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Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences

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https://www.readbyqxmd.com/read/28057166/similar-biologics-global-opportunities-and-issues
#1
REVIEW
Prasanta Kumar Ghosh
The invention and use of a large number of biologics during the last three decades for treating various deficiencies and chronic disorders has resulted in great benefit to human health. Abundant use of these biologics has been considerably constrained due to the reasons of their increased prices, charged by the inventors up to the time up to which their use were/are protected by intellectual property rights (IPR).Some of these biologics are presently being manufactured by the existing and newer companies as "similar biologics" after the IPR on these products have expired and as a result the prices of several such medicines are coming down...
October 2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29145936/biosimilars-state-of-clinical-and-regulatory-science
#2
Agnes Victoria Klein, Jian Wang, Brian G Feagan, Mark Omoto
On May 12, 2017, various issues and challenges associated with biologics were discussed during a session of the annual joint conference of Canadian Society for Pharmaceutical Sciences and Canadian Chapter of Controlled Release Society at Hyatt Regency Hotel, Montréal, QC, Canada.  An update on the Canadian regulatory guidelines for biosimilars was given, followed by viewpoints expressed by regulatory, academic and industry scientists.  Topics of discussion included: reference biologic drug, clinical considerations, immunogenicity, extrapolation and clarification of terminology, product monograph, international collaboration, switching and interchangeability, naming conventions, clinical and non-clinical evaluation, authorization of indications, statistical equivalence, the nor-switch study and biologics marketplace...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29145935/effectiveness-of-pharmacist-led-anticoagulation-management-on-clinical-outcomes-a-systematic-review-and-meta-analysis
#3
Kelu Hou, Hui Yang, Zhikang Ye, Ying Wang, Lihong Liu, Xiangli Cui
OBJECTIVES: We performed this systematic review and meta-analysis to confirm whether patients benefit more from pharmacist-led anticoagulation management than other models. METHODS: We searched PubMed, Embase, Cochrane Library and reference lists of yielded results conducted up to April 25, 2017. RCTs and observational cohort studies and case-control studies which compared the percentage of time within the target therapeutic range (TTR), the percentage of time within the expanded therapeutic range (TER), haemorrhage events, thrombosis events, mortality, patient satisfaction and/or medicine cost saving of pharmacist-led anticoagulation management with other models, and species were limited to humans...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29145934/economic-evaluations-on-antimicrobial-stewardship-programme-a-systematic-review
#4
Nor Haizan Ibrahim, Khalidah Maruan, Hasryn Azzuar Mohd Khairy, Yet Hoi Hong, Ahmad Fauzi Dali, Chin Fen Neoh
PURPOSE: To systematically review studies on cost-effectiveness of implementing Antimicrobial stewardship programmes (ASP) in the hospital setting. METHODS: A systematic literature search was performed using electronic databases, such as EMBASE, PubMed/Medline, CINAHL, NHS and CEA Registry from 2000 until 2017. The quality of each included study was assessed using Joanna Briggs Institute Critical Appraisal Checklist for Economic Evaluations and Consolidated Health Economic Evaluation Reporting Standards Statement checklist...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29145933/quantitative-structure-pharmacokinetics-relationships-for-plasma-protein-binding-of-basic-drugs
#5
Zvetanka Dobreva Zhivkova
PURPOSE: Binding of drugs to plasma proteins is a common physiological occurrence which may have a profound effect on both pharmacokinetics and pharmacodynamics. The early prediction of plasma protein binding (PPB) of new drug candidates is an important step in drug development process. The present study is focused on the development of quantitative structure - pharmacokinetics relationship (QSPkR) for the negative logarithm of the free fraction of the drug in plasma (pfu) of basic drugs...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29145932/lipid-emulsion-more-than-reversing-bupivacaine-cardiotoxicity-potential-organ-protection
#6
Negar Motayagheni, Sheshanna Phan, Ala Nozari, Anthony Atala
Efforts to develop a treatment for bupivacaine cardiotoxicity led to the discovery that Intralipid, a popular brand of intravenous lipid emulsion, could be used not only as an effective treatment for anesthetic-induced cardiac arrest, but also as a means of reversing many other toxicities. Contradictory data exist regarding the mechanism of action of lipid emulsion, a combination of fatty acids traditionally used in parenteral nutrition. Some researchers attribute the effects to lipophilicity and the individual characteristics of the lipids, while other data demonstrate a direct empowering mechanism through cellular upstream and downstream pathways...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29145931/in-vitro-and-in-silico-approaches-to-study-cytochrome-p450-mediated-interactions
#7
Boon Hooi Tan, Yan Pan, Amelia Nathania Dong, Chin Eng Ong
