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Rajesh Patel, Jonathan L Palmer, Shashidhar Joshi, Alejandro Di Ció Gimena, Florencia Esquivel
Two bioavailability/bioequivalence studies were carried out to evaluate the pharmacokinetics of candesartan cilexetil 16mg tablet formulations. A pilot study was used to optimise the formulation and manufacturing process prior to conducting the definitive study. The pilot study was a single dose, randomised two period crossover and the definitive study was a single dose randomised three period, 6 sequence cross over study in healthy adults. In the pilot study the test formulation was 24% and 18% greater for Cmax and AUC compared to the innovator product...
October 18, 2016: Clinical Pharmacology in Drug Development
Hong-Wei Fan, Zhi-Xiang Ma, Jing Chen, Xing-Ye Yang, Jun-Lin Cheng, Ying-Bin Li
INTRODUCTION: Hydroxychloroquine (HCQ), 4-aminoquinoline, is an antimalarial drug and has become a basic therapy for rheumatic disease treatment. It can stabilize the condition of SLE patients and reduce the chances of patient relapse through its immunosuppressive function and antiinflammatory effects. This drug was absorbed completely and rapidly by oral administration, but has a prolonged half-life for elimination. The objective of this study was to evaluate the pharmacokinetic parameters and relative bioequivalence of a new generic (test) formulation with the branded (reference) formulation of HCQ in healthy Chinese male volunteers...
December 2015: Rheumatol Ther
Luc Dirix, Helen Swaisland, Henk M W Verheul, Sylvie Rottey, Karin Leunen, Guy Jerusalem, Christian Rolfo, Dorte Nielsen, L Rhoda Molife, Rebecca Kristeleit, Judith de Vos-Geelen, Morten Mau-Sørensen, Patricia Soetekouw, Carla van Herpen, Anitra Fielding, Karen So, Wendy Bannister, Ruth Plummer
PURPOSE: The metabolism of olaparib, a potent inhibitor of poly(ADP-ribose) polymerase (PARP) with demonstrated efficacy in patients with BRCA-mutated ovarian cancer, is mediated by cytochrome P450 (CYP) enzymes (predominantly CYP3A4/5). We assessed the potential of a CYP3A4 inhibitor (itraconazole) and inducer (rifampin) to alter the pharmacokinetic (PK) profile of olaparib following single oral tablet doses. METHODS: Two Phase I, open-label, non-randomized trials were conducted in patients with advanced solid tumors...
October 10, 2016: Clinical Therapeutics
Nora Angélica Núñez Guzmán, Daniel Ruiz Molina, Benigno Figueroa Núñez, Juan Carlos Soto-Sosa, Jorge Eduardo Herrera Abarca
OBJECTIVE: The aim of this clinical trial was to establish the bioequivalence of two tablets containing acetaminophen 650 mg (reference) and acetaminophen 650 mg plus caffeine 65 mg (test), administered orally, in fasting conditions in healthy Mexican volunteers. METHODS: Blood samples were taken from 21 male and five female individuals, during a 24-h period, to characterize the pharmacokinetic profile of acetaminophen. Plasma samples were quantified by ultra-performance liquid chromatography, tandem mass spectrometry...
October 12, 2016: Drugs in R&D
(no author information available yet)
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This final rule implements portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications...
October 6, 2016: Federal Register
Huma Ali, Muhammad Harris Shoaib, Farya Zafar, Muhammad Hanif, Rabia Bushra, Asia Naz, Raheela Khursheed
This study was conducted with the aim to determine the pharmacokinetic and bioequivalence of diclofenac potassium 50 mg test (F4) tablet formulation with reference product (Caflam). Present study was single dose, randomized, two phase cross over design, conducted in 12 healthy Pakistani volunteers and planned in accordance with FDA guidelines. In this study a simple, selective, sensitive and reproducible HPLC procedure was developed and validated for the estimation of diclofenac potassium in plasma. The process was validated in the range of 50 - 0...
September 2016: Pakistan Journal of Pharmaceutical Sciences
E Burmeister Getz, K J Carroll, J Mielke, L Z Benet, B Jones
We previously demonstrated pharmacokinetic differences among manufacturing batches of an FDA-approved dry powder inhalation product (Advair Diskus(®) 100/50) large enough to establish between-batch bio-inequivalence. Here, we provide independent confirmation of pharmacokinetic bio-inequivalence among Advair Diskus 100/50 batches, and quantify residual and between-batch variance component magnitudes. These variance estimates are used to consider the Type I error rate of FDA's current two-way crossover design recommendation...
