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https://www.readbyqxmd.com/read/28535123/topical-otic-drugs-in-a-multi-purpose-manufacturing-facility-a-guide-on-determination-and-application-of-permitted-daily-exposure-pde
#1
Lisa Wiesner, Maarten Prause, Ester Lovsin Barle
Due to newly introduced EU GMP guideline for Medicinal Products for Human and Veterinary use (PIC/S, 2015), product specific PDE for toxicological evaluation in multi-purpose facilities are required within a documented process for risk assessment. EMA (2014) guidance on setting PDE limits so far focused on systemic administration routes such as IV, oral or inhalation. This manuscript wants to give guidance on setting PDE values for risk management purposes in multi-purpose facilities for Active Pharmaceutical Ingredients (APIs) applied as topical otic drugs to the outer ear canal...
May 23, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28533405/spatial-evolutionary-games-with-weak-selection
#2
Mridu Nanda, Richard Durrett
Recently, a rigorous mathematical theory has been developed for spatial games with weak selection, i.e., when the payoff differences between strategies are small. The key to the analysis is that when space and time are suitably rescaled, the spatial model converges to the solution of a partial differential equation (PDE). This approach can be used to analyze all [Formula: see text] games, but there are a number of [Formula: see text] games for which the behavior of the limiting PDE is not known. In this paper, we give rules for determining the behavior of a large class of [Formula: see text] games and check their validity using simulation...
May 22, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28531338/placental-exosomes-as-early-biomarker-of-preeclampsia-potential-role-of-exosomal-micrornas-across-gestation
#3
Carlos Salomon, Dominic Guanzon, Katherin Scholz-Romero, Sherri Longo, Paula Correa, Sebastian E Illanes, Gregory E Rice
Context: There is a need to develop strategies for early prediction of patients who will develop preeclampsia (PE), in order to establish preventive strategies to reduce the prevalence and severity of the disease and their associated complications. Objective: The objective of this study was to investigate whether exosomes and their microRNA cargo present in maternal circulation can be used as early biomarker for PE. Design, Setting, Patients, and Interventions: A retrospective stratified study design was used to quantify total exosomes (EXO) and placenta-derived exosomes (PdE) present in maternal plasma of normal (n=32 per time point) and PE (n=15 per time point) pregnancies...
May 22, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28526924/effects-of-water-ph-on-life-history-parameters-of-a-new-bosminid-cladocera-bosmina-bosmina-tripurae-korinek-saha-and-bhattachaya-1999-in-laboratory-condition
#4
Himadri Saha, K S Wisdom, Asem Lembika Devi, Da-U-Ruhi Pde, Sukham Tuni Devi, Makamguang Kamei, Anamika Biswas, Ratan K Saha, Prasenjit Pal
The effects of water pH on life history parameters of Bosmina tripurae have been studied to determine the most suitable water pH desired for the maximum growth and development of this newly discovered cladoceran species. The study was carried out under the laboratory condition at 20 ± 2°C. Five pH ranges 5.0 ± 0.2, 6.0 ± 0.2, 7.0 ± 0.2, 8.0 ± 0.2 and 9.0 ± 0.2 with six replicates for each pH consisting of one animal in each Petri dish (80 × 15 mm) were used for the study...
May 19, 2017: Bulletin of Environmental Contamination and Toxicology
https://www.readbyqxmd.com/read/28520446/-diabetic-foot-syndrome-importance-of-calf-muscles-mr-spectroscopy-in-the-assessment-of-limb-ischemia-and-effect-of-revascularization
#5
Andrea Němcová, Michal Dubský, Alexandra Jirkovská, Petr Šedivý, Miloslav Drobný, Milan Hájek, Monika Dezortová, Robert Bém, Vladimíra Fejfarová, Anna Pyšná
AIM: The standard method for assessment of effect of revascularization in patients with diabetic foot (DF) and critical limb ischemia (CLI) is transcutaneous oxygen pressure (TcPO2). Phosphorus magnetic resonance spectroscopy (31P MRS) enables to evaluate oxidative muscle metabolism that could be impaired in patients with diabetes and its complications. The aim of our study was to compare MRS of calf muscle between patients with DF and CLI and healthy controls and to evaluate the contribution of MRS in the assessment of the effect of revascularization...