In vitro and in silico models of drug metabolism are utilized regularly in the drug research and development as tools for assessing pharmacokinetic variability and drug-drug interaction risk. The use of in vitro and in silico predictive approaches offers advantages including guiding rational design of clinical drug-drug interaction studies, minimization of human risk in the clinical trials, as well as cost and time savings due to lesser attrition during compound development process. This article gives a review of some of the current in vitro and in silico methods used to characterize cytochrome P450(CYP)-mediated drug metabolism for estimating pharmacokinetic variability and the magnitude of drug-drug interactions...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29145930/assessment-of-predicted-rate-and-associated-factors-of-dabigatran-induced-bleeding-events-in-malaysian-patients-with-non-valvular-atrial-fibrillation
#8
Semira Abdi Beshir, Lok Bin Yap, Szyuin Sim, Kok Han Chee, Yoke Lin Lo
PURPOSE: To assess the predicted rate and the factors associated with bleeding events among patients with non-valvular atrial fibrillation (NVAF) receiving dabigatran therapy. METHODS: This retrospective cohort study includes adult patients of two tertiary hospitals in Malaysia. Potential study subjects were identified using pharmacy supply database or novel oral anticoagulant (NOAC) registry. Demographics, clinical data and laboratory test results were extracted from the medical records of the patients or electronic databases...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29145929/ciprofloxacin-does-not-prolong-the-qtc-interval-a-clinical-study-in-icu-patients-and-review-of-the-literature
#9
Charlotte Heemskerk, Evelien Woldman, Marieke Pereboom, Ruud Van der Hoeven, Aukje Mantel-Teeuwisse, Claudia Van Gemeren, Matthijs Lambertus Becker
PURPOSE: Ciprofloxacin may prolong the QT interval and increase the risk of Torsade de Pointes (TdP). Intravenous administration of ciprofloxacin in patients with additional risks may elevate the risk of QTc interval prolongation. We prospectively assessed whether intravenous ciprofloxacin prolongs the QT interval in patients with additional co-morbidities and risk factors. We also reviewed the literature on the QT prolonging effect or TdP inducing effect of ciprofloxacin. METHODS: ICU Patients who were treated with intravenous ciprofloxacin as part of their therapy were recruited...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28885916/calcitriol-reverses-induced-expression-of-efflux-proteins-and-potentiates-cytotoxic-activity-of-gemcitabine-in-capan-2-pancreatic-cancer-cells
#10
Hamed Gilzad-Kohan, Shabnam Sani, Mehdi Boroujerdi
PURPOSE: Efflux and influx proteins play a major role in chemo-resistance by affecting the net cellular uptake of anti-cancer drugs. Hence, alteration of the efflux and influx protein expression may result in variations of chemotherapeutics uptake and consequently cell death rate. The present study investigated the effects of pre-treatment of capan-2 pancreatic cancer cells with calcitriol, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA) or silibinin on the induction of three major efflux proteins and the main gemcitabine influx protein...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28885915/nanosized-liposomes-containing-bile-salt-a-vesicular-nanocarrier-for-enhancing-oral-bioavailability-of-bcs-class-iii-drug
#11
Mosab Arafat, Cathrin Kirchhoefer, Momir Mikov, Muhammad Sarfraz, Raimar Löbenberg
PURPOSE: Liposomes have been studied as a colloidal carrier in drug delivery systems, especially for oral administration. However, their low structural integrity in the gut is still a major shortcoming. Membrane disruptive effects of physiological bile salts in the small intestine result in premature drug release prior to intestinal absorption. Thus, we analyzed the stabilizing effect of sodium deoxycholate when incorporated into nano-sized liposomes. METHOD: Cefotaxime-loaded liposomes were prepared with different sodium deoxycholate concentrations (3...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28810950/clofibrate-attenuates-ros-production-by-lipid-overload-in-cultured-rat-hepatoma-cells
#12
Yufei Chen, Wei Li, Guqi Wang, Frank J Burczynski
PURPOSE: To investigate the effect of clofibrate on inducing liver fatty acid binding protein (FABP1) following a high-fat load in a hepatocyte cell culture model. METHODS: Rat hepatoma cells (CRL-1548) were treated with a fatty acid (FA) mixture consisting of oleate:palmitate (2:1) in the presence of 3% albumin. Cells were treated with 0, 0.5, 1, 2, or 3 mM FA for 24 and 48 hr, or further treated with 500 µM clofibrate (CLO) to induce FABP1 levels. Cytotoxicity was determined using the WST-1 assay...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28810949/analysis-of-non-pivotal-bioequivalence-studies-submitted-in-abbreviated-new-drug-submissions-for-delayed-release-drug-products
#13
Paramjeet Kaur, Xiaojian Jiang, Ethan Stier
The US FDA's rule on "Requirements for Submission of Bioequivalence Data" requiring submission of all bioequivalence (BE) studies conducted on the same formulation of the drug product submitted for approval was published in Federal Register in January 2009. With the publication of this rule, we evaluated the impact of data from non-pivotal BE studies in assessing BE and identified the reasons for failed in vivo BE studies for generic oral delayed-release (DR) drug products only. We searched the Agency databases from January 2009 toDecember 2016 to identify Abbreviated New Drug Applications (ANDAs) submitted for DR drug products containing non-pivotal BE studies...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28810948/development-and-validation-of-a-robust-and-efficient-hplc-method-for-the-simultaneous-quantification-of-levodopa-carbidopa-benserazide-and-entacapone-in-complex-matrices
