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Bioequivalence

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https://www.readbyqxmd.com/read/29330847/interchangeability-of-generic-drugs-a-non-parametric-pharmacokinetic-model-of-gabapentin-generic-drugs
#1
P J Glerum, Y Yu, W M Yamada, M N Neely, M Maliepaard, D M Burger, C Neef
Substitution by generic drugs is allowed when bioequivalence to the originator drug has been established. However, it is known that similarity in exposure may not be achieved at every occasion for all individual patients when switching between formulations. The ultimate aim of our research is to investigate if pharmacokinetic subpopulations exist when subjects are exposed to bioequivalent formulations. For that purpose, we developed a pharmacokinetic model for gabapentin, based on data from a previously conducted bioavailability study comparing gabapentin exposure following administration of the gabapentin originator and three generic gabapentin formulations in healthy subjects...
January 13, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29329941/analysis-of-refuse-to-file-policy-for-generic-drug-application-in-taiwan
#2
I-Chen Sun, Churn-Shiouh Gau
Generic drugs are accounted for majority of medicinal products. To reduce the unnecessary review for incomplete dossiers of generic drugs, Taiwanese government launched a refuse-to-file (RTF) procedure since 2017. The present study aimed to examine the outcome of RTF procedure by analyzing application characteristic, RTF rate and deficiencies found in the submitted dossiers. Descriptions of administrative information, chemistry, manufacturing and controls, bioequivalence study, and comparative dissolution testing were presented during the first 6 months after the implementation of RTF policy...
January 9, 2018: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29327295/common-deficiencies-of-in-vitro-binding-bioequivalence-be-studies-submitted-in-abbreviated-new-drug-applications-andas
#3
Dongmei Lu, Diana Vivian, Ping Ren, Yongsheng Yang, Hongling Zhang, Xiaojian Jiang, Ethan Stier
There are several drug products that bind phosphate or bile acid in the gastrointestinal (GI) tract to exert their therapeutic efficacy. In vitro binding studies are used to assess bioequivalence (BE) of these products. The objective of this study is to identify the common deficiencies in Abbreviated New Drug Applications (ANDAs) for these products. Deficiencies were compiled from ANDAs containing in vitro binding BE studies. The deficiencies were classified into eight categories: Pre-Study Method Validation, During-Study Sample Analysis, Study Design, Study Procedure, Dissolution/Disintegration, Analytical Site Inspection, Data Submission, and Formulations...
January 11, 2018: AAPS Journal
https://www.readbyqxmd.com/read/29325225/influence-of-cyp2d6-cyp3a4-cyp3a5-and-abcb1-polymorphisms-on-pharmacokinetics-and-safety-of-aripiprazole-in-healthy-volunteers
#4
Carmen Belmonte, Dolores Ochoa, Manuel Román, Miriam Saiz-Rodríguez, Aneta Wojnicz, Clara Isabel Gómez-Sánchez, Samuel Martín-Vilchez, Francisco Abad-Santos
The aim of this study was to investigate the effect of polymorphisms in cytochrome P450 (CYP) 2D6, CYP3A4 and CYP3A5 enzymes and in P-glycoprotein (P-gp) on the pharmacokinetics and safety of aripiprazole and, its active metabolite, dehydro-aripiprazole, in 148 healthy volunteers from 6 bioequivalence trials receiving a single oral dose of aripiprazole. The plasma concentrations of both analytes were measured by LC-MS/MS. CYP2D6 (*3,*4,*5,*6,*7,*9 and copy number variations), CYP3A4 (*20 and *22), CYP3A5*3 and C3435T, C1236T and G2677T/A in ABCB1 gene were determined...
January 11, 2018: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/29324280/effective-phospholipids-removing-microelution-solid-phase-extraction-lc-ms-ms-method-for-simultaneous-plasma-quantification-of-aripiprazole-and-dehydro-aripiprazole-application-to-human-pharmacokinetic-studies
#5
Aneta Wojnicz, Carmen Belmonte, Dora Koller, Ana Ruiz-Nuño, Manuel Román, Dolores Ochoa, Francisco Abad Santos
A simple liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for simultaneous quantification of aripiprazole and its active metabolite, dehydro-aripiprazole, in human plasma. Stable isotopically labeled aripiprazole, aripiprazole-D8, has been used as the internal standard (IS) for both analytes. Only 200 μl of human plasma was needed for analyte extraction, using effective phospholipids-eliminating three-step microelution-solid-phase extraction (SPE, Oasis PRiME HLB 96-well μElution Plate)...
