Abstract:
OBJECTIVE:The Aluetta™ reusable pen device and instructions for use (IFU) for growth hormone (r-hGH; Saizen®, Merck KGaA, Darmstadt, Germany) administration were tested for Human-Factors Usability, to ensure it could be used safely and effectively by the intended users in the intended use environment. RESEARCH DESIGN AND METHODS:Usability testing was conducted under simulated conditions in three groups of participants: pediatric or adult patients with growth hormone deficiency (GHD), participants without GHD, and healthcare professionals (HCPs). The testing comprised a 45-minute training session, a 2-hour testing session, and a participant-feedback session. RESULTS:Twenty-six participants completed the training session and performed all critical tasks related to the pen use across three scenarios. The most difficult tasks were related to the preparation, checking, and maintenance of the device; only 8% of use errors occurred during tasks related to the injection process. Eighty-five percent considered the pen safe and effective to use without further modifications and the training to be clear and effective. CONCLUSIONS:The pen device and associated materials benefited from Human Factors Engineering throughout the development process. These evaluations show that patients and HCPs could safely and effectively use the pen device, and the IFU and training were clear and effective.
journal_name
Expert Opin Drug Delivjournal_title
Expert opinion on drug deliveryauthors
Cachemaille A,Warren SE,Moss Sdoi
10.1080/17425247.2020.1774549subject
Has Abstractpub_date
2020-07-01 00:00:00pages
1041-1048issue
7eissn
1742-5247issn
1744-7593journal_volume
17pub_type
杂志文章abstract:INTRODUCTION:Apart from statins, anti-platelet agents and invasive procedures, the anti-atherosclerotic medical weaponry for coronary heart disease (CHD) is scarce and only partially protects CHD patients from major adverse cardiac events. AREAS COVERED:Several novel non-invasive strategies are being developed to wide...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2015.999663
更新日期:2015-07-01 00:00:00
abstract:INTRODUCTION:Dextran is a family of natural polysaccharides that is widely under investigation for use as polymeric carriers in novel drug delivery systems. The optimal drug delivery (and consequently maximum therapeutic effect) will be accomplished when carrier systems are used mainly for drugs with antitumoral activi...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2012.673580
更新日期:2012-05-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to improve the drug loading (DL) and stability of clarithromycin (CLA)-loaded liposomes, and reduce the irritation caused by intravenous administration of CLA. METHODS:A CLA-cholesteryl hemisuccinate (CHEMS) ion pair (CIP) was prepared by the solvent evaporation method and confirmed...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1517/17425247.2016.1123247
更新日期:2016-01-01 00:00:00
abstract:INTRODUCTION:Pressurized metered dose inhalers (pMDIs) are evolving to be a very effective drug delivery option in patients with airway diseases. They offer comparable lung deposition and reduced oropharyngeal deposition similar with the dry powder inhalers. As recommended by the Global Initiative for Asthma guidelines...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2015.987661
更新日期:2015-06-01 00:00:00
abstract::The treatment of genetic diseases using therapeutic gene transfer is considered to be a significant development. This development has brought with it certain limitations, and the process of overcoming these barriers has seen a drastic change in gene delivery. Many metal ions such as Mg2+, Mn2+, Ba2+ and, most importan...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1517/17425247.3.2.235
更新日期:2006-03-01 00:00:00
abstract:INTRODUCTION:In any manufacturing process, the success of producing an end product with the desired properties and yield depends on a range of factors that include the equipment, process and formulation variables. It is the interest of manufacturers and researchers to understand each manufacturing process better and as...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2014.915805
更新日期:2014-07-01 00:00:00
abstract::FlexTouch® (FT) is a new prefilled insulin pen with the unique characteristic of no extendable push button at any dose setting and consequently a low activation force. Its technical features along with health care professionals' and patients' preferences in comparison to other traditionally used devices for insulin de...
