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Bioequivalence

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https://www.readbyqxmd.com/read/28211784/generic-antiretrovirals-for-the-treatment-of-hiv-a-novel-challenge-for-western-countries-%C3%A2
#1
Dario Cattaneo, Massimo Andreoni, Gianpiero Carosi, Roberto Cauda, Adriano Lazzarin, Giuliano Rizzardini
The introduction of generic antiretroviral medications in developing countries has resulted in significant CD4 cell restoration, HIV viral decline, and a noteworthy reduction in the time to initiation of therapy. Projection models have also predicted significant cost saving associated with the extensive diffusion of generic antiretrovirals in developed countries. However, some uncertainties on generics have recently been raised. These concerns mainly relate to the adequacy of the study design for bioequivalence testing, the potential for uncontrolled switching from one generic to another, and the loss of adherence if patients switched from fixed-dose coformulations to single components in order to incorporate the new generic drugs...
February 17, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28204953/pharmacokinetics-of-coadministration-of-levothyroxine-sodium-and-alendronate-sodium-new-effervescent-formulation
#2
H G Bone, M A Walter, M E Hurley, S Epstein
: No clinically important pharmacokinetic interference of alendronate occurred between a new effervescent formulation of alendronate and levothyroxine when coadministered. The combination does not materially affect levothyroxine absorption. INTRODUCTION: Concurrent treatment of osteoporosis with alendronate (Aln) and hypothyroidism with levothyroxine (LT4) may be problematic because both drugs are to be taken separately after fasting overnight. The primary objective was to assess pharmacokinetic interactions between a new effervescent formulation of Aln (Aln-NEF) and LT4...
February 16, 2017: Osteoporosis International
https://www.readbyqxmd.com/read/28197753/asparaginase-pharmacology-challenges-still-to-be-faced
#3
REVIEW
Claudia Lanvers-Kaminsky
PURPOSE: The benefits of asparaginase (ASNASE) in the treatment of ALL and NHL are indisputable and new ASNASE preparations are under clinical development to overcome limitations of the actual ASNASE therapy, especially immunogenicity. Apart from ALL and NHL further indications of ASNASE are preclinically and clinically evaluated. METHODS: We reviewed ASNASE literature and especially focused on the mechanism of action, on biomarker, which determine ASNASE sensitivity and resistance, and on ASNASE pharmacodynamics in vivo...
February 14, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28196046/bioequivalence-of-a-new-oral-levosulpiride-formulation-compared-with-a-standard-one-in-healthy-volunteers
#4
Simona De Gregori, Laura Cipollina, Annalisa De Silvestri, Marianna Ventura, Roberta Michelini, Monica Morosini, Michela Montagna, Carmine Tinelli, Mario Regazzi, Mariadelfina Molinaro, Roberto Imberti
BACKGROUND: A monocentric, single-dose, open-label, two-way, crossover randomized study was conducted by the San Matteo Phase I Clinical Trial Unit and Experimental Therapy (Pavia, Italy) to assess the bioequivalence and the systemic tolerability of a new oral formulation of levosulpiride (tablet 25 mg: test) versus a commercially available formulation on the Italian market (tablet 25 mg: reference). METHODS: Thirty-five healthy adult volunteers, males (n = 19) and females (n = 16), aged between 18 and 55 years were screened and 32 of them were enrolled in the study...
February 11, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28194623/comparison-of-non-compartmental-and-mixed-effect-modelling-methods-for-establishing-bioequivalence-for-the-case-of-two-compartment-kinetics-and-censored-concentrations
#5
Jim H Hughes, Richard N Upton, David J R Foster
Non-compartmental analysis (NCA) is regarded as the standard for establishing bioequivalence, despite its limitations and the existence of alternative methods such as non-linear mixed effects modelling (NLMEM). Comparisons of NCA and NLMEM in bioequivalence testing have been limited to drugs with one-compartment kinetics and have included a large number of different approaches. A simulation tool was developed with the ability to rapidly compare NCA and NLMEM methods in determining bioequivalence using both R and NONMEM and applied to a drug with two-compartment pharmacokinetics...
