cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.3381274
title: • Regulatory requirement for drug development and approval in United States: review

description: ABSTRACT:In this paper a brief history and an overview of the regulatory process for drug approval in the United States through illustrations of Investigational New Drug (INDs) Applications and New Drug Applications (NDAs), abbreviated new drug applications (ANDAs) and supplemental new drug applications (SNDAs) are provided. For INDs, the regulatory requirements for a well-designed protocol, the role and responsibility of institutional review boards, and the applicability of treatment INDs are discussed. For NDAs, issues regarding the application of expanded access, the submission of abbreviated NDAs for a generic drug, the submission of supplemental NDAs for labeling changes, and the role and responsibility of advisory committees are addressed. Along with this a brief description of review steps taken by FDA is provided.INTRODUCTION:HISTORY:The research, development, and approval of a drug productis a continuous but lengthy process involving drugdiscovery, laboratory development, animal studies, clinicaltrials, and regulatory registration. This lengthy process isnecessary to assure the effectiveness and safety of the drug product. In the United States, however, no regulations were put forth until the Pure Food and Drug Act was passed by Congress in 1906. The purpose of this act is to preventmisbranding and adulteration of food and drugs yet it doesnot give the government any authority to inspect food anddrugs. The act was amended in 1912 (the SherleyAmendment) to prohibit labeling medicines with false andfraudulent claims. In 1931, the United States Food andDrug Administration (FDA) was formed. The provisions ofthe FDA are intended to ensure that:
DOI: 10.6084/m9.figshare.3381271
title: Simultaneous Estimation of Amoxycillin and Potassium Clavulanate in Injection Formulation By simultaneous equation method and its validation

description: A simple, fast and precise simultaneous equation method has been developed for simultaneous determination of Amoxycillin (AMX) and Potassium clavulanate (PTC)in injection formulation. The absorption maxima were found to be 246.6 nm for AMX and 257.6 nm for PTC in 0.1M NaOH used as the solvent. The linearity for these drugs at the selected wavelengths lies between 0-200 μg/ml for AMX and 0-75 μg/ml for PTC. The concentrations of these drugs were evaluated in laboratory mixture and marketed formulation. Accuracy was determined by recovery study from injection dosages forms were found to be 99.75 for AMX and 99.08 for PTC.Precision of method was determined as repeatability, day to day and analyst to analyst variation and a show the value within acceptable limit i.e R.S.D was found to be less than 2 percent).RESULTS AND DISCUSSIONThe UV spectra of AMX and PTC, obtained from different solvent (methanol, water, 0.1mHCl and 0.1M NaOH) were studied. The wavelength maximum of the main band was found to be dependent of solvent effects. In water lmax found to be 228nm AMX and 222nm for PTC, butthe injection powder was turbid and non filterable. Also the lmax of both drugs found to be very close. In 0.1M HCl drug is freely soluble and lmax found to be 229nm AMX and224.2nm for PTC but the drug stock solution were dark and yellowish in colour. In methanol drug is slightly soluble and ?max found to be 232nm AMX and 220.8nm for PTC, but as per solvent effect ( Bathochromic shift ) the lmax of PTC could not be considerable. In case of 0.1M NaOH the drug is freely soluble and ?max found to be 246.8nm AMX and 257.6nm for PTC. Thus at the end of these studies 0.1M NaOH was selected as best solvent because it fulfill all the parameters required for simultaneous estimation and also to avoid the time gain while preparing solution and cost saving by eliminating the purchase and disposal of organicsolvent. After considering the solubility, stability and economic feature for both the drugs, 0.1M NaOH was selected as the solvent. From the characteristic spectra of the two drugs ?max was observed at 246.8nm & 257.6nm for AMX and PTC respectively. The linearity was observed in the range of 0-200 ìg per ml for AMX and 0-75 ìg per ml for PTC in the selected solvent.CONCLUSIONThe present work concerned with method development and its validation for simultaneous estimation of Amoxycillin and Pot.Clavulanate by simultaneous equation method.The methodinvolved responses were measured for a series of dilutions, in concentration range of 10-50mg/ml for Amoxycillin and 2-10mg/ml for Pot. Clavulanate at their selected wavelength. The value of relative standard deviation (R.S.D.) for the validation parameters (linearity, repeatability intermediate and precision) was found below 2 hence this method can be used in the laboratories for estimation of this combination.<br>
DOI: 10.6084/m9.figshare.3381196
title: Synthesis and antibacterial study of novel fluoro-benzothiazole derivatives