December 28, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29322620/rice-protein-matrix-enhances-circulating-levels-of-xanthohumol-following-acute-oral-intake-of-spent-hops-in-humans
#6
Annalouise O'Connor, Veera Konda, Ralph L Reed, J Mark Christensen, Jan F Stevens, Nikhat Contractor
SCOPE: Xanthohumol (XN), a prenylated flavonoid found in hops, exhibits anti-inflammatory and antioxidant properties. However, poor bioavailability may limit therapeutic applications. As food components are known to modulate polyphenol absorption, the objective was to determine whether a protein matrix could enhance the bioavailability of XN post oral consumption in humans. METHODS AND RESULTS: This was a randomized, double-blind, cross-over study in healthy participants (n = 6) evaluating XN and its major metabolites [isoxanthohumol (IX), 6- and 8-prenylnaringenin (6-PN, 8-PN)] for 6 hours following consumption of 12...
January 11, 2018: Molecular Nutrition & Food Research
https://www.readbyqxmd.com/read/29322231/the-effect-of-food-on-the-pharmacokinetics-of-niraparib-a-poly-adp-ribose-polymerase-parp-inhibitor-in-patients-with-recurrent-ovarian-cancer
#7
Kathleen Moore, Zhi-Yi Zhang, Shefali Agarwal, Howard Burris, Manish R Patel, Vikram Kansra
PURPOSE: Niraparib is a highly selective inhibitor of PARP-1 and PARP-2 approved in the United States for maintenance treatment of adult patients with recurrent ovarian cancer in complete or partial response to platinum-based chemotherapy. In this open-label crossover study, we evaluated the effects of food on niraparib pharmacokinetics (PK) and safety. METHODS: Patients received a single 300-mg dose of niraparib either after a high-fat meal or under fasting conditions...
January 10, 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29319935/clinical-bioavailability-of-the-novel-bace1-inhibitor-lanabecestat-azd3293-assessment-of-tablet-formulations-versus-an-oral-solution-and-the-impact-of-gastric-ph-on-pharmacokinetics
#8
Naidong Ye, Scott A Monk, Pankaj Daga, David M Bender, Laura B Rosen, Jamie Mullen, Margaret C Minkwitz, Alan R Kugler
The relative bioavailability of lanabecestat administered as 2 tablet formulations versus an oral solution was investigated. This phase 1 single-center, open-label, randomized, 3-period crossover study involved healthy male and nonfertile female subjects aged 18-55 years (NCT02039180). Subjects received a single 50-mg lanabecestat dose as solution, tablet A, or tablet B on day 1 of each crossover period; 14 of 16 subjects completed the study. Relative bioavailability based on plasma lanabecestat AUC0-∞ (area under the plasma drug concentration-time curve from zero to infinity) geometric mean ratio versus oral solution (primary variable) was: tablet A, 1...
January 10, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29319446/comparison-of-absorption-characteristics-of-oral-reference-and-compounded-itraconazole-formulations-in-healthy-cats
#9
Dianne I Mawby, Jacqueline C Whittemore, Leanne E Fowler, Mark G Papich
OBJECTIVE To compare absorption characteristics of orally administered compounded itraconazole capsules and suspension with those of reference (brand-name) formulations in healthy cats. DESIGN Randomized crossover study. ANIMALS 8 healthy adult cats. PROCEDURES After 12 hours of food withholding, cats received 50 mg of itraconazole (reference capsule, reference solution, compounded capsule, and compounded suspension) in a randomized crossover design, with a 21-day washout period. Capsules were administered with a small meal...
