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Bioequivalence

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https://www.readbyqxmd.com/read/27922340/ratio-of-means-vs-difference-of-means-as-measures-of-superiority-non-inferiority-and-average-bioequivalence
#1
Wanjie Sun, Stella Grosser, Yi Tsong
Ratio of means (ROM) and difference of means (DOM) are often used in a superiority, non-inferiority (NI), or average bioequivalence (ABE) test to evaluate whether the test mean is superior, NI, or equivalent to the reference (placebo or active control) mean. Literature provided recommendations regarding how to choose between ROM and DOM, mainly for superiority testing. In this paper, we evaluated these two measures from other perspectives and cautioned the potential impact of different scoring systems/transformation for the same outcome (which is not rarely seen in practice) on power of a ROM or DOM test for superiority, NI or ABE: 1) For superiority, with the same margin, power remains the same for a location, scale, or combined shift (no other transformations) to scoring systems for both measures; however, for NI and ABE, different shifts can change the power of the test significantly; 2) Direction of scores (larger or smaller value indicating desirable effects) does not change power for a DOM superiority, NI, or ABE test, but it does change power tremendously for a ROM NI or ABE test...
December 6, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27911675/on-safety-margin-for-drug-interchangeability
#2
Jiayin Zheng, Shein-Chung Chow, Fuyu Song
As more and more generic (or biosimilar) drug products become available in the market place, it is a concern whether the approved generic (or biosimilar) drug products are safe and efficacious and hence can be used interchangeably. According to current regulation, most regulatory agencies such as the United States Food and Drug Administration (FDA) indicate an approved generic (or biosimilar) drug product can serve as a substitute for the innovative drug product. Bioequivalence (biosimilarity) assessment for regulatory approval among generic copies (or biosimilars) of the innovative drug product are not required...
December 2, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27907869/is-a-deuterated-internal-standard-appropriate-for-the-reliable-determination-of-olmesartan-in-human-plasma
#3
Edyta Piórkowska, Jacek Musijowski, Katarzyna Buś-Kwaśnik, Piotr J Rudzki
A right choice of the internal standard is one of the most challenging tasks during bioanalytical method development. Surprisingly, among the HPLC-MS methods for the determination of a cardiovascular drug olmesartan in plasma only structural analogues or similar compounds were used as internal standards. We have tried to answer the question whether the stable isotope labelled (deuterated) internal standard, as recommended by regulatory agencies, can be used for the reliable determination of olmesartan in human plasma...
November 16, 2016: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/27906608/bioequivalence-evaluation-of-sparse-sampling-pharmacokinetics-data-using-bootstrap-resampling-method
#4
Meiyu Shen, Stella G Machado
Bioequivalence studies are an essential part of the evaluation of generic drugs. The most common in-vivo bioequivalence study design is the two-period two-treatment crossover design. The observed drug concentration-time profile for each subject from each treatment under each sequence can be obtained. AUC (the area under the concentration-time curve) and Cmax (the maximum concentration) are obtained from the observed drug concentration-time profiles for each subject from each treatment under each sequence. However, such a drug concentration-time profile for each subject from each treatment under each sequence cannot possibly be available during development of generic ophthalmic products since there is only one-time point measured drug concentration of aqueous humor for each eye...
December 1, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27900658/fixed-combination-gels-of-adapalene-and-benzoyl-peroxide-provide-optimal-percutaneous-absorption-compared-to-monad-formulations-of-these-compounds-results-from-two-in-vitro-studies
#5
Hanan Osman-Ponchet, Karine Sevin, Alexandre Gaborit, Nathalie Wagner, Michel Poncet
INTRODUCTION: Adapalene 0.1%/benzoyl peroxide 2.5% (0.1% A/BPO) and adapalene 0.3%/BPO 2.5% (0.3% A/BPO) gels are fixed-combination options for the topical treatment of acne. However, the active compounds of these combinations are also available as monads, to be used in association or as monotherapy. These two in vitro studies determined the effect of different treatment regimens on the percutaneous absorption of adapalene (0.1% and 0.3%) gels and BPO 2.5% gel in ex vivo human skin. METHODS: In vitro percutaneous absorption studies were conducted using full-thickness human skin from six donors...