description: Synthesis and antibacterial study of novel fluoro-benzothiazole derivatives
DOI: 10.6084/m9.figshare.3381196.v1
title: Synthesis and antibacterial study of novel fluoro-benzothiazole derivatives

description: Synthesis and antibacterial study of novel fluoro-benzothiazole derivatives
DOI: 10.6084/m9.figshare.3381148
title: Brain metabolites and language abilities in young children

description: Processed spectroscopy data from voxels in the left angular gyrus (LAG_only) and anterior cingulate (ACG_only) in a group of young children. Includes metabolite concentrations calculated from LCModel, and Phonological Processing and Speeded Naming standard scores from the NEPSY-II assessment.
DOI: 10.6084/m9.figshare.3381148.v1
title: Brain metabolites and language abilities in young children

description: Processed spectroscopy data from voxels in the left angular gyrus (LAG_only) and anterior cingulate (ACG_only) in a group of young children. Includes metabolite concentrations calculated from LCModel, and Phonological Processing and Speeded Naming standard scores from the NEPSY-II assessment.
DOI: 10.6084/m9.figshare.3381124.v3
title: Schematic representation of dye-sensitized solar cell

description: Schematic representation of dye-sensitized solar cell
DOI: 10.6084/m9.figshare.3381109
title: Pedagogy of oppression: Reconstruction narratives in Mississippi history textbooks 1887-1976

description: Published manuscript from research into Reconstruction narratives in Mississippi history textbooks.
DOI: 10.6084/m9.figshare.3381109.v1
title: Pedagogy of oppression: Reconstruction narratives in Mississippi history textbooks 1887-1976

description: Published manuscript from research into Reconstruction narratives in Mississippi history textbooks.
DOI: 10.6084/m9.figshare.3381073
title: Jaric et al., Data mining in conservation research using Latin and vernacular species names. Peerj - Supplementary material

description: Supplementary material for: Jaric et al., Data mining in conservation research using Latin and vernacular species names. Peerj<br><br>Abstract - In conservation science, assessments of trends and priorities often focus on species as the management unit. Studies on species coverage in online media are commonly conducted by using species vernacular names. However, use of species vernacular names for web-based data search is problematic due to high risk of mismatches in results. While the use of Latin names may produce more consistent results, it is uncertain whether a search using Latin names will produce unbiased results as compared to vernacular names. We assessed the potential of Latin names to be used as an alternative to vernacular names for the data mining within the field of conservation science. By using Latin and vernacular names, we searched for species from four species groups: diurnal birds of prey, Carnivora, Primates and marine mammals. We assessed the relationship of the results obtained within different online sources, such as Internet pages, newspapers and social media networks. Results indicated that the search results based on Latin and vernacular names were highly correlated, and confirmed that one can be used as an alternative for the other. We also demonstrated the potential of the number of images posted on the Internet to be used as an indication of the public attention towards different species. <br> <br>
DOI: 10.6084/m9.figshare.3381073.v1
title: Jaric et al., Data mining in conservation research using Latin and vernacular species names. Peerj - Supplementary material

description: Supplementary material for: Jaric et al., Data mining in conservation research using Latin and vernacular species names. Peerj<br><br>Abstract - In conservation science, assessments of trends and priorities often focus on species as the management unit. Studies on species coverage in online media are commonly conducted by using species vernacular names. However, use of species vernacular names for web-based data search is problematic due to high risk of mismatches in results. While the use of Latin names may produce more consistent results, it is uncertain whether a search using Latin names will produce unbiased results as compared to vernacular names. We assessed the potential of Latin names to be used as an alternative to vernacular names for the data mining within the field of conservation science. By using Latin and vernacular names, we searched for species from four species groups: diurnal birds of prey, Carnivora, Primates and marine mammals. We assessed the relationship of the results obtained within different online sources, such as Internet pages, newspapers and social media networks. Results indicated that the search results based on Latin and vernacular names were highly correlated, and confirmed that one can be used as an alternative for the other. We also demonstrated the potential of the number of images posted on the Internet to be used as an indication of the public attention towards different species. <br> <br>
DOI: 10.6084/m9.figshare.8020106
title: Pubertal and adult testicular functions in nonclassic lipoid congenital adrenal hyperplasia: a case series and review.

