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Bioequivalence

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https://www.readbyqxmd.com/read/28549905/on-the-use-of-group-sequential-study-designs-for-the-test-of-bioequivalence-for-complicated-products
#1
Rajesh Krishna, Wen-Lin Luo, Patrick J Larson, Paul H Fackler
A novel modeling approach together with a use of group sequential study design for a complicated triple fixed-dose combination was attempted. Probability of success (POS) was used for determining a weighted average power, where weight was based on available information such as data from previous pilot studies or literature. A simulation study was conducted that resulted in the development of the necessary sample size for the studies in addition to identifying a decision algorithm that was prospectively defined in the protocols...
May 23, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28541778/bioequivalence-and-statistics-in-clinical-pharmacology
#2
Julie Bertrand
No abstract text is available yet for this article.
May 25, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28535819/does-the-placebo-effect-modulate-drug-bioavailability-randomized-cross-over-studies-of-three-drugs
#3
Muhammad M Hammami, Ahmed Yusuf, Faduma S Shire, Rajaa Hussein, Reem Al-Swayeh
BACKGROUND: Medication effect is the sum of its drug, placebo, and drug*placebo interaction effects. It is conceivable that the interaction effect involves modulating drug bioavailability; it was previously observed that being aware of caffeine ingestion may prolong caffeine plasma half-life. This study was set to evaluate such concept using different drugs. METHODS: Balanced single-dose, two-period, two-group, cross-over design was used to compare the pharmacokinetics of oral cephalexin, ibuprofen, and paracetamol, each described by its name (overt) or as placebo (covert)...
May 23, 2017: Journal of Negative Results in Biomedicine
https://www.readbyqxmd.com/read/28531119/quality-attributes-and-in-vitro-bioequivalence-of-different-brands-of-amoxicillin-trihydrate-tablets
#4
Moawia M Al-Tabakha, Khairi M S Fahelelbom, Dana Emad Eddin Obaid, Sadik Sayed
Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigate whether locally marketed amoxicillin tablets have the required chemical and physical attributes, including in vitro bioequivalence performance. Five generic products (T1, T2, T3, T4, and T5) containing combination of amoxicillin trihydrate and potassium clavulanate as 1 g strength present in immediate release tablets were compared to the reference listed drug product Augmentin® (R) for weight variation, friability, resistance to crushing, and chemical content of amoxicillin...
May 20, 2017: Pharmaceutics
https://www.readbyqxmd.com/read/28530143/intranasal-melatonin-nanoniosomes-pharmacokinetic-pharmacodynamics-and-toxicity-studies
#5
Aroonsri Priprem, Jeffrey R Johns, Sucharat Limsitthichaikoon, Wanwisa Limphirat, Pramote Mahakunakorn, Nutjaree Prateepawanit Johns
AIM: Intranasal melatonin encapsulated in nanosized niosomes was preclinically evaluated. METHODOLOGY: A formula of melatonin niosomes (MN) was selected through physicochemical and cytotoxic data for pharmacokinetic, pharmacodynamics and toxicity studies in male Wistar rats. RESULTS: Intranasal MN was bioequivalent to intravenous injection of melatonin, providing therapeutic level doses. Acute and subchronic toxicity screening showed no abnormal signs, symptoms or hematological effects in any animals...
June 2017: Therapeutic Delivery
https://www.readbyqxmd.com/read/28528664/enhanced-lc-ms-ms-analysis-of-alogliptin-and-pioglitazone-in-human-plasma-applied-to-a-preliminary-pharmacokinetic-study
#6
Maha F Abdel-Ghany, Miriam F Ayad, Mariam M Tadros
A new fast LC-MS/MS method was developed for determination of alogliptin and pioglitazone in human plasma. Linearity ranges of 10-400ngmL(-1) for alogliptin and 25-2000ngmL(-1) for pioglitazone, were found to be suitable for their bioanalysis covering the Cmin and Cmax values of the drugs. Direct precipitation technique was used for simultaneous extraction of the drugs successfully from human plasma samples. Chromatographic separation was achieved on a BEH C18 column (50mm×2.1mm, 1.7μm) with 0.1% aqueous formic acid: acetonitrile (40:60, v/v) at a flow rate of 0...