October 11, 2016: Clinical Pharmacology and Therapeutics
Ulrike Gottwald-Hostalek, Wolfgang Uhl, Peter Wolna, George J Kahaly
OBJECTIVE: Small levothyroxine (L-T4) dose changes can lead to significant clinical effects. To ensure thyroid hormone levels are safely maintained, authorities are increasingly adopting stricter potency specifications for L-T4, the most stringent of these being 95-105% of the labeled dose over the whole shelf-life. Levothyroxine sodium (Euthyrox®, Eutirox®, Lévothyrox®) has been reformulated, and two studies performed to ensure bioequivalence to the currently marketed formulation and dosage form proportionality of the new formulation...
October 8, 2016: Current Medical Research and Opinion
Wan-Su Park, Jongtae Lee, Taegon Hong, Gabjin Park, Sunil Youn, Youngwhan Seo, Sanghun Lee, Seunghoon Han
PURPOSE: Fursultiamine and benfotiamine are lipophilic thiamine derivatives used as oral sources of thiamine. Although there are many publications on the pharmacokinetic (PK) properties of thiamine-containing products, no direct comparisons between these agents . We aimed to compare the PK profiles of these lipophilic thiamine derivatives and to compare the extent of the increase in bioavailability to that of naïve thiamine. METHODS: Two randomized, single-dose, 2-way crossover, full PK studies were conducted in healthy Korean male subjects (n = 24 per group)...
October 1, 2016: Clinical Therapeutics
Lisa Murray, Antonio Arias, Jibin Li, Sid Bhoopathy, Ismael J Hidalgo
To improve the quality of pharmaceutical products in their markets, several Latin American countries have begun to require that new generic products demonstrate bioequivalence against innovator or reference products. However, given the number of products involved, it is not feasible to rely on clinical studies to comply with this requirement. Instead, it makes sense to adopt or develop strategies that are appropriate to the characteristics of the region. To streamline drug development and accelerate patients' access to quality drug products, 15 years ago the United States Food and Drug Administration (FDA) decided to grant exemptions from clinical bioequivalence studies (i...
August 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Man-Yun Chen, Yong-Jun Tang, Yi-Cheng Wang, Chong-Zhi Wang, Chun-Su Yuan, Yao Chen, Zhi-Rong Tan, Wei-Hua Huang, Hong-Hao Zhou
The compound medicine of betamethasone sodium phosphate (BSP) and betamethasone dipropionate (BDP) is widely used for diverse glucocorticoid-sensitive acute and chronic diseases such as asthma, rheumatoid arthritis and systemic lupus erythematosus. It will be useful and beneficial to validate sensitive method for the determination of BSP, BDP and their metabolites for their pharmacokinetic study. Hereby, an ultra-high pressure liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) has been validated for the determination of BSP, BDP and their metabolites betamethasone (BOH), betamethasone 17-monodipropionate (B17P) and betamethasone 21-monodipropionate (B21P) in human plasma...
May 7, 2016: Analytical Methods: Advancing Methods and Applications
Ronald Christopher, Mike Morgan, Jim Ferry, Bhaskar Rege, Yong Tang, Allan Kristensen, William Shanahan
PURPOSE: Lorcaserin is a serotonin 2C receptor agonist indicated for chronic weight management as an adjunct to diet and exercise. The initial approved formulation is a 10-mg, immediate-release (IR) tablet for administration BID. These studies investigated the single- and multiple-dose pharmacokinetic properties of a new, recently US Food and Drug Administration-approved, extended-release, 20-mg once-daily formulation. METHODS: We performed 2 separate 2-period, 2-sequence crossover studies in 36 healthy adults: a study comparing the IR formulation to the extended-release formulation under fasting conditions and a study comparing the extended-release formulation under fed and fasted conditions...
September 27, 2016: Clinical Therapeutics
Chia-Ying Lee, Xiaohan Chen, Robert J Romanelli, Jodi B Segal
BACKGROUND: The United States (U.S.) Food and Drug Administration, as protectors of public health, encourages generic drug development and use so that patients can access affordable medications. The FDA, however, has limited mechanisms to encourage generic drug manufacturing. MAIN RESULTS: Generic drug manufacturers make decisions regarding development of products based on expected profitability, influenced by market forces, features of the reference listed drug, and manufacturing capabilities, as well as regulatory restrictions...
