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Bioequivalence

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https://www.readbyqxmd.com/read/28929357/risk-based-bioequivalence-recommendations-for-antiepileptic-drugs
#1
REVIEW
Zhichuan Li, Lanyan Fang, Wenlei Jiang, Myong-Jin Kim, Liang Zhao
PURPOSE OF REVIEW: This review summarizes the current FDA practice in developing risk- and evidence-based product-specific bioequivalence guidances for antiepileptic drugs (AEDs). RECENT FINDINGS: FDA's product-specific guidance (PSG) for AEDs takes into account the therapeutic index of each AED product. Several PSGs for AEDs recommend fully replicated studies and a reference-scaled average bioequivalence (RS-ABE) approach that permit the simultaneous equivalence comparison of the mean and within-subject variability of the test and reference products...
September 19, 2017: Current Neurology and Neuroscience Reports
https://www.readbyqxmd.com/read/28926562/generics-for-the-treatment-of-hepatitis-c-in-monoinfected-and-hiv-coinfected-patients-pros-and-cons
#2
Dario Cattaneo, Alessandro Fossati, Chiara Resnati, Massimo Galli, Cristina Gervasoni
The treatment of hepatitis C virus in monoinfected and HIV-coinfected patients has greatly changed over recent years as a result of the introduction of direct-acting antiviral agents (DAAs), which have revolutionized clinical outcomes and led to sustained virological response rates above 90-95%. The discovery of new molecules and the subsequent competition between pharmaceutical companies, together with the negotiated price policies pursued by many national health systems, have led to a gradual reduction in the cost of DAAs, and expand their use to an increasing number of patients, including those with mild liver damage...
September 19, 2017: AIDS Reviews
https://www.readbyqxmd.com/read/28926095/model-based-assessment-using-conventional-bioequivalence-limits-to-ensure-safety-and-efficacy-of-rivaroxaban-in-patients-undergoing-hip-or-knee-replacement
#3
Mario González-Sales, Lanyan Fang, Myong-Jin Kim, Liang Zhao
We evaluated whether the current bioequivalence limit is adequate to ensure safety and efficacy of rivaroxaban in patients under total hip arthroplasty and total knee arthroplasty based on its model informed benefit/risk profile. Clinical data from a total of 7145 patients from 3 phase 2 and 4 phase 3 clinical trials were included in the current model-based exposure-response analysis. The relationships between rivaroxaban exposure measurements (ie, minimum or trough, maximum, average concentration, and area under the concentration-time curve [AUC] at steady state) and clinical outcomes (ie, the probabilities of major bleeding [MB] and venous thromboembolism [VTE]) were modeled using NONMEM 7...
September 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28925046/in-vivo-pharmacodynamic-and-pharmacokinetic-interactions-of-hibiscus-sabdariffa-calyces-extracts-with-simvastatin
#4
S J Showande, O M Adegbolagun, S I Igbinoba, T O Fakeye
WHAT IS KNOWN AND OBJECTIVES: Increasing number of patients use herbs with their medications. Such practice may result in beneficial or harmful herb-drug interactions. A recent survey reported that some participants co-administered Hibiscus sabdariffa, a widely used beverage, or tea, with their antihyperlipidaemic medications. This study therefore evaluated the effect of concomitant administration of Hibiscus sabdariffa calyces' extracts with simvastatin on hyperlipidaemia and pharmacokinetics of the drug in vivo...
September 18, 2017: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/28924447/passive-blood-anaphylaxis-subcutaneous-immunoglobulins-are-a-cause-of-ongoing-passive-anaphylactic-reaction
#5
Przemyslaw Zdziarski, Andrzej Gamian, Jacek Majda, Agnieszka Korzeniowska-Kowal
BACKGROUND: Allergic, especially anaphylactic, reactions during immunoglobulin replacement therapy are rare, but their pathophysiology and classification remain ambiguous. Recent findings show positive results of skin tests with commercially available immunoglobulins, but target antigens and responsible compounds of the tested immunoglobulins have not been strictly identified. CASE DESCRIPTION AND FINDINGS: Four adult patients with recently diagnosed common variable immunodeficiency qualified for standard subcutaneous immunoglobulin replacement therapy regimen...