February 13, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28190508/navigating-the-clinical-trial-pathway-conception-design-execution-and-results-dissemination
#6
John S Sampalis, Joanne Watson, Stella Boukas, Marianna Boukas, Natalie Harvey, Sanjay Machado, Michel Bordeleau, Emmanouil Rampakakis
Dr Sampalis is founder, Chief Executive Officer, and Chief Scientific Officer of JSS Medical Research Inc, founded in 1997. He is a tenured professor of Surgery and Epidemiology & Biostatistics of McGill University, the University of Montreal and University of Laval. Recognized as a leading clinical epidemiologist and one of the top trauma researchers in Canada, he possesses extensive expertise in health services research, clinical trials, and offers services as a Research and Epidemiological Consultant for numerous pharmaceutical companies, hospitals and government organizations and agencies...
March 2017: Surgery
https://www.readbyqxmd.com/read/28181177/outcomes-associated-with-generic-drugs-approved-using-product-specific-determinations-of-therapeutic-equivalence
#7
Joshua J Gagne, Jennifer M Polinski, Wenlei Jiang, Sarah K Dutcher, Jing Xie, Joyce Lii, Lisa A Fulchino, Aaron S Kesselheim
OBJECTIVE: We sought to examine rates of clinical outcomes among patients before and after market introduction of generic versions of five drugs approved using product-specific equivalence determinations. METHODS: We used data from a large national insurer to identify patients who initiated a study (acarbose tablets, salmon calcitonin nasal spray, enoxaparin injection, vancomycin capsules, venlafaxine extended-release tablets) or control drug (nateglinide, glimepiride, alendronate, fondaparinux, metronidazole, sertraline, paroxetine) in each calendar month between 2003 and 2012 and to determine rates of claims-based proxies for lack of effectiveness outcomes following initiation...
February 8, 2017: Drugs
https://www.readbyqxmd.com/read/28176487/lornoxicam-immediate-release-tablets-formulation-and-bioequivalence-study-in-healthy-mediterranean-volunteers-using-a-validated-lc-ms-ms-method
#8
Abdel Naser Zaid, Ayman Mousa, Nidal Jaradat, Rana Bustami
This study aimed to demonstrate interchangeability between 2 lornoxicam tablet formulations under fasting conditions among Mediterranean Arabs by using a newly validated high-pressure liquid chromatography-tandem mass spectrometry method. A single-oral solid dosage form (8 mg/tablet), randomized, open-label, 2-way crossover study was conducted on 30 healthy male volunteers. Blood samples were collected prior to dosing and over a 24-hour period, and the washout period was 9 days. Statistical comparison of the main pharmacokinetic parameters showed no significant difference between generic and branded products...
February 8, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28176222/saxagliptin-dapagliflozin-a-review-in-type-2-diabetes-mellitus
#9
Karly P Garnock-Jones
Saxagliptin/dapagliflozin fixed-dose combination tablets (Qtern(®)) are indicated in the EU for the improvement of glycaemic control in adults with type 2 diabetes mellitus (T2DM), either when treatment with metformin and/or a sulfonylurea plus a monocomponent of saxagliptin/dapagliflozin provides inadequate glycaemic control, or when the patient is already being treated with the free combination of saxagliptin + dapagliflozin. This narrative review summarizes pharmacological, efficacy and tolerability data relevant to the use of saxagliptin/dapagliflozin in this indication...
