keyword
MENU ▼
Read by QxMD icon Read
search

Bioequivalence

keyword
https://www.readbyqxmd.com/read/28342789/enhanced-gastric-stability-of-esomeprazole-by-molecular-interaction-and-modulation-of-microenvironmental-ph-with-alkalizers-in-solid-dispersion
#1
Hien Van Nguyen, Namhyun Baek, Beom-Jin Lee
Due to the instability of esomeprazole magnesium dihydrate (EPM), a proton pump inhibitor, in gastric fluid, enteric-coated dosage form is commonly used for therapeutic application. In this study, we prepared new gastric fluid resistant solid dispersions (SDs) containing alkalizers. Then, new mechanistic evidence regarding the effects of pharmaceutical alkalizers on the aqueous stability of EPM in simulated gastric fluid was investigated. The alkalizer-loaded SD were prepared by dissolving or dispersing EPM, hydroxypropyl methylcellulose (HPMC) 6 cps, and an alkalizer, in ethanol 50% (v/v) followed by spray drying...
March 22, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28335525/the-history-of-clotting-factor-concentrates-pharmacokinetics
#2
REVIEW
Massimo Morfini
Clotting factor concentrates (CFCs) underwent tremendous modifications during the last forty years. Plasma-derived concentrates made the replacement therapy feasible not only in the hospital but also at patients' home by on-demand or prophylactic regimen. Virucidal methods, implemented soon after hepatitis and AIDS outbreak, and purification by Mabs made the plasma-derived concentrates safer and purer. CFCs were considered equivalent to the other drugs and general rules and methods of pharmacokinetics (PK) were applied to their study...
March 20, 2017: Journal of Clinical Medicine
https://www.readbyqxmd.com/read/28335023/qbd-driven-development-and-validation-of-liquid-chromatography-tandem-mass-spectrometric-method-for-the-quantitation-of-sildenafil-in-human-plasma
#3
M Saquib Hasnain, Shaukat Ali Ansari, Shireen Rao, Mohammad Tabish, Mukul Singh, Mohammad Syafiq Abdullah, Mohammed Tahir Ansari
The present work was employing the Quality by Design approach for the development and validation of a LC-MS-MS method to support the clinical advancement in determination of sildenafil in human plasma using lorazepam as an internal standard. Sample preparation involved solid phase extraction and calibration range observed between 3 and 1,700 ng/mL. The method was systematically optimized by employing Box-Behnken design and used mobile phase flow rate, pH and composition of mobile phase as the critical factors, and assessing the design for retention time and peak area as the responses...
February 27, 2017: Journal of Chromatographic Science
https://www.readbyqxmd.com/read/28316019/population-pharmacokinetic-analysis-of-rebamipide-in-healthy-korean-subjects-with-the-characterization-of-atypical-complex-absorption-kinetics
#4
Lien Ngo, Hee-Doo Yoo, Phuong Tran, Hea-Young Cho, Yong-Bok Lee
In this study, the population pharmacokinetic (PK) analysis of rebamipide (Reba) in healthy male Korean subjects was analyzed using the nonlinear mixed effects modeling method. The possible effects of physiological covariates and the multidrug resistance (MDR1) gene 3435C>T polymorphism on PK parameters were also investigated. Data were collected from a bioequivalence study, in which 26 subjects who participated in the study were administered a single oral dose of 100 mg Reba; only data from the reference formulation were used...
March 18, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28316003/evaluation-of-the-safety-tolerability-and-pharmacokinetics-of-gammaplex-%C3%A2-10-versus-gammaplex-%C3%A2-5-in-subjects-with-primary-immunodeficiency
#5
Richard L Wasserman, Isaac R Melamed, Mark R Stein, Stephen Jolles, Miranda Norton, James N Moy
PURPOSE: This phase 3, multicenter, open-label, randomized, two-period, crossover bioequivalence trial evaluated the safety, tolerability, and pharmacokinetics of intravenous immunoglobulins (IVIGs) Gammaplex 5% and Gammaplex 10% in 33 adults and 15 children with primary immunodeficiency diseases (PIDs). METHODS: Eligible adults received five Gammaplex 5% infusions followed by five Gammaplex 10% infusions, or vice versa, stratified by a 21- or 28-day dosing regimen...