April 26, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28516359/evolution-of-choice-of-solubility-and-dissolution-media-after-two-decades-of-biopharmaceutical-classification-system
#7
Nadia Bou-Chacra, Katherine Jasmine Curo Melo, Ivan Andrés Cordova Morales, Erika S Stippler, Filippos Kesisoglou, Mehran Yazdanian, Raimar Löbenberg
The introduction of the biopharmaceutics drug classification system (Biopharmaceutics Classification System (BCS)), in 1995, provided a simple way to describe the biopharmaceutics behavior of a drug. Solubility and permeability are among the major parameters, which determine the fraction dose absorbed of a drug substance and consequently its chances to be bioavailable. The purpose of this review is to summarize the evolution of the media used for determining solubility and dissolution and how this can be used in modern drug development...
May 17, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28516342/pharmacokinetic-bioequivalence-studies-of-an-extended-release-oxycodone-hydrochloride-tablet-in-healthy-japanese-subjects-under-fasting-and-fed-conditions-without-an-opioid-antagonist
#8
Kaoru Toyama, Hidetoshi Furuie, Kana Kuroda, Hitoshi Ishizuka
Oxycodone is a semisynthetic opioid used for the treatment of moderate to severe pain. Two separate studies were conducted to assess the pharmacokinetic bioequivalence of a newly formulated oxycodone hydrochloride extended-release tablet to a marketed oxycodone product in Japan under fasting and fed conditions. Each study was a randomized, open-label, single-dose, single-center, two-period, two-way crossover study. Healthy male Japanese subjects received the oxycodone 10-mg products under fasting and fed conditions...
May 17, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28513426/pharmacokinetics-and-bioequivalence-of-a-pregabalin-150-mg-capsule-in-healthy-thai-subjects%C3%A2
#9
Nantaporn Prompila, Wanna Eiamart, Yaowatree Jumroen, Nonlanee Sayankuldilok, Pajaree Chariyavilaskul, Wannarasami Ketchat, Supeecha Wittayalertpanya
OBJECTIVE: The purpose of the study was to evaluate the pharmacokinetics and bioequivalence of pregabalin following administration of a 150-mg capsule of test and reference products. METHOD: The study was designed as a randomized, two-treatment, two-period, two-sequence, single-dose crossover with 1-week washout period between period I and period II dosing. 20 healthy male and female Thai subjects were enrolled in the study. Each subject was in fasted state for ~ 10 hours prior to receiving a single oral 150-mg pregabalin capsule...
May 17, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28512699/an-open-label-crossover-study-of-the-pharmacokinetics-of-the-60-mg-edoxaban-tablet-crushed-and-administered-either-by-a-nasogastric-tube-or-in-apple-puree-in-healthy-adults
#10
Kenneth Duchin, Anil Duggal, George J Atiee, Motonori Kidokoro, Tadanobu Takatani, Nicole Lazarus Shipitofsky, Ling He, George Zhang, Tarundeep Kakkar
BACKGROUND: Edoxaban is an orally active, direct factor Xa inhibitor indicated to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation and for the treatment of venous thromboembolism. OBJECTIVES: This study assessed the pharmacokinetics, safety, and tolerability of the edoxaban 60-mg tablet crushed and administered via a nasogastric tube in a water suspension or orally mixed in apple puree. METHODS: This phase 1, open-label, crossover study randomized 30 healthy adults to receive three edoxaban treatment regimens (oral 60-mg edoxaban tablet, or 60-mg edoxaban tablet crushed and administered via a nasogastric tube or orally in apple puree) in one of six treatment sequences...