February 7, 2017: Drugs
https://www.readbyqxmd.com/read/28166190/pharmacokinetics-of-crushed-elvitegravir-combination-tablet-given-with-or-without-enteral-nutrition
#10
Mieke Jongbloed-de Hoon, Angela Colbers, Kirsten Velthoven-Graafland, Marjolijn Duisenberg-van Essenberg, Martine Kruijssen, Evertine Abbink, Reinout van Crevel, David Burger
We investigated whether a fixed-dose combination tablet of elvitegravir, cobicistat, emtricitabine, and tenofovirDF (Stribild®), can be crushed and combined with enteral nutrition without influencing pharmacokinetics. This was an open-label, 3-period, single dose, randomized, cross-over, trial in 24 healthy volunteers. Subjects received Stribild whole tablet with breakfast (reference), crushed/suspended Stribild+breakfast, crushed/suspended Stribild+enteral nutrition. Crushed/suspended Stribild plus enteral nutrition was bio-equivalent (90% CI between 80-125%) with a whole Stribild tablet...
January 3, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28162680/-430-bioequivalence-and-food-effect-of-a-novel-abuse-deterrent-ad-extended-release-er-morphine-product-candidate-compared-with-a-currently-available-non-ad-er-morphine-product
#11
J Dayno, J Lawler, G Niebler, K Lindhardt
No abstract text is available yet for this article.
April 2016: Journal of Pain: Official Journal of the American Pain Society
https://www.readbyqxmd.com/read/28160427/performance-of-redox-active-and-chelatable-iron-assays-to-determine-labile-iron-release-from-intravenous-iron-formulations
#12
A B Pai, D E Meyer, B C Bales, V E Cotero, M P Pai, N Zheng, W Jiang
Emerging data from global markets outside the United States, where many generic iron sucrose formulations are available, have revealed that non-US generic intravenous (i.v.) iron formulations may have iron release profiles that differ from the reference listed drug (RLD). The first generic i.v. iron approved in the United States was sodium ferric gluconate complex in 2011. We evaluated chelatable and redox labile iron assay methods to measure the amount of labile iron released from i.v. iron formulations in biorelevant matrices in vitro...
February 3, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28156443/a-single-dose-comparative-bioavailability-study-of-dronabinol-oral-solution-versus-dronabinol-capsules-in-healthy-volunteers
#13
Neha Parikh, William G Kramer, Varun Khurana, Santosh Vetticaden
: 198 Background: The capsule formulation of dronabinol, a pharmaceutical tetrahydrocannabinol (THC), is approved for anorexia associated with weight loss in patients with AIDS and for cancer chemotherapy-associated nausea/vomiting in patients with inadequate response to conventional antiemetics. A new oral formulation (i.e., dronabinol solution) was evaluated in a bioequivalence study versus currently marketed dronabinol capsules. METHODS: In an open-label, 2-treatment, 2-sequence, 4-period, single-dose crossover study, healthy volunteers were randomized to receive 1 of 2 treatment sequences (T-R-T-R or R-T-R-T; T = dronabinol 4...
October 9, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28155028/the-two-main-goals-of-bioequivalence-studies
#14
Laszlo Endrenyi, Henning H Blume, Laszlo Tothfalusi
The principal goal of bioequivalence (BE) investigations has crucial importance and has been the subject of extensive discussions. BE studies are frequently considered to serve as procedures for sensitive discrimination. The BE investigation should be able to provide methods and conditions sensitively identifying relevant differences between drug products if such differences in fact exist. Alternatively, BE studies can be deemed as surrogates of clinical investigations assessing therapeutic equivalence. Bioequivalent drug products will be provided to patients for their benefits...
February 2, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28152215/comparison-of-generic-to-brand-switchback-rates-between-generic-and-authorized-generic-drugs
#15
Richard A Hansen, Jingjing Qian, Richard Berg, James Linneman, Enrique Seoane-Vazquez, Sarah K Dutcher, Saeid Raofi, C David Page, Peggy Peissig
STUDY OBJECTIVE: Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. The objective of this study was to compare generic-to-brand switchback rates between generic and authorized generic drugs. DESIGN: Retrospective cohort study...
