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https://www.readbyqxmd.com/read/28720174/selective-determination-of-human-growth-hormone-somatropin-in-the-presence-of-its-chemical-degradation-products
#1
Mamdouh R Rezk, Marwa F Mohamed, Faten Abdelaziz Fathalla, Mostafa A Shehata
A rapid and sensitive HPLC method was developed and validated for selective determination of the human growth hormone (hGH) somatropin in the presence of its deamidated and oxidized degradation products. Reversed-phase chromatography with an acetonitrile and ammonium bicarbonate mobile phase in gradient elution mode was used. A short run time of 15 min allowed rapid and cost-effective analysis, with an average retention time of 7.4 min for native hGH, 6.2 min for its deamidated form, and 4.3 and 6 min for its oxidized variants...
July 1, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28642700/pricing-and-reimbursement-of-biosimilars-in-central-and-eastern-european-countries
#2
Paweł Kawalec, Ewa Stawowczyk, Tomas Tesar, Jana Skoupa, Adina Turcu-Stiolica, Maria Dimitrova, Guenka I Petrova, Zinta Rugaja, Agnes Männik, Andras Harsanyi, Pero Draganic
Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries. Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28611730/exploiting-nanobodies-in-the-detection-and-quantification-of-human-growth-hormone-via-phage-sandwich-enzyme-linked-immunosorbent-assay
#3
Hossam Murad, Jana Mir Assaad, Rasha Al-Shemali, Abdul Qader Abbady
BACKGROUND: Monitoring blood levels of human growth hormone (hGH) in most children with short stature deficiencies is crucial for taking a decision of treatment with extended course of daily and expensive doses of recombinant hGH (rhGH or Somatropin(®)). Besides, misusing of rhGH by sportsmen is banned by the World Anti-Doping Agency and thus sensitive GH-detecting methods are highly welcome in this field. Nanobodies are the tiniest antigen-binding entity derived from camel heavy chain antibodies...
2017: Frontiers in Endocrinology
https://www.readbyqxmd.com/read/28192978/in-vitro-functional-quality-characterization-of-nota-modified-somatropins
#4
Nathalie Bracke, Han Yao, Evelien Wynendaele, Frederick Verbeke, Xiaolong Xu, Bert Gevaert, Alex Maes, Christophe Van de Wiele, Mike Sathekge, Sarah De Saeger, Bart De Spiegeleer
Chemical modifications on protein biopharmaceuticals introduce extra variability in addition to their inherent complexity, hence require more comprehensive analytical and functional characterization during their discovery, development, and manufacturing. Somatropin (i.e., recombinant human growth hormone, rhGH) modified with the chelating agent S-2-(4-isothiocyanatobenzyl)-1,4,7-triazacyclononane-1,4,7-triacetic acid (p-SCN-Bn-NOTA) allows the incorporation of radiometals for research and possible theranostic purposes...
February 16, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28190647/human-growth-hormone-stabilizes-walking-and-improves-strength-in-a-patient-with-dominantly-inherited-calpainopathy
#5
Kira Philipsen Prahm, Ulla Feldt-Rasmussen, John Vissing
The aim was to investigate if daily low-dose treatment with recombinant human growth hormone (somatropine) can stabilize or improve muscle strength and walking capability in a patient with dominantly inherited calpainopathy. The patient was treated with daily injections of somatropine, except for a 6-month pause, over a period of 4.5 years. Efficacy was assessed by repeated muscle dynamometry tests and 6-minute walk tests (6MWT). Strength improved in most muscle groups on treatment, deteriorated in the 6-month off treatment, and improved again when treatment was resumed...
