randomised-double-blind-parallel-group-non-inferiority-phase-3-trial
#1
Won Seog Kim, Christian Buske, Michinori Ogura, Wojciech Jurczak, Juan-Manuel Sancho, Edvard Zhavrid, Jin Seok Kim, José-Ángel Hernández-Rivas, Aliaksandr Prokharau, Mariana Vasilica, Rajinish Nagarkar, Dzhelil Osmanov, Larry W Kwak, Sang Joon Lee, Sung Young Lee, Yun Ju Bae, Bertrand Coiffier
BACKGROUND: Studies in patients with rheumatoid arthritis have shown that the rituximab biosimilar CT-P10 (Celltrion, Incheon, South Korea) has equivalent efficacy and pharmacokinetics to rituximab. In this phase 3 study, we aimed to assess the non-inferior efficacy and pharmacokinetic equivalence of CT-P10 compared with rituximab, when used in combination with cyclophosphamide, vincristine, and prednisone (CVP) in patients with newly diagnosed advanced-stage follicular lymphoma. METHODS: In this ongoing, randomised, double-blind, parallel-group, active-controlled study, patients aged 18 years or older with Ann Arbor stage III-IV follicular lymphoma were assigned 1:1 to CVP plus intravenous infusions of 375 mg/m(2) CT-P10 or rituximab on day 1 of eight 21-day cycles...
July 13, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28710684/utility-of-physiologically-based-pharmacokinetic-absorption-modeling-to-predict-the-impact-of-salt-to-base-conversion-on-prasugrel-hcl-product-bioequivalence-in-the-presence-of-proton-pump-inhibitors
#2
Jianghong Fan, Xinyuan Zhang, Liang Zhao
Prasugrel HCl may convert to prasugrel base during manufacturing or storage. It was reported that formulations with different ratios of salt to base were bioequivalent in healthy subjects, but formulations with a higher extent of conversion were not bioequivalent in subjects taking proton pump inhibitor (PPI) whose stomach pH is elevated. The objective of this study was to assess the magnitude of impact of salt-to-base conversion on prasugrel HCl products BE evaluation in healthy subjects on PPI. A physiologically based pharmacokinetic (PBPK) absorption model was constructed to predict pharmacokinetic (PK) profiles of active metabolite after oral administration of prasugrel HCl products containing various fractions of base based on the prasugrel salt and base intrinsic solubility...
July 14, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28709077/phytonanotherapy-for-management-of-diabetes-using-green-synthesis-nanoparticles
#3
K Anand, C Tiloke, Pragalathan Naidoo, A A Chuturgoon
The world has a rich diversity of indigenous medicinal plants. The World Health Organization (WHO) gives high priority to eco-friendly, non-hazardous and cost effective healthcare such as the use of medicinal plants to treat various illnesses, including Human immunodeficiency virus (HIV) infection and Acquired immune deficiency syndrome (AIDS), tuberculosis (TB), diabetes mellitus (DM), malaria, and cancer. In developing countries, a high proportion of the population tends to use complementary and alternative medicines (CAM) together with conventional prescription drugs...
June 27, 2017: Journal of Photochemistry and Photobiology. B, Biology
https://www.readbyqxmd.com/read/28708443/regulatory-approaches-and-considerations-in-establishing-bioequivalence-of-inhaled-compounds
#4
Irvin Mayers, Mohit Bhutani
To be considered bioequivalent to their branded counterparts, generic drugs must meet the standards for bioequivalence (BE) described by the regulatory agencies. While BE of generic inhalational drugs can be evaluated using a similar approach as that for oral dosage from products or drugs that are delivered systemically, the approach is insufficient to address the complexities of inhalational products (e.g., localized site of action, device-patient interface). Therefore, more considerations are needed and caution should be applied when evaluating BE of inhaled compounds...
July 14, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28706331/bioequivalence-of-generic-and-branded-amoxicillin-capsules-in-healthy-human-volunteers
#5
Priyanka Pathak, Vijaya A Pandit, Priti P Dhande
CONTEXT: The Medical Council of India urges doctors to prescribe generic drugs as far as possible. The Indian Medical Association had responded earlier saying that it requires guarantees on the quality of generic forms of drugs. Although no published scientific reports are available on the issue of therapeutic inequivalence, unconfirmed clinician accounts and newspaper reports of therapeutic inequivalence exist. AIM: This study was planned to ascertain whether bioequivalence of branded and generic amoxicillin capsule is comparable...
