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https://www.readbyqxmd.com/read/27906611/on-evaluation-of-reliability-repeatability-and-reproducibility-of-instrumental-evaluation-methods-and-measurement-systems
#1
Samir Salah, Shein-Chung Chow, Fuyu Song
Validation of instrumental evaluation methods or measurement systems plays an important role in both pharmaceutical and cosmetic research and development. In practice, it is suggested that validation should be done according to performance characteristics as described in the United States Pharmacopedia and National Formulary (USP/NF, 2000) for analytical methods validation. A validated method or measurement system is expected to achieve a certain degree of accuracy and reliability. However, it is a concern whether the test results obtained are repeatable (with similar test samples) and/or reproducible (under similar but slightly different experimental conditions)...
December 1, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27900836/spectrofluorimetric-determination-of-certain-adrenergic-agonist-drugs-in-their-pure-forms-and-pharmaceutical-formulations-content-uniformity-test-application
#2
Khalid M Badr El-Din, Tamer Z Attia
A new, simple, sensitive and rapid spectrofluorimetric method has been developed for determination of certain adrenergic agonists such as isoxsuprine hydrochloride, ritodrine hydrochloride and etilefrine hydrochloride in their pure forms and pharmaceutical dosage forms. The method depends on micellar enhancement of the native fluorescence of investigated drugs by using 2% w/v sodium dodecyl sulfate (SDS) as an anionic surfactant. The enhanced fluorescence intensity of investigated drugs was measured at 305 nm after excitation at 278 nm...
November 29, 2016: Luminescence: the Journal of Biological and Chemical Luminescence
https://www.readbyqxmd.com/read/27899535/a-tomato-universal-stress-protein-involved-in-oxidative-stress-is-a-cipk6-phosphorylation-target
#3
Emilio Gutierrez-Beltran, José María Personat, Fernando N de la Torre, Olga Del Pozo
Calcineurin B-like interacting protein kinases (CIPKs) decode calcium signals upon interaction with the calcium sensors calcineurin B like proteins (CBLs) into phosphorylation events that result into adaptation to environmental stresses. Few phosphorylation targets of CIPKs are known and therefore the molecular mechanisms underlying their downstream output responses are not fully understood. Tomato (Solanum lycopersicum) Cipk6 regulates immune and susceptible Programmed cell death (PCD) in immunity transforming Ca2+ signals into Reactive Oxygen Species (ROS) signaling...
November 29, 2016: Plant Physiology
https://www.readbyqxmd.com/read/27895634/cytosolic-proteome-profiling-of-aminoglycosides-resistant-mycobacterium-tuberculosis-clinical-isolates-using-maldi-tof-ms
#4
Divakar Sharma, Manju Lata, Rananjay Singh, Nirmala Deo, Krishnamurthy Venkatesan, Deepa Bisht
Emergence of extensively drug resistant tuberculosis (XDR-TB) is the consequence of the failure of second line TB treatment. Aminoglycosides are the important second line anti-TB drugs used to treat the multi drug resistant tuberculosis (MDR-TB). Main known mechanism of action of aminoglycosides is to inhibit the protein synthesis by inhibiting the normal functioning of ribosome. Primary target of aminoglycosides are the ribosomal RNA and its associated proteins. Various mechanisms have been proposed for aminoglycosides resistance but still some are unsolved...
2016: Frontiers in Microbiology
https://www.readbyqxmd.com/read/27894560/analysis-of-temperature-variability-in-medication-storage-compartments-in-emergency-transport-helicopters
#5
Margaret A O'Donnell, Justin Whitfield
The purpose of this study was to determine whether the temperature in medication storage compartments in air medical helicopters was within United States Pharmacopeia (USP)-defined limits for controlled room temperature. This was a prospective study using data obtained from a continuous temperature monitoring device. A total of 4 monitors were placed within 2 medication storage locations in 2 identical helicopters. The data collection period lasted 2 weeks during the summer and winter seasons. Data retrieved from monitors were compared against USP parameters for proper medication storage...