journal_title:Expert opinion on drug delivery
pub_type: 社论
doi:10.1517/17425247.2014.894505
更新日期:2014-05-01 00:00:00
abstract::Introduction: Making selective inhibitors of novel Gram-negative targets is not a substantial challenge - getting them into Gram-negative bacteria to reach their lethal target is the bottleneck. Poor permeability of the antibiotic requires high concentration causing off target activity. The lack of simple experimental...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1080/17425247.2021.1847080
更新日期:2020-11-13 00:00:00
abstract:INTRODUCTION:RNA interference (RNAi) is a powerful mechanism for gene silencing with the potential to greatly impact the development of new therapies for many human diseases. Short interfering RNAs (siRNAs) may be the ideal molecules for therapeutic RNAi. However, therapeutic siRNAs face significant challenges that mus...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2014.866089
更新日期:2014-02-01 00:00:00
abstract:INTRODUCTION:Hepatocellular carcinoma (HCC) is one of the most common lethal malignancies. The prognosis is poor despite progress in early diagnosis. The initial treatment of choice is hepatic resection; unfortunately, not all patients are eligible for liver resection. Moreover, there are significant recurrences. Diffe...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2013.770733
更新日期:2013-05-01 00:00:00
abstract::In the last decade, interest in physical organogels has grown rapidly with the discovery and synthesis of a very large number of diverse molecules, which can gel organic solvents at low concentrations. The gelator molecules immobilise large volumes of liquid following their self-assembly into a variety of aggregates s...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2.3.489
更新日期:2005-05-01 00:00:00
abstract:INTRODUCTION:Radioimmunotherapy (RIT) with monoclonal antibodies and their fragments labelled with radionuclides emitting α -particles, β-particles or Auger electrons have been used for many years in the development of anticancer strategies. While RIT has resulted in approved radiopharmaceuticals for the treatment of h...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1080/17425247.2018.1378180
更新日期:2018-02-01 00:00:00
abstract:INTRODUCTION:Neurodegenerative diseases (NDs) represent a group of different clinical entities that, despite the specific primary etiologies, share a common signature in terms of a general mitochondrial dysfunction with consequent oxidative stress accumulation. As these two events occur early during neurodegenerative p...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1080/17425247.2016.1218461
更新日期:2017-04-01 00:00:00
abstract:OBJECTIVES:This study focuses on the development of amlodipine bilayer buccal tablets of hydroxypropyl methylcellulose (HPMC) matrix system containing polyacrylate polymer (Carbopol(®))/β-cyclodextrin as the drug layer and ethylcellulose as the non-swellable backing layer, and their biointerfacial phenomena. METHODS:T...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1517/17425247.2016.1154038
更新日期:2016-01-01 00:00:00
abstract::Introduction: Current therapies of neurodegenerative or neurometabolic diseases are, to a large extent, hampered by the inability of drugs to cross the blood-brain barrier (BBB). This very tight barrier severely restricts the entrance of molecules from the blood into the brain, especially macromolecular substances (i....
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1080/17425247.2020.1698544
更新日期:2020-01-01 00:00:00
abstract:INTRODUCTION:For poorly soluble compounds, a good bioavailability is typically needed to assess the therapeutic index and the suitability of the compound for technical development. In industry, the selection of the delivery technology is not only driven by technical targets, but also by constraints, such as production ...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2011.614228
更新日期:2011-11-01 00:00:00
abstract:IMPORTANCE OF THE FIELD:Vascular delivery of several classes of therapeutic agents may benefit from carriage by red blood cells (RBC), for example, drugs that require delivery into phagocytic cells and those that must act within the vascular lumen. The fact that several protocols of infusion of RBC-encapsulated drugs a...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425241003610633
更新日期:2010-04-01 00:00:00
abstract::Introduction: Pulmonary drug delivery is a complex field of research combining physics which drive aerosol transport and deposition and biology which underpins efficacy and toxicity of inhaled drugs. A myriad of preclinical methods, ranging from in-silico to in-vitro, ex-vivo and in-vivo, can be implemented.Areas cove...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1080/17425247.2020.1730807
更新日期:2020-04-01 00:00:00