March 18, 2017: Journal of Clinical Immunology
https://www.readbyqxmd.com/read/28290731/a-randomized-double-blind-single-dose-two-arm-parallel-study-comparing-pharmacokinetics-immunogenicity-and-tolerability-of-branded-adalimumab-and-its-biosimilar-lbal-in-healthy-male-volunteers
#6
Kyoung Ryun Park, Hyewon Chung, Sung Mo Yang, SeungHwan Lee, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, Kyung-Sang Yu
OBJECTIVES: This study aimed to compare the pharmacokinetics (PK), immunogenicity, and tolerability of LBAL, a biosimilar of adalimumab, with the originator, Humira(®), in healthy volunteers. METHODS: A randomized, double-blind, single-dose, two-arm, parallel-group study was conducted in 116 healthy subjects. They randomly received a single subcutaneous (SC) 40 mg injection of LBAL or Humira. Blood samples were collected for PK and immunogenicity assessment. PK parameters were determined using the noncompartmental method, and primary endpoint parameters were compared using the point estimates and 90% confidence intervals (CIs) of the geometric mean ratios (GMRs)...
March 14, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28290274/relative-bioavailability-of-an-empagliflozin-25-mg-linagliptin-5-mg-fixed-dose-combination-tablet%C3%A2
#7
Stephan Glund, Michaela Mattheus, Frank Runge, Peter Rose, Christian Friedrich
OBJECTIVE: This relative bioavailability study compared a fixed-dose combination (FDC) tablet of empagliflozin 25 mg/linagliptin 5 mg with the corresponding individual components. In addition, the effect of food on the bioavailability of the FDC was studied, and the standard-dissolving formulation FDC was compared with a slow-dissolving side batch. METHODS: An open-label, randomized, crossover study design was used (ClinicalTrials.gov Identifier NCT01189201). Healthy volunteers (n = 42) each received three single-dose treatments: FDC standard dissolution, individual tablets, and either FDC standard dissolution with food or FDC slow dissolution...
March 14, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28290122/scientific-rationale-for-determining-the-bioequivalence-of-inhaled-drugs
#8
REVIEW
Omar S Usmani, Mathieu Molimard, Vaibhav Gaur, Jaideep Gogtay, Gur Jai Pal Singh, Geena Malhotra, Eric Derom
In recent years, pathways for the development and approval of bioequivalent inhaled products have been established for regulated markets, including the European Union (EU), and a number of orally inhaled products (OIPs) have been approved in the EU solely on the basis of in vitro and pharmacokinetic data. This review describes how these development pathways are structured and their implications for the treatment of airway diseases such as asthma. The EU guidance follows a stepwise approach that includes in vitro criteria as the first step...
March 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28283987/evaluating-the-feasibility-of-use-of-a-foreign-reference-product-for-generic-drug-applications-a-retrospective-pilot-study
#9
Yi-Lin Wang, Li-Feng Hsu
BACKGROUND AND OBJECTIVES: The adoption of a domestic reference product in bioequivalence (BE) studies for generic drug applications is required by some countries. The objective of this study is to assess the feasibility of this by investigating whether innovative products from different countries are bioequivalent. METHODS: Data were collected from all generic drug applications received by the Taiwan regulatory authority 2012-2016. If a submission package contained BE studies, that generic product was compared separately with different reference products, and the resulting data included in this analysis...
March 10, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/28283842/a-pharmaceutical-study-on-lornoxicam-fast-disintegrating-tablets-formulation-and-in-vitro-and-in-vivo-evaluation
#10
Mohamed Yousif Moutasim, Aliaa Nabil ElMeshad, Mohamed Ahmed El-Nabarawi
Lornoxicam is an anti-inflammatory drug used to relieve rheumatoid arthritis pain, but the low water solubility and bitter taste of the drug present challenges for formulation as fast disintegrating tablets (FDTs). Complexation of the drug with β-cyclodextrin was initially carried out to increase the drug solubility and to mask its bitter taste. Tablets were prepared by direct compression of drug complex (DC), F-Melt, mannitol, crospovidone, and sodium starch glycolate (SSG). FDTs were characterized in terms of disintegration time (DT) and dissolution...
