Abstract：
:A "microdose clinical trial" (microdosing) is one kind of early phase exploratory clinical trial, administering the compound at doses estimated to have no pharmacological or toxicological effects, aimed at screening candidates for further clinical development. This article's objective is to clarify the ethical, legal, and social implications (ELSI) of such an exploratory minimum-risk human trial. The definition and non-clinical study requirements for microdosing have been harmonized among the European Union (EU), United States (US), and Japan. Being conducted according to these regulations, microdosing seems to be ethically well justified in terms of respect for persons, beneficence, justice, human dignity, and animal welfare. Three big projects have been demonstrating the predictability of therapeutic dose pharmacokinetics from microdosing. The article offers suggestions as how microdosing can become a more useful and socially accepted strategy.
journal_name
Adv Drug Deliv Revjournal_title
Advanced drug delivery reviewsauthors
Kurihara Cdoi
10.1016/j.addr.2011.01.002subject
Has Abstractpub_date
2011-06-19 00:00:00pages
503-10issue
7eissn
0169-409Xissn
1872-8294pii
S0169-409X(11)00006-8journal_volume
63pub_type
杂志文章,评审abstract：:Synthetic micro/nanomotors are tiny devices than can be self-propelled or externally powered in the liquid phase by different types of energy source including but not limited to: catalytic, magnetic or acoustic. Showing a myriad of mechanical movements, building block materials, sizes, shapes and propulsion mechanisms...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2015.09.004
更新日期：2015-12-01 00:00:00
abstract：:The role of metal ions in the body and particularly in the formation, regulation and maintenance of bone is only just starting to be unravelled. The role of some ions, such as zinc, is more clearly understood due to its central importance in proteins. However, a whole spectrum of other ions is known to affect bone for...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2012.05.015
更新日期：2013-04-01 00:00:00
abstract：:Silicon is one of the most abundant chemical elements found on the Earth. Due to its unique chemical and physical properties, silicon based materials and their oxides (e.g. silica) have been used in several industries such as building and construction, electronics, food industry, consumer products and biomedical engin...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2012.05.008
更新日期：2012-12-01 00:00:00
abstract：:The interaction of biological cells with artificial biomaterials is one of the most important issues in tissue engineering and regenerative medicine. The interaction is strongly governed by physical and chemical properties of the materials and displayed with differentiated cellular behaviors, including cell self-renew...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2018.06.020
更新日期：2018-07-01 00:00:00
abstract：:Infliximab (Remicade) is an antitumor necrosis factor (TNF) therapy effective in both induction and maintenance of remission in Crohn's disease. Identifying predictors of response or relapse to infliximab is important given the potential toxicities and cost of this therapy. Currently available data suggest that concur...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2004.08.006
更新日期：2005-01-06 00:00:00
abstract：:The description of irregular particle morphology and powder properties may offer unique insights into the performance of materials intended for use in dry powder inhalers. A number of mathematically similar approaches have been used to study these phenomena, all based on evaluating data in terms of irregular oscillati...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/s0169-409x(97)00508-5
更新日期：1997-06-09 00:00:00
abstract：:Solid lipid nanoparticles (SLN) were developed at the beginning of the 1990 s as an alternative carrier system to emulsions, liposomes and polymeric nanoparticles. The paper reviews advantages-also potential limitations-of SLN for the use in topical cosmetic and pharmaceutical formulations. Features discussed include ...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(02)00118-7
更新日期：2002-11-01 00:00:00
abstract：:The mammalian immune system has evolved mechanisms to recognize and respond to 'danger' signals arising from pathogens. Among those danger signals are the unmethylated CpG dinucleotide motifs found in bacteria. At least some of the recognition of these sequences is through cellular components of the innate immune syst...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(00)00090-9
更新日期：2000-11-15 00:00:00
abstract：:The development of lipid-based delivery vehicles for therapeutic molecules has become a topic of intense research. Recently, much of this effort has been directed towards mimicking the characteristics of viruses that give them an advantage for the delivery of genetic medicines. One of the most desirable properties of ...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/s0169-409x(99)00032-0
更新日期：1999-08-20 00:00:00
abstract：:This article reviews the latest progresses regarding the applications of carbon nanotubes (CNTs), including single-walled carbon nanotubes (SWNTs) and multi-walled carbon nanotubes (MWNTs), as multifunctional nano-probes for biomedical imaging. Utilizing the intrinsic band-gap fluorescence of semi-conducting single-wa...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2013.10.002
更新日期：2013-12-01 00:00:00
abstract：:Oral lipid-based drug delivery systems may include a broad range of oils, surfactants, and cosolvents. This diversity makes comparison of lipid-based formulations difficult. Although the relationship between formulation and drug absorption is understood at a conceptual level, performance in vivo cannot be predicted wi...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2007.10.010
更新日期：2008-03-17 00:00:00
abstract：:A polymer stereocomplex is defined as a stereoselective interaction between two complementing stereoregular polymers, that interlock and form a new composite, demonstrating altered physical properties in comparison to the parent polymers. The main interactions, resulting in the complexation, are suggested to rely on s...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(03)00042-5
更新日期：2003-04-25 00:00:00
abstract：:Non-communicable diseases including cancer, cardiovascular disease, diabetes, and neuropathy are chronic in nature. Treatment of these diseases with traditional delivery systems is limited due to lack of site-specificity, non-spatiotemporal release and insufficient doses. Numerous responsive delivery systems which res...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2018.02.008
更新日期：2018-04-01 00:00:00
abstract：:Small G proteins or GTPases comprise a growing family of signal transduction molecules with inducible properties dependent upon reversible interactions with guanine nucleotides. Activation status of the proteins is characterized by preferential affinity for triphosphorylated guanine nucleotides, initiating signaling e...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(00)00050-8