abstract::Devices for the aqueous delivery of intranasal corticosteroids to patients with allergic rhinitis have been available since 1984, so there is a need for new devices to be developed to provide ease of use, efficacy and safety. A novel drug delivery system has been developed for fluticasone furoate (FF; GlaxoSmithKline)...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.4.6.689
更新日期:2007-11-01 00:00:00
abstract:BACKGROUND:The distribution and metabolism of a drug in the organism are dependent on the administration route as well as on the drug formulation. It is important to be able to assess which impact the administration route or formulation of a drug has for its distribution and metabolism. METHODS:The antidepressant drug...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1080/17425247.2018.1541084
更新日期:2018-12-01 00:00:00
abstract:INTRODUCTION:Oral delivery of therapeutic peptide hormones offers the promise of greater patient compliance when compared to parenteral administration routes. However, it is a huge challenge in the pharmaceutical field. Due to increasing demand for oral delivery of peptide hormones such as insulin, gonadotropin-releasi...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2016.1142526
更新日期:2016-01-01 00:00:00
abstract:INTRODUCTION:Interest in mesoporous silica nanoparticles for drug delivery has resulted in a good understanding of the impact of size and surface chemistry of these nanoparticles on their performance as drug carriers. Shape has emerged as an additional factor that can have a significant effect on delivery efficacy. Rod...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1080/17425247.2018.1517748
更新日期:2018-09-01 00:00:00
abstract:INTRODUCTION:Respiratory infections and diseases are accompanied by or exhibit inflammation. Recent advances in nanoparticle engineering technology, together with the increased knowledge of inflammatory pathophysiology, have ignited interest in the pulmonary delivery of anti-inflammatory agents (AIAs) to achieve local ...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2015.993968
更新日期:2015-06-01 00:00:00
abstract:INTRODUCTION:The use of hydrophilic polymers as a substitute for the Fc-domain in immuno- or non-immuno-based binding proteins is accelerating. Chemical PEGylation has led the way and is still the most advanced and clinically-approved approach. Hydrophilic polymers act by maintaining a flexible conformation and hydroge...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2011.602399
更新日期:2011-09-01 00:00:00
abstract:BACKGROUND:The present work aims to formulate nanostructured lipid carriers (NLCs) exhibiting high skin deposition and high inherent antioxidant potential to repurpose the use of melatonin hormone and some antioxidant oils in the treatment of androgenic alopecia (AGA). RESEARCH DESIGN AND METHODS:NLCs were characteriz...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1080/17425247.2018.1517740
更新日期:2018-10-01 00:00:00
abstract:INTRODUCTION:Delivery of macromolecular drugs is an important field in medical research. However, macromolecules are usually unable to cross the cell membrane without the assistance of a delivery system. Cell penetrating peptides (CPPs) are unique tools to gain access to the cell interior and deliver a bioactive cargo ...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2016.1125879
更新日期:2016-01-01 00:00:00
abstract:IMPORTANCE OF THE FIELD:Spontaneously constructed from block copolymers in aqueous media, the polymer micelle has been extensively studied as a potential carrier of poorly water-soluble drugs, but cellular uptake pathways and stability of micelles in blood have not yet been clearly understood. An in-depth insight into ...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425240903380446
更新日期:2010-01-01 00:00:00
abstract:OBJECTIVES:The aim of the present study is to evaluate the influence of factors such as biopharmaceutical properties and study protocol on the emptying of pellets from the human stomach in a fed state. METHODS:A systematic literature search for data on human gastric emptying of pellets from a fed stomach state investi...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1517/17425247.2015.1035707
更新日期:2015-08-01 00:00:00
abstract:INTRODUCTION:Calcium channel blockers are a very important class of antihypertensive drugs. Most calcium channel blockers (CCBs) exhibiting low oral bioavailability are required to be taken more than once a day due to their short half-lives which result in poor patient compliance. There is an ineluctable requirement fo...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2013.783562
更新日期:2013-08-01 00:00:00
abstract:BACKGROUND:Photodynamic therapy (PDT) is a medical treatment in which a combination of a photosensitising drug and visible light causes destruction of selected cells. Due to the lack of true selectivity of preformed photosensitisers for neoplastic tissue and their high molecular weights, PDT of superficial skin lesions...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.5.7.757
更新日期:2008-07-01 00:00:00