March 2017: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28702969/bi-layered-collagen-nano-structured-membrane-prototype-collagen-matrix-10826%C3%A2-for-soft-tissue-regeneration-in-rabbits-an-in-vivo-ultra-structural-study-of-the-early-healing-phase
#6
D De Santis, G B Menchini Fabris, J Lotti, C Palumbo, M Ferretti, R Castellani, T Lotti, G Zanotti, F Gelpi, C Covani, P F Nocini
Collagen Matrix (CM) 10826 is a nanostructured bi-layered collagen membrane obtained from type I and III porcine collagen, which in vitro has shown to have the potential to be a substitute and/or stimulant for soft oral tissue regeneration. The objective of this study was to evaluate the in vivo potential and safety of this membrane for soft tissue regeneration in the early stage of wound healing. Two soft tissue wounds (test and control) were created on the back skin of 5 rabbits (female New Zealand White Rabbits specific pathogen free)...
July 13, 2017: Journal of Biological Regulators and Homeostatic Agents
https://www.readbyqxmd.com/read/28695267/impact-of-an-alternative-steroid-on-the-relative-bioavailability-and-bioequivalence-of-a-novel-versus-the-originator-formulation-of-abiraterone-acetate
#7
Azra Hussaini, Anthony J Olszanski, Cy A Stein, Bill Bosch, Paul Nemeth
PURPOSE: The originator abiraterone acetate (OAA) formulation is used for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This study evaluated the bioavailability and bioequivalence of a novel formulation, abiraterone acetate fine particle (AAFP), versus OAA on a steady-state background of steroids. METHODS: Thirty-seven healthy male subjects were randomized in a crossover design to receive methylprednisolone (4 mg twice daily) or prednisone (5 mg twice daily) for 12 days in Period 1...
July 10, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28685397/application-of-exposure-response-analyses-to-establish-the-pharmacodynamic-similarity-of-a-once-daily-regimen-to-an-approved-twice-daily-dosing-regimen-for-the-treatment-of-hcv-infection
#8
Akshanth R Polepally, Haoyu Wang, Patrick J Marroum, Mukul Minocha, Balakrishna Hosmane, Amit Khatri, Sven Mensing, Thomas J Podsadecki, Daniel E Cohen, Walid M Awni, Rajeev M Menon
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 reformulated for once-daily administration containing all three active DAAs (3QD regimen). Two bioequivalence studies compared the 3-DAA and 3QD regimens. In study 1, fed, single-, and multiple-dose crossover comparisons revealed exposures for drug components that were slightly outside the bioequivalence criteria, i...
July 6, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28685396/pharmacokinetics-and-pharmacogenomics-of-bupropion-in-three-different-formulations-with-different-release-kinetics-in-healthy-human-volunteers
#9
Jamie N Connarn, Stephanie Flowers, Marisa Kelly, Ruijuan Luo, Kristen M Ward, Gloria Harrington, Ila Moncion, Masoud Kamali, Melivin McInnis, Meihua R Feng, Vicki Ellingrod, Andrew Babiskin, Xinyuan Zhang, Duxin Sun
The purpose of this pharmacokinetics (PK) study was to investigate whether different release kinetics from bupropion hydrochloride (HCl) immediate release (IR), sustained release (SR), and extended release (ER) formulations alter its metabolism and to test the hypothesis that the unsuccessful bioequivalence (BE) study of the higher strength (300 mg) of bupropion HCl ER tablets based on the successful BE study of the lower strength (150 mg) was due to metabolic saturation in the gastrointestinal (GI) lumen...
July 6, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28683953/a-multicentre-prospective-non-randomized-sequential-open-label-trial-to-demonstrate-the-bioequivalence-between-intravenous-immunoglobulin-new-generation-igng-and-standard-iv-immunoglobulin-ivig-in-adult-patients-with-primary-immunodeficiency-pid
#10
J-F Viallard, J-P Brion, M Malphettes, I Durieu, M Gardembas, N Schleinitz, C Hoarau, E Lazaro, S Puget
OBJECTIVES: To demonstrate the bioequivalence between 2 intravenous immunoglobulin (IVIG) preparations, TEGELINE(®) and ClairYg(®), a ready-to-use 5% IVIG, in primary immunodeficiency (PID). Secondary objectives were to assess the efficacy, safety and pharmacokinetics of ClairYg(®). METHODS: Twenty-two adult PID patients receiving stable doses of TEGELINE(®) (5% lyophilized IVIG) were switched to ClairYg(®) for 6 months. ClairYg(®) was administered under the same conditions as TEGELINE(®), either every 3 or 4 weeks...
