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This is an open-label, Phase 2 study composed of two study phases, Phase A consists of a randomized, two period, cross over study design with single SC dose injections; Phase B consists of a randomized, single period, parallel-group study with a single SC injection.
To obtain user acceptance data (usability) and verify the time to complete the injection (injection time) of a pen type of delivery device
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Adalimumab in the Physiolis syringe drug delivery device and in the currently FDA approved syringe drug delivery device, Adalimumab in the Physiolis autoinjector drug delivery device and in the currently FDA approved autoinjector drug delivery device.
Published on BioPortfolio: 2014-08-27T03:12:10-0400
The study design is a randomized study to directly compare the performance and the outcome of syringe and needle procedures with a standard syringe or the new reciprocating procedure devi...
The main goal of this study is to determine optimal cut-off values of adalimumab trough levels corresponding to good clinical response. Determination of these values is necessary to compos...
Microdermics Inc. is a British Columbia-based Canadian incorporation primarily focusing on microneedle-based painless and effective drug delivery systems.The Microneedle Adapter (model UAR...
The purpose of this study is to evaluate the safety and tolerability of a single iontophoretic dose of buffered solution administered through the EyeGate® II Drug Delivery System in healt...
The primary objective of this study is to compare patient preference of the h-Patch as delivery device for insulin lispro compared with either an insulin pen or needle and syringe in patie...
Delivery of inhalational dry powders (DPs) to the lung of mice is pivotal for pre-clinical pharmacokinetic and pharmacodynamic investigations. Although several devices have been reported, their applic...
Similar Pharmacokinetics of the Adalimumab (Humira) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE-AI and VOLTAIRE-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials.
BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira. We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity ...
Restricted needle and syringe program (NSP) operating hours in Australia have been reported as a barrier to access for people who inject drugs (PWID). We explored the prevalence of drug use occurring ...
A significant proportion of patients with Crohn's disease (CD) require dose escalation or fail adalimumab (ADL) therapy over time. ADL, a monoclonal antibody directed against tumor necrosis factor, is...
[18F]-radiopharmaceuticals registered as ready-to-use drugs are prepared in multi-dose flasks. When the change of packaging must be made extemporaneously for the preparation of patient unit doses in a...
Forms to which substances are incorporated to improve the delivery and the effectiveness of drugs. Drug carriers are used in drug-delivery systems such as the controlled-release technology to prolong in vivo drug actions, decrease drug metabolism, and reduce drug toxicity. Carriers are also used in designs to increase the effectiveness of drug delivery to the target sites of pharmacological actions. Liposomes, albumin microspheres, soluble synthetic polymers, DNA complexes, protein-drug conjugates, and carrier erythrocytes among others have been employed as biodegradable drug carriers.
Systems for the delivery of drugs to target sites of pharmacological actions. Technologies employed include those concerning drug preparation, route of administration, site targeting, metabolism, and toxicity.
The practice of prescribing or using a drug outside the scope of the drug's official approved label as designated by a regulatory agency concerning the treatment of a particular disease or condition.
Artificial, single or multilaminar vesicles (made from lecithins or other lipids) that are used for the delivery of a variety of biological molecules or molecular complexes to cells, for example, drug delivery and gene transfer. They are also used to study membranes and membrane proteins.
A standardized nomenclature for clinical drugs and drug delivery devices. It links its names to many of the drug vocabularies commonly used in pharmacy management.
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...
Arthritis is by definition the inflammation of one or more joints, characterized by swelling, pain, warmth, redness and diminished range of joint movement (Oxford Medical Dictionary). There are many different types; Noninflammatory; Osteoarthritis, N...