2017: Allergy, Asthma, and Clinical Immunology
https://www.readbyqxmd.com/read/28920454/investigation-of-o-glycosylation-heterogeneity-of-recombinant-coagulation-factor-ix-using-lc-ms-ms
#6
Youngsuk Seo, Gyeong Mi Park, Myung Jin Oh, Hyun Joo An
AIM: Recombinant coagulation factor IX (rFIX) has extraordinarily multiple post-translational modifications including N-glycosylation and O-glycosylation which have a drastic effect on biological functions and in vivo recovery. Unlike N-glycosylation extensively characterized, there are a few studies on O-glycosylation due to its intrinsic complexity. In-depth O-glycosylation analysis is necessary to better understand and assess pharmacological activity of rFIX. RESULTS: We determined unusual O-glycosylations including O-fucosylation and O-glucosylation which were located at Serine 53 and 61, respectively in EGF domain...
September 18, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28918665/considerations-in-establishing-bioequivalence-of-inhaled-compounds
#7
Irvin Mayers, Mohit Bhutani
Generic inhalers are often perceived as inferior to their branded counterparts; however, they are safe and effective if they can meet the regulatory requirements. The approach to assess bioequivalence (BE) in oral dosage form products is not sufficient to address the complexities of inhalational products (e.g., patient-device interface); hence, more considerations are needed and caution should be applied in determining BE of inhaled compounds. Areas covered: This review outlines the evaluation process for generic inhalers, explores the regulatory approaches in BE assessment, and highlights the considerations and challenges in the current in vitro and in vivo approaches (lung deposition, pharmacokinetic, pharmacodynamic/clinical studies, and patient-device interface) for establishing BE of inhaled compounds...
September 18, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28918318/high-sensitivity-method-validated-to-quantify-estradiol-in-human-plasma-by-lc-ms-ms
#8
Mônica Siqueira Ferreira, André M M Arruda, Giovanni Tieghi Pepi, Aline Cristina Martho, Pâmela Maria Maximiano, Lina S O B O Ricci, Maria Francesca Riccio, Ana Cláudia Noboli, Pedro Serafim
17β-Estradiol (E2) is an endogenous steroid in the human body. Its measurement is important for health and human biology understanding. However, E2 concentration in human plasma is in the range of pg/mL, which makes it difficult to detect. In this way, LC-MS/MS has been shown the most sensitive tool, although E2 is a weakly ionizable molecule. In this work, we validated a more sensitive and accurate method for E2 quantification in human plasma. Our extraction step ensured a cleaner chromatography, resulting in a precise measurement and highly reproducible method in the range of 2-150pg/mL...
September 5, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28906561/bioequivalence-of-intravenous-and-oral-rolapitant-results-from-a-randomized-open-label-pivotal-study
#9
Xiaodong Wang, Zhi-Yi Zhang, Daniel Powers, Jing Wang, Sharon Lu, Sujata Arora, Lorraine Hughes, Jennifer Christensen, Vikram Kansra
Rolapitant, a selective and long-acting neurokinin-1 receptor antagonist, is approved in an oral formulation for the prevention of delayed chemotherapy-induced nausea and vomiting in adults. The objective of this pivotal study was to assess the bioequivalence of a single intravenous infusion of rolapitant versus a single oral dose of rolapitant. In this randomized, open-label phase 1 study, healthy volunteers were administered rolapitant as a 180-mg oral dose or a 30-minute 166.5-mg intravenous infusion. Blood samples for pharmacokinetic analysis were collected predose and at points up to 912 hours postdose...
