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Bioequivalence

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https://www.readbyqxmd.com/read/28081041/a-systematic-literature-review-approach-to-estimate-the-therapeutic-index-of-selected-immunosuppressant-drugs-after-renal-transplantation
#1
Jessica E Ericson, Kanecia O Zimmerman, Daniel Gonzalez, Chiara Melloni, Jeffrey T Guptill, Kevin D Hill, Huali Wu, Michael Cohen-Wolkowiez
BACKGROUND: Drugs that exhibit close margins between therapeutic and toxic blood concentrations are considered to have a narrow therapeutic index (NTI). The Food and Drug Administration has proposed that NTI drugs should have more stringent bioequivalence standards for approval of generic formulations. However, many immunosuppressant drugs do not have a well-defined therapeutic index (TI). METHODS: We sought to determine whether safety, efficacy, and pharmacokinetic data obtained from the medical literature through a comprehensive literature search could be used to estimate the TI of cyclosporine, tacrolimus, and sirolimus...
February 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28080136/isoniazid-a-review-of-characteristics-properties-and-analytical-methods
#2
Guilherme Felipe Dos Santos Fernandes, Hérida Regina Nunes Salgado, Jean Leandro Dos Santos
Isoniazid is a synthetic antimicrobial and one of the most important first-line drugs used in the treatment of tuberculosis. Since it was introduced in the therapy in 1952, the drug remains at the front line of the antituberculosis treatment mainly due to its potency and high selectivity against Mycobacterium tuberculosis. Pharmaceutical analysis and therapeutic drug monitoring of isoniazid in both, pharmaceuticals and biological samples, plays an important role to comprehend aspects regarding to bioavailability, bioequivalence and therapeutic monitoring during patients following-up...
January 12, 2017: Critical Reviews in Analytical Chemistry
https://www.readbyqxmd.com/read/28079517/pharmacokinetic-and-bioequivalence-study-comparing-a-candesartan-cilexetil-rosuvastatin-calcium-fixed-dose-combination-with-the-concomitant-administration-of-candesartan-cilexetil-and-rosuvastatin-calcium-in-healthy-korean-subjects%C3%A2
#3
Dan-Bee Park, Kyungho Jang, Jae-Won Lee, Cheol-Won Park, Back-Hwan Lee, Min-Gul Kim, Ji-Young Jeon
CONTEXT: A fixed-dose combination (FDC) of candesartan and rosuvastatin was recently developed for the treatment of cardiovascular disease and expected to enhance patient compliance. OBJECTIVE: This study was performed to compare the single-dose pharmacokinetic properties and tolerability of DP-R208 (candesartan and rosuvastatin FDC) to those of each component administered alone in healthy Korean male volunteers. MATERIALS AND METHODS: A total of 40 healthy Korean volunteers were enrolled in this randomized, open-label, single-dose, two-treatment, two-way crossover study...
January 12, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28074334/saliva-versus-plasma-bioequivalence-of-azithromycin-in-humans-validation-of-class-i-drugs-of-the-salivary-excretion-classification-system
#4
Nasir Idkaidek, Tawfiq Arafat, Hazim Hamadi, Salim Hamadi, Ibrahim Al-Adham
AIM: The aim of this study was to compare human pharmacokinetics and bioequivalence metrics in saliva versus plasma for azithromycin as a model class I drug of the Salivary Excretion Classification System (SECS). METHODS: A pilot, open-label, two-way crossover bioequivalence study was done, and involved a single 500-mg oral dose of azithromycin given to eight healthy subjects under fasting conditions, followed by a 3-week washout period. Blood and unstimulated saliva samples were collected over 72 h and deep frozen until analysis by a validated liquid chromatography with mass spectroscopy method...
January 10, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28070984/an-approach-for-sample-size-determination-of-average-bioequivalence-based-on-interval-estimation
#5
Chieh Chiang, Chin-Fu Hsiao
In 1992, the US Food and Drug Administration declared that two drugs demonstrate average bioequivalence (ABE) if the log-transformed mean difference of pharmacokinetic responses lies in (-0.223, 0.223). The most widely used approach for assessing ABE is the two one-sided tests procedure. More specifically, ABE is concluded when a 100(1 - 2α) % confidence interval for mean difference falls within (-0.223, 0.223). As known, bioequivalent studies are usually conducted by crossover design. However, in the case that the half-life of a drug is long, a parallel design for the bioequivalent study may be preferred...
