Journal•ISSN: 1060-1333
Clinical Research and Regulatory Affairs
Marcel Dekker
About: Clinical Research and Regulatory Affairs is an academic journal. The journal publishes majorly in the area(s): Health care & Bioequivalence. It has an ISSN identifier of 1060-1333. Over the lifetime, 388 publications have been published receiving 2749 citations.
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TL;DR: As described in the previous chapter, natural folate compounds exist in tissues as polyglutamates, which serve to keep the folates within the cell since only the monoglutamate forms are transported.
Abstract: As described in the previous chapter, natural folate compounds exist in tissues as polyglutamates. These serve to keep the folates within the cell since only the monoglutamate forms are transported...
290 citations
TL;DR: This chapter presents an overview of current knowledge of the mechanisms by which folate is handled in the body and how tissue folate levels and homeostasis are regulated.
Abstract: The vitamin folic acid was initially investigated as a dietary antianemia factor distinct from the pernicious anemia factor [1] and a recent historical review details early studies on the isolation...
234 citations
Spaulding Rehabilitation Hospital1, University of Göttingen2, University of New South Wales3, University of São Paulo4, Marche Polytechnic University5, University of Minho6, University of Milan7, Universidade Federal do Rio Grande do Sul8, Seoul National University9, Tehran University of Medical Sciences10, University of Oregon11, Virginia Tech12, University of Lyon13, City University of New York14, National Central University15, National Institute of Mental Health and Neurosciences16, Mackenzie Presbyterian University17
TL;DR: It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials.
Abstract: The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials.
218 citations
TL;DR: A two-level, mathematically derived multiples of four screening design popularly known as Plackett-Burman screening design is thoroughly reviewed and its potential in screening unbiased estimates of all main effects in the smallest design is explored.
Abstract: Application of statistics has broadened far beyond its origin to various areas of research and one among them is the design of experiments. Design of experiments gathers the maximum amount of information in the lowest number of analyses. In order to optimize a process and maintain repeatability, screening designs are performed. A two-level, mathematically derived multiples of four screening design, popularly known as Plackett-Burman screening design, is thoroughly reviewed in this paper. Application of this design in various areas of research such as formulation development and analytical development has also been focused to explore its potential in screening unbiased estimates of all main effects in the smallest design.
128 citations
TL;DR: This article reviews statistical methods of blinding assessment along with software options, and discusses some of the most pressing issues surrounding the acquisition, interpretation, and reporting of blinding data.
Abstract: There is strong consensus in the clinical trial community that blinding is an important issue in randomized controlled trials. At present grossly incomplete reporting of procedures and the use of any assessment for blinding still prevails. The term ‘double-blind’ has almost become a convention without any checks or balances. Also there is a lack of consensus on quantitative procedures for evaluating the success of blinding in the literature. This article reviews statistical methods of blinding assessment along with software options, and discusses some of the most pressing issues surrounding the acquisition, interpretation, and reporting of blinding data. Finally, it proposes a sample blinding assessment protocol to address some of these issues.
88 citations