2017: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/28520337/pde-5-inhibitors-should-be-used-post-radical-prostatectomy-as-erection-function-rehabilitation-opinion-no
#6
EDITORIAL
Jonathan Clavell-Hernández, Run Wang
No abstract text is available yet for this article.
May 2017: International Braz J Urol: Official Journal of the Brazilian Society of Urology
https://www.readbyqxmd.com/read/28520336/pde-5-inhibitors-should-be-used-post-radical-prostatectomy-as-erection-function-rehabilitation-opinion-yes
#7
EDITORIAL
Laith M Alzweri, Arthur L Burnett
No abstract text is available yet for this article.
May 2017: International Braz J Urol: Official Journal of the Brazilian Society of Urology
https://www.readbyqxmd.com/read/28515693/rolipram-improves-outcome-in-a-rat-model-of-infant-sepsis-induced-cardiorenal-syndrome
#8
Clark R Sims, Sharda P Singh, Shengyu Mu, Neriman Gokden, Dala Zakaria, Trung C Nguyen, Philip R Mayeux
While the mortality rate associated with sepsis in children has fallen over the years, it still remains unacceptably high. The development of both acute cardiac dysfunction and acute kidney injury during severe sepsis is categorized as type 5 cardiorenal syndrome (CRS) and is poorly understood in infants. To address this lack of understanding and the need for an appropriate animal model in which to conduct relevant preclinical studies, we developed a model of infant sepsis-induced CRS in rat pups then evaluated the therapeutic potential of the phosphodiesterase (PDE) 4 inhibitor, rolipram...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28507431/targeted-drugs-for-pulmonary-arterial-hypertension-a-network-meta-analysis-of-32-randomized-clinical-trials
#9
Xiao-Fei Gao, Jun-Jie Zhang, Xiao-Min Jiang, Zhen Ge, Zhi-Mei Wang, Bing Li, Wen-Xing Mao, Shao-Liang Chen
BACKGROUND: Pulmonary arterial hypertension (PAH) is a devastating disease and ultimately leads to right heart failure and premature death. A total of four classical targeted drugs, prostanoids, endothelin receptor antagonists (ERAs), phosphodiesterase 5 inhibitors (PDE-5Is), and soluble guanylate cyclase stimulator (sGCS), have been proved to improve exercise capacity and hemodynamics compared to placebo; however, direct head-to-head comparisons of these drugs are lacking. This network meta-analysis was conducted to comprehensively compare the efficacy of these targeted drugs for PAH...
2017: Patient Preference and Adherence
https://www.readbyqxmd.com/read/28506928/distinct-phosphodiesterase-5a-containing-compartments-allow-selective-regulation-of-cgmp-dependent-signalling-in-human-arterial-smooth-muscle-cells
#10
Lindsay S Wilson, Manhong Guo, M Bibiana Umana, Donald H Maurice
Cyclic GMP (cGMP) translates and integrates much of the information encoded by nitric oxide (NO(·)) and several natriuretic peptides, including the atrial natriuretic peptide (ANP). Previously, we reported that integration of a cGMP-specific cyclic nucleotide phosphodiesterase, namely phosphodiesterase 5A (PDE5A), into a protein kinase G (PKG)- and inositol-1,4,5-trisphosphate receptor (IP3R)-containing endoplasmic reticulum (ER) signalosome allows localized control of PDE5A activity and of PKG-dependent inhibition of IP3-mediated release of ER Ca(2+) in human platelets...
May 12, 2017: Cellular Signalling
https://www.readbyqxmd.com/read/28505067/risk-assessment-of-florists-exposed-to-pesticide-residues-through-handling-of-flowers-and-preparing-bouquets
#11
Khaoula Toumi, Laure Joly, Christiane Vleminckx, Bruno Schiffers
Flowers are frequently treated with pesticides and, as a result, florists handling daily a large number of flowers can be exposed to pesticide residues. A study was conducted among twenty volunteer florists located in Namur Province and in the Brussels Capital Region of Belgium in order to assess their potential dermal exposure to dislodgeable pesticide residues transferred from flowers to hands. Two pairs of cotton gloves were worn during two consecutive half days while handling flowers and preparing bouquets (from min 2 h to max 3 h/day)...
