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Bioequivalence

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https://www.readbyqxmd.com/read/29165079/comparison-of-clobetasol-propionate-generics-using-simplified-in-vitro-bioequivalence-method-for-topical-drug-products
#1
Kelen Carine Costa Soares, Weidson Carlos de Souza, Leonardo de Souza Texeira, Marcilio Sergio Soares da Cunha-Filho, Guilherme Martins Gelfuso, Tais Gratieri
The aim of this paper is to propose a simple in vitro skin penetration experiment in which the drug is extracted from the whole skin piece as a test valid for formulation screening and optimization during development process, equivalence assessment during quality control or post-approval after changes to the product. Twelve clobetasol propionate (CP) formulations (six creams and six ointments) from the local market were used as a model to challenge the proposed methodology in comparison to in vitro skin penetration following tape-stripping for drug extraction...
November 20, 2017: Current Drug Delivery
https://www.readbyqxmd.com/read/29165078/pharmaceutical-product-lead-optimization-for-better-in-vivo-bioequivalence-performance-a-case-study-of-diclofenac-sodium-extended-release-matrix-tablets
#2
Aliasgar Shahiwala, Aisha Zarar
BACKGROUND: In order to prove the validity of a new formulation, a considerable amount of efforts is required to study bioequivalence, not only increases the burden of carrying out a number of bioequivalence studies but eventually increase the cost of the optimization process. OBJECTIVE: The aim of the present study was to develop sustained release matrix tablets containing diclofenac sodium using natural polymers and to demonstrate step by step process of product development till the prediction of in vivo marketed product equivalence of the developed product...
November 20, 2017: Current Drug Delivery
https://www.readbyqxmd.com/read/29162214/pharmacokinetics-and-bioequivalence-of-a-rosuvastatin-ezetimibe-fixed-dose-combination-tablet-versus-single-agents-in-healthy-male-subjects%C3%A2
#3
Woo Youl Kang, Sook Jin Seong, Boram Ohk, Mi-Ri Gwon, Bo Kyung Kim, Sookie Na, Hyun-Ju Kim, Young-Ran Yoon, Hae Won Lee
OBJECTIVE: The pharmacokinetic profiles and bioequivalence of a new rosuvastatin/ezetimibe fixed-dose combination (FDC; NVP-1205) vs. rosuvastatin and ezetimibe concomitantly administered as single agents were evaluated. MATERIALS AND METHODS: In this open-label, single-dose, crossover study (NCT02029625), eligible subjects were randomly assigned in a 1 : 1 ratio to receive a single dose of rosuvastatin (10 mg) with ezetimibe (10 mg) as either a FDC or as single agents concomitantly administered under fasted conditions, followed by a 2-week washout period and administration of the alternate formulation...
November 22, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29156456/impact-of-truncated-area-on-point-estimate-and-intra-subject-variability-in-bioequivalence-of-dutasteride-with-long-half-life
#4
Budi Prasaja, Yahdiana Harahap, Windy Lusthom, Lia Yumi, Anna Sofiana, Monica Sandra, Falah Safira, Uci Chilmi
Purpose To investigate the effect of using truncated area under the curve (AUC0-72) on bioequivalence of dutasteride with long half-life in point estimate and intra-subject variability. Methods Fifteen subjects were enrolled in this single-dose, open-label, randomized two-way crossover design following an overnight fasting with five-week washout period. Plasma samples were collected to 72 h and 144 h following drug administration and dutasteride were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods...
November 20, 2017: Drug Research
https://www.readbyqxmd.com/read/29135993/bioequivalence-between-innovator-and-generic-tacrolimus-in-liver-and-kidney-transplant-recipients-a-randomized-crossover-clinical-trial
#5
Rita R Alloway, Alexander A Vinks, Tsuyoshi Fukuda, Tomoyuki Mizuno, Eileen C King, Yuanshu Zou, Wenlei Jiang, E Steve Woodle, Simon Tremblay, Jelena Klawitter, Jost Klawitter, Uwe Christians
BACKGROUND: Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, "brand") product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29135980/bioequivalence-of-twice-daily-oral-tacrolimus-in-transplant-recipients-more-evidence-for-consensus
#6
Simon Ball
In this Perspective on the clinical trial by Rita Alloway and colleagues, Simon Ball explains the benefits to healthcare systems and individual patients of the bioequivalence established between generic and brand-name formulations of an immunosuppressive drug in transplant recipients.