March 10, 2017: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/28277845/topical-safety-and-vasoconstrictive-assay-based-bioequivalence-of-a-new-reformulated-mometasone-cream
#11
Rajesh Krishna, Ann Horowitz, Patrick Larson, James Bolognese, Eugene E Marcantonio
OBJECTIVES: A new improved mometasone furoate (Elocon) cream with an emulsification system that produces a stable emulsion has been developed. In order to register the product in various markets, it was essential to ensure the cream was topically well tolerated and that it was bioequivalent to the reference product. METHODS: Phase I clinical studies were performed to assess the local safety and tolerability upon multiple dosing of this new cream as well as to assess the single dose bioequivalence relative to the marketed product...
March 3, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28265983/global-harmonization-of-comparator-products-for-bioequivalence-studies
#12
Luther Gwaza, John Gordon, Hubert Leufkens, Matthias Stahl, Alfredo García-Arieta
Comparator products should be the products that were shown to be safe and efficacious in pivotal clinical trials to ensure prescribability of generics. The use of a common comparator ensures switchability between generics. The selection of the comparator is a national responsibility and may be different between countries. This paper discusses the current recommendations on selection of comparators, the associated problems, and the possibility of harmonization. Most countries follow the World Health Organization (WHO) recommendations for selecting comparator products and require the comparator product to be obtained from their national markets to ensure switchability between the local comparator and their generics...
March 6, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28260694/a-case-study-of-chewed-truvada-%C3%A2-for-prep-maintaining-protective-drug-levels-as-measured-by-a-novel-urine-tenofovir-assay
#13
Linden Lalley-Chareczko, Devon Clark, Athena F Zuppa, Ganesh Moorthy, Caitlin Conyngham, Karam Mounzer, Helen Koenig
FTC/TDF (Truvada®) given as pre-exposure prophylaxis (PrEP) successfully blocks HIV when taken once daily prior to potential HIV exposure. A 22 year old male reported difficulty swallowing FTC/TDF for PrEP and subsequently began chewing the FTC/TDF tablets. Monthly urine samples assessed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) indicated tenofovir levels >1000 ng/mL, indicative of protection from HIV acquisition, over a 48 week period. Data from observational studies of HIV positive patients details the successful treatment of HIV using crushed FTC/TDF delivered via feeding and gastronomy tubes while small, randomized trials of healthy volunteers demonstrate bioequivalence between whole and crushed FTC/TDF...
March 6, 2017: Antiviral Therapy
https://www.readbyqxmd.com/read/28257283/presentation-of-coefficient-of-variation-for-bioequivalence-sample-size-calculation%C3%A2
#14
Yi Lin Lee, Wen Yao Mak, Irene Looi, Jia Woei Wong, Kah Hay Yuen
The current study aimed to further contribute information on intrasubject coefficient of variation (CV) from 43 bioequivalence studies conducted by our center. Consistent with Yuen et al. (2001), current work also attempted to evaluate the effect of different parameters (AUC0-t, AUC0-∞, and Cmax) used in the estimation of the study power. Furthermore, we have estimated the number of subjects required for each study by looking at the values of intrasubject CV of AUC0-∞ and have also taken into consideration the minimum sample-size requirement set by the US FDA...
March 3, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28255251/bioavailability-of-a-dexlansoprazole-delayed-release-orally-disintegrating-tablet-effects-of-food-and-mode-of-administration
#15
Michael Kukulka, Sai Nudurupati, Maria Claudia Perez
BACKGROUND: Dexlansoprazole is a proton pump inhibitor (PPI) approved for use in dual delayed-release capsule and orally disintegrating tablet (ODT) formulations. AIM: To assess effects of food, water, and route of administration on the bioavailability of dexlansoprazole 30-mg ODT. METHODS: Two separate open-label, phase 1, single-dose crossover studies were conducted in healthy adults. In study 1, pharmacokinetic parameters were analyzed in participants receiving dexlansoprazole ODT in a fed or fasted state with and without water...