May 17, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28507991/evaluation-of-bioequivalence-of-two-long-acting-20-oxytetracycline-formulations-in-pigs
#11
Zhixin Lei, Qianying Liu, Bing Yang, Saeed Ahmed, Jincheng Xiong, Tingting Song, Pin Chen, Jiyue Cao, Qigai He
The aim of this study was to explore the bioequivalence of long-acting oxytetracycline in two formulations, a reference formulation (Terramycin 20% LA, Pfizer) and a test one (Kangtekang 20% LA, Huishen). Both formulations were administered intramuscularly at 20 mg/kg body weight at each of 24 healthy animals during a two-period crossover parallel experimental design. The oxytetracycline (OTC) concentrations in plasma were measured by high-performance liquid chromatography, and the limit of quantification was 0...
2017: Frontiers in Veterinary Science
https://www.readbyqxmd.com/read/28497561/on-assessing-bioequivalence-and-interchangeability-between-generics-based-on-indirect-comparisons
#12
Jiayin Zheng, Shein-Chung Chow, Mengdie Yuan
As more and more generics become available in the market place, the safety/efficacy concerns may arise as the result of interchangeably use of approved generics. However, bioequivalence assessment for regulatory approval among generics of the innovative drug product is not required. In practice, approved generics are often used interchangeably without any mechanism of safety monitoring. In this article, based on indirect comparisons, we proposed several methods to assessing bioequivalence and interchangeability between generics...
May 11, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28485775/determination-of-phloroglucinol-by-hplc-ms-ms-and-its-application-to-a-bioequivalence-study-in-healthy-volunteers
#13
X-Q Li, R-T Wang, Q-H Wang, X-L Tang, C-T Lu, H-G Gong, A-D Wen
OBJECTIVE: The aim of this study was to compare the pharmacokinetic characteristics of phloroglucinol between an orally disintegrating tablet and an orally lyophilized tablet of phloroglucinol in healthy volunteers under fasting condition. PATIENTS AND METHODS: A rapid and simple method based on high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method has been developed and validated for the determination of phloroglucinol in human plasma...
April 2017: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/28483422/biowaiver-monograph-for-immediate-release-solid-oral-dosage-forms-amoxicillin-trihydrate
#14
REVIEW
Dhanusha Thambavita, Priyadarshani Galappatthy, Uthpali Mannapperuma, R L Jayakody, Rodrigo Cristofoletti, Bertil Abrahamsson, D W Groot, Peter Langguth, Mehul Mehta, Alan Parr, James E Polli, Vinod P Shah, Jennifer Dressman
Literature and experimental data relevant to waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing amoxicillin trihydrate are reviewed. Solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), therapeutic uses, therapeutic index, excipient interactions, as well as dissolution and BE/bioavailability (BA) studies were taken into consideration. Solubility and permeability studies indicate that amoxicillin doses up to 875mg belong to BCS class I, while 1000 mg belongs to BCS class II and doses above 1000mg belong to BCS class IV...
May 5, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28475455/higher-concentration-insulins-an-overview-of-clinical-considerations
#15
Timothy S Reid, Fryn Schafer, Cynthia Brusko
Three higher concentration insulin products (insulin lispro 200 units/mL, insulin degludec 200 units/mL, and insulin glargine 300 units/mL) received US Food and Drug Administration (FDA) approval in 2015. Although human regular insulin 500 units/mL (U-500) was approved in 1997, a pen and dedicated U-500 syringe became available in 2016. These products offer more treatment options for the increasing numbers of patients requiring insulin to achieve and maintain glycemic targets. Higher concentration insulins have some unique safety and efficacy considerations...
May 12, 2017: Postgraduate Medicine
https://www.readbyqxmd.com/read/28474741/metformin-and-daclatasvir-absence-of-a-pharmacokinetic-pharmacodynamic-drug-interaction-in-healthy-volunteers
#16
Elise J Smolders, Angela Colbers, Clara T M M de Kanter, Kirsten Velthoven-Graafland, Leonie T Wolberink, Noor van Ewijk-Beneken Kolmer, Joost P H Drenth, Rob E Aarnoutse, Cees J Tack, David M Burger
AIM: The aim of this study was to evaluate the effect of the proposed organic cation transporter (OCT) inhibitor daclatasvir on the pharmacokinetics and pharmacodynamics of the OCT substrate metformin. METHODS: This was an open-label, two-period, randomized, crossover trial in 20 healthy subjects. Treatment A consisted of metformin and treatment B consisted of metformin + daclatasvir. Pharmacokinetic curves were recorded at steady state. Geometric mean ratios (GMRs) with 90% confidence intervals (CIs) were calculated for metformin area under the concentration-time curve from 0 to 12 hours (AUC0-12 ), maximum plasma concentration (Cmax ) and final plasma concentration (Clast )...