November 2016: Air Medical Journal
https://www.readbyqxmd.com/read/27890717/ecdysone-receptor-ecr-and-ultraspiracle-usp-genes-from-the-cyclopoid-copepod-paracyclopina-nana-identification-and-expression-in-response-to-water-accommodated-fractions-wafs
#6
Jayesh Puthumana, Min-Chul Lee, Jeonghoon Han, Hui-Su Kim, Dae-Sik Hwang, Jae-Seong Lee
Ecdysteroid hormones are pivotal in the development, growth, and molting of arthropods, and the hormone pathway is triggered by binding ecdysteroid to a heterodimer of the two nuclear receptors; ecdysone receptors (EcR) and ultraspiracle (USP). We have characterized EcR and USP genes, and their 5'-untranslated region (5'-UTR) from the copepod Paracyclopina nana, and studied mRNA transcription levels in post-embryonic stages and in response to water accommodated fractions (WAFs) of crude oil. The open reading frames (ORF) of EcR and USP were 1470 and 1287bp that encoded 490 and 429 amino acids with molecular weight of 121...
November 23, 2016: Comparative Biochemistry and Physiology. Toxicology & Pharmacology: CBP
https://www.readbyqxmd.com/read/27890577/transcription-factors-regulating-uspa-genes-in-catharanthus%C3%A2-roseus
#7
Ahmed Bahieldin, Ahmed Atef, Ahmed M Shokry, Saleh Al-Karim, Sanaa G Al Attas, Nour O Gadallah, Sherif Edris, Magdy A Al-Kordy, Sabah M Hassan, Salah Abo-Aba, Fotouh M El-Domyati
RNA-Seq of the Catharanthus roseus SRA database was done in order to detect putative universal stress proteins (USPs) and their possible controlling factors. Previous analysis indicated the existence and characterization of uspA-like genes. In silico analysis of RNA-Seq database in several plant tissues revealed the possible functions and regulations of some uspA-like transcripts whose transcription factors (TFs) that might drive their expression were detected. BLAST indicated the existence of TF superfamilies erf (ethylene-responsive TF), bHLH (basic helix-loop-helix) and WRKY that might regulate several uspA-like genes...
November 24, 2016: Comptes Rendus Biologies
https://www.readbyqxmd.com/read/27887889/development-of-intramammary-drug-delivery-systems-novel-in-vitro-release-method
#8
Sanjay Garg, Wen Wang, Yunmei Song, Patricia Eats, Darren J Trott, Stephen W Page, Kiro Petrovski
The aim of this study was to develop an in vitro release model for intramammary drug delivery system (IDDS) evaluation. This study was the first to establish an in vitro-in vivo correlation with investigation of IDDS containing losalocid. Three different methods including standard USP dissolution method with apparatus 2, modified USP method by using a dialysis bag or by using a specific designed enhancer cell system were assessed for the release study. Full cream milk and water were selected as the release media...
November 22, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27884873/optimization-of-robust-hplc-method-for-quantitation-of-ambroxol-hydrochloride-and-roxithromycin-using-a-doe-approach
#9
Rashmin B Patel, Nilay M Patel, Mrunali R Patel, Ajay B Solanki
The aim of this work was to develop and optimize a robust HPLC method for the separation and quantitation of ambroxol hydrochloride and roxithromycin utilizing Design of Experiment (DoE) approach. The Plackett-Burman design was used to assess the impact of independent variables (concentration of organic phase, mobile phase pH, flow rate and column temperature) on peak resolution, USP tailing and number of plates. A central composite design was utilized to evaluate the main, interaction, and quadratic effects of independent variables on the selected dependent variables...
November 24, 2016: Journal of Chromatographic Science
https://www.readbyqxmd.com/read/27864786/clinical-pharmacokinetics-of-an-amorphous-solid-dispersion-tablet-of-elacridar
#10
Emilia Sawicki, Remy B Verheijen, Alwin D R Huitema, Olaf van Tellingen, Jan H M Schellens, Bastiaan Nuijen, Jos H Beijnen, Neeltje Steeghs
Elacridar is an inhibitor of the permeability glycoprotein (P-gp) and the breast cancer resistance protein (BCRP) and is a promising absorption enhancer of drugs that are substrates of these drug-efflux transporters. However, elacridar is practically insoluble in water, resulting in low bioavailability which currently limits its clinical application. We evaluated the in vitro dissolution and clinical pharmacokinetics of a novel amorphous solid dispersion (ASD) tablet containing elacridar. The dissolution from ASD tablets was compared to that from a crystalline powder mixture in a USP type II dissolution apparatus...