更新日期：2000-06-30 00:00:00
abstract：:Inflammation, a common feature of many diseases, is an essential immune response that enables survival and maintains tissue homeostasis. However, in some conditions, the inflammatory process becomes detrimental, contributing to the pathogenesis of a disease. Targeting inflammation by using nanomedicines (i.e. nanopart...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2020.07.010
更新日期：2020-01-01 00:00:00
abstract：:In spite of significant exposure to drugs and chemicals through breast milk, there are very few reports of documented adverse effects on the infant. It is perhaps appropriate to consider that the presence of drugs and chemicals in milk may have a positive effect on developmental processes of the young infant. New expe...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(03)00029-2
更新日期：2003-04-29 00:00:00
abstract：:Despite the wide use of antibiotics, bacterial infection is still one of the leading causes of hospitalization and mortality. The clinical failure of antibiotic therapy is linked with low bioavailability, poor penetration to bacterial infection sites, and the side effects of antibiotics, as well as the antibiotic resi...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2014.02.002
更新日期：2014-11-30 00:00:00
abstract：:The extracellular matrix represents a complex alloy of variable members of diverse protein families defining structural integrity and various physiological functions. The most abundant family is the collagens with more than 20 different collagen types identified so far. Collagens are centrally involved in the formatio...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2003.08.002
更新日期：2003-11-28 00:00:00
abstract：:Clinical trials are crucial to determining the human safety and efficacy of new therapeutic innovations. Extraordinary amounts of human experiential data are generated over the course of any clinical trial, however, much of these data is never made publicly accessible. Improved, reliable data sharing is essential to i...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2018.01.017
更新日期：2018-01-01 00:00:00
abstract：:Two-photon excitation imaging is the least invasive optical approach to study living tissues. We have established two-photon extracellular polar-tracer (TEP) imaging with which it is possible to visualize and quantify all exocytic events in the plane of focus within secretory tissues. This technology also enables esti...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/j.addr.2006.07.008
更新日期：2006-09-15 00:00:00
abstract：:When an artificial biomaterial (e.g., a stent or implantable pump) is exposed to blood, plasma proteins immediately adhere to the surface, creating a new interface between the biomaterial and the blood. The recognition proteins within the complement and contact activation/coagulation cascade systems of the blood will ...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2011.06.012
更新日期：2011-09-16 00:00:00
abstract：:Nuclear import of macromolecules or particles is a strictly regulated phenomenon that is now understood in some depth at the molecular level. Transport across nuclear membranes is controlled by nuclear pores, with the involvement of cytoplasmic receptors and accessory molecules. Each nuclear pore complex is an assembl...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/s0169-409x(98)00050-7
更新日期：1998-10-05 00:00:00
abstract：:The novel corona virus termed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread throughout the globe at a formidable speed, causing tens of millions of cases and more than one million deaths in less than a year of its report in December 2019. Since then, companies and research institutions have r...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2020.12.008
更新日期：2021-02-01 00:00:00
abstract：:Clinical development of orally active peptide drugs has been restricted by their unfavorable physicochemical properties, which limit their intestinal mucosal permeation and their lack of stability against enzymatic degradation. Successful oral delivery of peptides will depend, therefore, on strategies designed to alte...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/s0169-409x(97)00045-8
更新日期：1997-09-15 00:00:00
abstract：:miRNA-based technologies provide attractive tools for several liver tissue engineering approaches. Herein, we review the current state of miRNA applications in liver tissue engineering. Several miRNAs have been implicated in hepatic disease and proper hepatocyte function. However, the clinical translation of these fin...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2015.06.005
更新日期：2015-07-01 00:00:00
abstract：:Mid-IR and Raman spectroscopy are versatile tools in pharmaceutics and biopharmaceutics, with a wide field of applications ranging from characterization of drug formulations to elucidation of kinetic processes in drug delivery. After an introduction to the basic principles of IR and Raman spectroscopy, new development...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2005.01.022
更新日期：2005-06-15 00:00:00
abstract：:Spray drying is a well-established manufacturing technique which can be used to formulate amorphous solid dispersions (ASDs) which is an effective strategy to deliver poorly water soluble drugs (PWSDs). However, the inherently complex nature of the spray drying process coupled with specific characteristics of ASDs mak...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2015.12.010
更新日期：2016-05-01 00:00:00
abstract：:In the preparation of biomimetic materials it is often required that efficient methods of polymerization be used, often methods that can lead to biomimetic polymers with relatively narrow molecular weight distribution. Living radical polymerization techniques have successfully been used to create low polydispersity li...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2003.10.046
更新日期：2004-09-22 00:00:00
abstract：:Amorphisation of poorly water-soluble drugs is one approach that can be applied to improve their solubility and thus their bioavailability. Amorphisation is a process that usually requires deliberate external energy input. However, amorphisation can happen both unintentionally, as in process-induced amorphisation duri...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2015.12.014
更新日期：2016-05-01 00:00:00
abstract：:Calcium phosphate cements are used as synthetic bone grafts, with several advantages, such as their osteoconductivity and injectability. Moreover, their low-temperature setting reaction and intrinsic porosity allow for the incorporation of drugs and active principles in the material. It is the aim of the present work ...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2012.01.008
更新日期：2012-09-01 00:00:00