May 13, 2017: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28497245/single-species-growth-consuming-inorganic-carbon-with-internal-storage-in-a-poorly-mixed-habitat
#12
Sze-Bi Hsu, King-Yeung Lam, Feng-Bin Wang
This paper presents a PDE system modeling the growth of a single species population consuming inorganic carbon that is stored internally in a poorly mixed habitat. Inorganic carbon takes the forms of "CO2" (dissolved CO2 and carbonic acid) and "CARB" (bicarbonate and carbonate ions), which are substitutable in their effects on algal growth. We first establish a threshold type result on the extinction/persistence of the species in terms of the sign of a principal eigenvalue associated with a nonlinear eigenvalue problem...
May 11, 2017: Journal of Mathematical Biology
https://www.readbyqxmd.com/read/28494463/plasma-drug-concentrations-in-patients-with-pulmonary-arterial-hypertension-on-combination-treatment
#13
Ekkehard Grünig, Johanna Ohnesorge, Nicola Benjamin, Jürgen Burhenne, Yeliz Enderle, Benjamin Egenlauf, Christine Fischer, Satenik Harutyunova, Andrea Huppertz, Hans Klose, Walter E Haefeli
BACKGROUND: Combination therapy with the phosphodiesterase type 5 inhibitors (PDE-5i) sildenafil or tadalafil and the endothelin receptor antagonists (ERA) bosentan, ambrisentan, or macitentan may cause mutual pharmacokinetic interactions in patients with pulmonary arterial hypertension (PAH). OBJECTIVE: The objective of this study was to analyze plasma drug concentrations in PAH patients receiving different combination treatments. METHODS: PAH patients receiving a stable combination treatment with ERA and PDE-5i with targeted dosage for at least 1 month were routinely assessed, including clinical parameters and plasma drug concentrations...
May 12, 2017: Respiration; International Review of Thoracic Diseases
https://www.readbyqxmd.com/read/28489901/characterization-and-proteomic-profile-of-extracellular-vesicles-from-peritoneal-dialysis-efflux
#14
Laura Carreras-Planella, Jordi Soler-Majoral, Cristina Rubio-Esteve, Sara Inés Lozano-Ramos, Marcella Franquesa, Josep Bonet, Maria Isabel Troya-Saborido, Francesc Enric Borràs
Peritoneal Dialysis (PD) is considered the best option for a cost-effective mid-term dialysis in patients with Chronic Renal Failure. However, functional failure of the peritoneal membrane (PM) force many patients to stop PD treatment and start haemodialysis. Currently, PM functionality is monitored by the peritoneal equilibration test, a tedious technique that often show changes when the membrane damage is advanced. As in other pathologies, the identification and characterization of extracellular vesicles (EVs) in the peritoneal dialysis efflux (PDE) may represent a non-invasive alternative to identify biomarkers of membrane failure...
2017: PloS One
https://www.readbyqxmd.com/read/28486684/superior-vasodilation-of-human-pulmonary-vessels-by-vardenafil-compared-with-tadalafil-and-sildenafil-additive-effects-of-bosentan%C3%A2
#15
Michael Ried, Reiner Neu, Karla Lehle, Christian Großer, Tamas Szöke, Gunter Lang, Hans-Stefan Hofmann, Markus Hoenicka
OBJECTIVES: Pulmonary arterial hypertension is characterized by pulmonary vascular proliferation and remodelling, leading to a progressive increase in pulmonary arterial resistance. Vasodilator properties of 3 different phosphodiesterase (PDE)-5 inhibitors alone and in combination with an endothelin (ET) receptor antagonist were compared in an ex vivo model. METHODS: Segments of human pulmonary arteries (PAs) and pulmonary veins (PVs) were harvested from lobectomy specimens...
May 9, 2017: Interactive Cardiovascular and Thoracic Surgery
https://www.readbyqxmd.com/read/28485811/the-effects-of-second-messenger-camp-and-its-relative-components-on-the-contraction-of-uterine-smooth-muscle-of-rat
#16
S-J Shu, X-G Lei, J-H Liang, Y-H Song, Q Xu, X-D Chen, L-G Mao, Z-G Li
OBJECTIVE: To investigate the effect of second messenger pathways on the uterine smooth muscle contraction and their associated mechanisms, and compare the evaluation methods. MATERIALS AND METHODS: Preparation of uterine smooth muscle strips from healthy pregnant 18-21 d SD and non-pregnant rats. When the contraction of muscle strips was stable, we conducted gradient administration: PDE4 inhibitors (Z90), prostaglandin PGE2, adenylate cyclase inhibitor (SQ 22,530), cAMP analogs (dbcAMP) and AMPK agonists (AICAR), solvent dimethyl sulfoxide (DMSO) as controlled...