January 9, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28070894/a-phase-1-open-label-randomized-crossover-study-evaluating-the-bioavailability-of-tas-102-trifluridine-tipiracil-tablets-relative-to-an-oral-solution-containing-equivalent-amounts-of-trifluridine-and-tipiracil
#6
Carlos R Becerra, Kenichiro Yoshida, Hirokazu Mizuguchi, Manish Patel, Daniel Von Hoff
TAS-102 (trifluridine/tipiracil) is composed of an antineoplastic thymidine-based nucleoside analogue trifluridine (FTD), and a thymidine phosphorylase inhibitor, tipiracil (TPI), at a molar ratio of 1:0.5 (weight ratio, 1:0.471). A phase 1 study evaluated relative bioavailability of TAS-102 tablets compared with an oral solution containing equivalent amounts of FTD and TPI. In an open-label, 2-sequence, 3-period, crossover bioavailability study (part 1), patients 18 years or older with advanced solid tumors were randomized to receive TAS-102 tablets (60 mg; 3 × 20-mg tablets) on day 1 and TAS-102 oral solution (60 mg) on days 8 and 15, or the opposite sequence...
January 9, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28060026/exponential-decay-metrics-of-topical-tetracaine-hydrochloride-administration-describe-corneal-anesthesia-properties-mechanistically
#7
Jason Ethington, David Goldmeier, Bruce I Gaynes
PURPOSE: To identify pharmacodynamic (PD) and pharmacokinetic (PK) metrics that aid in mechanistic understanding of dosage considerations for prolonged corneal anesthesia. METHODS: A rabbit model using 0.5% tetracaine hydrochloride was used to induce corneal anesthesia in conjunction with Cochet-Bonnet anesthesiometry. Metrics were derived describing PD-PK parameters of the time-dependent domain of recovery in corneal sensitivity. Curve fitting used a 1-phase exponential dissociation paradigm assuming a 1-compartment PK model...
January 4, 2017: Cornea
https://www.readbyqxmd.com/read/28052851/population-pharmacokinetic-model-of-doxycycline-plasma-concentrations-pooled-study-data
#8
Ashley M Hopkins, Jessica Wojciechowski, Ahmad Y Abuhelwa, Stuart Mudge, Richard N Upton, David J R Foster
The literature is presently void of a population pharmacokinetic analysis of doxycycline. This study aimed to develop a population pharmacokinetic model of doxycycline plasma concentrations that could be used to assess the power of bioequivalence between Doryx® Delayed-Release tablets and Doryx MPC®. Doxycyline pharmacokinetic data was avalible from eight phase 1 clinical trials following single/multiple doses of conventional release doxycycline capsules, Doryx® Delayed-Release tablets and Doryx MPC® under fed and fasted conditions...
January 4, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28041968/medicines-for-pediatric-patients-biopharmaceutical-developmental-and-regulatory-considerations
#9
David P Elder, René Holm, Martin Kuentz
This commentary reflects current developments in pediatric medicine. The underpinning legislation in both Europe and the US has led to the initiation of an increased number of clinical trials in the pediatric population, but there are still a number of outstanding issues within this field. These include the differences in the physiology between adults and the very heterogeneous nature of pediatric patients. There is an ongoing scientific debate on the applicability of a Pediatric Biopharmaceutical Classification System (PBCS) to define when waivers for bioequivalence studies can be supported by in vitro dissolution...
December 29, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28039605/pharmacokinetic-characteristics-and-clinical-efficacy-of-an-sglt2-inhibitor-plus-dpp-4-inhibitor-combination-therapy-in-type-2-diabetes
#10
REVIEW
André J Scheen
Type 2 diabetes (T2D) generally requires a combination of several pharmacological approaches to control hyperglycaemia. Combining a sodium-glucose cotransporter type 2 inhibitor (SGLT2I, also known as gliflozin) and a dipeptidyl peptidase-4 inhibitor (DPP-4I, also known as gliptin) appears to be an attractive strategy because of complementary modes of action. This narrative review analyzes the pharmacokinetics and clinical efficacy of different combined therapies with an SGLT2I (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin, luseogliflozin, tofogliflozin) and DPP-4I (linagliptin, saxagliptin, sitagliptin, teneligliptin)...