September 14, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28906001/overcoming-interference-of-plasma-phospholipids-using-hybridspe-for-the-determination-of-trimetazidine-by-uplc-ms-ms
#10
Pravin G Vanol, Manish Yadav, Mallika Sanyal, Priyanka A Shah, Pranav S Shrivastav
An improved, precise and reliable ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed for the quantification of trimetazidine, using trimetazidine-d8 as the internal standard (IS). Interference due to plasma phospholipids during sample preparation was overcome by using hybrid solid phase extraction-phospholipid ultra cartridge. The mean extraction recovery of trimetazidine (98.66 %) and trimetazidine-d8 (97.63 %) from spiked plasma was consistent and reproducible...
September 14, 2017: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/28905988/lack-of-bioequivalence-among-low-dose-enteric-coated-aspirin-preparations
#11
Dermot Cox, Desmond Fitzgerald
Low-dose aspirin (75 mg or 81 mg) is considered to be the lowest effective dose for cardiovascular protection, however, the use of enteric preparations has created a source of variability in bioavailability. As part of regulatory requirements we carried out bioequivalence tests for two 75 mg enteric-coated aspirin preparations (Caprin and Protek) using Nu-Seals 75 mg aspirin as the comparator. The primary endpoint was serum thromboxane levels after 14 days of treatment. Protek failed to meet bioequivalence, as it was significantly less effective than Nu-Seals...
September 14, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28895227/comparing-generic-drug-markets-in-europe-and-the-united-states-prices-volumes-and-spending
#12
COMPARATIVE STUDY
Olivier J Wouters, Panos G Kanavos, Martin McKEE
Policy Points: Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. CONTEXT: Rising drug prices are putting pressure on health care budgets...
September 2017: Milbank Quarterly
https://www.readbyqxmd.com/read/28894622/a-liquid-chromatography-tandem-mass-spectrometry-method-for-evaluation-of-two-brands-of-enalapril-20%C3%A2-mg-tablets-in-healthy-human-volunteers
#13
Wael Abu Dayyih, Mohammed Hamad, Ahmad Abu Awwad, Eyad Mallah, Zainab Zakarya, Alice Abu Dayyih, Tawfiq Arafat
Enalapril is an angiotensin-converting enzyme inhibitor used for treatment of hypertension and chronic heart disease. Enalaprilat is its active metabolite responsible for the activity. This study aimed to develop and validate a method for enalapril and enalaprilat analysis and to determine the bioequivalence of two tablet formulae of enalapril. LC-MS/MS bioanalytical method was developed and validated and then applied to evaluate the bioavailability of two enalapril formulae. Antihyperglycemic sitagliptin was used as internal standard (IS)...
2017: Journal of Analytical Methods in Chemistry
https://www.readbyqxmd.com/read/28884969/evaluation-of-bioequivalence-between-the-new-procaterol-hydrochloride-hydrate-dry-powder-inhaler-and-the-approved-dry-powder-inhaler-in-patients-with-asthma-in-a-randomized-double-blind-double-dummy-crossover-comparison-study-a-phase%C3%A2-3-study
#14
Ryo Shirai, Yuki Suzaki, Kyoko Sato, Yuko Takeuchi, Issei Tokimatsu, Nobuyuki Koga, Junichi Kadota, Kyoichi Ohashi
Procaterol hydrochloride hydrate (procaterol) is a β2 -adrenergic receptor agonist that induces a strong bronchodilatory effect. The procaterol dry powder inhaler (DPI) has been frequently used in patients with bronchial asthma or chronic obstructive pulmonary disease. We evaluated the bioequivalence and safety between the new procaterol DPI (new DPI) and the approved procaterol DPI (approved DPI). This study was a randomized, double-blind, double-dummy, crossover comparison to evaluate the pharmacodynamic equivalence of the new DPI and the approved DPI in patients with bronchial asthma...
September 8, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28880704/sample-size-estimation-for-the-u-s-food-and-drug-administration-s-in-vitro-population-bioequivalence-test-of-dpis-mdis-nasal-sprays-and-nebules
#15
Anders Fuglsang
No abstract text is available yet for this article.