April 2017: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/28477148/a-low-ca-2-i-induced-enhancement-of-camp-activated-ciliary-beating-by-pde1a-inhibition-in-mouse-airway-cilia
#17
Haruka Kogiso, Shigekuni Hosogi, Yukiko Ikeuchi, Saori Tanaka, Chikao Shimamoto, Hitoshi Matsumura, Takashi Nakano, Koh-Ichi Sano, Toshio Inui, Yoshinori Marunaka, Takashi Nakahari
This study demonstrated that PDE1 (phosphodiesterase 1) existing in the ciliary beat frequency (CBF)-regulating metabolon regulates CBF in procaterol-stimulated lung airway ciliary cells of mouse. Procaterol (an β2-agonist) increased the ciliary bend angle (CBA) and CBF via cAMP accumulation in the ciliary cells of mice: interestingly, the time course of CBF increase was slower than that of CBA increase. However, IBMX (3-isobutyl-1-methylxanthine, an inhibitor of PDE) increased CBA and CBF in an identical time course...
May 5, 2017: Pflügers Archiv: European Journal of Physiology
https://www.readbyqxmd.com/read/28476896/altered-cargo-proteins-of-human-plasma-endothelial-cell-derived-exosomes-in-atherosclerotic-cerebrovascular-disease
#18
Edward J Goetzl, Janice B Schwartz, Maja Mustapic, Iryna V Lobach, Richard Daneman, Erin L Abner, Gregory A Jicha
Plasma endothelial cell-derived exosomes (EDEs) and platelet-derived exosomes (PDEs) were precipitated and enriched separately by immunospecific absorption procedures for analyses of cargo proteins relevant to atherosclerosis. EDEs had usual exosome size and marker protein content, and significantly higher levels than PDEs of the endothelial proteins vascular cell adhesion molecule-1 (VCAM-1) and endothelial nitric oxide synthase, whereas PDEs had significantly higher levels of platelet glycoprotein VI. EDE levels of VCAM-1, von Willebrand factor, platelet-derived growth factor (PDGF)-BB, angiopoietin-1, and lysyl oxidase-2 and the cerebrovascular-selective proteins glucose transporter 1, permeability-glycoprotein, and large neutral amino acid transporter 1 were significantly higher for 18 patients with cerebrovascular disease (CeVD) than for 18 age- and gender-matched control subjects...
May 5, 2017: FASEB Journal: Official Publication of the Federation of American Societies for Experimental Biology
https://www.readbyqxmd.com/read/28474020/characterization-of-the-structure-dynamics-and-allosteric-pathways-of-human-npp1-in-its-free-form-and-substrate-bound-complex-from-molecular-modeling
#19
Xavier Barbeau, Patrick Mathieu, Jean-François Paquin, Patrick Lagüe
The ectonucleotide phosphodiesterase/pyrophosphatase-1 (NPP1) is a type II transmembrane glycoprotein that regulates extracellular inorganic purine nucleotide and inorganic diphosphate levels through the hydrolysis of ATP into AMP and diphosphate. NPP1 is a promising drug target as it plays a role in several disorders. In the present work, we report the 3D structure modeling and extensive molecular dynamics simulations of NPP1-h, both in its free and ATP-bound forms. We identified the key residues involved in the binding of the ATP and the binding modes...
May 5, 2017: Molecular BioSystems
https://www.readbyqxmd.com/read/28463252/ray-mapping-approach-in-double-freeform-surface-design-for-collimated-beam-shaping-beyond-the-paraxial-approximation
#20
Christoph Bösel, Norman G Worku, Herbert Gross
Numerous applications require the simultaneous redistribution of the irradiance and phase of a laser beam. The beam shape is thereby determined by the respective application. An elegant way to control the irradiance and phase at the same time is from double freeform surfaces. In this work, the numerical design of continuous double freeform surfaces from ray-mapping methods for collimated beam shaping with arbitrary irradiances is considered. These methods consist of the calculation of a proper ray mapping between the source and the target irradiance and the subsequent construction of the freeform surfaces...
May 1, 2017: Applied Optics
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