January 15, 2018: Journal of the American Veterinary Medical Association
https://www.readbyqxmd.com/read/29319156/overview-of-the-european-medicines-agency-s-development-of-product-specific-bioequivalence-guidelines
#10
Jane O' Sullivan, Kevin Blake, Michael Berntgen, Tomas Salmonson, Jan Welink
The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms...
December 5, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29314090/development-and-validation-of-lc-ms-ms-method-for-simultaneous-determination-of-sofosbuvir-and-daclatasvir-in-human-plasma-application-to-pharmacokinetic-study
#11
Ola M Abdallah, Ahmed M Abdel-Megied, Amira S Gouda
The first simple and highly sensitive Liquid chromatography-tandem mass spectrometry (LC-MS/MS) bioanalytical method was developed and fully validated for the simultaneous determination of newly discovered antiviral drugs namely, Sofosbuvir (SOF) and Daclatasvir (DAC) in human plasma. Tadalafil (TAD) was used as internal standard (IS). SOF, DAC and TAD (IS) were extracted from plasma using liquid-liquid extraction technique with methyl tert-butyl ether. The chromatographic separation was carried out using ZorbaxSB-C18 column (4...
January 3, 2018: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/29308592/abuse-deterrent-features-of-an-extended-release-morphine-drug-product-developed-using-a-novel-injection-molding-technology-for-oral-drug-delivery
#12
Nikolaj Skak, Torben Elhauge, Jeffrey M Dayno, Karsten Lindhardt
OBJECTIVE: A novel technology platform (Guardian™ Technology, Egalet Corporation, Wayne, PA) was used to manufacture morphine abuse-deterrent (AD), extended-release (ER), injection-molded tablets (morphine-ADER-IMT; ARYMO® ER [morphine sulfate] ER tablets; Egalet Corporation), a recently approved morphine product with AD labeling. The aim of this article is to highlight how the features of Guardian™ Technology are linked to the ER profile and AD characteristics of morphine-ADER-IMT...
November 2017: Journal of Opioid Management
https://www.readbyqxmd.com/read/29305981/the-effect-of-formulation-additives-on-in-vitro-dissolution-absorption-profile-and-in-vivo-bioavailability-of-telmisartan-from-brand-and-generic-formulations
#13
Enikő Borbás, Zsombor K Nagy, Brigitta Nagy, Attila Balogh, Balázs Farkas, Oksana Tsinman, Konstantin Tsinman, Bálint Sinkó
In this study, brand and four generic formulations of telmisartan, an antihypertensive drug, were used in in vitro simultaneous dissolution-absorption, investigating the effect of different formulation additives on dissolution and on absorption through an artificial membrane. The in vitro test was found to be sensitive enough to show even small differences between brand and generic formulations caused by the use of different excipients. By only changing the type of filler from sorbitol to mannitol in the formulation, the flux through the membrane was reduced by approximately 10%...
January 3, 2018: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29300350/exploring-the-knowledge-and-perception-of-generic-medicines-among-final-year-undergraduate-medical-pharmacy-and-nursing-students-in-sierra-leone-a-comparative-cross-sectional-approach
#14
Peter Bai James, Abdulai Jawo Bah, Emmanuel Kamanda Margao, Christian Hanson, John Alimamy Kabba, Shazia Qasim Jamshed
Most low-income nations have national medicine policy that emphasized the use of generic medicines in the public health sector. However, the use of generics is often debatable as there are concerns over its efficacy, quality, and safety compared to their branded counterparts. This study was conducted to compare the knowledge and perception of generic medicines among final year undergraduate medical, pharmacy, and nursing students in Sierra Leone. We conducted a questionnaire-based cross-sectional study among these students at the College of Medicine and Allied Health Sciences University of Sierra Leone...