November 30, 2016: Dermatology and Therapy
https://www.readbyqxmd.com/read/27884077/from-patient-to-tube-the-importance-of-physiologically-relevant-quantitative-bioanalytical-assays
#6
Scott Summerfield, Matthew Barfield, Neil Spooner, Steve White
Circulating drug concentrations (clinical or preclinical) underly many interactions between industry and regulators; expressing safety coverage, pharmacokinetic-pharmacodynamic relationships or defining bioequivalence and dosing regimens. Accurate and precise measurement of these circulating concentrations is pivotal to the evolution and validation of any bioanalytical method that supports regulatory interactions. Since the bioanalyst is presented with a sub-aliquot of sampled biological matrix, how do they ensure this aliquot reflects the concentration in the subject at the time of collection? Here we share experiences from project support (internal and at CROs) that suggests we need to be ever vigilant translating the needs of bioanalysis with those of project teams...
December 2016: Bioanalysis
https://www.readbyqxmd.com/read/27879195/the-pharmacokinetic-comparison-and-bioequivalence-evaluation-of-two-10-mg-baclofen-formulations-in-healthy-male-subjects%C3%A2
#7
Sumin Yoon, SeungHwan Lee, Kyung-Sang Yu, Sung-Vin Yim, Bo-Hyung Kim
BACKGROUNDS: Baclofen is used as a skeletal muscle relaxant for multiple sclerosis patients. It depresses the transmission of monosynaptic and polysynaptic reflex by stimulating GABAβ (gamma-aminobutyric acid) receptors. OBJECTIVES: The aim of this study was to compare the pharmacokinetic characteristics of two 10-mg baclofen formulations and to assess bioequivalence. METHODS: A randomized, single-dose, two-period, two-sequence crossover study was conducted in healthy male subjects...
November 23, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27879193/pharmacokinetic-comparison-of-two-formulations-of-talniflumate-370%C3%A2-mg-tablets-in-healthy-korean-volunteers%C3%A2
#8
Yun Kim, Sung- Yim, Bo-Hyung Kim, SeungHwan Lee
BACKGROUND: Talniflumate, a prodrug of niflumic acid, is a potent analgesic and anti-inflammatory drug that has been widely used for the treatment of rheumatoid diseases. OBJECTIVE: The aim of this study was to compare the pharmacokinetics and to evaluate the bioequivalence of two formulations of talniflumate 370 mg tablets (test formulation: Flumagen® 370 mg tablet; reference formulation: Somalgen® 370 mg tablet). METHODS: A randomized, open-label, single dose, two-sequence, two-period crossover clinical study was conducted...
November 23, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27874307/single-center-single-dose-open-label-randomized-two-period-crossover-study-on-the-bioavailability-of-methotrexate-administered-using-a-novel-prefilled-needle-free-delivery-system-zeneo
#9
Boris Bienvenu, Achille Aouba, Jacques-Eric Gottenberg, Celine Verstuyft
OBJECTIVE: ZENEO (Crossject, Chenôve, France) is a needle-free injection device. We performed a pharmacokinetic study to investigate the bioequivalence of methotrexate administered subcutaneously using either ZENEO or a conventional needle and syringe. RESEARCH DESIGN AND METHODS: This was a single-dose, open-label, laboratory-blind, randomized crossover study performed in adult healthy volunteers. Each participant received two methotrexate injections (each 25 mg), one via ZENEO and one via conventional injection, with a 21-28 day wash-out interval between dosing...
November 22, 2016: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/27873172/erratum-to-open-flow-microperfusion-as-a-dermal-pharmacokinetic-approach-to-evaluate-topical-bioequivalence
#10
Manfred Bodenlenz, Katrin I Tiffner, Reingard Raml, Thomas Augustin, Christian Dragatin, Thomas Birngruber, Denise Schimek, Gerd Schwagerle, Thomas R Pieber, Sam G Raney, Isadore Kanfer, Frank Sinner
No abstract text is available yet for this article.
