PubMed Journals Articles About "Safety Efficacy Micronized Formulation ALIAmide Palmitoylglucosamine Preclinical Models" RSS

15:02 EDT 3rd April 2020 | BioPortfolio

Safety Efficacy Micronized Formulation ALIAmide Palmitoylglucosamine Preclinical Models PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Safety Efficacy Micronized Formulation ALIAmide Palmitoylglucosamine Preclinical Models articles that have been published worldwide.

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Showing "Safety efficacy micronized formulation ALIAmide palmitoylglucosamine preclinical models" PubMed Articles 1–25 of 21,000+

Safety and Efficacy Evaluation of Aspiration Thrombectomy with Large Bore Catheters in a Porcine Model.

Thrombectomy with aspiration catheters has shown to be effective for treatment of intracranial large vessel occlusion (LVO). We present preclinical evaluation of the safety and efficacy of React68 and React71 catheters in animal models of LVO.

A Short Review on the Safety of Bromphenol Blue for Dye-Assisted Vitreoretinal Interventions.

Bromphenol blue was approved for the intraoperative staining of the vitreous, epiretinal membranes, and internal limiting membrane of the retina several years ago. It has been marketed as a combined dye formulation of bromphenol blue (1.3 mg/mL) and brilliant blue G (0.25 mg/mL). So far, comprehensive information on preclinical and clinical safety data of bromphenol blue is lacking. A PubMed analysis of available literature was performed. Ten relevant publications on preclinical and clinical evaluations...

Comparative Pharmacokinetic Profiles of a Novel Low-dose Micronized-isotretinoin 32 mg Formulation and Lidose-isotretinoin 40 mg in Fed and Fasted Conditions: Two Open-label, Randomized, Crossover Studies in Healthy Adult Participants.

Two open-label, crossover studies compared the bioavailability of micronized-isotretinoin 32 mg and Lidose-isotretinoin 40 mg in healthy adults. In the fed bioequivalence/food-effect study, participants (n = 71) received single doses of fed-state micronized-isotretinoin 32 mg, fed-state Lidose-isotretinoin 40 mg and fasted-state micronized-isotretinoin 32 mg. In the fasting study, participants (n = 8) received single doses of fasted-state micronized-isotretinoin 32 mg and fasted-state Lidose-isotret...

Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial.

More than a third of patients with epilepsy are treatment resistant, and thus new, more effective therapies to achieve seizure freedom are needed. Cenobamate (YKP3089), an investigational antiepileptic drug, has shown broad-spectrum anticonvulsant activity in preclinical studies and seizure models. We aimed to evaluate the safety, efficacy, and tolerability of adjunctive cenobamate in patients with uncontrolled focal (partial)-onset epilepsy.

Protective effects of micronized fat against UVB-induced photoaging.

Autologous fat grafting has long been an essential technique in cosmetic and reconstructive surgery. Here, we report the advantages of a new device for preparing micronized fat, and we also investigated the therapeutic potential of micronized fat against UVB-induced photoaging.

A Randomized Trial of Erythropoietin for Neuroprotection in Preterm Infants.

High-dose erythropoietin has been shown to have a neuroprotective effect in preclinical models of neonatal brain injury, and phase 2 trials have suggested possible efficacy; however, the benefits and safety of this therapy in extremely preterm infants have not been established.

Protective Effects of Micronized Fat against Ultraviolet B-Induced Photoaging.

Autologous fat grafting has long been an essential technique in cosmetic and reconstructive surgery. Here, the authors report the advantages of a new device for preparing micronized fat, and they also investigated the therapeutic potential of micronized fat against ultraviolet B-induced photoaging.

Efficacy of combined CDK9/BET inhibition in preclinical models of MLL-rearranged acute leukemia.

Repurposing amino-bisphosphonates by liposome formulation for a new role in cancer treatment.

Amino-bisphosphonates (N-BPs) have been commercially available for over four decades and are used for the treatment of osteoporosis, Paget's disease, hypercalcemia of malignancy, and bone metastases derived from various cancer types. Zoledronate and alendronate, two of the most potent N-BPs, have demonstrated direct tumoricidal activity on tumor cells and immune modulatory effects on myeloid cells and T cells in vitro and in animal models of cancer. However, the rapid renal clearance and sequestration in mi...