September 7, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28879628/in-vitro-approaches-to-support-bioequivalence-and-substitutability-of-generic-proton-pump-inhibitors-via-nasogastric-tube-administration
#16
Ping Ren, Minglei Cui, Om Anand, Li Xia, Zhuojun J Zhao, Dajun Sun, Trueman Sharp, Dale P Conner, John Peters, Wenlei Jiang, Ethan Stier, Xiaojian Jiang
Administration of proton pump inhibitors (PPIs) through nasogastric tubes may present risks. If the PPI drug products are not prepared properly, clogging or obstruction of nasogastric tubes can pose a safety concern. In addition, the integrity of the enteric coating of the drug product may be damaged resulting in reduced bioavailability of the active moiety. From the perspective of administration of generic PPIs when compared to the reference drug product, differences in formulation can potentially result in a greater relative risk for the generic drug product...
September 6, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28871228/interplay-of-the-quality-of-ciprofloxacin-and-antibiotic-resistance-in-developing-countries
#17
Deepali Sharma, Rahul P Patel, Syed Tabish R Zaidi, Md Moklesur Rahman Sarker, Qi Ying Lean, Long C Ming
Ciprofloxacin, a second generation broad spectrum fluoroquinolone, is active against both Gram-positive and Gram-negative bacteria. Ciprofloxacin has a high oral bioavailability and a large volume of distribution. It is used for the treatment of a wide range of infections including urinary tract infections caused by susceptible bacteria. However, the availability and use of substandard and spurious quality of oral ciprofloxacin formulations in the developing countries has been thought to have contributed toward increased risk of treatment failure and bacterial resistance...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28864922/a-phase-i-randomized-single-dose-study-evaluating-the-pharmacokinetic-equivalence-of-biosimilar-abp-215-and-bevacizumab-in-healthy-adult-men
#18
Richard Markus, Vincent Chow, Zhiying Pan, Vladimir Hanes
PURPOSE: This study compared the pharmacokinetic (PK) profiles of the proposed biosimilar ABP 215 with bevacizumab in healthy males. METHODS: In this randomized, single-blind, single-dose, three-arm, parallel-group study, healthy subjects were randomized to receive ABP 215 (n = 68), bevacizumab (US) (n = 67), or bevacizumab (EU) (n = 67) 3 mg/kg intravenously. Primary endpoints were area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) and the maximum observed concentration (C max)...
September 1, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28864856/comparison-of-adverse-events-following-injection-of-original-or-generic-docetaxel-for-the-treatment-of-breast-cancer
#19
Nao Tagawa, Erika Sugiyama, Masataka Tajima, Yasutsuna Sasaki, Seigo Nakamura, Hiromi Okuyama, Hisanori Shimizu, Vilasinee Hirunpanich Sato, Tadanori Sasaki, Hitoshi Sato
PURPOSE: The approval of injectable generic drugs does not require bioequivalence testing. However, although generic products contain the same level of the active compound, the levels and types of additives present can differ from those used in the original product. Since docetaxel is highly lipophilic, polysorbate 80 (PS80), polyethylene glycol (PEG), and ethyl alcohol are employed to solubilize this anticancer agent. This retrospective study compared the safety of five docetaxel products (Taxotere(®), Docetaxel Hospira, Docetaxel Sandoz, Docetaxel Sawai, and Docetaxel EE)...
September 1, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28858753/development-and-validation-of-a-new-hplc-dad-method-for-quantification-of-sofosbuvir-in-human-serum-and-its-comparison-with-lc-ms-ms-technique-application-to-a-bioequivalence-study
#20
Shahram Miraghaei, Bahareh Mohammadi, Atefeh Babaei, Samira Keshavarz, Gholamreza Bahrami
Although for many analyses tandem mass spectrometry (LC-MS/MS) systems have significant advantage over the high-performance liquid chromatography with diode array detection (HPLC-DAD) however, the HPLC methods are easier, cheaper and more available to perform. As no published method is available for quantitative HPLC analysis of sofosbuvir (SOF), an orally administered anti-hepatitis drug in human serum, this study was aimed to evaluate applicability of the HPLC technique to quantify sofosbuvir and comparison of the two methods for analytical performance...
August 28, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
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