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29134635/ribociclib-bioavailability-is-not-affected-by-gastric-ph-changes-or-food-intake-in-silico-and-clinical-evaluations
#7
Tanay S Samant, Shyeilla Dhuria, Yasong Lu, Marc Laisney, Shu Yang, Arnaud Grandeury, Martin Mueller-Zsigmondy, Kenichi Umehara, Felix Huth, Michelle Miller, Caroline Germa, Mohamed Elmeliegy
Ribociclib (KISQALI®), a cyclin-dependent kinase 4/6 inhibitor approved for the first-line treatment of HR+/HER2- advanced breast cancer with an aromatase inhibitor, is administered with no restrictions on concomitant gastric pH-elevating agents or food intake. The influence of proton pump inhibitors (PPIs) on ribociclib bioavailability was assessed using (1) biorelevant media solubility, (2) physiologically based pharmacokinetic (PBPK) modeling, (3) non-compartmental analysis (NCA) of clinical trial data, and (4) population PK (PopPK) analysis...
November 14, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29125715/two-phase-1-open-label-single-dose-randomized-crossover-studies-to-assess-the-pharmacokinetics-safety-and-tolerability-of-orally-administered-granules-of-secnidazole-2-g-in-healthy-female-volunteers-under-different-administration-conditions
#8
Helen S Pentikis, Nikki Adetoro
Bacterial vaginosis (BV) is the most common vaginal infection in reproductive-age women and a significant risk factor for sexually transmitted diseases and pregnancy complications. Standard 5- to 7-day antimicrobial treatments for BV are associated with high rates of recurrence and adverse events. SYM-1219 is a novel granule formulation containing 2 g of secnidazole, developed as an oral, single-dose BV treatment. Two phase 1, open-label, single-center, randomized, crossover trials (studies 102 and 103) assessed the pharmacokinetics and safety of SYM-1219 single doses (≥7-day washout between doses) in healthy, nonpregnant women aged 18 to 65 years inclusive...
November 10, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29110389/equivalence-testing-for-similarity-in-bioassays-using-bioequivalence-criteria-on-the-relative-bioactivity
#9
Corine Baljé-Volkers, Thembile Mzolo, Erik Talens, Pieta IJzerman-Boon, Edwin Van den Heuvel
Similarity in bioassays means that the test preparation behaves as a dilution of the standard preparation with respect to their biological effect. Thus, similarity must be investigated to confirm this biological property. Historically, this was typically conducted with traditional hypothesis testing, but this has received substantial criticism. Failing to reject similarity does not imply that the 2 preparations are similar. Also, rejecting similarity when bioassay variability is small might simply demonstrate a nonrelevant deviation in similarity...
November 6, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/29099732/error-in-drugs-consumption-among-older-patients
#10
Yosefa Bar-Dayan, Thomas Shotashvily, Mona Boaz, Julio Wainstein
The cost effectiveness of generic drugs has promoted their use worldwide. However, the large variety of bioequivalent generic and brand-name drugs found in the marketplace increases the complexity and frequency of mistakes in drug consumption. This clinical study investigated the prevalence of various mistakes in drug consumption by patients using a hospital setting. This prospective clinical trial used a hospital setting to identify errors in drug consumption. Six hundred patients who were hospitalized for a minimum of 48 hours in the Internal Medicine Departments were checked at various time points...
November 2017: American Journal of Therapeutics
https://www.readbyqxmd.com/read/29092731/bioequivalence-of-cyclobenzaprine-hydrochloride-extended-release-capsule-taken%C3%A2-intact-or-sprinkled-over-applesauce%C3%A2
#11
Liat Adar, William Zarycranski, Jill B Conner, Jeffrey Dragone, Lindsay Janka, Laura Rabinovich-Guilatt
OBJECTIVE: Difficulty swallowing pills can compromise pain control in painful musculoskeletal disorders. This open-label, 2-period crossover study assessed pharmacokinetics and safety of cyclobenzaprine extended-release (CER) 30-mg capsule contents sprinkled over applesauce compared with intact capsules in healthy subjects. MATERIALS AND METHODS: 32 subjects were randomized to treatment sequences AB or BA (A = single CER intact capsule; B = single CER capsule contents sprinkled over applesauce (15 mL))...
