PubMed Journals Articles About "Vasostrict Injectable Product Healthy Volunteer Safety Study" RSS

22:41 EDT 5th April 2020 | BioPortfolio

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Showing "Vasostrict Injectable Product Healthy Volunteer Safety Study" PubMed Articles 1–25 of 67,000+

The compositions of injectable poly-D,L-lactic acid and injectable poly-L-lactic acid.

Injectable poly-L-lactic acid (PLLA) was first available in Europe in 1999. It was approved by US FDA for facial filling of lipotrophic HIV patients in 2004 (Sculptra; Dermik Laboratories, Bridgewater, NJ), and then the use of injectable PLLA was further expanded to facial cosmetic applications in 2009. Injectable poly-D,L-lactic acid (PDLLA) is a new sub-dermal filler (AestheFill; REGEN Biotech, Inc., Seoul, South Korea). It was first approved by Korean FDA in 2014. The clinical trials of injectable PDLLA ...

Bioavailability and safety of diazepam intranasal solution compared to oral and rectal diazepam in healthy volunteers.

The study assesses the bioavailability of diazepam after intranasal administration (diazepam nasal spray) in healthy volunteers. Comparative agents were diazepam rectal gel, which served as the regulatory reference product; and oral diazepam, a product with decades of clinical use. Tolerability of diazepam nasal spray was also assessed.

'Becoming-with' a repeat healthy volunteer: Managing and negotiating trust among repeat healthy volunteers in commercial clinical drug trials.

Recent sociological research has raised important sociological and ethical questions about the role of financial rewards in terms of healthy volunteer involvement in clinical trials. Research suggests that it would be parochial to assume financial rewards alone are sufficient to explain repeat healthy volunteering. This paper explores other factors that might explain repeat healthy volunteering behaviours in phase I clinical drug trials. Drawing on qualitative research with healthy volunteers, the paper arg...

Visible Particulate Contamination Control for Injectable Products: A Lifecycle Approach.

Visible particulate matter contamination is responsible for the rejection or recall of numerous batches of injectable product each year. The result is wasted time, effort, money, product, and the limited availability of medically necessary drug and biologic products. Recently published compendial standards have alleviated some of the confusion surrounding suitable test methods and acceptance criteria for visible particulates, however the complexities of visual inspection methods across a wide range of injec...

Complications and Litigation Associated With Injectable Facial Fillers: A Cross-Sectional Study.

Soft-tissue injectable fillers are a popular treatment option for patients seeking minimally invasive facial rejuvenation. The use of soft-tissue fillers has increased significantly in the past 10 years. In 2017 alone, clinicians administered nearly 2.7 million soft-tissue fillers, up from 1.3 million in 2007. Although injectable fillers have a relatively high safety profile compared with more invasive rejuvenation procedures, serious adverse events, including intra-arterial injections, necrosis, and visua...

Quality by Design Approach for the Preparation of Fat-Soluble Vitamins Lipid Injectable Emulsion.

The fat-soluble vitamins lipid injectable emulsion, a parenteral supplement, commonly used for hospitalized patients to meet daily requirements of fat-soluble vitamins. This study attempts to reduce risk, improve the stability and safety of fat-soluble vitamins lipid injectable emulsion using a Quality by Design (QbD) approach. The quality target product profile and critical quality attributes were defined based on a comprehensive understanding of fat-soluble vitamins lipid injectable emulsions. The emulsio...

Application of a DSS colitis model in toxicologically assessing norisoboldine.

In standard nonclinical drug safety evaluation studies, limitations exist in predicting the clinical risk of a drug based only on data from healthy animals. To obtain more comprehensive toxicological information on norisoboldine (NOR), we conducted an exploratory study using C57BL/6 mice in addition to healthy mice as models of dextran sodium sulfate (DSS) colitis to evaluate the safety of NOR. The healthy mice and DSS colitis mice were exposed to 30 or 90 mg NOR/kg body weight or water for 15 days. Compa...