December 30, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28035612/transdermal-adhesive-patches-loaded-with-ketoprofen-evaluated-by-dynamic-detection-of-percutaneous-absorption
#11
Menglin Wang, Longwei Li, Junxia Xie, Yinghua Sun, Guixia Ling, Zhonggui He
Topical delivery has many benefits toward NSAIDs administration, and the best-selling transdermal preparation in 2015 was the NSAID patch MOHRUS®. Herein, we report a ketoprofen adhesive patch (KAP) and evaluate the penetration and absorption compared to MOHRUS®. Microdialysis sampling technique was applied to determine drug penetration in the dermis and subcutaneous tissue. Simultaneously, blood samples were withdrawn over time to obtain the drug absorption in plasma. The ketoprofen concentrations in the dermis, subcutaneous tissue, and plasma were compared with the commercially available patch (MOHRUS®)...
December 29, 2016: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28035201/the-role-of-biosimilars-in-inflammatory-bowel-disease
#12
Sudarshan Paramsothy, Noa Krugliak Cleveland, Nada Zmeter, David T Rubin
Monoclonal antibody biologic therapies, introduced nearly 20 years ago, revolutionized the treatment of inflammatory bowel disease (IBD) and are now well established as the most effective agents available. As the first of these biologic agents starts to come off patent, biosimilar agents have emerged as alternatives to originator drugs. The unique drug development and manufacturing processes involved in the creation of biologic agents pose distinct regulatory challenges compared to generic formulations of conventional medications...
December 2016: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28034518/sex-effect-on-average-bioequivalence
#13
Manuel Ibarra, Marta Vázquez, Pietro Fagiolino
PURPOSE: Generic formulations are by far the most prescribed drugs. This scenario is highly beneficial for society because medication expenses are significantly reduced after expiration of the exclusivity period conceded to the branded name drug. Correspondingly, these formulations must be adequately evaluated to avoid drug inefficacy and toxicity in the overall patient population. Bioequivalence studies are the only in vivo evaluation that a generic drug must overcome to reach the market...
December 26, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/28031604/assessment-of-knowledge-and-perceptions-toward-generic-medicines-among-basic-science-undergraduate-medical-students-at-aruba
#14
P Ravi Shankar, Burton L Herz, Arun K Dubey, Mohamed A Hassali
OBJECTIVE: Use of generic medicines is important to reduce rising health-care costs. Proper knowledge and perception of medical students and doctors toward generic medicines are important. Xavier University School of Medicine in Aruba admits students from the United States, Canada, and other countries to the undergraduate medical (MD) program. The present study was conducted to study the knowledge and perception about generic medicines among basic science MD students. MATERIALS AND METHODS: The cross-sectional study was conducted among first to fifth semester students during February 2015...
October 2016: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28025969/quantitative-analysis-of-valsartan-by-two-dimensional-liquid-chromatography-2d-hplc-method-and-its-application-in-a-bioequivalence-study-in-chinese-volunteers%C3%A2
#15
Min Zhang, Yang Deng, Hua-Lin Cai, Ping-Fei Fang, Miao Yan, Bi-Kui Zhang, Yan-Qin Wu
PURPOSE: To develop a sensitive, two-dimensional liquid chromatography (2D-LC) method for determination of valsartan, applied to investigate bioequivalence of two valsartan tablets in Chinese volunteers under fasting condition. METHODS: A full automatic 2D-HPLC system was used to quantify valsartan in human plasma. The analytes were extracted by protein precipitation, using telmisartan as internal standard. The analytical method was applied in a randomized, crossover bioequivalence study of valsartan tablets; the study enrolled 18 Chinese volunteers (12 were men and 6 were women)...