February 2, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28133772/pharmacokinetics-safety-tolerability-and-immunogenicity-of-fkb327-a-new-biosimilar-medicine-of-adalimumab-humira-in-healthy-subjects
#16
Adeep Puri, Andrew Niewiarowski, Yasumasa Arai, Hideaki Nomura, Mark Baird, Isobel Dalrymple, Steve Warrington, Malcolm Boyce
AIMS: to compare the pharmacokinetics, safety, tolerability, and immunogenicity of FKB327, a biosimilar of adalimumab, with European Union (EU)-approved Humira and United States (US)-licensed Humira after single subcutaneous doses in healthy subjects. METHODS: in a randomised, double-blind, parallel-group study, 180 healthy subjects received by subcutaneous injection 40 mg of EU-Humira, or US-Humira, or FKB327, in a 1:1:1 ratio, stratified by bodyweight. Pharmacokinetics, local tolerability, immunogenicity, adverse events, vital signs, ECG, and laboratory safety tests were assessed before and up to 1536 h after treatment...
January 30, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28131654/effects-of-udp-glucuronosyltransferase-ugt-polymorphisms-on-the-pharmacokinetics-of-febuxostat-in-healthy-chinese-volunteers
#17
Meihua Lin, Jian Liu, Huili Zhou, Minglan Wu, Duo Lv, Yujie Huang, Yunliang Zheng, Jianzhong Shentu, Lihua Wu
The pharmacokinetics (PKs) of febuxostat varies among individuals, while the main causes are still unknown. We investigated whether the polymorphisms of UGT1A1 and UGT1A3 played an important role in the disposition of the drug after oral administration of febuxostat tablet in Chinese subjects. A total of 42 healthy subjects were from two previous independent clinical bioequivalence (BE) trials of febuxostat, in which the same reference formulation (ULORIC(®) tablet, 80 mg) was taken, and thus the PK data were combined for the evaluation of pharmacogenomic effect on febuxostat PKs...
August 20, 2016: Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/28127948/bioequivalence-studies-of-a-reformulated-dutasteride-and-tamsulosin-hydrochloride-combination-capsule-and-a-commercially-available-formulation
#18
Renee Kurczewski, Chet Bowen, David Collins, John Zhu, Gulyeter Serbest, Michael Manyak
A dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg combination (DTC) capsule (Duodart(®) ) was reformulated to reduce the capsule size and enhance product stability. Bioequivalence of the reformulated DTC capsule with the commercial formulation was evaluated in 2 single-dose, open-label, randomized, 2-way crossover studies in healthy adult male volunteers. Subjects in a fasted or fed state received a single oral dose of either the reformulated DTC or the commercial formulation followed by a 28-day washout period between treatments...
January 27, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28127938/an-open-label-randomized-bioavailability-study-of-alternative-methods-of-oral-administration-of-naloxegol-in-healthy-subjects
#19
Khanh Bui, Bruce Birmingham, Ulysses Diva, Bruce Berger
Naloxegol is a peripherally acting μ-opioid receptor antagonist approved as an orally administered tablet for the treatment of opioid-induced constipation. Patients with swallowing difficulties may benefit from alternative approaches to the oral administration of the whole-tablet formulation of naloxegol. This open-label, randomized, 4-period, 4-treatment, crossover, single-dose study (NCT02446171) evaluated the pharmacokinetic (PK) characteristics of crushed naloxegol 25-mg tablets (suspended in water) administered orally or by nasogastric tube and a naloxegol solution compared with the commercially available 25-mg tablet formulation in healthy volunteers...
January 27, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28120254/application-of-pharmacokinetics-and-pharmacodynamics-in-product-life-cycle-management-a-case-study-with-a-carbidopa-levodopa-extended-release-formulation
#20
Nishit B Modi
Increasing costs in discovering and developing new molecular entities and the continuing debate on limited company pipelines mean that pharmaceutical companies are under significant pressure to maximize the value of approved products. Life cycle management in the context of drug development comprises activities to maximize the effective life of a product. Life cycle approaches can involve new formulations, new routes of delivery, new indications or expansion of the population for whom the product is indicated, or development of combination products...
January 24, 2017: AAPS Journal
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