A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of lisdexamfetamine dimesylate in Japanese and Caucasian healthy adult subjects.

To assess safety, tolerability, and pharmacokinetics of lisdexamfetamine dimesylate in Japanese and Caucasian healthy adults.

Understanding the Role of Comparative Clinical Studies in the Development of Oncology Biosimilars.

Biosimilars have the potential to broaden patient access to biologics and provide cost savings for health care systems. During the development of a biosimilar, data that directly compare the proposed biosimilar with the reference product are required. Such comparative data are generated in a stepwise hierarchical process that begins with extensive laboratory-based structural analyses and functional assays. This initial analytical phase serves as the foundation for the demonstration of biosimilarity and is f...

Evaluation of pharmacokinetics and safety with bioequivalence of Amlodipine in healthy Chinese volunteers: Bioequivalence Study Findings.

Amlodipine, a main series of L-type calcium channel blockers (CCBs), exerts potent antihypertensive effects. The aim of this trial was to explore the pharmacokinetics (PK) and safety with bioequivalence of orally administered Amlodipine provided by two sponsors in healthy volunteers (HVs).

Evaluation of an Innovative, Hospital-Based Volunteer Doula Program.

To evaluate program growth, doula characteristics, patient satisfaction, and characteristics and perceptions of labor and delivery nurses who work with volunteer doulas in a hospital-based volunteer doula program.

Why mentor? A validation study of the volunteer functions inventory for use in youth mentoring.

This study explores the functional motivations of volunteers in youth mentoring programs and tests the validity of the Volunteer Functions Inventory (VFI) for this population. Participants included 473 volunteer mentors matched within a one-to-one mentoring program. The study utilizes a mixed-methods approach to validate the VFI, which was administered before the match. Exploratory and confirmatory factor analyses were employed to test for content validity and determine fit. These were complemented by an e...

The gut microbiome in epilepsy.

The close relationship between epilepsy and autoimmune diseases and the fact that the cause of epilepsy is idiopathic in 60% of cases suggest that intestinal microbiota may play a role in the etiology of epilepsy. In this study, we analyzed and compared the intestinal microbiota composition of patients with idiopathic focal epilepsy (n = 30) and healthy volunteer group (n = 10) by 16s ribosomal DNA sequencing. Proteobacteria phylum was found to be higher in patients with epilepsy (25.4%) than in hea...

International volunteer activities of US dentists: results of a survey.

Although several recent studies have gauged the participation of US dental schools and dental students in international volunteer programs, no study of US dentists' international dental volunteer activities has been published to date. The goal of this study was to quantify that participation and explore dentists' motivation for service. A web-based survey was developed, and, in August 2018, a hyperlink to a web-based survey consisting of 12 questions was sent to 19,679 US dentists whose names and contact in...

Phase 1 study of crisaborole in Japanese healthy volunteers and patients with atopic dermatitis.

Crisaborole ointment, 2%, is a non-steroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis (AD). This parallel-cohort, phase 1 study was conducted to investigate skin irritation potential and safety of crisaborole in healthy Japanese adults (cohort 1) and the safety and pharmacokinetic profile of crisaborole and metabolites AN7602 and AN8323 in Japanese adults with mild to moderate AD (cohort 2). In cohort 1, 20 healthy volunteers received single applications of crisa...

Toward the Definition of Efficacy and Safety Criteria for Advancing Gene Drive-Modified Mosquitoes to Field Testing.

Mosquitoes containing gene drive systems are being developed as complementary tools to prevent transmission of malaria and other mosquito-borne diseases. As with any new tool, decision makers and other stakeholders will need to balance risks (safety) and benefits (efficacy) when considering the rationale for testing and deploying gene drive-modified mosquito products. Developers will benefit from standards for judging whether an investigational gene drive product meets acceptability criteria for advancing t...

Safety, tolerability, pharmacokinetics, and immunogenicity of a human monoclonal antibody targeting the G glycoprotein of henipaviruses in healthy adults: a first-in-human, randomised, controlled, phase 1 study.