January 23, 2017: Neuromuscular Disorders: NMD
https://www.readbyqxmd.com/read/28161880/long-term-safety-and-efficacy-of-omnitrope-%C3%A2-in-adults-with-growth-hormone-deficiency-italian-interim-analysis-of-the-patro-adults-study
#6
D Ferone, E Profka, V Gasco, M R Ambrosio, A Colao, C Di Somma, E Puxeddu, G Arnaldi, C Pagano, E Zecchi, A Pietropoli, P Beck-Peccoz
PURPOSE: To report the long-term effectiveness and safety of the recombinant human growth hormone Omnitrope(®), a somatropin biosimilar to Genotropin(®), in Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO Adults study. METHODS: The PATRO Adults study is an ongoing observational, longitudinal, non-interventional global post-marketing surveillance study, conducted in several European countries. The primary endpoint is long-term safety; secondary endpoints include the effectiveness of Omnitrope(®), which was assessed using serum insulin-like growth factor-1 levels, body composition, bone mineral density and lipid levels...
June 2017: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/28105973/selective-determination-of-human-growth-hormone-somatropin-in-the-presence-of-its-chemical-degradation-products
#7
Mamdouh R Rezk, Marwa F Mohamed, Faten Abdelaziz Fathalla, Mostafa A Shehata
A rapid and sensitive HPLC method was developedand validated for selective determination of thehuman growth hormone (hGH) somatropin in thepresence of its deamidated and oxidized degradationproducts. Reversed-phase chromatographywith an acetonitrile and ammonium bicarbonatemobile phase in gradient elution mode was used.A short run time of 15 min allowed rapid andcost-effective analysis, with an average retentiontime of 7.4 min for native hGH, 6.2 min for itsdeamidated form, and 4.3 and 6 min for its oxidizedvariants...
January 19, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28003839/twin-arginine-translocation-system-in-secretory-expression-of-recombinant-human-growth-hormone
#8
Mohammad Reza Bagherinejad, Hamid Mir-Mohammad Sadeghi, Daryoush Abedi, C Perry Chou, Fatemeh Moazen, Mohammad Rabbani
Recombinant protein production in E. coli has several advantages over other expression systems. Misfolding, inclusion body formation, and lack of eukaryotic post translational modification are the most disadvantages of this system. Exporting of correctly folded proteins to the outside of reductive cytoplasmic environment through twin-arginine system could help to pass these limiting steps. Two signal sequences, TorA and SufI are used at N-terminal of human growth hormone (hGH) bearing DsbA gene sequence at C-terminal to enhance folding...
December 2016: Research in Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27888454/availability-and-quality-of-illegitimate-somatropin-products-obtained-from-the-internet
#9
Róbert György Vida, András Fittler, Ivett Mikulka, Eszter Ábrahám, Viktor Sándor, Ferenc Kilár, Lajos Botz
Background Growth hormones are widely available on the Internet for those who want to enhance their physical performance and improve body satisfaction. Illegitimate websites market somatropin injections without medical prescription and encourage misuse. Customers potentially put their health at risk when purchasing parenteral medications online. Objective The objective of our study was to evaluate the online market of no-prescription somatropin products and to analyse and document Internet pharmacy characteristics, distribution and pharmaceutical quality...
February 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/27876365/midyear-commentary-on-trends-in-drug-delivery-and-clinical-translational-medicine-growth-in-biosimilar-complex-injectable-drug-formulation-products-within-evolving-collaborative-regulatory-interagency-fda-ftc-and-doj-practices-and-enforcement
#10
Rodney J Y Ho
Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14...
February 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27809913/long-term-safety-and-efficacy-of-omnitrope%C3%A2-a-somatropin-biosimilar-in-children-requiring-growth-hormone-treatment-italian-interim-analysis-of-the-patro-children-study
#11
MULTICENTER STUDY
Lorenzo Iughetti, Gianluca Tornese, Maria Elisabeth Street, Flavia Napoli, Claudia Giavoli, Franco Antoniazzi, Stefano Stagi, Caterina Luongo, Sara Azzolini, Letizia Ragusa, Gianni Bona, Clara Zecchino, Tommaso Aversa, Luca Persani, Laura Guazzarotti, Emiliano Zecchi, Alberto Pietropoli, Stefano Zucchini
BACKGROUND: PATRO Children is an ongoing observational, longitudinal, non-interventional, global post-marketing surveillance study, which is investigating the long-term safety and effectiveness of Omnitrope®, a somatropin biosimilar to Genotropin®, in children with growth disturbances. The primary endpoint of PATRO Children is long-term safety and the secondary endpoint is effectiveness, which is assessed by analysing auxological data such as height (HSDS) and height velocity (HVSDS) standard deviation scores...