2016: Journal of Pharmaceutical Policy and Practice
Carmen Belmonte, Dolores Ochoa, Manuel Román, Teresa Cabaleiro, Maria Talegón, Sergio Daniel Sánchez-Rojas, Francisco Abad-Santos
AIMS: The aim of this study was the evaluation of the possible relationship between pharmacokinetics and the safety of aripiprazole as well as its influence on blood pressure (BP), heart rate (HR), and corrected QT (QTc) interval. METHODS: The study population comprised 157 healthy volunteers from 6 bioequivalence clinical trials. Subjects were administered a single 10-mg oral dose of each formulation separated by a 28-day washout period. Plasma concentrations were measured using high-performance liquid chromatography coupled to mass spectrometry...
September 28, 2016: Journal of Clinical Psychopharmacology
Aaron S Kesselheim, Katsiaryna Bykov, Joshua J Gagne, Shirley V Wang, Niteesh K Choudhry
OBJECTIVE: With more antiepileptic drugs (AED) becoming available in generic form, we estimated the risk of seizure-related events associated with refilling generic AEDs and the effect of switching between different manufacturers of the same generic drug. METHODS: We designed a population-based case-crossover study using the Medicaid Analytic eXtract and a US commercial health insurance database. We identified 83,001 generic AED users who experienced a seizure-related hospital admission or emergency room visit between 2000 and 2013 and assessed whether they received a refill of the same AED from the same manufacturer or a different manufacturer...
September 28, 2016: Neurology
John Sarantopoulos, Sanjay Goel, Vincent Chung, Pamela Munster, Shubham Pant, Manish R Patel, Jeffrey Infante, Hussein Tawbi, Carlos Becerra, Justine Bruce, Fairooz Kabbinavar, A Craig Lockhart, Eugene Tan, Shu Yang, Gary Carlson, Jeffrey W Scott, Sunil Sharma
PURPOSE: A capsule formulation of the tyrosine kinase inhibitor dovitinib (TKI258) was recently studied in a phase 3 renal cell carcinoma trial; however, tablets are the planned commercial formulation. Therefore, this randomized 2-way crossover study evaluated the bioequivalence of dovitinib tablet and capsule formulations in pretreated patients with advanced solid tumors, excluding breast cancer. METHODS: In this 2-part study, eligible patients received dovitinib 500 mg once daily on a 5-days-on/2-days-off schedule...
September 28, 2016: Cancer Chemotherapy and Pharmacology
Jeffrey M Dayno, John Lawler, Gwendolyn Niebler, Karsten Lindhardt
No abstract text is available yet for this article.
September 2016: PM & R: the Journal of Injury, Function, and Rehabilitation
Ernest A Kopecky, Alison B Fleming, Naama Levy-Cooperman, Melinda O'Connor, Edward Sellers
Oxycodone DETERx(®) (Collegium Pharmaceutical Inc, Canton, MA) is an extended-release, microsphere-in-capsule, abuse-deterrent formulation designed to retain its extended-release properties after tampering (eg, chewing/crushing). This randomized, double-blind, placebo-controlled, triple-dummy study evaluated the oral abuse potential of intact and chewed oxycodone DETERx capsules compared with crushed immediate-release oxycodone. Subjects with a history of recreational opioid use who were nondependent/nontolerant to opioids were enrolled...
September 27, 2016: Journal of Clinical Pharmacology
Meiyu Shen, Estelle Russek-Cohen, Eric V Slud
Bioequivalence (BE) studies are an essential part of the evaluation of generic drugs. The most common in vivo BE study design is the two-period two-treatment crossover design. AUC (area under the concentration-time curve) and Cmax (maximum concentration) are obtained from the observed concentration-time profiles for each subject from each treatment under each sequence. In the BE evaluation of pharmacokinetic crossover studies, the normality of the univariate response variable, e.g. log(AUC)(1) or log(Cmax), is often assumed in the literature without much evidence...
August 12, 2016: Journal of Biopharmaceutical Statistics
Bill H McCarberg, Ernest A Kopecky, Melinda O'Connor, Ann Marseilles, Ravi K Varanasi, Christy Thompson, Alison B Fleming
BACKGROUND: Patients with chronic pain may experience difficulty swallowing, in part due to worsening disease, comorbid conditions, iatrogenic etiology, or age. Patients or caregivers may manipulate extended-release (ER) opioid formulations to facilitate oral dosing due to a lack of therapeutic options that allow for sprinkle or enteral feeding tube administration. If crushed or broken, current oral ER opioids can be associated with adverse sequelae, including risk of potentially fatal overdose...
September 26, 2016: Current Medical Research and Opinion
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