November 18, 2016: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/27860529/a-comparison-of-central-corneal-thicknesses-measured-with-two-different-methods-in-cases-of-primary-open-angle-glaucoma
#11
Fatih Mehmet Adibelli, Halit Oğuz, Tuğba Göncü, Omer Faruk Yilmaz, Funda Yuksekyayla
Accurate and repeatable measurement of the central cornea thickness (CCT) is important in terms of follow-up of glaucoma patients. The aim of this study was to compare CCT measurements made with an ultrasonic pachymeter (USP) and with the Spectralis Anterior Segment Module optical coherence tomography (OCT) device. The study included 52 eyes of 26 primary open-angle glaucoma patients. CCT measurements were taken with the USP device and then with the OCT by imaging cornea slices. The mean CCT was measured as 555...
November 18, 2016: Seminars in Ophthalmology
https://www.readbyqxmd.com/read/27859483/a-report-of-the-automated-radiosynthesis-of-the-tau-pet-radiopharmaceutical-18-f-thk-5351
#12
Ramesh Neelamegam, Daniel L Yokell, Peter A Rice, Shozo Furumoto, Yukitsuka Kudo, Nobuyuki Okamura, Georges El Fakhri
The radiotracer, [(18) F]-THK-5351 is a highly selective and high binding affinity PET imaging agent for aggregates of hyper-phosphorylated tau protein. Our report is a simplified one-pot, two-step radiosynthesis of [(18) F]-THK-5351. This report is broadly applicable for routine clinical production and multi-center trials on account of favorable half-life of flourine-18 and the use of a commercially available radiosynthesis module, the GE TRACERlab™ FXFN . First, the O-THP protected tosyl precursor underwent nucleophilic fluorinating reaction with potassium cryptand fluoride ([(18) F] fluoride (K[(18) F]/K222 )) in DMSO at 110 °C for 10 min followed by O-THP removal by using diluted hydrochloric acid (HCl) at same temperature...
November 17, 2016: Journal of Labelled Compounds & Radiopharmaceuticals
https://www.readbyqxmd.com/read/27854438/preparation-and-evaluation-of-indomethacin-loaded-alginate-microspheres
#13
Penjuri Subhash Chandra Bose, Ravouru Nagaraju, Damineni Saritha, Budumuru Padmasri, Poreddy Srikanth Reddy
Indomethacin-loaded alginate microspheres were prepared by the ionic cross linking technique using calcium chloride. The effect of calcium chloride concentration was evaluated with respect to the size, entrapment efficiency and shape (sphericity) of the particles. The entrapment efficiency and in vitro release profiles were found to be altered by changing various formulation parameters. The desired indomethacin in vitro release profile (as per USP specifications for extended release formulations) was obtained from microspheres prepared from gel containing 2% of sodium alginate and 2% of methyl cellulose hardened in 3% calcium chloride solution...
2016: Ceská a Slovenská Farmacie
https://www.readbyqxmd.com/read/27849307/cardiopulmonary-bypass-ischemic-hepatitis-reported-in-five-patients
#14
Telma A Damasceno, Adilson Scorzoni, Fernando Chahud, Alfredo José Rodrigues, Walter Vilella de Andrade Vicente, Paulo Roberto Barbosa Evora
Objective: In cardiac surgery, the lung, renal and neurological events are the most frequent complications. Less common, acute liver failure is a serious complication that adds high morbidity, mortality, and costs. Therefore, this communication aimed to retrospectively evaluate five patients who presented, in 2014, severe acute liver failure in the immediate postoperative period. Methods: Retrospective data analysis of patients' medical records that showed severe liver failure has been computed in the medical records of five patients undergoing cardiac surgery at the Hospital da Faculdade de Medicina de Ribeirão Preto - USP in the immediate postoperative period from February 1, 2014 to December 12, 2014...