October 26, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29092730/bioequivalence-and-pharmacokinetic-pharmacodynamic-correlation-of-clopidogrel-in%C3%A2-healthy-thai-subjects%C3%A2
#12
Malinee Chunsangchan, Pajaree Chariyavilaskul, Wannarasmi Ketchart, Nantaporn Prompila, Supeecha Wittayalertpanya
Clopidogrel is an antiplatelet drug, selectively binding to the platelet P2Y12 receptor of adenosine diphosphate. Clopidogrel is a prodrug modified through active metabolite in the liver by two steps of CYP enzyme. The active metabolite is responsible for inhibiting platelet aggregation. OBJECTIVE: The study aimed to assess the bioequivalence of clopidogrel 75 mg generic and reference drugs and to investigate the correlation between pharmacokinetics of active metabolites and its antiplatelet activities...
October 26, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29092729/bioequivalence-and-food-effect-study-of-two-zaltoprofen-preparations-in-healthy-chinese-volunteers%C3%A2
#13
Ying Song, Yi Ding, Yanyan Jia, Jinyi Zhao, Kai Gao, Chengtao Lu, Ruili Li, Aidong Wen
OBJECTIVE: Zaltoprofen, a propionic acid derivative of nonsteroidal anti-inflammatory drug (NSAID), has powerful anti-inflammatory and analgesic effects on inflammatory pain. This study was undertaken to investigate the effect of food on the pharmacokinetic parameters of zaltoprofen capsule (trial preparation, T) and tablet (reference preparation, R), and to assess the relative bioequivalence of two zaltoprofen preparations. MATERIALS AND METHODS: In this open-label, randomized, crossover, two-state, four-period study, 24 healthy Chinese volunteers were randomized to receive a single oral dose of zaltoprofen capsule/tablet (80 mg) under fasting and fed state...
October 26, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29076742/impact-of-the-us-fda-biopharmaceutics-classification-system-bcs-guidance-on-global-drug-development
#14
Mehul U Mehta, Ramana S Uppoor, Dale P Conner, Paul Seo, Jayabharathi Vaidyanathan, Donna A Volpe, Ethan Stier, Dakshina Chilukuri, Angelica Dorantes, Tapash Ghosh, Haritha Mandula, Kimberly Raines, Pariban Dhanormchitphong, Janet Woodcock, Lawrence X Yu
The FDA guidance on application of the biopharmaceutics classification system (BCS) for waiver of in vivo bioequivalence (BE) studies was issued in August 2000. Since then, this guidance has created worldwide interest among biopharmaceutical scientists in regulatory agencies, academia, and industry toward its implementation and further expansion. This article describes how the review implementation of this guidance was undertaken at the FDA and results of these efforts over last dozen years or so across the new, and the generic, drug domains are provided...
November 7, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/29058298/pharmacokinetics-and-tolerability-of-oral-dosage-forms-of-huperzine-a-in-healthy-chinese-male-volunteers-a-randomized-single-dose-three-period-six-sequence-crossover-study
#15
San-Lan Wu, Jun Gan, Jing Rao, Si-Jie He, Wen-Wen Zhu, Ying Zhao, Yong-Ning Lv, Jian-Geng Huang, Ya-Ni Liu
Huperzine A is a potent, reversible, and blood-brain barrier permeable acetylcholinesterase inhibitor. The aim of this study was to compare the pharmacokinetics, tolerability, and bioavailability of two formulations with the established reference formulation of huperzine A in a fasting, healthy Chinese male population. This was a randomized, single-dose, 3-period, 6-sequence crossover study. The plasma concentrations of huperzine A were determined by liquid chromatography tandem mass spectrometry. Tolerability was assessed based on subject interview, vital sign monitoring, physical examination, and routine blood and urine tests...
