15 results match your criteria ich elaborated

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Application of Hydrophobic Magnetic Nanoparticles as Cleanup Adsorbents for Pesticide Residue Analysis in Fruit, Vegetable, and Various Soil Samples.

J Agric Food Chem 2020 Nov 5;68(47):13550-13561. Epub 2020 Nov 5.

Department of Organic and Inorganic Chemistry, Faculty of Chemistry, University of Oviedo-CINN, 8 Avda. Julián Clavería, 33006, Oviedo, Spain.

A cleanup procedure based on hydrophobic magnetic nanoparticles for QuEChERS extraction followed by GC-MS method for the simultaneous determination of 16 organochlorine pesticides was developed. The type and amount of cleanup adsorbents (C18/GCB/FeO/[email protected]), the volume and polarity of the extraction solvent were optimized. The method was validated according to SANTE/11813/2017 and ICH/2005/Q2/R1 guidelines. Read More

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November 2020

Hematoma Expansion in Intracerebral Hemorrhage: An Update on Prediction and Treatment.

Front Neurol 2020 17;11:702. Epub 2020 Jul 17.

Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Intracerebral hemorrhage (ICH) is the most lethal type of stroke, but there is no specific treatment. After years of effort, neurologists have found that hematoma expansion (HE) is a vital predictor of poor prognosis in ICH patients, with a not uncommon incidence ranging widely from 13 to 38%. Herein, the progress of studies on HE after ICH in recent years is updated, and the topics of definition, prevalence, risk factors, prediction score models, mechanisms, treatment, and prospects of HE are covered in this review. Read More

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Opportunities and obstacles for microsampling techniques in bioanalysis: Special focus on DBS and VAMS.

J Pharm Biomed Anal 2020 Apr 25;182:113102. Epub 2020 Jan 25.

SPPSPTM, SVKM's Narsee Monjee Institute of Management Studies, V.L. Mehta Road, Vile Parle (W), Mumbai 400056, India; Sitec Labs. Ltd. PEE-DEE Infotech, Plot no. Gen-40, TTC, MIDC Behind Millennium Business Park, Near Nelco, Mahape, New Mumbai 400710, India.

Microsampling, a reduced volume (< 50 μl) sampling method has successfully gained attention at the International Conference on Harmonization (ICH) level. It has been reflected in a few guidelines like ICH SA3, S11 and M10. The established benefits of microsampling support its use in Toxicokinetic (TK) and Pharmacokinetic (PK) studies, clinical studies, neonate sampling and remote sampling. Read More

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A novel pharmaceutical approach for the analytical validation of probiotic bacterial count by flow cytometry.

J Microbiol Methods 2020 03 7;170:105834. Epub 2020 Jan 7.

Biofarma SpA, Via Castelliere 2, 33036 Mereto di Tomba UD, Italy. Electronic address:

Introduction: Flow cytometry is a powerful and sensitive technique able to characterize single cells within a heterogeneous population. Different fluorescent dyes can be combined and used together to analyze a great variety of parameters simultaneously. In particular, flow-cytometry allows to measure viability and vitality of probiotics measuring their metabolic activity, fermentation capacity, acidification potential or oxygen uptake ability (Hayouni et al. Read More

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A High-Demanding Strategy to Ensure the Highest Quality Standards of Oral Liquid Individualized Medicines for Pediatric Use.

AAPS PharmSciTech 2019 Jun 3;20(5):208. Epub 2019 Jun 3.

Departamento Ingeniería Química y Tecnología Farmacéutica, Facultad de Farmacia, Universidad de La Laguna, Entrada Campus Anchieta, 4, 38206, San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain.

Individualized medicines for pediatrics are a useful alternative if there is no correct dosage marketed for this segment (easy to swallow, adequate volume and content, correct composition for pediatrics, good organoleptic properties, etc.). Its validation process must ensure quality testing: its content uniformity, physical (homogeneity after shaking), chemical, and microbiological stability. Read More

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Study of aldehyde oxidase with phthalazine as substrate using both off-line and on-line capillary electrophoresis.

J Pharm Biomed Anal 2019 Feb 19;165:393-398. Epub 2018 Dec 19.

KU Leuven - University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, Herestraat 49, O&N2, PB 923, 3000, Leuven, Belgium. Electronic address:

An optimized and economical capillary electrophoretic method for both off-line and on-line study of the enzyme aldehyde oxidase and its substrate phthalazine was developed. The separation of the substrate phthalazine and its metabolite 1-phthalazinone was achieved using micellar electrokinetic chromatography (MEKC) with sodium dodecyl sulphate in the background electrolyte (BGE). The BGE consists of 25 mM sodium phosphate buffer containing 50 mM sodium dodecyl sulphate at pH 7. Read More

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February 2019

Development of efficient one-pot three-component assembly of trityl olmesartan medoxomil.

Bioorg Med Chem 2018 08 28;26(14):4348-4359. Epub 2018 Jun 28.

Lek Pharmaceuticals, d.d., Sandoz Development Center Slovenia, Verovškova ulica 57, 1526 Ljubljana, Slovenia; Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia. Electronic address:

We have elaborated a one-pot three-component assembly of trityl olmesartan medoxomil starting from commercially available ethyl 4-(2-hydroxypropan-2-yl)-2-propyl-1H-imidazole-5-carboxylate, 5-(4'-(bromomethyl)-[1,1'-biphenyl]-2-yl)-1-trityl-1H-tetrazole and 4-(chloromethyl)-5-methyl-1,3-dioxol-2-one intermediates. The developed and optimized one-pot process provides 72-75% yield of trityl olmesartan medoxomil over three steps, which represents in average ca. 90% yield per synthetic step, on a 300 g scale. Read More

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The Early Preclinical Development Program for Locally Administered Investigational Medicinal Products in Ophthalmology: Preclinical Data Required for Starting a First-in-Human Clinical Trial in Europe-Basic Considerations and 2 Case Studies.