May 5, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28458360/comparison-of-dissolution-similarity-assessment-methods-for-products-with-large-variations-f2-statistics-and-model-independent-multivariate-confidence-region-procedure-for-dissolution-profiles-of-multiple-oral-products
#17
Hiroyuki Yoshida, Hiroko Shibata, Ken-Ichi Izutsu, Yukihiro Goda
The current Japanese Ministry of Health Labour and Welfare (MHLW)'s Guideline for Bioequivalence Studies of Generic Products uses averaged dissolution rates for the assessment of dissolution similarity between test and reference formulations. This study clarifies how the application of model-independent multivariate confidence region procedure (Method B), described in the European Medical Agency and U.S. Food and Drug Administration guidelines, affects similarity outcomes obtained empirically from dissolution profiles with large variations in individual dissolution rates...
2017: Biological & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28457109/salvage-radiation-therapy-for-biochemical-failure-following-radical-prostatectomy
#18
Benjamin Spieler, Jeffrey Goldstein, Yaacov R Lawrence, Akram Saad, Raanan Berger, Jacob Ramon, Zohar Dotan, Menachem Laufer, Ilana Weiss, Lev Tzvang, Philip Poortmans, Zvi Symon
BACKGROUND: Radiotherapy to the prostate bed is used to eradicate residual microscopic disease following radical prostatectomy for prostate cancer. Recommendations are based on historical series. OBJECTIVES: To determine outcomes and toxicity of contemporary salvage radiation therapy (SRT) to the prostate bed. METHODS: We reviewed a prospective ethics committee-approved database of 229 patients referred for SRT. Median pre-radiation prostate-specific antigen (PSA) was 0...
January 2017: Israel Medical Association Journal: IMAJ
https://www.readbyqxmd.com/read/28450554/biodistribution-pharmacokinetics-and-dosimetry-of-177-lu-90-y-and-111-in-labeled-somatostatin-receptor-antagonist-ops201-in-comparison-to-the-agonist-177-lu-dota-tate-the-mass-effect
#19
Guillaume Pierre Nicolas, Rosalba Mansi, Lisa McDougall, Jens Kaufmann, Hakim Bouterfa, Damian Wild, Melpomeni Fani
Radiolabeled somatostatin receptor (sstr) antagonists have shown in vivo higher uptake in sstr-expressing tumors than agonists. In this pre-clinical study the sstr2-antagonist OPS201 (DOTA-JR11; DOTA-[Cpa-c(DCys-Aph(Hor)-DAph(Cbm)-Lys-Thr-Cys)-DTyr-NH2]) labeled with (177)Lu, (90)Y and (111)In was compared with the sstr2-agonist (177)Lu-DOTA-TATE. Methods: Biodistribution, pharmacokinetics, single-photon emission computed tomography/computed tomography (SPECT/CT) and dosimetry studies were performed to assess the bioequivalence of all radiotracers...
April 27, 2017: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/28448752/temperature-measurements-in-a-capacitive-system-of-deep-loco-regional-hyperthermia
#20
H Sahinbas, M Rosch, M Demiray
Hyperthermia has been shown to be a medically useful procedure applicable for different indications. For the connection between clinical effects and heat, it is important to understand the actual temperatures achieved in the tissue. There are limited temperature data available when using capacitive hyperthermia devices even though this is worldwide the most widespread method for loco-regional heating. Hence, this study examines temperature measurements using capacitive heating. Bioequivalent phantoms were used for the measurements, which, however, do not consider perfusion in live tissue...
April 27, 2017: Electromagnetic Biology and Medicine
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