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Clinical Pharmacology: Advances and Applications

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https://www.readbyqxmd.com/read/28790869/etanercept-enbrel-%C3%A2-alternative-storage-at-ambient-temperature
#1
Edel Shannon, Joanne Daffy, Heather Jones, Andrea Paulson, Steven M Vicik
BACKGROUND: Biologic disease-modifying antirheumatic drugs, including tumor necrosis factor inhibitors such as etanercept (Enbrel(®)), have improved outcomes for patients with rheumatic and other inflammatory diseases, with sustained remission being the optimal goal for patients with rheumatoid arthritis. Flexible and convenient treatment options, compatible with modern lifestyle, are important in helping patients maintain treatment and manage their disease. Etanercept drug product (DP) is available in lyophilized powder (Lyo) for solution injection, prefilled syringe, and prefilled pen presentations and is typically stored under refrigerated conditions...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28761381/nmda-receptors-are-important-regulators-of-pancreatic-cancer-and-are-potential-targets-for-treatment
#2
William G North, Fuli Liu, Liz Z Lin, Ruiyang Tian, Bonnie Akerman
Pancreatic cancer, particularly adenocarcinoma of the pancreas, is a common disease with a poor prognosis. In this study, the importance of N-methyl-D-aspartate (NMDA) receptors for the growth and survival of pancreatic cancer was investigated. Immunohistochemistry performed with antibodies against GluN1 and GluN2B revealed that all invasive adenocarcinoma and neuroendocrine pancreatic tumors likely express these two NMDA receptor proteins. These proteins were found to be membrane components of pancreatic cancer cell lines, and both channel-blocker antagonist and GluN2B antagonist significantly reduced cell viability in vitro...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28721106/adverse-reactions-in-leprosy-patients-who-underwent-dapsone-multidrug-therapy-a-retrospective-study
#3
Sanjeev Guragain, Namrata Upadhayay, Bishwa Mohan Bhattarai
OBJECTIVE: To investigate the occurrence and clinical characteristics of dapsone-related adverse drug reactions (ADRs) among leprosy patients who underwent multidrug therapy (MDT) from 2010 to 2013 in the western region of Nepal. METHODS: A retrospective review was carried out in the rehabilitation center. Data were collected from the record files of the hospital. RESULTS: From 2010 to 2013, there were 18 patients reported to have dapsone ADRs, with an occurrence rate of 0...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28721105/prediction-of-efficacy-for-conversion-from-adjunctive-therapy-to-monotherapy-with-eslicarbazepine-acetate-800-mg-once-daily-for-partial-onset-epilepsy
#4
Soujanya Sunkaraneni, Julie A Passarell, Elizabeth A Ludwig, Jill Fiedler-Kelly, Janet K Pitner, Todd A Grinnell, David Blum
PURPOSE: Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED) indicated for partial-onset seizures (POS). Clinical studies of gradual conversion to ESL 1,200 and 1,600 mg QD monotherapies were previously conducted in patients with POS who were not well-controlled by 1 or 2 AEDs. This report describes modeling and simulation of plasma eslicarbazepine (primary active metabolite of ESL) concentrations and time to monotherapy study exit to predict efficacy for conversion to ESL monotherapy at a lower dose of 800 mg, as an option for patients requiring or not tolerating higher doses since this regimen is effective in adjunctive therapy for POS...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28572740/an-integrated-epidemiological-and-neural-net-model-of-the-warfarin-effect-in-managed-care-patients
#5
David M Jacobs, Filip Stefanovic, Greg Wilton, Andres Gomez-Caminero, Jerome J Schentag
INTRODUCTION: Risk assessment tools are utilized to estimate the risk for stroke and need of anticoagulation therapy for patients with atrial fibrillation (AF). These risk stratification scores are limited by the information inputted into them and a reliance on time-independent variables. The objective of this study was to develop a time-dependent neural net model to identify AF populations at high risk of poor clinical outcomes and evaluate the discriminatory ability of the model in a managed care population...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28533699/comparative-analysis-of-the-safety-and-tolerability-of-fixed-dose-artesunate-amodiaquine-versus-artemether-lumefantrine-combinations-for-uncomplicated-falciparum-malaria-in-pregnancy-a-randomized-open-label-study