Ther Innov Regul Sci 2018 05 5;52(3):321-328. Epub 2017 Sep 5.

1 Appletree CI Group AG, Winterthur, Switzerland.

Background: Although regulatory guidance defines which preclinical data are required in general before proceeding to first-in-human clinical trials, a certain level of flexibility exists in the actual planning, timing, and design of a drug development program. Developing an ophthalmic medicinal product adds additional challenges, since the eye is a complex organ with unique features and specialized ophthalmic guidance documents are sparse.

Methods: We analyzed the preclinical guidelines with a focus on European Union legislation and guidance documents provided by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Read More

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"Long-distance" H/D isotopic self-organization phenomena in scope of the infrared spectra of hydrogen-bonded terephthalic and phthalic acid crystals.

Spectrochim Acta A Mol Biomol Spectrosc 2017 Feb 29;173:65-74. Epub 2016 Aug 29.

Physics Department, Faculty of Science, Ha'il University, P. O. Box 2440, 81451 Ha'il, Saudi Arabia; Laboratoire de Physique Quantique, Faculté des Sciences de Monastir, 5019 Monastir, Tunisia. Electronic address:

This paper deals with the experimental and theoretical studies of abnormal properties of terephthalic acid (TAC) and phthalic acid (PAC) crystals manifested in the H/D isotopic exchange. The widely utilized deuteration routine appeared to be insufficiently effective in the case of the h-TAC isotopomer. In the case of the d-TAC derivative the isotopic exchange process occurred noticeably more effectively. Read More

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February 2017

Genotoxicity assessment of peptide/protein-related biotherapeutics: points to consider before testing.

Mutagenesis 2016 07 21;31(4):375-84. Epub 2016 Mar 21.

ILSI Health and Environmental Sciences Institute (HESI), Washington, DC, USA

The ICH S6(R1) recommendations on safety evaluation of biotherapeutics have led to uncertainty in determining what would constitute a cause for concern that would require genotoxicity testing. A Health and Environmental Sciences Institute's Genetic Toxicology Technical Committee Workgroup was formed to review the current practice of genotoxicity assessment of peptide/protein-related biotherapeutics. There are a number of properties of peptide/protein-related biotherapeutics that distinguish such products from traditional 'small molecule' drugs and need to be taken into consideration when assessing whether genotoxicity testing may be warranted and if so, how to do it appropriately. Read More

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Analysis of flavonoids and iridoids in Vitex negundo by HPLC-PDA and method validation.

Nat Prod Commun 2013 Sep;8(9):1241-4

Department of Natural Products, National Institute of Pharmaceutical Education and Research (NIPER), Sector- 67, SAS Nagar, Mohali- 160062, Punjab, India.

The leaves of Vitex negundo have been reported to contain various bioactive constituents including iridoids and flavonoids. This is the first report on the simultaneous determination of iridoids and flavonoids by HPLC in three different samples of V. negundo leaves collected from three regions of India. Read More

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September 2013

[Brazilian guidelines for the manegement of intracerebral hemorrhage].

Arq Neuropsiquiatr 2009 Sep;67(3B):940-50

Among the stroke subtypes, intracerebral hemorrhage (ICH) has the worst prognosis and still lacks a specific treatment. The present manuscript contains the Brazilian guidelines for the management of ICH. It was elaborated by the executive committee of the Brazilian Cerebrovascular Diseases Society and was based on a broad review of articles about the theme. Read More

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September 2009

Development of the enteric nervous system: bringing together cells, signals and genes.

Authors:
A J Burns V Pachnis

Neurogastroenterol Motil 2009 Feb;21(2):100-2

Neural Development Unit, UCL Institute of Child Health, London, UK.

The enteric nervous system (ENS), the intrinsic innervation of the gastrointestinal tract that controls essential functions such as motility, secretion and blood flow, comprises a vast number of neurons and glial cells that are organized into complex networks of interconnected ganglia distributed throughout the entire length of the gut wall. Enteric neurons and glia are derived from neural crest cells that undergo extensive migration, proliferation, differentiation and survival in order to form a functional ENS. Investigations of the developmental processes that underlie ENS formation in animal models, and of the common human congenital ENS abnormality Hirschsprung's disease, have been intimately related and recently led to major advances in the field. Read More

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February 2009

Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--Part I.

J Pharm Biomed Anal 2004 Nov;36(3):579-86

Department of Analytical Pharmaceutical Chemistry, Institute of Pharmacy, University of Liège, CHU, B36, B-4000 Liège 1, Belgium.

This paper is the first part of a summary report of a new commission of the Société Française des Sciences et Techniques Pharmaceutiques (SFSTP). The main objective of this commission was the harmonization of approaches for the validation of quantitative analytical procedures. Indeed, the principle of the validation of theses procedures is today widely spread in all the domains of activities where measurements are made. Read More

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November 2004

Evaluation of chemical stability of St. John's wort commercial extract and some preparations.

Int J Pharm 2001 Feb;213(1-2):199-208

Department of Pharmaceutical Science, University of Florence, Via Gino Capponi 9, 50121 Firenze, Italy.

Thermal and photostability of a commercial dried extract and capsules of St. John's wort (Hypericum perforatum L.) were evaluated under the ICH test conditions. Read More

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February 2001
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