Rational design to biologics development: the polysorbates point of view.

Formulation development is an essential part of any biopharmaceuticals development programme, and this will affect quality, safety and efficacy of the final drug product. The vast majority of biopharmaceuticals on the market are therapeutic proteins; however, these are less stable compared to conventional pharmaceuticals. To counter aggregation, denaturation and surface adsorption of proteins in solution, surfactants are added to the formulations; however, the choice of the best formulation is a challenge t...

Optimization of LpxC inhibitor lead compounds focusing on efficacy and formulation for high dose intravenous administration.

LpxC inhibitors were optimized starting from lead compounds with limited efficacy and solubility, and with the goal to provide new options for the treatment of serious infections caused by Gram-negative pathogens in hospital settings. In order to enable the development of an aqueous formulation for intravenous administration of the drug at high dose, improvements in both solubility and antibacterial activity in vivo were prioritized early on. This lead optimization program resulted in the discovery of compo...

Binary and ternary solid dispersions of an anticancer preclinical lead, IIIM-290: In vitro and in vivo studies.

The objective of this study was to formulate an anticancer preclinical lead, IIIM-290, loaded in solid dispersions to enhance its solubility, dissolution, and oral pharmacokinetics. IIIM-290 is an in-house preclinical anticancer lead prepared by semisynthetic modification of the natural product rohitukine. It is an orally bioavailable Cdk inhibitor showing efficacy in xenograft models of pancreatic, colon and leukemia cancer. It demonstrated in vivo efficacy at a relatively higher dose owing to its poor aqu...

Pharmacokinetic and pharmacodynamic analysis of fulvestrant in preclinical models of breast cancer to assess the importance of its estrogen receptor-α degrader activity in antitumor efficacy.

Fulvestrant is a selective estrogen receptor downregulator (SERD) that is approved for first- or second-line use as a single agent or in combination with cyclin dependent kinase or phosphatidylinositol 3-kinase inhibitors for the treatment of metastatic breast cancer. Fulvestrant exhibits exceptionally effective antitumor activity in preclinical models of breast cancer, a success that has been attributed to its robust SERD activity despite modest receptor downregulation in patient tumors. By modeling human...

Pilot Study Comparing the Efficacy, Safety, Convertibility, and Tacrolimus Trough Levels of Twice-Daily Tacrolimus (Prograf) to Once-Daily Tacrolimus (Advagraf) Among Standard-Risk Kidney Transplant Patients at the National Kidney and Transplant Institute.

Recently, a once-daily formulation of tacrolimus (Advagraf) was released in the Philippines. Studies have shown that these 2 formulations are bioequivalent at a 1:1 conversion. This study aims to determine the efficacy, safety, convertibility, and tacrolimus trough level of once-daily tacrolimus at the end of 6 months post transplant.

Validated animal models for antiseizure drug (ASD) discovery: Advantages and potential pitfalls in ASD screening.

Since 1993, over 20 new anti-seizure drugs (ASDs) have been identified in well-established animal seizure and epilepsy models and subsequently demonstrated to be clinically effective in double-blinded, placebo-controlled clinical trials in patients with focal onset seizures. All clinically-available ASDs on the market today are effective in at least one of only three preclinical seizure and epilepsy models: the acute maximal electroshock (MES), the acute subcutaneous pentylenetetrazol (scPTZ) test, or the k...

Workshop report: Optimization of animal models to better predict influenza vaccine efficacy.

Animal models that can recapitulate the human immune system are essential for the preclinical development of safe and efficacious vaccines. Development and optimization of representative animal models are key components of the NIAID strategic plan for the development of a universal influenza vaccine. To gain insight into the current landscape of animal model usage in influenza vaccine development, NIAID convened a workshop in Rockville, Maryland that brought together experts from academia, industry and gove...

The Impact of Cannabinoid Receptor 2 Deficiency on Neutrophil Recruitment and Inflammation.

Neutrophil trafficking into damaged or infected tissues is essential for the initiation of inflammation, clearance of pathogens and damaged cells, and ultimately tissue repair. Neutrophil recruitment is highly dependent on the stepwise induction of adhesion molecules and promigratory chemokines and cytokines. A number of studies in animal models have shown the efficacy of cannabinoid receptor 2 (CB) agonists in limiting inflammation in a range of preclinical models of inflammation, including colitis, athero...