#6
Osede I Iribhogbe, Igue Emmanuel, Marylove Odianosen
A comparative clinical study was conducted to evaluate the safety and tolerability of two commonly used fixed dose artemisinin-based combinations for the treatment of uncomplicated Plasmodium falciparum malaria in the second and third trimester of pregnancy. To achieve this, a total of 155 participants were recruited for the study. Eighty of these were drawn from pregnant women who came for routine antenatal care while 40 nonpregnant participants were recruited from apparently healthy females in the community...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28280397/pharmacokinetics-and-outcome-of-tazobactam-piperacillin-in-japanese-patients-undergoing-low-flow-continuous-renal-replacement-therapy-dosage-considerations
#7
Hanako Kohama, Takeshi Ide, Kazuro Ikawa, Norifumi Morikawa, Shinichi Nishi
BACKGROUND: Tazobactam/piperacillin (TAZ/PIPC), which is often combined with continuous renal replacement therapy (CRRT), induces renal excretion and is thought to have a high component removal rate for blood purification. CRRT procedures vary depending on the country, region, and institution. It is not clear whether the dose of TAZ/PIPC for use in Japan can be determined based on studies conducted in other countries. Therefore, in this study, we examined the suitability of recommended dose in Japan...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28260952/pharmaceutical-characterization-of-novel-tenofovir-liposomal-formulations-for-enhanced-oral-drug-delivery-in-vitro-pharmaceutics-and-caco-2-permeability-investigations
#8
Crystal B Spinks, Ahmed S Zidan, Mansoor A Khan, Muhammad J Habib, Patrick J Faustino
Tenofovir, currently marketed as the prodrug tenofovir disoproxil fumarate, is used clinically to treat patients with HIV/AIDS. The oral bioavailability of tenofovir is relatively low, limiting its clinical effectiveness. Encapsulation of tenofovir within modified long-circulating liposomes would deliver this hydrophilic anti-HIV drug to the reticuloendothelial system for better therapeutic efficacy. The objectives of the current study were to prepare and pharmaceutically characterize model liposomal tenofovir formulations in an attempt to improve their bioavailability...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28260951/the-effect-of-apixaban-on-the-pharmacokinetics-of-digoxin-and-atenolol-in-healthy-subjects
#9
Charles Frost, Yan Song, Zhigang Yu, Jessie Wang, Lois S Lee, Alan Schuster, Allyson Pollack, Frank LaCreta
PURPOSE: Apixaban is often coadministered with treatments for cardiovascular comorbidities, which may lead to unintended drug-drug interactions (DDIs). The effects of apixaban on pharmacokinetics (PK) of multidose Lanoxin(®) (digoxin) and single-dose Tenormin(®) (atenolol) and the effects of single-dose atenolol on apixaban PK in healthy subjects were investigated in two Phase 1 studies. PATIENTS AND METHODS: The digoxin DDI study was an open-label, multidose, two-treatment, single-sequence study in which subjects received digoxin 0...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28138268/effect-of-food-on-the-pharmacokinetics-of-dronabinol-oral-solution-versus-dronabinol-capsules-in-healthy-volunteers
#10
D Alexander Oh, Neha Parikh, Varun Khurana, Christina Cognata Smith, Santosh Vetticaden
Dronabinol is a pharmaceutical tetrahydrocannabinol originally developed as an oral capsule. A dronabinol oral solution was recently approved, and the effects of food on absorption and bioavailability of the oral solution versus capsules were compared in an open-label, single-dose, 3-period crossover study. Healthy volunteers were randomized to either dronabinol oral solution 4.25 mg (fed) or dronabinol capsule 5 mg (fed or fasted). Dosing was separated by a 7-day washout period. Plasma pharmacokinetics were evaluated for dronabinol and its major metabolite, 11-hydroxy-delta-9-tetrahydrocannabinol (11-OH-Δ9-THC)...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28058034/retrospective-analysis-of-the-effects-of-a-highly-standardized-mixture-of-berberis-aristata-silybum-marianum-and-monacolins-k-and-ka-in-patients-with-dyslipidemia
