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Investigation of the Anti-asthmatic Activity of Solidagenone, In Vitro Toxicity Versus In Silico Studies
Solidagenone, a labdane diterpene isolated from inflorescences of Solidago chilensis Meyen, Asteraceae, was investigated for its anti-inflammatory...
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Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies
The U.S. Food and Drug Administration and European Commission have developed successful orphan drug legislation to promote the research, development,...
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Physical Chemistry
Many pharmaceutical dosage forms are liquids or semi-liquids such as solutions, colloidal systems, suspensions and emulsions. This chapter deals with...
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Translational Biomarkers: Application in the Clinical Development of Combination Therapies
Development of appropriate pharmacodynamic and safety markers early in drug development can result in a higher probability of success for new drug...
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Gallic and Vanillic Acids as Promising Succinate Dehydrogenase Inhibitors and Antigenotoxic Agents
The influence of gallic and vanillic acids in the activity of succinate dehydrogenase employing in silico and in vitro analyses was evaluated....
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Concepts and Strategies in the Design of Formulations for Freeze Drying
In order to enhance the storage stability of water labile molecules the common practice is to employ lyophilization (freeze drying) process to create...
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Molecular Dynamics Simulation Study of N-14 Side Chain Substituted Styelsamines Binding to DNA
N-14 side chain substituted marine styelsamines are synthesized ligands that have been evaluated for DNA binding and antitumor activity. Experimental...
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Design and Discovery of 3,6-Substituted 1,2,4,5-Tetraoxanes as New Class of Falcipain-2 Inhibitors for Antimalarial Action
A new series of tetraoxanes were developed and screened for in vitro antimalarial activity against chloroquine sensitive strains of Plasmodium...
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Assessing Real-World Data Quality: The Application of Patient Registry Quality Criteria to Real-World Data and Real-World Evidence
The use of real-world data and real-world evidence to inform health care decisions is increasing. Yet, the variable quality of these data and the...
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Antitumor effects of berberine against EGFR, ERK1/2, P38 and AKT in MDA-MB231 and MCF-7 breast cancer cells using molecular modelling and in vitro study
BackgroundBerberine is an alkaloid plant-based DNA intercalator that affects gene regulation, particularly expression of oncogenic and tumor...
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Natural products assessed in animal models for orofacial pain — a systematic review
Orofacial pain is related to tissues of the head, face, neck and all the intraoral structures; it is rather debilitating to the patient and also...
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Chronic antidepressant-like effect of EMD386088, a partial 5-HT6 receptor agonist, in olfactory bulbectomy model may be connected with BDNF and/or CREB signalling pathway
BackgroundThe removal of the olfactory bulbs has been attributed to behavioral changes and neuroplasticity manifesting themselves among others like...
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New Thomimarine E from Marine Isolate of the Fungus Penicillium thomii
The new eudesmane-type sesquiterpene thomimarine E ( 1 ) and the known compounds guaiadiol A ( 2 ) and 4,10,11-trihydroxyguaiane ( 3 ) were isolated from...
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Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project
BackgroundWhile patient groups, regulators, and sponsors are increasingly considering engaging with patients in the design and conduct of clinical...
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Assessment of 5-substituted Isatin as Surface Recognition Group: Design, Synthesis, and Antiproliferative Evaluation of Hydroxamates as Novel Histone Deacetylase Inhibitors
Histone deacetylase (HDAC) is a promising target for cancer treatment. HDAC inhibitors consist of three pharmacophoric features: an aromatic cap...
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Public- and Private-Sector Contributions to the Research and Development of the Most Transformational Drugs in the Past 25 Years: From Theory to Therapy
BackgroundWith available funding from the public sector decreasing while medical needs and scientific complexity increase, private-sector...
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Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28–29, 2014
The First Annual Neonatal Scientific Workshop focused on the needs of the neonate by addressing the basic question: what information is required to...
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Potential role of spinal TRPA1 channels in antinociceptive tolerance to spinally administered morphine
BackgroundProlonged morphine treatment leads to antinociceptive tolerance. Suppression of spinal astrocytes or d -amino acid oxidase (DAAO), an...
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Molecular Dynamics Simulation Approach to Understand Lamivudine Resistance in Hepatitis B Virus Polymerase
Hepatitis B virus (HBV) is a global threat that killed many human lives. HBV DNA polymerase (HDP) is the key target for antiviral drug treatment. The...
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A Model Data Management Plan Standard Operating Procedure: Results From the DIA Clinical Data Management Community, Committee on Clinical Data Management Plan
BackgroundThe DIA Clinical Data Management Community created a committee to develop a model standard operating procedure (SOP) for writing a data...