description: A supplemental material for a clinical research paper of doi.org/10.1210/js.2019-00086.
DOI: 10.6084/m9.figshare.8020106.v3
title: Pubertal and adult testicular functions in nonclassic lipoid congenital adrenal hyperplasia: a case series and review.

description: A supplemental material for a clinical research paper of doi.org/10.1210/js.2019-00086.
DOI: 10.6084/m9.figshare.8020106.v2
title: Supplemental Table 1. Primer sequences and annealing temperatures (Tm) for Sanger sequencing of STAR.

description: Supplemental Table 1.
DOI: 10.6084/m9.figshare.3380983
title: Patient profiles of post PK infections.xlsx

description: files of post PK infection patients<br>
DOI: 10.6084/m9.figshare.3380983.v2
title: Patient list.xlsx

description: files of post PK infection patients<br>
DOI: 10.6084/m9.figshare.3380902
title: Zhang_tree_user_input_for_BEAUTi.nex

description: User-specified starting tree for BEAST analysis, supplied to BEAUTi.
DOI: 10.6084/m9.figshare.3380902.v1
title: Zhang_tree_user_input_for_BEAUTi.nex

description: User-specified starting tree for BEAST analysis, supplied to BEAUTi.
DOI: 10.6084/m9.figshare.3380899
title: Zhang_tree_ML_FigS8.phy

description: Tree file in newick format for the phylogeny shown in supplementary figure S8.
DOI: 10.6084/m9.figshare.3380899.v1
title: Zhang_tree_ML_FigS8.phy

description: Tree file in newick format for the phylogeny shown in supplementary figure S8.
DOI: 10.6084/m9.figshare.3380896
title: Zhang_DNA_Ef1a.fas

description: Elongation factor 1 alpha (Ef1a) sequences
DOI: 10.6084/m9.figshare.3380896.v1
title: Zhang_DNA_Ef1a.fas

description: Elongation factor 1 alpha (Ef1a) sequences
DOI: 10.6084/m9.figshare.3380893
title: Zhang_BEAUTi_analysis4

description: BEAUTi output
DOI: 10.6084/m9.figshare.3380893.v1
title: Zhang_BEAUTi_analysis4

description: BEAUTi output
DOI: 10.6084/m9.figshare.3380890
title: Zhang_tree_BEAST_Fig2.tre

description: Tree file in newick format (for the phylogeny shown in Figure 2 of Zhang et al. 2017)
DOI: 10.6084/m9.figshare.3380890.v1
title: Zhang_tree_BEAST_Fig2.tre

description: Tree file in newick format (for the phylogeny shown in Figure 2 of Zhang et al. 2017)
DOI: 10.6084/m9.figshare.3380884
title: Zhang_partition_scheme.txt

description: Partition scheme used on the sequence matrix
DOI: 10.6084/m9.figshare.3380884.v1
title: Zhang_partition_scheme.txt

description: Partition scheme used on the sequence matrix
DOI: 10.6084/m9.figshare.3380881
title: Zhang_DNA_COI.fas

description: COI sequences
DOI: 10.6084/m9.figshare.3380881.v1
title: Zhang_DNA_COI.fas

description: COI sequences
DOI: 10.6084/m9.figshare.3380878
title: Zhang_DNA_matrix.nex

description: Aligned, concatenated DNA sequence matrix
DOI: 10.6084/m9.figshare.3380878.v1
title: Zhang_DNA_matrix.nex

description: Aligned, concatenated DNA sequence matrix
DOI: 10.6084/m9.figshare.3380875
title: Zhang_DNA_AK.fas

description: Arginine kinase (AK) sequences
DOI: 10.6084/m9.figshare.3380875.v1
title: Zhang_DNA_AK.fas

description: Arginine kinase (AK) sequences
DOI: 10.6084/m9.figshare.3380872
title: Zhang_DNA_COII_3.fas

description: COII sequences
DOI: 10.6084/m9.figshare.3380872.v1
title: Zhang_DNA_COII_3.fas

description: COII sequences
DOI: 10.6084/m9.figshare.3380869
title: Zhang_DNA_28S.fas

description: 28s sequences
DOI: 10.6084/m9.figshare.3380869.v1
title: Zhang_DNA_28S.fas

