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Open-label Phase I pharmacokinetic (PK) study of Vasostrict® (vasopressin injection, USP) in healthy volunteers.
Healthy Volunteer Safety Study
Vasostrict Injectable Product
Endo Clinical Trial Site #1
Published on BioPortfolio: 2019-09-23T04:51:43-0400
The purpose of this study is to compare the effectiveness of three commercially available botulinum toxin neuromodulators in the treatment of facial synkinesis using patient reported outco...
Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable Suspensi...
A Double-Blind, Randomized, Single-Dose, Parallel-Group Study in Healthy Volunteers to Assess the Bioequivalence of a 120 mg Denosumab Subcutaneous Dose When Administered as Denosumab CP4 Drug Product or as Commercially Available Denosumab CP2 Drug Produc
Approximately 140 male and female healthy subjects will be randomized (1:1 ratio) to receive a 120 mg single dose of denosumab either as a 1.7 mL single injection of 70 mg/mL denosumab CP4...
Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed and approved for the treatment of type 2 diabetes mellitus. Currently, lyophilized albiglutide a...
The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine pa...
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...
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...
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 limi...
Governments intend to meet resource constraints in professional palliative care by stimulating informal care, including volunteerism. However, little is known about current volunteer-professional coll...
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 ye...
The removal of a consumer product from the market place. The reason for the removal can be due a variety of causes, including the discovery of a manufacturing defect, a safety issue with the product's use, or marketing decisions.
Work that is the report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques based on a small number of healthy persons and conducted over the period of about a year in either the United States or a foreign country.
Work that is a report of a planned post-marketing study of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale after clinical trials, phases I, II, and III. These studies, conducted in the United States or a foreign country, often garner additional data about the safety and efficacy of a product.
Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.
The sum total of measures taken and regulatory policies enacted to ensure the safe use of consumer products.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
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