November 3, 2016: Italian Journal of Pediatrics
https://www.readbyqxmd.com/read/27736009/the-effect-of-growth-hormone-gh-replacement-on-blood-glucose-homeostasis-in-adult-nondiabetic-patients-with-gh-deficiency-real-life-data-from-the-nordinet-%C3%A2-international-outcome-study
#12
Matthias M Weber, Beverly M K Biller, Birgitte Tønnes Pedersen, Effie Pournara, Jens Sandahl Christiansen, Charlotte Höybye
OBJECTIVE: To assess the effect of 4 years' growth hormone (GH) replacement on glucose homeostasis and evaluate factors affecting glycosylated haemoglobin (HbA1c ) in adults with growth hormone deficiency (GHD). DESIGN: NordiNet(®) International Outcome Study, a noninterventional study, monitors long-term effectiveness and safety of GH replacement [Norditropin(®) (somatropin), Novo Nordisk A/S] in real-life clinical practice. PATIENTS: Nondiabetic patients (n = 245) with adult-onset GHD (age ≥20 years at GH start), ≥4 years' GH replacement and HbA1c values at baseline and 4 years were included in the analysis...
February 2017: Clinical Endocrinology
https://www.readbyqxmd.com/read/27473484/analysis-of-somatropin-by-double-injection-capillary-zone-electrophoresis-in-polybrene-chondroitin-sulfate-a-double-coated-capillaries
#13
Ahmad Amini
Purity determination of somatropin as a recombinant protein is important to ensure its safety and quality. This is carried out by capillary zone electrophoresis in double-injection mode using polybrene/chondroitin sulfate A double-coated capillaries. Modification of the capillary wall eliminates protein-wall interactions which results in improved accuracy and precision of the determinations. In the double-injection mode two somatropin samples are analyzed within a single electrophoretic run. Prior to the second injection, the first injected plug is electrophoresed for a predetermined time period in order to adjust the inter-plug distance...
2016: Methods in Molecular Biology
https://www.readbyqxmd.com/read/27465108/stability-indicating-determination-of-human-growth-hormone-by-novel-se-lc-method
#14
Mamdouh R Rezk, Mostafa A Shehata, Marwa F Mohamed, Faten Abdel Aziz Fathalla
A selective, rapid size-exclusion chromatographic method was developed and validated for the separation of the human growth hormone (hGH) somatropin from its high-molecular-weight aggregates. Separation was achieved using a nontoxic mobile phase compared with the official method of the European Pharmacopoeia that uses 2-propanol in a mobile phase. The developed method used a YMC-Pack Diol (YMC Karasuma, Kyoto, Japan; 300 × 8.0 mm, 5 μm) analytical column. The mobile phase was formed with a pH 7phosphate buffer that was pumped at a flow rate of 1 mL/min with UV detection at 214 nm...
September 2016: Journal of AOAC International
https://www.readbyqxmd.com/read/26903552/is-safety-of-childhood-growth-hormone-therapy-related-to-dose-data-from-a-large-observational-study
#15
MULTICENTER STUDY
Lars Sävendahl, Effie Pournara, Birgitte Tønnes Pedersen, Oliver Blankenstein
OBJECTIVE: Concerns have been raised of increased mortality risk in adulthood in certain patients who received growth hormone treatment during childhood. This study evaluated the safety of growth hormone treatment in childhood in everyday practice. DESIGN: NordiNet(®) International Outcome Study (IOS) is a noninterventional, observational study evaluating safety and effectiveness of Norditropin(®) (somatropin; Novo Nordisk A/S, Bagsvaerd, Denmark). METHODS: Long-term safety data (1998-2013) were collected on 13 834 growth hormone treated pediatric patients with short stature...