Making Emergency Use of Experimental Vaccines Safer.

Ethical and logistical challenges of deploying experimental vaccines in humanitarian emergencies are exacerbated by a paucity of safety and efficacy data. For outbreaks caused by pathogens with high mortality rates and few treatments, such as Ebola virus disease, not offering access to experimental vaccines with some evidence of efficacy can also be ethically suspect. This article recommends (1) gathering more preclinical data about experimental vaccines' safety and (2) improving research infrastructure to ...

Multiscale modelling of drug mechanism and safety.

Here, we introduce models at three levels (molecular level, cellular and omics level, and organ and system level) that study drug mechanism and safety in preclinical drug discovery. The models differ in both their scope of study and technical details, but are all rooted in mathematical descriptions of complex biological systems, and all require informatics tools that handle large-volume, heterogeneous, and noisy data. We present principles and recent developments with examples at each level, and highlight t...

A Dose-Ranging Study of Epinephrine Hydrofluroalkane Metered-Dose Inhaler (Primatene MIST) in Subjects with Intermittent or Mild-to-Moderate Persistent Asthma.

Two sequential single-dose crossover dose-ranging studies were performed to evaluate the clinical efficacy and safety profile of epinephrine hydrofluroalkane (HFA) metered-dose inhaler (MDI) formulation at various doses in subjects with asthma. In these multicenter, multiarm, double-blinded, or evaluator-blinded studies, subjects were randomized to receive the epinephrine HFA (Primatene MIST HFA) MDI medication at doses ranging from 90 to 440 μg/dose, as well as to a placebo (PLA) control and an active ...

Safety and efficacy of percutaneous microwave ablation for post-procedural hemostasis: a bi-central retrospective study focusing on safety and efficacy.

To review safety and efficacy of percutaneous microwave ablation (MWA) for post-procedural haemostasis.

Mechanism of lipid metabolism regulation by soluble dietary fibre from micronized and non-micronized powders of lotus root nodes as revealed by their adsorption and activity inhibition of pancreatic lipase.

Soluble dietary fibre (SDF) of micronized and non-micronized powders of lotus root nodes were investigated based on its adsorption and activity inhibition of pancreatic lipase (PL) by using circular dichroism, fluorescence spectroscopy and modification. Results showed that SDF2 (SDF from micronized powders of lotus root nodes) had stronger PL adsorption and enzyme activity inhibition than SDF1 (SDF from non-micronized powders of lotus root nodes). Specifically, SDF2 showed more binding sites than SDF1 in PL...

The NIH microphysiological systems program: developing in vitro tools for safety and efficacy in drug development.

Approximately 30% of drugs have failed in human clinical trials due to adverse reactions despite promising pre-clinical studies, and another 60% fail due to lack of efficacy. One of the major causes in the high attrition rate is the poor predictive value of current preclinical models used in drug development despite promising pre-clinical studies in 2-D cell culture and animal models. Microphysiological Systems or Tissue Chips are bioengineered microfluidic cell culture systems seeded with primary or stem c...

Improved efficacy, tolerance, safety and abuse liability profile of the combination CR4056-morphine over morphine alone in rodent models.

Prolonged use of opioids causes analgesic tolerance and adverse effects including constipation and dependence. Evidence exists that molecules targeting imidazoline-2 receptors (I2Rs) potentiate opioid analgesia in rodents. We investigated whether combination with the I2R ligand CR4056 could improve efficacy and safety of morphine, and explored the mechanisms of CR4056-opioid interaction.

Humanized mice are precious tools for evaluation of hematopoietic gene therapies and preclinical modeling to move towards a clinical trial.

Over the last decade, incrementally improved xenograft mouse models, which support the engraftment and development of a human hemato-lymphoid system, have been developed and represent an important fundamental and preclinical research tool. Immunodeficientmicecan be transplanted with human hematopoietic stem cells (HSCs) and this process is accompanied by HSC homing to the murine bone marrow. This is followed by stem cell expansion, multilineage hematopoiesis, long-term engraftment, and functional human anti...

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