January 4, 2018: Pharmacy (Basel, Switzerland)
https://www.readbyqxmd.com/read/29296077/hx575-established-biosimilarity-in-the-treatment-of-renal-anemia-and-10-years-of-clinical-experience
#15
REVIEW
Frank Dellanna, David Goldsmith, Andriy Krendyukov, Andreas Seidl, Nadja Höbel, Christian Combe
Erythropoiesis-stimulating agents, such as recombinant human erythropoietin, are commonly used for the treatment of anemia in patients with chronic kidney disease (CKD). In 2007, HX575 (Binocrit®) became the first biosimilar epoetin alfa to be approved by the European Medicines Agency (EMA). The decision to approve a biosimilar is based on the totality of evidence obtained in a comprehensive comparability exercise that involves extensive analytical characterization, nonclinical studies and clinical studies...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29289674/investigating-the-impact-of-drug-crystallinity-in-amorphous-tacrolimus-capsules-on-pharmacokinetics-and-bioequivalence-using-discriminatory-in-vitro-dissolution-testing-and-pbpk-modeling-and-simulation
#16
Hitesh S Purohit, Niraj S Trasi, Dajun D Sun, Edwin C Y Chow, Hong Wen, Xinyuan Zhang, Yi Gao, Lynne S Taylor
Delivering a drug in amorphous form in a formulated product is a strategy used to enhance the apparent solubility of a drug substance and its oral bioavailability. Drug crystallization in such products may occur during the manufacturing process or upon storage, reducing the solubility advantage of the amorphous drug. However, the impact of partial drug crystallization in the drug product on the resulting bioavailability and pharmacokinetics is unknown. In this study, dissolution testing of commercial tacrolimus capsules (which are formulated to contain amorphous drug), both fresh and those containing different amounts of crystalline drug, was conducted using both USP and non-compendial dissolution tests with different dissolution media and volumes...
December 28, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29283507/evaluation-of-bioequivalence-between-0-5-mg-dutasteride-capsules-manufactured-by-glaxosmithkline-and-an-existing-formulation-a-randomized-study-in-healthy-japanese-male-volunteers
#17
Hiroko Ino, Hiroshi Itoh, Yohei Doi, Harue Igarashi, Yotaro Numachi
No abstract text is available yet for this article.
December 28, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29282055/knowledge-attitudes-and-practices-of-community-pharmacists-on-generic-medicines-in-palestine-a-cross-sectional-study
#18
Naser Y Shraim, Tasneem A Al Taha, Rawan F Qawasmeh, Hiba N Jarrar, Maram A N Shtaya, Lama A Shayeb, Waleed M Sweileh
BACKGROUND: Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine...
December 28, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/29281130/effect-of-study-design-on-sample-size-in-studies-intended-to-evaluate-bioequivalence-of-inhaled-short-acting-%C3%AE-agonist-formulations
#19
Yaohui Zeng, Sachinkumar Singh, Kai Wang, Richard C Ahrens
Pharmacodynamic studies that use methacholine challenge to assess bioequivalence of generic and innovator albuterol formulations are generally designed per published Food and Drug Administration guidance, with 3 reference doses and 1 test dose (3-by-1 design). These studies are challenging and expensive to conduct, typically requiring large sample sizes. We proposed 14 modified study designs as alternatives to the Food and Drug Administration-recommended 3-by-1 design, hypothesizing that adding reference and/or test doses would reduce sample size and cost...
December 27, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29277422/formulation-and-in-vivo-pharmacokinetic-evaluation-of-ethyl-cellulose-coated-sustained-release-multiple-unit-system-of-tacrolimus
#20
Taek Hwan Shin, Myoung Jin Ho, Sung Rae Kim, Sung Hyun Im, Chang Hyun Kim, Sangkil Lee, Myung Joo Kang, Young Wook Choi
A novel once-a-day sustained-release (SR) system of tacrolimus (FK506), a poorly water-soluble immunosuppressive agent, was designed employing ethyl cellulose (EC) polymer as release retardant. Drug (5 mg) was layered onto sugar spheres (518.3 mg) with hypromellose (5 mg), to transform the drug from a crystalline to an amorphous form. Subsequently, the drug-layered pellets were recoated with EC polymer (0.5-1.5 mg) using a fluid bed granulator. Drug release from the reservoir-type pellets was markedly impeded by the outer EC-based coating layer (EC 1 mg), displaying about 60% of drug release after 8 h, regardless of the acidity of the media...
December 22, 2017: International Journal of Biological Macromolecules
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