December 27, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28025967/a-single-dose-randomized-open-label-cross-over-bioequivalence-study-of-sildenafil-citrate-tablets-in-healthy-chinese-volunteers%C3%A2
#16
Dai Li, Yu-Lu Wang, Su-Mei Xu, Dan Li, Xiao-Min Li, Jing Pan, Ping-Sheng Xu
OBJECTIVE: The present study was designed to evaluate the bioequivalence of a newly developed sildenafil citrate tablet 50 mg (Jinge®, Test) and a marketed counterpart (Viagra®, 100 mg, Reference) in healthy adult male Chinese volunteers. METHODS: This single-dose, randomized, open-label, four-period, and two-treatment self-crossover study included two parts: fasting and postprandial studies. In each part of the study, the subjects were randomly assigned to receive test or reference products (100 mg sildenafil) in a 1 : 1 ratio, and then received the alternative products, following a 1-week washout period...
December 27, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28025964/bioequivalence-of-two-formulations-of-pregabalin-150-mg-capsules-under-fasting-conditions-in-healthy-male-subjects%C3%A2
#17
Hyun Lee, SeungHwan Lee, Sung-Vin Yim, Bo-Hyung Kim
BACKGROUND: Pregabalin binds to the α2δ auxiliary subunit of voltage-gated calcium channels, which are widely distributed throughout the central and peripheral nervous systems and modulate calcium-dependent neurotransmitter release. Pregabalin is indicated for the treatment of peripheral and central neuropathic pain, partial seizures with or without secondary generalization, and treatment of generalized anxiety disorder (GAD). OBJECTIVE: The purpose of this study was to assess the bioequivalence of two different formulations of pregabalin 150-mg capsules in healthy Korean male subjects under fasting conditions...
December 27, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28012307/a-sensitive-lc-ms-ms-method-for-analysis-of-pericyazine-in-presence-of-7-hydroxypericyazine-and-pericyazine-sulphoxide-in-human-plasma-and-its-application-to-a-comparative-bioequivalence-study-in-chinese-healthy-volunteers
#18
Hua Lin Cai, Yang Deng, Ping Fei Fang, SiSi Cao, Zhen Yan Hou, Yan Qin Wu, Xue Jiao Chen, Miao Yan, BiKui Zhang
A robust and highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for the determination of pericyazine in human plasma. The plasma sample was alkalized with sodium hydroxide solution and handled by liquid-liquid extraction with ethyl acetate after adding perphenazine as an internal standard (IS). The analytes were separated on an Ultimate™ AQ-C18 analytical column at 40°C, with a gradient elution consisting of A (aqueous phase: 5mM ammonium acetate buffer solution containing 0...
December 15, 2016: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28009518/measurement-of-in-vivo-gastrointestinal-release-and-dissolution-of-three-locally-acting-mesalamine-formulations-in-regions-of-the-human-gastrointestinal-tract
#19
Alex Yu, Jason R Baker, Ann F Fioritto, Ying Wang, Ruijuan Luo, Siwei Li, Bo Wen, Michael Bly, Yasuhiro Tsume, Mark J Koenigsknecht, Xinyuan Zhang, Robert Lionberger, Gordon L Amidon, William L Hasler, Duxin Sun
As an orally administered, locally acting gastrointestinal drug, mesalamine products are designed to achieve high local drug concentration in the gastrointestinal (GI) tract for the treatment of ulcerative colitis. The aim of this study was to directly measure and compare drug dissolution of three mesalamine formulations in human GI tract and to correlate their GI concentration with drug concentration in plasma. Healthy human subjects were orally administered Pentasa, Apriso, or Lialda. GI fluids were aspirated from stomach, duodenum, proximal jejunum, mid jejunum, and distal jejunum regions...
December 23, 2016: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28004346/bioavailability-and-bioequivalence-aspects-of-oral-modified-release-drug-products
#20
Rong Wang, Dale P Conner, Bing V Li
Oral modified-release (MR) products are dosage forms administered through the mouth and designed to release drug in a controlled manner to achieve maximum efficacy, minimal side effects, and better patient compliance. With significant progress in pharmaceutical technologies and favored therapeutic benefit, more and more oral MR products including the generic versions of these products are being developed, marketed, and used in the USA. Because different types of MR products may exhibit unique drug release modes and specific pharmacokinetic profiles, a better understanding of the regulation and evaluation of these generic MR products can help development and marketing of generic MR products that are therapeutically equivalent to the corresponding reference product...
December 21, 2016: AAPS Journal
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