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Regulatory Documents for IND to Support FIH
This chapter is used as a reference for provided various resources as it comes to regulatory authorities. This includes the counties, codes of US... -
Behavioral and Metabolic Effects of ABCG4 KO in the APPswe,Ind (J9) Mouse Model of Alzheimer’s Disease
The pathogenesis of Alzheimer’s disease (AD) is complex and involves an imbalance between production and clearance of amyloid-ß peptides (Aß),...
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Efficacy and immunogenicity of MultiTEP-based DNA vaccines targeting human α-synuclein: prelude for IND enabling studies
Accumulation of misfolded proteins such as amyloid-β (Aβ), tau, and α-synuclein (α-Syn) in the brain leads to synaptic dysfunction, neuronal damage,...
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Integrated genomic and transcriptomic analysis reveals the activation of PI3K signaling pathway in HPV-independent cervical cancers
BackgroundHPV-independent cervical cancers (HPV-ind CCs) are uncommon with worse prognosis and poorly understood. This study investigated the...
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Co-delivery of indomethacin and uricase as a new strategy for inflammatory diseases associated with high uric acid
Uric acid is the final metabolite in humans. High level of uric acid chronically induces urate deposition, aggravates kidney damage, and...
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A dual role of lysophosphatidic acid type 2 receptor (LPAR2) in nonsteroidal anti-inflammatory drug-induced mouse enteropathy
Lysophosphatidic acid (LPA) is a bioactive phospholipid mediator that has been found to ameliorate nonsteroidal anti-inflammatory drug...
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Indomethacin Combined with Ciprofloxacin Improves the Prognosis of Mice under Severe Traumatic Infection via the PI3K/Akt Pathway in Macrophages
The prevention and treatment strategies for traumatic infection often focus on the use of antibiotics, while eschew the combined treatment of the...
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Inhaled Indomethacin-Loaded Liposomes as Potential Therapeutics against Non-Small Cell Lung Cancer (NSCLC)
Most lung cancer instances are non-small cell lung cancers (NSCLC). As stated by recent literature, cycloxygenase-2 (COX-2) is upregulated in lung...
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Increased hip flexion gait as an exercise modality for individuals with obesity
PurposeExercise is a critical element for the management of body weight and improvement of quality of life of individuals with obesity. Due to its...
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The effect of acute heat exposure on the determination of exercise thresholds from ramp and step incremental exercise
PurposeThe aim of this study was to examine how respiratory (RT) and lactate thresholds (LT) are affected by acute heat exposure in the two most...
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Population Pharmacokinetic Analysis of Indacaterol/Glycopyrronium/Mometasone Furoate After Administration of Combination Therapies Using the Breezhaler® Device in Patients with Asthma
Background and ObjectiveClinical evidence suggests no clinically relevant pharmacokinetic interactions between indacaterol (IND), glycopyrronium...
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Scientific and Regulatory Considerations for Development and Commercialization of Poorly Water-Soluble Drugs
This chapter focuses on the Chemistry, Manufacturing, and Controls (CMC) from the scientific and regulatory perspective of the development of poorly... -
Host-parasite interactions: a study on the pathogenicity of different Mesanophrys sp. densities and hemocytes-mediated parasitic resistance of swimming crabs (Portunus trituberculatus)
Mesanophrys sp. is a parasitic ciliate that invades and destroys the hemocytes of the swimming crab ( Portunus trituberculatus ). In the present study,...
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Recombination drives the emergence of orf virus diversity: evidence from the first complete genome sequence of an Indian orf virus isolate and comparative genomic analysis
Contagious pustular dermatitis is a disease that primarily infects small ruminants and possesses zoonotic potential. It is caused by orf virus...
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N-Methyl-D-aspartate (NMDA) and cannabinoid CB2 receptors form functional complexes in cells of the central nervous system: insights into the therapeutic potential of neuronal and microglial NMDA receptors
BackgroundThe cannabinoid CB 2 receptor (CB 2 R), which is a target to afford neuroprotection, and N-methyl-D-aspartate (NMDA) ionotropic glutamate...
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The Effect of Adding PVP to the Binary Solid Dispersion (Indomethacin: Kaolin) on the Formation of Physically Stable Amorphous Drug
PurposeIn this work, we investigate the effect of adding polyvinylpyrrolidone (PVP K30) to the binary solid dispersion (indomethacin/kaolin) on the...
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GMP-grade human neural progenitors delivered subretinally protect vision in rat model of retinal degeneration and survive in minipigs
BackgroundStem cell products are increasingly entering early stage clinical trials for treating retinal degeneration. The field is learning from...
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Effects of indacaterol on the LPS-evoked changes in fluid secretion rate and pH in swine tracheal membrane
An acquired dysregulation of airway secretion is likely involved in the pathophysiology of chronic bronchitis and chronic obstructive pulmonary...