November 21, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27872088/h-ras-and-k-ras-oncoproteins-induce-different-tumor-spectra-when-driven-by-the-same-regulatory-sequences
#11
Matthias Drosten, Lucía Simón-Carrasco, Isabel Hernández-Porras, Carmen G Lechuga, María T Blasco, Harrys Kc Jacob, Salvatore Fabbiano, Nicoletta Potenza, Xosé R Bustelo, Carmen Guerra, Mariano Barbacid
Genetic studies in mice have provided evidence that H-Ras and K-Ras proteins are bioequivalent. However, human tumors display marked differences in the association of RAS oncogenes with tumor type. Thus, to further assess the bioequivalency of oncogenic H-Ras and K-Ras, we replaced the coding region of the murine K-Ras locus with H-RasG12V oncogene sequences. Germline expression of H-RasG12V or K-RasG12V from the K-Ras locus resulted in embryonic lethality. However, expression of these genes in adult mice led to different tumor phenotypes...
November 21, 2016: Cancer Research
https://www.readbyqxmd.com/read/27869754/a-comparative-pharmacokinetics-study-of-the-anti-parkinsonian-drug-pramipexole
#12
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/27865610/assessment-of-bioequivalence-of-weak-base-formulations-under-various-dosing-conditions-using-physiologically-based-pharmacokinetic-simulations-in-virtual-populations-case-examples-ketoconazole-and-posaconazole
#13
Rodrigo Cristofoletti, Nikunjkumar Patel, Jennifer B Dressman
Postabsorptive factors which can affect systemic drug exposure are assumed to be dependent on the active pharmaceutical ingredient (API), and thus independent of formulation. In contrast, preabsorptive factors, for example, hypochlorhydria, might affect systemic exposure in both an API and a formulation-dependent way. The aim of this study was to evaluate whether the oral absorption of 2 poorly soluble, weakly basic APIs, ketoconazole (KETO) and posaconazole (POSA), would be equally sensitive to changes in dissolution rate under the following dosing conditions-coadministration with water, with food, with carbonated drinks, and in drug-induced hypochlorhydria...
November 16, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27859251/a-randomized-two-way-crossover-bioequivalence-study-in-healthy-adult-volunteers-of-paediatric-zidovudine-lamivudine-nevirapine-fast-disintegrating-fixed-dose-combination-tablet
#14
Anjali Joshi, Daniel Gbadero, Fredrick Esseku, Olufikayo J Adesanya, Moji C Adeyeye
OBJECTIVE: The bioequivalence study was conducted to compare the developed paediatric fixed-dose combination (FDC) zidovudine/lamivudine/nevirapine (60/30/50 mg) tablet - the test formulation - with the combined mixture of single-entity innovator products (reference product). METHODS: A single-dose open-label randomized two-way crossover study was conducted in healthy adult African volunteers after an informed consent was obtained. The 24 volunteers, divided into two groups, were administered the products after an overnight fast on two treatment days with 14 days of washout period...
November 18, 2016: Journal of Pharmacy and Pharmacology
https://www.readbyqxmd.com/read/27849125/clinical-bioequivalence-of-ot329-solis%C3%A2-and-advair-diskus%C3%A2-in-adults-with-asthma
#15
Malinda V Longphre, Elise Burmeister Getz, Rick Fuller
RATIONALE: OT329 SOLIS™ is a generic candidate for the branded asthma treatment ADVAIR DISKUS® (fluticasone propionate/salmeterol xinafoate) and as such is required to provide evidence of clinical bioequivalence as a condition for regulatory approval. OBJECTIVES: The objective of the current study was to determine if SOLIS™ and DISKUS® provided "bioequivalent" improvements in lung function at two time points: Day 1 and Week 4. METHODS: This study was a randomized, multiple-dose, placebo-controlled, parallel-group design conducted in the U...