description: 28s sequences
DOI: 10.6084/m9.figshare.3380866
title: Zhang_BEAUTi_analysis2

description: BEAUTi output file used for BEAST
DOI: 10.6084/m9.figshare.3380866.v1
title: Zhang_BEAUTi_analysis2

description: BEAUTi output file used for BEAST
DOI: 10.6084/m9.figshare.3380863
title: Zhang_DNA_12S.fas

description: 12s sequences
DOI: 10.6084/m9.figshare.3380863.v1
title: Zhang_DNA_12S.fas

description: 12s sequences
DOI: 10.6084/m9.figshare.3380857
title: Zhang_BEAUTi_analysis3

description: File saved from BEAUTi.
DOI: 10.6084/m9.figshare.3380854
title: Zhang_BEAUTi_analysis1

description: File saved from BEAUTi.
DOI: 10.6084/m9.figshare.3380854.v1
title: Zhang_BEAUTi_analysis1

description: File saved from BEAUTi.
DOI: 10.6084/m9.figshare.3380848
title: Transcription/translation of mt genome in the box jellyfishA. alata (Cnidaria: Cubozoa)

description: Fasta and GFF files containing sequence and annotations of genes involved in the transcription and translation of <i>Alatina alata</i>'s (box jellyfish) linear mt genome chromosomes. In addition, the (almost) complete mt genome is included in the fileset.<br><br>This dataset accompanies the following publication:<br><br>Kayal E, Bnetlage B, Collins AG (2016) Insights into the transcriptional and translational mechanisms of linear organellar chromosomes in the box jellyfish Alatina alata (Cnidaria: Medusozoa: Cubozoa). RNA Biology, in press.<br><br>DOI: 10.1080/15476286.2016.1194161
DOI: 10.6084/m9.figshare.3380848.v1
title: Transcription/translation of mt genome in A. alata

description: Fasta and GFF files containing sequence and annotations of genes involved in the transcription and translation of <i>Alatina alata</i>'s (box jellyfish) linear mt genome chromosomes. In addition, the (almost) complete mt genome is included in the fileset.<br>
DOI: 10.6084/m9.figshare.3380848.v2
title: Transcription/translation of mt genome in A. alata

description: Fasta and GFF files containing sequence and annotations of genes involved in the transcription and translation of <i>Alatina alata</i>'s (box jellyfish) linear mt genome chromosomes. In addition, the (almost) complete mt genome is included in the fileset.<br><br>This dataset accompanies the following publication:<br><br>Kayal E, Bnetlage B, Collins AG (2016) Insights into the transcriptional and translational mechanisms of linear organellar chromosomes in the box jellyfish Alatina alata (Cnidaria: Medusozoa: Cubozoa). RNA Biology, in press.<br><br>DOI: 10.1080/15476286.2016.1194161
DOI: 10.6084/m9.figshare.3380845
title: mbovisdataset20002015

description: dataset
DOI: 10.6084/m9.figshare.3380845.v1
title: mbovisdataset20002015

description: dataset
DOI: 10.6084/m9.figshare.3380797
title: Zonal wind anomaly time series over the Southern Ocean for 1957-2011, DJF, described by Fan et al (2014)

description: Zonal wind anomalies for 1973-2011 derived from the ICOADS dataset, averaged over 50S-70S. As published in Fan et al. (2014), and used in Figure 4 (purple curve).
DOI: 10.6084/m9.figshare.3380797.v2
title: Zonal wind anomaly time series over the Southern Ocean for 1957-2011, DJF, described by Fan et al (2014)

description: Zonal wind anomalies for 1973-2011 derived from the ICOADS dataset, averaged over 50S-70S. As published in Fan et al. (2014), and used in Figure 4 (purple curve).
DOI: 10.6084/m9.figshare.3380797.v1
title: SLP-ICOADS.txt

description: Zonal wind anomalies for 1973-2011 derived from the ICOADS dataset, averaged over 50S-70S. As published in Fan et al. (2014), and used in Figure 4
DOI: 10.6084/m9.figshare.3380671
title: PlumX Altmetrics & Sci-Hub Downloads