July 2016: Brazilian Journal of Cardiovascular Surgery
https://www.readbyqxmd.com/read/27816615/nocturnal-urinary-disorders-in-multiple-sclerosis-clinical-and-urodynamic-study-of-309-patients
#15
Elsa Mauruc, Amandine Guinet-Lacoste, Lætitia Falcou, Philippe Manceau, Delphine Verollet, Frédérique Le Breton, Gérard Amarenco
PURPOSE: The aim of this study was to describe nocturia with or without leakage in a population of patients with multiple sclerosis. MATERIALS AND METHODS: This is a retrospective, single center study of 309 patients with multiple sclerosis who were followed at an experienced neurourology center between 2011 and 2013. All patients had daytime urinary symptoms associated with this disorder. Among the patients with nocturia 2 groups were defined, including those with isolated nocturia but without nocturnal urinary incontinence and patients with nocturia associated with nocturnal urinary incontinence...
November 2, 2016: Journal of Urology
https://www.readbyqxmd.com/read/27809302/multiple-functions-of-usp18
#16
REVIEW
Nadine Honke, Namir Shaabani, Dong-Er Zhang, Cornelia Hardt, Karl S Lang
Since the discovery of the ubiquitin system and the description of its important role in the degradation of proteins, many studies have shown the importance of ubiquitin-specific peptidases (USPs). One special member of this family is the USP18 protein (formerly UBP43). In the past two decades, several functions of USP18 have been discovered: this protein is not only an isopeptidase but also a potent inhibitor of interferon signaling. Therefore, USP18 functions as 'a' maestro of many biological pathways in various cell types...
November 3, 2016: Cell Death & Disease
https://www.readbyqxmd.com/read/27803508/potency-and-sterility-of-10-sodium-fluorescein-injection-usp-stored-in-sterile-polypropylene-syringes-for-use-during-cystoscopy
#17
Enrique Puertos, Greta Giles
Background: A shortage of indigotindisulfonate sodium has led to a search for an alternative visualizing agent. Objective: The primary objective of this study was to evaluate the potency and sterility of 10% sodium fluorescein, USP solutions stored in sterile polypropylene syringes and refrigerated. Methods: Four samples of 10% fluorescein injection, USP were aseptically drawn up in 3 mL polypropylene syringes and stored in a refrigerator at an average temperature of 3.9°C for 7 days. After 7 days, the samples were cultured for microbial growth...
October 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27801366/evaluation-of-paiusp-subtyping-to-characterize-uropathogenic-e-coli-isolates
#18
Yun Mei Lai, Myo Thura Zaw, Shamsul Bahari Shamsudin, Zaw Lin
INTRODUCTION: Uropathogenic virulence factors have been identified by comparing the prevalence of these among urinary tract isolates and environmental strains. The uropathogenic-specific protein (USP) gene is present on the pathogenicity island (PAI) of uropathogenic Escherichia coli (UPEC) and, depending on its two diverse gene types and the sequential patterns of three open reading frame units (orfUs) following it, there is a method to characterize UPEC epidemiologically called PAIusp subtyping...
October 31, 2016: Journal of Infection in Developing Countries
https://www.readbyqxmd.com/read/27789803/container-closure-integrity-testing-practical-aspects-and-approaches-in-the-pharmaceutical-industry
#19
Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger, Klaus Wuchner
The assurance of sterility of a parenteral drug product, prior to any human use, is a regulatory requirement. Hence, all strategies related to container closure integrity (CCI) must demonstrate absence of microbial contamination through leaks as part of the container closure system (CCS) qualification, during manufacturing, for Quality Control purposes and to ensure microbiological integrity (sterility) during storage and shipment up to the end of product shelf life. Current regulatory guidances, which differ between countries and regions, provide limited detail on how to assess CCI...
October 27, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27779380/quantitative-chemical-proteomic-profiling-of-ubiquitin-specific-proteases-in-intact-cancer-cells
#20
Jennifer A Ward, Lauren McLellan, Martin Stockley, Karl R Gibson, Gavin A Whitlock, Charlotte Knights, Jeanine A Harrigan, Xavier Jacq, Edward W Tate
Deubiquitinating enzymes play an important role in a plethora of therapeutically relevant processes and are emerging as pioneering drug targets. Herein, we present a novel probe, Ubiquitin Specific Protease (USP) inhibitor, alongside an alkyne-tagged activity-based probe analogue. Activity-based proteome profiling identified 12 USPs, including USP4, USP16, and USP33, as inhibitor targets using submicromolar probe concentrations. This represents the first intact cell activity-based profiling of deubiquitinating enzymes...
October 31, 2016: ACS Chemical Biology
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