July 3, 2017: La Revue de Médecine Interne
https://www.readbyqxmd.com/read/28670911/bioequivalence-study-of-rivastigmine-6-mg-capsules-single-dose-in-healthy-volunteers
#11
Dhiraj Abhyankar, Ashish Shedage, Milind Gole, Preeti Raut
OBJECTIVE: To assess the bioequivalence of generic formulation of rivastigmine (test) and Exelon (reference). METHODS: This randomized, open-label, 2-period, single-dose, 2-treatment, 2-sequence, crossover study was conducted in 40 healthy men under fed condition. Participants were randomized to receive a single dose of Exelon or rivastigmine capsule. RESULTS: A total of 31 participants completed the study. Area under the concentration-time curve from time zero to time t (AUC0- t) and area under the concentration-time curve from time zero to infinity (AUC0-∞) for Exelon (mean [standard deviation], h·ng/mL) were 126...
January 1, 2017: American Journal of Alzheimer's Disease and Other Dementias
https://www.readbyqxmd.com/read/28670733/determination-of-silodosin-and-its-active-glucuronide-metabolite-kmd-3213g-in-human-plasma-by-lc-ms-ms-for-a-bioequivalence-study
#12
Priyanka A Shah, Pranav S Shrivastav
A sensitive and selective liquid chromatography-tandem mass spectrometry (LC-MS/MS) method is described for the simultaneous determination of silodosin (SLD) and its active metabolite silodosin β-D-glucuronide (KMD-3213G) in human plasma. Liquid-liquid extraction of plasma samples was carried out with ethyl acetate and methyl tert-butyl ether solvent mixture using deuterated analogs as internal standards. The extraction recovery of SLD and KMD-3213G was in the range of 90.8-93.4 % and 87.6-89.9 % respectively...
July 3, 2017: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/28666638/a-study-on-the-bioequivalence-of-lithium-and-valproate-salivary-and-blood-levels-in-the-treatment-of-bipolar-disorder
#13
A Murru, M Torra, A Callari, I Pacchiarotti, S Romero, B Gonzalez de la Presa, C Varo, J M Goikolea, V Pérez-Sola, E Vieta, F Colom
Lithium (Li) and valproate (VPA) are used in the treatment of bipolar disorder (BD), with narrow therapeutic window requiring periodic control of serum levels. This prevents intoxication, lack of efficacy due to low serum concentrations, and allows monitoring adherence. We aimed at evaluating the bioequivalence of salivary and blood levels of LI or VPA in a sample of adult BD patients. Secondarily, lithium bioequivalence was evaluated across different patients' lifespans. BD patients treated with either Li or VPA underwent contemporary standard serum and salivary measurements...
June 27, 2017: European Neuropsychopharmacology: the Journal of the European College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28660366/nationwide-conversion-to-generic-tacrolimus-in-pediatric-kidney-transplant-recipients
#14
Derisha Naicker, Peter W Reed, Jane Ronaldson, Tonya Kara, William Wong, Chanel Prestidge
BACKGROUND: Bioequivalence between Tacrolimus Prograf® and generic tacrolimus formulations has been demonstrated in adult populations, however clinical experience and safety data regarding generic tacrolimus in pediatric transplant recipients is limited. This study aimed to evaluate conversion from Tacrolimus Prograf® to Sandoz® in pediatric renal transplant recipients nationwide. The primary outcome was a change in mean trough tacrolimus concentration. Additionally, changes in tacrolimus intra-patient coefficient of variation (CoV), allograft function, requirement for dose adjustments, and episodes of biopsy-proven rejection were evaluated...
June 28, 2017: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
https://www.readbyqxmd.com/read/28656944/a-comparative-pharmacokinetics-study-of-the-anti-parkinsonian-drug-pramipexole
#15
Ratih S I Putri, Effi Setiawati, Syifa A Aziswan, Fenny Ong, Raymond R Tjandrawinata, Liana W Susanto
The present study aimed to compare pharmacokinetic parameters of two pramipexole 0.25 mg formulations in order to show bioequivalence. The study was conducted in a randomized, open-label, two-period, two-sequence, and crossover design, involving 23 healthy volunteers. One of the 0.25 mg formulations of pramipexole evaluated in the study was manufactured by PT Dexa Medica, Palembang, Indonesia, the other, used as the reference, by Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. All eligible subjects were required to fast before each drug administration period, which was separated by a one-week washout period...