2017: Clinical and Experimental Gastroenterology
https://www.readbyqxmd.com/read/28211784/generic-antiretrovirals-for-the-treatment-of-hiv-a-novel-challenge-for-western-countries-%C3%A2
#16
Dario Cattaneo, Massimo Andreoni, Gianpiero Carosi, Roberto Cauda, Adriano Lazzarin, Giuliano Rizzardini
The introduction of generic antiretroviral medications in developing countries has resulted in significant CD4 cell restoration, HIV viral decline, and a noteworthy reduction in the time to initiation of therapy. Projection models have also predicted significant cost saving associated with the extensive diffusion of generic antiretrovirals in developed countries. However, some uncertainties on generics have recently been raised. These concerns mainly relate to the adequacy of the study design for bioequivalence testing, the potential for uncontrolled switching from one generic to another, and the loss of adherence if patients switched from fixed-dose coformulations to single components in order to incorporate the new generic drugs...
February 17, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28204953/pharmacokinetics-of-coadministration-of-levothyroxine-sodium-and-alendronate-sodium-new-effervescent-formulation
#17
H G Bone, M A Walter, M E Hurley, S Epstein
No clinically important pharmacokinetic interference of alendronate occurred between a new effervescent formulation of alendronate and levothyroxine when coadministered. The combination does not materially affect levothyroxine absorption. INTRODUCTION: Concurrent treatment of osteoporosis with alendronate (Aln) and hypothyroidism with levothyroxine (LT4) may be problematic because both drugs are to be taken separately after fasting overnight. The primary objective was to assess pharmacokinetic interactions between a new effervescent formulation of Aln (Aln-NEF) and LT4...
February 16, 2017: Osteoporosis International
https://www.readbyqxmd.com/read/28197753/asparaginase-pharmacology-challenges-still-to-be-faced
#18
REVIEW
Claudia Lanvers-Kaminsky
PURPOSE: The benefits of asparaginase (ASNASE) in the treatment of ALL and NHL are indisputable and new ASNASE preparations are under clinical development to overcome limitations of the actual ASNASE therapy, especially immunogenicity. Apart from ALL and NHL further indications of ASNASE are preclinically and clinically evaluated. METHODS: We reviewed ASNASE literature and especially focused on the mechanism of action, on biomarker, which determine ASNASE sensitivity and resistance, and on ASNASE pharmacodynamics in vivo...
February 14, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28196046/bioequivalence-of-a-new-oral-levosulpiride-formulation-compared-with-a-standard-one-in-healthy-volunteers
#19
Simona De Gregori, Laura Cipollina, Annalisa De Silvestri, Marianna Ventura, Roberta Michelini, Monica Morosini, Michela Montagna, Carmine Tinelli, Mario Regazzi, Mariadelfina Molinaro, Roberto Imberti
BACKGROUND: A monocentric, single-dose, open-label, 2-way, crossover randomized study was conducted by the San Matteo Phase I Clinical Trial Unit and Experimental Therapy (Pavia, Italy) to assess the bioequivalence and the systemic tolerability of a new oral formulation of levosulpiride (tablet 25 mg: test) versus a commercially available formulation on the Italian market (tablet 25 mg: reference). METHODS: Thirty-five healthy adult volunteers, men (n = 19) and women (n = 16), aged between 18 and 55 years were screened and 32 of them were enrolled in the study...
April 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28194623/comparison-of-non-compartmental-and-mixed-effect-modelling-methods-for-establishing-bioequivalence-for-the-case-of-two-compartment-kinetics-and-censored-concentrations
#20
Jim H Hughes, Richard N Upton, David J R Foster
Non-compartmental analysis (NCA) is regarded as the standard for establishing bioequivalence, despite its limitations and the existence of alternative methods such as non-linear mixed effects modelling (NLMEM). Comparisons of NCA and NLMEM in bioequivalence testing have been limited to drugs with one-compartment kinetics and have included a large number of different approaches. A simulation tool was developed with the ability to rapidly compare NCA and NLMEM methods in determining bioequivalence using both R and NONMEM and applied to a drug with two-compartment pharmacokinetics...
February 13, 2017: Journal of Pharmacokinetics and Pharmacodynamics
keyword
keyword
13124
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"