October 2017: Journal of Huazhong University of Science and Technology. Medical Sciences
https://www.readbyqxmd.com/read/29042832/evaluation-of-the-efficacy-of-a-onetime-injectable-dexamethasone-administered-orally-in-the-pediatric-emergency-department-for-asthma-exacerbation
#16
Ashley McCallister, Tsz-Yin So, Josh Stewart
OBJECTIVE: This study assessed the efficacy of injectable dexamethasone administered orally in pediatric patients who presented to the emergency department with asthma exacerbation. METHODS: This was a retrospective study of patients 0 to 18 years of age who presented to and who were directly discharged from the emergency department at Moses H. Cone Memorial Hospital between September 1, 2012, and September 30, 2015, for the diagnosis of asthma or asthma exacerbation...
September 2017: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
https://www.readbyqxmd.com/read/29039320/pharmacokinetic-and-bioequivalence-studies-of-fast-dispersible-ketoprofen-tablets-in-healthy-volunteers
#17
Farya Zafar, Muhammad Harris Shoaib, Rabia Ismail Yousuf, Huma Ali, Rabia Bushra
In the present study the pharmacokinetic and bioequivalence parameter of Ketoprofen 100 mg fast dispersible tablets (test) were measured with marketed (reference) product. This study was accomplished following FDA guidance. A single dose, open labeled, cross over (two way), randomized study design was used to conduct investigation on 12 Pakistani healthy volunteers. At various time points blood samples (10mL) were drawn i.e. at 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 13hr. Plasma was then separated and ketoprofen concentrations were estimated by validated HPLC technique using LC 20A pump (Shimadzu Corp, Japan) and Spectrophotometric SPD-20Adetector (Shimadzu Corp, Japan)...
July 2017: Pakistan Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29039106/improved-ultrafiltration-method-to-measure-drug-release-from-nanomedicines-utilizing-a-stable-isotope-tracer
#18
Sarah L Skoczen, Stephan T Stern
An important step in the early development of a nanomedicine formulation is the evaluation of stability and drug release in biological matrices. Additionally, the measurement of encapsulated and unencapsulated nanomedicine drug fractions is important for the determination of bioequivalence (pharmacokinetic equivalence) of generic nanomedicines. Unfortunately, current methods to measure drug release in plasma are limited, and all have fundamental disadvantages including non-equilibrium conditions and process-induced artifacts...
2018: Methods in Molecular Biology
https://www.readbyqxmd.com/read/29032734/gammaplex-%C3%A2-5-and-10-in-the-treatment-of-primary-immunodeficiency-and-chronic-immune-thrombocytopenic-purpura
#19
Richard L Wasserman
Immunoglobulin G is used to both prevent infection in primary immunodeficiency diseases (PIDs) and prevent bleeding in immune thrombocytopenic purpura. Gammaplex is a highly purified human intravenous immunoglobulin G available as 5 and 10% liquid formulations. Gammaplex 5% has proven efficacy and safety in PID and immune thrombocytopenic purpura, protecting against serious acute bacterial infections and treating bleeding by improving platelet counts, respectively. The therapeutic effect of Gammaplex 10% is expected to be similar to that of Gammaplex 5% based on demonstrated bioequivalence in a bridging study in PID...
October 2017: Immunotherapy
https://www.readbyqxmd.com/read/29032305/physicochemical-pharmacokinetics-as-an-optimization-tool-for-generic-development-a-case-study
#20
Stefan Horkovics-Kovats, Ivan Ulč, Ladislav Vít, Bohdan Němec, Václav Rada
In spite of the fact that dissolution time profiles of 250mg ursodeoxycholic acid (UCDA) capsules developed by Sponsor and 250mg hard capsules produced by Ursofalk®, Dr. Falk Pharma GmbH, indicated similarity (f2=60.6), a bioavailability study indicated unexpected differences in the formulations. To find an explanation of the in vivo performance of the compared formulations, the dissolution profiles were analyzed using a novel dissolution theory considering: The dissolution model was applied to the measured data using SADAPT...
October 13, 2017: European Journal of Pharmaceutical Sciences
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