November 18, 2016: Scientia Pharmaceutica
https://www.readbyqxmd.com/read/28656793/regulatory-framework-on-bioequivalence-criteria-for-locally-acting-gastrointestinal-drugs-the-case-for-oral-modified-release-mesalamine-formulations
#16
Gianluca Sferrazza, Paolo D Siviero, Giuseppe Nicotera, Paola Turella, Annalucia Serafino, Corrado Blandizzi, Pasquale Pierimarchi
Bioequivalence testing for locally acting gastrointestinal drugs is a challenging issue for both regulatory authorities and pharmaceutical industries. The international regulatory framework has been characterized by the lack of specific bioequivalence tests that has generated a negative impact on the market competition and drug use in clinical practice. Areas covered: This review article provides an overview of the European Union and United States regulatory frameworks on bioequivalence criteria for locally acting gastrointestinal drugs, also discussing the most prominent scientific issues and advances that has been made in this field...
June 28, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28654954/bioequivalence-between-generic-and-branded-lamotrigine-in-people-with-epilepsy-the-equigen-randomized-clinical-trial
#17
Michel Berg, Timothy E Welty, Barry E Gidal, Francisco J Diaz, Ron Krebill, Jerzy P Szaflarski, Barbara A Dworetzky, John R Pollard, Edmund J Elder, Wenlei Jiang, Xiaohui Jiang, Regina D Switzer, Michael D Privitera
Importance: Switching between generic antiepileptic drugs is a highly debated issue that affects both clinical care and overall health care costs. Objective: To evaluate the single-dose pharmacokinetic bioequivalence of 3 (1 branded and 2 generic drugs) on-market, immediate-release lamotrigine drug products. Design, Setting, and Participants: The Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy (EQUIGEN) single-dose study is a crossover, prospective, sequence-randomized, replicate pharmacokinetic study conducted at 5 US academic epilepsy centers...
June 26, 2017: JAMA Neurology
https://www.readbyqxmd.com/read/28651442/a-randomized-single-blind-phase-i-trial-invictan-1-assessing-the-bioequivalence-and-safety-of-bi-695502-a-bevacizumab-biosimilar-candidate-in-healthy-subjects
#18
Willem Hettema, Christopher Wynne, Benjamin Lang, Mario Altendorfer, Niklas Czeloth, Ragna Lohmann, Sandeep Athalye, Dorothee Schliephake
OBJECTIVES: This Phase I trial (INVICTAN(®)-1) evaluated three-way bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, and reference product bevacizumab from two sources (US-approved Avastin(®), Genentech; EU-approved Avastin, Roche). METHODS: Healthy male subjects (N = 91) were randomized 1:1:1 to receive a single intravenous infusion of 1 mg/kg of BI 695502 or US- or EU-approved Avastin. An interim analysis was planned when ~50% of subjects were evaluable for the primary endpoint to determine if the prespecified criteria for bioequivalence were achieved; if demonstrated, the study could be stopped early...
June 27, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28650526/a-dual-administration-microtracer-technique-to-characterize-the-absorption-distribution-metabolism-and-excretion-of-14-c-seletalisib-ucb5857-in-healthy-subjects
#19
Eric Helmer, Jean-Marie Nicolas, Jeff Long, Ad F Roffel, Emma Jones, Hugues Chanteux, Nieves Diaz, Holly Garratt, Tjerk Bosje
Phosphoinositide 3 kinases are targets for development of small-molecule inhibitors to disrupt progression of immune-inflammatory diseases. This phase 1 open-label study (Eudract 2014-005353-39) evaluated the safety and relative bioavailability of 2 new seletalisib (UCB5857) formulations (A and B) compared with a reference formulation. Absolute bioavailability (period 1a, n = 6) and disposition and metabolism (period 1b, n = 6) of the reference formulation were evaluated: healthy subjects received 30 mg orally plus ∼20 μg of a (14) C-labeled microtracer (intravenously in 1a, orally in 1b)...
June 26, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28648862/octacosanol-educes-physico-chemical-attributes-release-and-bioavailability-as-modified-nanocrystals
#20
Surashree Sen Gupta, Mahua Ghosh
Octacosanol is a lesser known nutraceutical with the potential for treatment of several inflammatory diseases, high cholesterol, Parkinson's symptoms and tumour growth along with the capacity to improve athletic performance. But its lipophilicity and large structure inhibits extended solubility in water resulting in poor absorption and a low bioavailability. In the present work, sodium salt of octacosyl sulfate was synthesized. It displayed improved water solubility. Its nanocrystals, synthesized by means of nanoprecipitation technique, enhanced diffusion velocity, antioxidant capacity, shelf-life, penetrability and bioavailability...
June 22, 2017: European Journal of Pharmaceutics and Biopharmaceutics
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