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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
This study has been designed as a multicentre, randomised, open label study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in Pre-Filled...
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 purpose of this report was to: (1) detail the construction of a low-cost device that provides a "reference" flow waveform for pneumotachograph (PNT) calibration: i.e., the "syringe potentiometer" ...
Hidradenitis suppurativa/acne inversa (HS) is a chronic, inflammatory, skin disease. Adalimumab is the only approved drug for the treatment of hidradenitis suppurativa (HS), but it only partially cont...
The TNF-α blocker adalimumab is a well-proven therapy for rheumatoid arthritis (RA). A biosimilar adalimumab (ZRC-3197; Exemptia™), a 'fingerprint match' to reference adalimumab, has been approve...
Due to the increase in people who use opioids in the US, there has been a steady increase in injection drug use. Without access to safe syringe disposal locations, people who inject drugs (PWID) have ...
The present research work was aimed to synthesize neem gum-based site-specific drug delivery device for anticancer drug methotrexate at different pH condition. The hydrogel-based drug delivery device ...
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...