#11
Francesco Di Pierro, Pietro Putignano, Tarcisio Ferrara, Carmela Raiola, Giuliana Rapacioli, Nicola Villanova
BACKGROUND: Berberis aristata, because of its berberine content, and Monascus purpureus fermented rice, because of the presence of monacolins (naturally derived statins), are widely investigated food-grade ingredients used to formulate cholesterol-lowering supplements. Although they are extensively used, berberine is poorly absorbed and monacolins are poorly chemically characterized, not standardized, and possibly contaminated with toxic compounds. Silymarin is reported to enhance berberine absorption, while Monakopure™-K20 (MK-20) is a highly standardized red yeast rice containing monacolins K and KA in the ratio of 1:1 but not secondary monacolins, dehydromonacolins, or citrinin...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28008289/a-phase-i-study-evaluating-the-effect-of-age-and-weight-on-the-pharmacokinetics-of-an-injectable-formulation-of-diclofenac-solubilized-with-hydroxypropyl-%C3%AE-cyclodextrin
#12
Ronald Goldwater, William G Kramer, Douglas A Hamilton, Eric Lang, Jianyuan Wang, Donna E Madden, Peter G Lacouture, Atulkumar Ramaiya, Daniel B Carr
PURPOSE: The analgesic and opioid-sparing effects of nonsteroidal anti-inflammatory drugs can be beneficial in postoperative populations. Hydroxypropyl-β-cyclodextrin (HPβCD)-diclofenac is an injectable formulation of diclofenac solubilized with HPβCD that is administered as a low-volume intravenous bolus. This open-label, single-dose study examined the effects of age and weight on the pharmacokinetic (PK) profile of HPβCD-diclofenac. METHODS: Eighty-eight adult volunteers were enrolled...
2016: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28008288/a-case-of-probable-esomeprazole-induced-transient-liver-injury-in-a-pregnant-woman-with-hyperemesis
#13
Binny Thomas, Mahmoud Mohamed, Moza Al Hail, Fatma Alzahra Y Awwad, Ramy M Wahba, Sabir B Hassan, Khalid Omar, Wessam El Kassem, Palivalappila Abdul Rouf
We report a case of 22-year-old primigravida presented to Women's Hospital - Hamad Medical Corporation emergency with severe epigastric pain, nausea, and vomiting. On admission, she was dehydrated with remarkably worsening symptoms. Laboratory findings revealed significantly elevated liver enzymes with unknown etiology. Her past medical history showed an admission for nausea and vomiting 3 weeks previously and she was discharged on antiemetics, and esomeprazole for the first time. Due to the predominantly elevated liver enzymes, the clinical pharmacist discussed the possibility of esomeprazole-induced adverse effects and suggested to suspend esomeprazole based on the evidence from literature review...
2016: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/27895516/a-prospective-observational-study-comparing-the-pk-pd-relationships-of-generic-meropenem-mercide-%C3%A2-to-the-innovator-brand-in-critically-ill-patients
#14
Mervyn Mer, Jacques Rene Snyman, Constance Elizabeth Jansen van Rensburg, Jacob John van Tonder, Ilze Laurens
INTRODUCTION: Clinicians' skepticism, fueled by evidence of inferiority of some multisource generic antimicrobial products, results in the underutilization of more cost-effective generics, especially in critically ill patients. The aim of this observational study was to demonstrate equivalence between the generic or comparator brand of meropenem (Mercide(®)) and the leading innovator brand (Meronem(®)) by means of an ex vivo technique whereby antimicrobial activity is used to estimate plasma concentration of the active moiety...
2016: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/27799832/lrrk2-inhibitors-and-their-potential-in-the-treatment-of-parkinson-s-disease-current-perspectives
#15
REVIEW
Farzaneh Atashrazm, Nicolas Dzamko
Major advances in understanding how genetics underlies Parkinson's disease (PD) have provided new opportunities for understanding disease pathogenesis and potential new targets for therapeutic intervention. One such target is leucine-rich repeat kinase 2 (LRRK2), an enigmatic enzyme implicated in both familial and idiopathic PD risk. Both academia and industry have promoted the development of potent and selective inhibitors of LRRK2, and these are currently being employed to assess the safety and efficacy of such compounds in preclinical models of PD...
