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20 Newest Publications about the topic regulatory approval

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Ligand-Targeted Drug Delivery

12-Sep-2017 | Madduri Srinivasarao; Philip S. Low, Chemical Reviews, 2017

Safety and efficacy constitute the major criteria governing regulatory approval of any new drug. The best method to maximize safety and efficacy is to deliver a proven therapeutic agent with a targeting ligand that exhibits little affinity for healthy cells but high affinity for pathologic cells. ...

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Stability indicating assay method for acotiamide: separation, identification and characterization of its hydroxylated and hydrolytic degradation products along with a process related impurity by UHPLC‐ESI‐QTOF‐MS/MS

24-Aug-2017 | Mohit Thummar, Prinesh N. Patel, S. Gananadhamu, R. Srinivas, Rapid Communications in Mass Spectrometry, 2017

Rationale The presence of impurities and degradation products will affect the pharmacokinetic, pharmacodynamic properties and alter the safety of the drug. Hence, development of stability indicating assay method is an integral part of quality product development and is crucial for the ...

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Translation of plasma technology from the lab to the food industry

23-Aug-2017 | Patrick J. Cullen, James Lalor, Laurence Scally, Daniela Boehm, Vladimir Milosavljević, Paula Bourke, Kevin Keener, Plasma Processes and Polymers, 2017

The potential of cold plasma as a food processing aid has been demonstrated for a range of processes and products. The potential applications of plasma technology are extensive and include microbial decontamination, pest control, toxin elimination, food and package functionalisation and many ...

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A Materials Roadmap to Functional Neural Interface Design

19-Jul-2017 | Steven M. Wellman, James R. Eles, Kip A. Ludwig, John P. Seymour, Nicholas J. Michelson, William E. McFadden, Albert ..., Advanced Functional Materials, 2017

Advancements in neurotechnologies for electrophysiology, neurochemical sensing, neuromodulation, and optogenetics are revolutionizing scientific understanding of the brain while enabling treatments and preventative measures for a variety of neurological disorders. The grand challenge in neural ...

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Development, Validation, and Interlaboratory Evaluation of a Quantitative Multiplexing Method To Assess Levels of Ten Endogenous Allergens in Soybean Seed and Its Application to Field Trials Spanning Three Growing Seasons

29-Jun-2017 | Ryan C. Hill; Trent J. Oman; Xiujuan Wang; Guomin Shan; Barry Schafer; Rod A. Herman; Rowel Tobias; Jeff Shippar; Bh ..., Journal of Agricultural and Food Chemistry, 2017

As part of the regulatory approval process in Europe, comparison of endogenous soybean allergen levels between genetically engineered (GE) and non-GE plants has been requested. A quantitative multiplex analytical method using tandem mass spectrometry was developed and validated to measure 10 ...

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Effects of Drug–Antibody Ratio on Pharmacokinetics, Biodistribution, Efficacy, and Tolerability of Antibody–Maytansinoid Conjugates

13-Apr-2017 | Xiuxia Sun; Jose F. Ponte; Nicholas C. Yoder; Rassol Laleau; Jennifer Coccia; Leanne Lanieri; Qifeng Qiu; Rui Wu; Er ..., Bioconjugate Chemistry, 2017

Antibody–drug conjugates (ADCs) are being actively pursued as a treatment option for cancer following the regulatory approval of brentuximab vedotin (Adcetris) and ado-trastuzumab emtansine (Kadcyla). ADCs consist of a cytotoxic agent conjugated to a targeting antibody through a linker. The two ...

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[In Depth] Antisense rescues babies from killer disease

16-Dec-2016 | Meredith Wadman, Science , 2016

Spinal muscular atrophy, the leading inherited killer of children, has forced generations of parents to watch their kids become progressively weaker and, in severe cases, die by about their second birthdays.The recessively inherited disease inexorably destroys the motor neurons of the spinal ...

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IJMS, Vol. 17, Pages 1935: Clinical Decision-Making in the Treatment of Schizophrenia: Focus on Long-Acting Injectable Antipsychotics

19-Nov-2016 | Samalin, Ludovic ; Garnier, Marion ; Auclair, Candy ; Llorca, Pierre-Michel, International Journal of Molecular Sciences, 2016

The purpose of this study was to identify clinician characteristics associated with higher prescription rates of long-acting injectable (LAI) antipsychotics, as well as the sources that influence medical decision-making regarding the treatment of schizophrenia. We surveyed 202 psychiatrists ...

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Heat Shock Protein (HSP) Drug Discovery and Development: Targeting Heat Shock Proteins in Disease

30-Aug-2016 | Shrestha, Liza; Bolaender, Alexander; J. Patel, Hardik; Taldone, Tony, Current Topics in Medicinal Chemistry, 2016

Abstract: Heat shock proteins (HSPs) present as a double edged sword. While they play an important role in maintaining protein homeostasis in a normal cell, cancer cells have evolved to co-opt HSP function to promote their own survival. As a result, HSPs such as HSP90 have attracted a great ...

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Prodrugs Bioactivated to Quinones Target NF-κB and Multiple Protein Networks: Identification of the Quinonome

13-Jun-2016 | Emily N. Pierce; Sujeewa C. Piyankarage; Tareisha Dunlap; Vladislav Litosh; Marton I. Siklos; Yue-Ting Wang; Gregory ..., Chemical Research in Toxicology, 2016

Electrophilic reactive intermediates resulting from drug metabolism have been associated with toxicity and off-target effects and in some drug discovery programs trigger NO-GO decisions. Many botanicals and dietary supplements are replete with such reactive electrophiles, notably Michael ...

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