May 2016: European Journal of Endocrinology
https://www.readbyqxmd.com/read/26869423/development-and-characterization-of-sodium-hyaluronate-microparticle-based-sustained-release-formulation-of-recombinant-human-growth-hormone-prepared-by-spray-drying
#16
Sun J Kim, Chan W Kim
The purpose of this study was to develop and characterize a sodium hyaluronate microparticle-based sustained release formulation of recombinant human growth hormone (SR-rhGH) prepared by spray-drying. Compared to freeze-drying, spray-dried SR-rhGH showed not only prolonged release profiles but also better particle property and injectability. The results of size-exclusion high-performance liquid chromatography showed that no aggregate was detected, and dimer was just about 2% and also did not increase with increase of inlet temperature up to 150 °C...
February 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/26727076/reversible-albumin-binding-gh-possesses-a-potential-once-weekly-treatment-profile-in-adult-growth-hormone-deficiency
#17
RANDOMIZED CONTROLLED TRIAL
Michael Højby Rasmussen, Jurgita Janukonyté, Marianne Klose, Djordje Marina, Mette Tanvig, Lene F Nielsen, Charlotte Höybye, Marianne Andersen, Ulla Feldt-Rasmussen, Jens Sandahl Christiansen
CONTEXT: NNC0195-0092 is a reversible, albumin-binding GH derivative, developed for once-weekly administration. OBJECTIVES: The objective of the study was to evaluate safety, local tolerability, pharmacodynamics, and pharmacokinetics of multiple, once-weekly doses of NNC0195-0092, compared with daily GH. DESIGN AND SETTING: This was a phase 1, randomized, open-label, active-controlled, multiple-dose, dose-escalation trial. PATIENTS: Thirty-four GH-treated adult subjects (male, n = 25) with GH deficiency participated in the study...
March 2016: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/26574788/trends-in-growth-hormone-stimulation-testing-and-growth-hormone-dosing-in-adult-growth-hormone-deficiency-patients-results-from-the-answer-program
#18
Murray B Gordon, Richard A Levy, Robert Gut, John Germak
OBJECTIVE: Adult growth hormone deficiency (AGHD) results in physiologic impairments that may reduce quality of life and negatively impact body composition. AGHD can be treated with recombinant human growth hormone (GH). This study analyzes AGHD patients enrolled in the American Norditropin(®) STUDIES: Web-Enabled-Research (ANSWER) Program/NovoNet, a U.S. observational noninterventional study of patients treated with Norditropin(®) (somatropin [recombinant DNA origin] injection) at the discretion of their physicians...
April 2016: Endocrine Practice
https://www.readbyqxmd.com/read/26534307/potential-public-resource-savings-in-brazil-the-somatropin-case
#19
L L Lemos, M R Silva, J B Santos, Costa Jd, R M Gomes, R C Nascimento, A M Almeida, A A Guerra Júnior
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/26108298/evaluating-ae-reporting-of-two-off-patent-biologics-to-inform-future-biosimilar-naming-and-reporting-practices
#20
REVIEW
Stella Stergiopoulos, Kenneth Getz
Historical studies of voluntary, spontaneous drug reports show poor attribution of adverse events to generic versions of commonly prescribed medications. As biosimilars enter the market place, it may be similarly difficult to accurately attribute adverse events to their respective reference products. At this time, lack of global consensus with regard to biosimilar naming conventions may result in drug reporting confusion, misattribution of adverse events and insufficient active monitoring of safety signals...
August 2015: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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