2016: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/27799831/skin-models-for-the-testing-of-transdermal-drugs
#16
REVIEW
Eman Abd, Shereen A Yousef, Michael N Pastore, Krishna Telaprolu, Yousuf H Mohammed, Sarika Namjoshi, Jeffrey E Grice, Michael S Roberts
The assessment of percutaneous permeation of molecules is a key step in the evaluation of dermal or transdermal delivery systems. If the drugs are intended for delivery to humans, the most appropriate setting in which to do the assessment is the in vivo human. However, this may not be possible for ethical, practical, or economic reasons, particularly in the early phases of development. It is thus necessary to find alternative methods using accessible and reproducible surrogates for in vivo human skin. A range of models has been developed, including ex vivo human skin, usually obtained from cadavers or plastic surgery patients, ex vivo animal skin, and artificial or reconstructed skin models...
2016: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/27785111/bioavailability-study-of-dronabinol-oral-solution-versus-dronabinol-capsules-in-healthy-volunteers
#17
Neha Parikh, William G Kramer, Varun Khurana, Christina Cognata Smith, Santosh Vetticaden
BACKGROUND: Dronabinol, a pharmaceutical Δ-9-tetrahydrocannabinol, was originally developed as an oral capsule. This study evaluated the bioavailability of a new formulation, dronabinol oral solution, versus a dronabinol capsule formulation. METHODS: In an open-label, four-period, single-dose, crossover study, healthy volunteers were randomly assigned to one of two treatment sequences (T-R-T-R and R-T-R-T; T = dronabinol 4.25 mg oral solution and R = dronabinol 5 mg capsule) under fasted conditions, with a minimum 7-day washout period between doses...
2016: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/27713650/glibenclamide-population-pharmacokinetic-pharmacodynamic-modeling-in-south-african-type-2-diabetic-subjects
#18
Virendra Rambiritch, Poobalan Naidoo, Goonaseelan Pillai
AIM: To determine the effective dose of glibenclamide by quantifying the dose-response relationship in South African type 2 diabetic patients. PATIENTS AND METHODS: A total of 24 type 2 diabetic patients participated in a glibenclamide dose-escalation study during which glibenclamide, glucose, and insulin concentrations were quantified, while the dose of glibenclamide was progressively increased. All except four subjects contributed data on all dose-escalation steps; however, data from all 24 patients were included in the model-based analysis...
2016: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/27703398/cystic-fibrosis-transmembrane-conductance-regulator-modulators-in-cystic-fibrosis-current-perspectives
#19
REVIEW
Béla Z Schmidt, Jérémy B Haaf, Teresinha Leal, Sabrina Noel
Mutations of the CFTR gene cause cystic fibrosis (CF), the most common recessive monogenic disease worldwide. These mutations alter the synthesis, processing, function, or half-life of CFTR, the main chloride channel expressed in the apical membrane of epithelial cells in the airway, intestine, pancreas, and reproductive tract. Lung disease is the most critical manifestation of CF. It is characterized by airway obstruction, infection, and inflammation that lead to fatal tissue destruction. In spite of great advances in early and multidisciplinary medical care, and in our understanding of the pathophysiology, CF is still considerably reducing the life expectancy of patients...
2016: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/27672344/exposure-response-analysis-to-assess-the-concentration-qtc-relationship-of-cc-122
#20
Yan Li, Leonidas N Carayannopoulos, Michael Thomas, Maria Palmisano, Simon Zhou
CC-122 hydrochloride is a novel pleiotropic pathway modifier compound that binds cereblon, a substrate receptor of the Cullin 4 RING E3 ubiquitin ligase complex. CC-122 has multiple activities including modulation of immune cells, antiproliferative activity of multiple myeloma and lymphoma cells, and antiangiogenic activity. CC-122 is being developed as an oncology treatment for hematologic malignancies and advanced solid tumors. Cardiovascular and vital sign assessments of CC-122 have been conducted in hERG assays in vitro and in a 28-day good laboratory practice monkey study with negative signals...
2016: Clinical Pharmacology: Advances and Applications
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