November 16, 2016: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/27843352/profile-of-once-daily-darunavir-cobicistat-fixed-dose-combination-for-the-treatment-of-hiv-aids
#16
REVIEW
Jordi Navarro, Adrian Curran
Efficacy is the main objective of antiretroviral treatment and adherence is one of the cornerstones to achieve it. For this reason, treatment simplification is of key importance with regard to antiretroviral regimens. Rezolsta® (darunavir/cobicistat) is the first fixed-dose combination containing a protease inhibitor approved for HIV treatment. This coformulation includes darunavir, a protease inhibitor that has shown its efficacy and safety in naïve and treatment-experienced patients, and cobicistat, the new pharmacokinetic enhancer that is expected to replace ritonavir...
2016: HIV/AIDS: Research and Palliative Care
https://www.readbyqxmd.com/read/27824428/development-and-validation-of-an-lc-ms-ms-esi-method-for-comparative-pharmacokinetic-study-of-ciprofloxacin-in-healthy-male-subjects
#17
H Choudhury, B Gorain, A Paul, P Sarkar, S Dan, P Chakraborty, T K Pal
A sensitive, specific and reproducible liquid chromatography coupled to tandem mass spectrometric method was developed and validated for the estimation of ciprofloxacin, an extensively used second-generation quinolone antibiotics, in human plasma. A liquid-liquid extraction of ciprofloxacin and the internal standard, ofloxacin, has been approached from the biological matrix using chloroform. Chromatographic separation was achieved in positive ion modes, isocratically on a 3.5 μm C18 analytical column (75 mm×4...
November 7, 2016: Drug Research
https://www.readbyqxmd.com/read/27822013/pharmacokinetics-and-relative-bioavailability-of-fixed-dose-combination-of-clopidogrel-and-aspirin-versus-coadministration-of-individual-formulations-in-healthy-korean-men
#18
Hyang-Ki Choi, Jong-Lyul Ghim, Jihong Shon, Young-Kyung Choi, Jin Ah Jung
BACKGROUND: Simultaneous prescription of clopidogrel and low-dose aspirin is recommended for the treatment of acute coronary syndrome because of improvements in efficacy and patient compliance. In this study, the pharmacokinetics of a fixed-dose combination (FDC) of clopidogrel and aspirin was compared with coadministration of individual formulations to clarify the equivalence of the FDC. METHODS: This was a randomized, open-label, two-period, two-treatment, crossover study in healthy Korean men aged 20-55 years...
2016: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/27819247/generic-oncology-drugs-are-they-all-safe
#19
REVIEW
Y Tony Yang, Sumimasa Nagai, Brian K Chen, Zaina P Qureshi, Akida A Lebby, Samuel Kessler, Peter Georgantopoulos, Dennis W Raisch, Oliver Sartor, Terhi Hermanson, Robert C Kane, William J Hrushesky, Joshua J Riente, LeAnn B Norris, Laura R Bobolts, James O Armitage, Charles L Bennett
Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel)...
November 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27819159/empagliflozin-metformin-fixed-dose-combination-a-review-in-patients-with-type-2-diabetes
#20
Jingbo Hu, Ping Zou, Shuo Zhang, Minzhi Zhou, Xueying Tan
Most patients with type 2 diabetes, who receive monotherapy, are unable to maintain glucose levels with the progress of disease. Therefore, combination therapy with two or more anti-diabetic agents of different classes is highly desired. Sodium glucose co-transporter 2 (SGLT2) inhibitors improve glycemic control through increasing urinary glucose excretion, which is independent of β-cell function. In addition, they are generally well tolerated and associated with a low risk of hypoglycaemia. SGLT2 inhibitors as add-on therapy to metformin have an additive effect on glycemic control in patients with type 2 diabetes, and fixed-dose tablet is likely to reduce pill burden and then improve patients' adherence...
December 2016: Expert Opinion on Pharmacotherapy
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