The monoclonal antibody m102.4 is a potent, fully human antibody that neutralises Hendra and Nipah viruses in vitro and in vivo. We aimed to investigate the safety, tolerability, pharmacokinetics, and immunogenicity of m102.4 in healthy adults.

First-in-human, randomized dose-escalation study of the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of PF-06480605 in healthy subjects.

Human genetic, tissue expression, proteomics, transcriptomics, and nonclinical studies implicate tumor necrosis factor α-like ligand 1A (TL1A) as a novel target in inflammatory bowel disease (IBD). PF-06480605, a fully human immunoglobulin G1 monoclonal antibody, targets TL1A. This first-in-human, Phase 1, dose-escalation study assessed safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of intravenous (IV) and subcutaneous (SC) PF-06480605 in healthy subjects (NCT01989143).

Healthy mum - healthy baby? Safety of vedolizumab during periconceptual period.

Pharmacokinetic Similarity of ABP 710, a Proposed Biosimilar to Infliximab: Results From a Randomized, Single-Blind, Single-Dose, Parallel-Group Study in Healthy Subjects.

This was a randomized, single-blind, single-dose, 3-arm parallel-group study. Healthy subjects were randomized to receive ABP 710 (n = 50) or infliximab reference product (RP) sourced from the United States (infliximab US; n = 50) or the European Union (infliximab EU; n = 50) 5 mg/kg intravenously over 2 hours. The primary endpoint was area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC ) for the comparison of ABP 710 to infliximab US and infliximab EU. Secondary en...

French Red Cross Volunteer Rescue Workers: Psychological Characteristics and Healthcare Support After the January 2015 Terrorist Attacks in Paris.

Few studies have explored the psychological consequences of terrorism on volunteer rescuers. We examined the psychological characteristics of volunteer rescuers after the January 2015 terrorist attacks in France. We analyzed the results of the IMPACTS study regarding the somatic, psychological, and social characteristics of the French Red Cross volunteer rescuers who intervened during these terrorist attacks. We used a standardized questionnaire during a face-to-face interview, 6 to 9 months after the attac...

A Randomized, Single-dose, Two-sequence, Two-period, Crossover Study to assess the Bioequivalence between Two Formulations of Clonazepam Tablet in Healthy Subjects.

Clonazepam is a benzodiazepine commonly prescribed to treat panic disorder, epilepsy, anxiety, depression and certain types of seizures. This study aimed to evaluate the bioequivalence between two formulations of clonazepam tablets in order to meet regulatory requirements for marketing in Colombia and others countries in Latin America. An open-label, randomized, single-dose, two-period, two-sequence, two-treatment crossover study was conducted in 36 healthy subjects of both genders. Subjects received a sing...

Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients.

The aim of the study was to compare the pharmacokinetics, safety and tolerability of secukinumab with different devices for subcutaneous (s.c.) administration of 2 mL.

Feasibility study of a safe sled environment for reclined frontal deceleration tests with human volunteers.

The goal of the study was to assess the feasibility of a safe crash environment for volunteer tests in reclined seating positions. An iterative multimodal approach was chosen, consisting of full-body human body model (HBM) simulations, anthropomorphic test device (ATD) physical testing, and volunteer testing. To estimate a noninjurious deceleration pulse, the iterative inclination of the seat was supported through HBM simulations and physical ATD testing. One male volunteer was exposed to 5 low-speed fronta...

Safety, Pharmacokinetics and Pharmacodynamics of Branebrutinib (BMS-986195), a Covalent, Irreversible Inhibitor of Bruton's Tyrosine Kinase: Randomised Phase I, Placebo-Controlled Trial in Healthy Participants.

Branebrutinib (BMS-986195) is a potent, highly selective, oral, small-molecule, covalent inhibitor of Bruton's tyrosine kinase (BTK). This study evaluated safety, pharmacokinetics and pharmacodynamics of branebrutinib in healthy participants.

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