#14
Erik Wollmer, Sandra Klein
PURPOSE: A variety of fixed-dose combination products is used in the therapy of Parkinson Disease. However, to date a proper analytical method applicable for comparative screening of different antiparkinson products was not available. The objective of the present work was thus to develop and validate an analytical method for the simultaneous quantification of levodopa, carbidopa, benserazide and entacapone. The method should be applicable for quantifying samples from drug release experiments with marketed products and prototype formulations performed under compendial and biorelevant test conditions...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28810947/intravaginal-delivery-approaches-for-contraception-an-overview-with-emphasis-on-gels
#15
Sonia Gupta, Vijay Prabha
The rising population with grave ramifications for the future is a fundamental issue, demanding for newer and better contraceptive modalities. Also, in order to achieve the contraceptive purpose, the choice of the most suitable delivery system is of unquestionable importance. Out of all dosage forms, vaginal gel formulations present indubitable benefits for contraceptive administration. Therefore, this review summarizes the history of research in the field of vaginal delivery systems with special emphasis on the development of vaginal gels containing safer and more effective contraceptive agents...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28810946/safety-and-efficacy-of-rotigotine-for-treating-parkinson-s-disease-a-meta-analysis-of-randomised-controlled-trials
#16
Fei Chen, Lingjing Jin, Zhiyu Nie
We aimed to comprehensively analyse the safety and efficiency of rotigotine for treating Parkinson's disease (PD). We conducted systematic literature searches of Cochrane library, PubMed and Embase databases up to April 2016, with 'Rotigotine', 'Parkinson Disease ' and 'Parkinson's disease' as key searching terms. Outcomes, including Unified Parkinson's Disease Rating Scale (UPDRS) Part III and Part II scores, 'off' time, adverse events (AEs), serious AEs and discontinuation because of AEs, were compared between rotigotine and placebo groups under a fixed or random effect model...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28719362/association-between-vancomycin-blood-brain-barrier-penetration-and-clinical-response-in-postsurgical-meningitis
#17
Qing Wang, Si Chen, Yan-Gang Zhou, Ping Xu, Yi-Ping Liu, Hua-Lin Cai, Hong Chen, Zheng Luo, Hoan Linh Banh
PURPOSE: This study investigated the association between vancomycin blood brain barrier penetration and clinical response in patients with postsurgical meningitis. METHODS: Adult patients with postsurgical meningitis were recruited. Eligible patients received vancomycin 500 mg every 6 h for at least 5 days. On day 3 or 4, cerebrospinal fluid (CSF) and simultaneous serum samples were obtained to determine CSF minimum concentrations (Cmin), serum Cmin and CSF to serum Cmin ratio...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28719361/effectiveness-of-valganciclovir-900mg-versus-450mg-for-cytomegalovirus-prophylaxis-in-renal-transplantation-a-systematic-review-and-meta-analysis
#18
Wang Xin, Yang Hui, Zhang Xiaodong, Cui Xiangli, Wang Shihui, Liu Lihong
OBJECTIVES: Valganciclovir 900 mg/day is approved for cytomegalovirus (CMV) prophylaxis, but 450 mg/day is seems also effective. We systematically reviewed the efficacy and safety of low-dose versus high-dose valganciclovir prophylaxis in renal transplantation recipients. METHODS: An electronic search was conducted up to November 29, 2016. The primary outcomes were incidences of CMV, CMV disease, mortality and opportunistic infection. The second outcomes were acute rejection, allograft loss, adverse drug reaction (ADR)...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28719360/alzheimer-s-disease-dawn-of-a-new-era
#19
Farideh Amirrad, Emira Bousoik, Kiumars Shamloo, Hassan Al-Shiyab, Viet-Huong V Nguyen, Hamidreza Montazeri Aliabadi
Alzheimer's disease (AD) is an irreversible neurodegenerative disease characterized by a progressive decline in cognition and memory, leading to significant impairment in daily activities and ultimately death. It is the most common cause of dementia, the prevalence of which increases with age; however, age is not the only predisposing factor. The pathology of this cognitive impairing disease is still not completely understood, which has limited the development of valid therapeutic options. Recent years have witnessed a wide range of novel approaches to combat this disease, so that they greatly increased our understanding of the disease and of the unique drug development issues associated with this disease...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28719359/levodopa-in-parkinson-s-disease-a-review-of-population-pharmacokinetics-pharmacodynamics-analysis
#20
Amélie Marsot, Romain Guilhaumou, Jean Philippe Azulay, Olivier Blin
BACKGROUND: Parkinson's disease is the second most common neurodegenerative disorder after Alzheimer's disease. Although levodopa remains the single effective agent in the management of Parkinson's disease, the accurate determination of this optimal dosage is complicated by marked between-subject and between-occasion variability in this population.  This review presents a synthesis of the population pharmacokinetic and pharmacodynamic models of levodopa described in Parkinson's disease...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
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