description: This dataset is a compilation of PlumX metrics with the top 100 most-downloaded papers from Sci-Hub between Sept 2015-Feb 2016.<br><br>Analysis of this dataset can be found here: http://plumanalytics.com/sci-hub-academic-cat-bag-post/.<br><br>If you'd like to explore the altmetrics about this data, it can be found here: https://plu.mx/scihub100.<br><br>The data used to compile the top 100 is the Sci-Hub dataset available on Dryad: Elbakyan A, Bohannon J (2016) Data from: Who's downloading pirated papers? Everyone. Dryad Digital Repository. http://dx.doi.org/10.5061/dryad.q447c
DOI: 10.6084/m9.figshare.3380479
title: BoxD - Copulation Control

description: Videos measuring copulation occurrence, latency and duration of 2 day old male <i>Drosophila melanogaster </i>with mature (2 day old) virgin females with no predation threat from zebra jumping spiders (controls). Trials from April 11-16th 2016
DOI: 10.6084/m9.figshare.3380479.v1
title: BoxD - Copulation Control

description: Videos measuring copulation occurrence, latency and duration of 2 day old male <i>Drosophila melanogaster </i>with mature (2 day old) virgin females with no predation threat from zebra jumping spiders (controls). Trials from April 11-16th 2016
DOI: 10.6084/m9.figshare.3380473
title: Fully Nonparametric Regression for Bounded Data Using Dependent Bernstein Polynomials

description: We propose a novel class of probability models for sets of predictor-dependent probability distributions with bounded domain. The proposal extends the Dirichlet–Bernstein prior for single density estimation, by using dependent stick-breaking processes. A general model class and two simplified versions are discussed in detail. Appealing theoretical properties such as continuity, association structure, marginal distribution, large support, and consistency of the posterior distribution are established for all models. The behavior of the models is illustrated using simulated and real-life data. The simulated data are also used to compare the proposed methodology to existing methods. Supplementary materials for this article are available online.
DOI: 10.6084/m9.figshare.3380473.v2
title: Fully Nonparametric Regression for Bounded Data Using Dependent Bernstein Polynomials

description: We propose a novel class of probability models for sets of predictor-dependent probability distributions with bounded domain. The proposal extends the Dirichlet–Bernstein prior for single density estimation, by using dependent stick-breaking processes. A general model class and two simplified versions are discussed in detail. Appealing theoretical properties such as continuity, association structure, marginal distribution, large support, and consistency of the posterior distribution are established for all models. The behavior of the models is illustrated using simulated and real-life data. The simulated data are also used to compare the proposed methodology to existing methods. Supplementary materials for this article are available online.
DOI: 10.6084/m9.figshare.3380473.v1
title: <b>Fully nonparametric regression for bounded data using dependent Bernstein polynomials</b>

description: We propose a novel class of probability models for sets of predictor-dependent probability distributions with bounded domain. The proposal extends the Dirichlet-Bernstein prior for single density estimation, by using dependent stick-breaking processes. A general model class and two simplified versions are discussed in detail. Appealing theoretical properties such as continuity, association structure, marginal distribution, large support and consistency of the posterior distribution are established for all models. The behavior of the models is illustrated using simulated and real-life data. The simulated data are also used to compare the proposed methodology to existing methods.
DOI: 10.6084/m9.figshare.3380461.v2
title: Robust Treatment Comparison Based on Utilities of Semi-Competing Risks in Non-Small-Cell Lung Cancer

description: A design is presented for a randomized clinical trial comparing two second-line treatments, chemotherapy versus chemotherapy plus reirradiation, for treatment of recurrent non-small-cell lung cancer. The central research question is whether the potential efficacy benefit that adding reirradiation to chemotherapy may provide justifies its potential for increasing the risk of toxicity. The design uses two co-primary outcomes: time to disease progression or death, and time to severe toxicity. Because patients may be given an active third-line treatment at disease progression that confounds second-line treatment effects on toxicity and survival following disease progression, for the purpose of this comparative study follow-up ends at disease progression or death. In contrast, follow-up for disease progression or death continues after severe toxicity, so these are semi-competing risks. A conditionally conjugate Bayesian model that is robust to misspecification is formulated using piecewise exponential distributions. A numerical utility function is elicited from the physicians that characterizes desirabilities of the possible co-primary outcome realizations. A comparative test based on posterior mean utilities is proposed. A simulation study is presented to evaluate test performance for a variety of treatment differences, and a sensitivity assessment to the elicited utility function is performed. General guidelines are given for constructing a design in similar settings, and a computer program for simulation and trial conduct is provided. Supplementary materials for this article are available online.