cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.4567999.v32
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a Type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this article, an alternative TOST based on the effect size is demonstrated to maintain the desired Type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the article. Supplementary materials for this article are avalilable online.
DOI: 10.6084/m9.figshare.4567999.v33
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this paper, an alternative TOST based on the effect size is demonstrated to maintain the desired type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the paper.
DOI: 10.6084/m9.figshare.4567999.v34
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a Type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this article, an alternative TOST based on the effect size is demonstrated to maintain the desired Type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the article. Supplementary materials for this article are avalilable online.
DOI: 10.6084/m9.figshare.4567999.v35
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this paper, an alternative TOST based on the effect size is demonstrated to maintain the desired type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the paper.
DOI: 10.6084/m9.figshare.4567999.v36
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a Type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this article, an alternative TOST based on the effect size is demonstrated to maintain the desired Type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the article. Supplementary materials for this article are avalilable online.
DOI: 10.6084/m9.figshare.4567999.v37
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this paper, an alternative TOST based on the effect size is demonstrated to maintain the desired type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the paper.
DOI: 10.6084/m9.figshare.4567999.v38
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a Type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this article, an alternative TOST based on the effect size is demonstrated to maintain the desired Type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the article. Supplementary materials for this article are avalilable online.
DOI: 10.6084/m9.figshare.4567999.v39
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this paper, an alternative TOST based on the effect size is demonstrated to maintain the desired type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the paper.
DOI: 10.6084/m9.figshare.4567999.v40
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a Type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this article, an alternative TOST based on the effect size is demonstrated to maintain the desired Type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the article. Supplementary materials for this article are avalilable online.
DOI: 10.6084/m9.figshare.4567999.v41
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this paper, an alternative TOST based on the effect size is demonstrated to maintain the desired type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the paper.
DOI: 10.6084/m9.figshare.4567999.v42
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a Type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this article, an alternative TOST based on the effect size is demonstrated to maintain the desired Type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the article. Supplementary materials for this article are avalilable online.
DOI: 10.6084/m9.figshare.4567999.v43
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this paper, an alternative TOST based on the effect size is demonstrated to maintain the desired type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the paper.
DOI: 10.6084/m9.figshare.4567999.v44
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a Type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this article, an alternative TOST based on the effect size is demonstrated to maintain the desired Type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the article. Supplementary materials for this article are avalilable online.
DOI: 10.6084/m9.figshare.4567999.v45
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this paper, an alternative TOST based on the effect size is demonstrated to maintain the desired type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the paper.
DOI: 10.6084/m9.figshare.4567999.v46
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a Type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this article, an alternative TOST based on the effect size is demonstrated to maintain the desired Type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the article. Supplementary materials for this article are avalilable online.
DOI: 10.6084/m9.figshare.4567999.v47
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this paper, an alternative TOST based on the effect size is demonstrated to maintain the desired type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the paper.
DOI: 10.6084/m9.figshare.4567999.v49
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this paper, an alternative TOST based on the effect size is demonstrated to maintain the desired type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the paper.
DOI: 10.6084/m9.figshare.4567999.v48
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a Type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this article, an alternative TOST based on the effect size is demonstrated to maintain the desired Type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the article. Supplementary materials for this article are avalilable online.
DOI: 10.6084/m9.figshare.4564186
title: data

description: This data is to replicate the paper: "Investment climate and Firm Productivity: An application to Vietnamese Manufacturing Firms"
DOI: 10.6084/m9.figshare.4564186.v2
title: data

description: This data is to replicate the paper: "Investment climate and Firm Productivity: An application to Vietnamese Manufacturing Firms"
DOI: 10.6084/m9.figshare.4564186.v1
title: journaldata

description: This data is to replicate the paper: "Investment climate and Firm Productivity: An application to Vietnamese Manufacturing Firms"
DOI: 10.6084/m9.figshare.4564000
title: NextSeq 500 InterOp example data

description: NextSeq 500 using V2 reagents InterOp example
DOI: 10.6084/m9.figshare.4563994
title: H3GJKBGX InterOp dir only

description: NextSeq 500 v2: Nextera Rapid Capture Exome (CEPH 9plex) - H3GJKBGXData generated from replicates of the CEPH trio NA12878, NA12891 and NA12892 sequenced on NextSeq 500 using V2 reagents. Samples prepared using Nextera Rapid Capture Exome reagent kit.
DOI: 10.6084/m9.figshare.4564000.v1
title: NextSeq 500 InterOp example data

description: NextSeq 500 using V2 reagents InterOp example
DOI: 10.6084/m9.figshare.4563994.v1
title: H3GJKBGX InterOp dir only

description: NextSeq 500 v2: Nextera Rapid Capture Exome (CEPH 9plex) - H3GJKBGXData generated from replicates of the CEPH trio NA12878, NA12891 and NA12892 sequenced on NextSeq 500 using V2 reagents. Samples prepared using Nextera Rapid Capture Exome reagent kit.
DOI: 10.6084/m9.figshare.4563982
title: Fileset for testing thread-safety of TChem

description: This fileset holds a self-contained example of how TChem is not thread-safe when parallelized with OpenMP. The testing program first uses TChem to evaluate the chemical kinetic Jacobian for a number of thermo-chemical states in an entirelysingle-threaded (i.e., serial) manner. Next, the tester turns on OpenMP parallelization and re-computes the Jacobian matrices for the same thermo-chemical states. Finally, the tester compares the results from the single-threaded and multi-threaded evaluations, and determines the error relative to the single-threaded version. <br>In all cases tested, significant error is found for the multi-threaded version.<br>See README.md for more information.
DOI: 10.6084/m9.figshare.4563973
title: Wikipedia Talk Labels: Toxicity

description: This data set includes over 100k labeled discussion comments from English Wikipedia. Each comment was labeled by multiple annotators via Crowdflower on whether it is a toxic or healthy contribution. We also include some demographic data for each crowd-worker. See our wiki for documentation of the schema of each file and our research paper for documentation on the data collection and modeling methodology. For a quick demo of how to use the data for model building and analysis, check out this ipython notebook.
DOI: 10.6084/m9.figshare.4563928
title: Model code, data, and output

description: Saved R files containing model outputs for the manuscript "Detecting the impact of temperature on transmission of Zika, dengue and chikungunya using mechanistic models."<br>
DOI: 10.6084/m9.figshare.4563922
title: IDU_ZNZ.xlsx

description: We used RDS to identify 408 participants, from whom we collected information on demographics, sexual behaviors, and injection practices and obtained samples for biological testing.
DOI: 10.6084/m9.figshare.4563880
title: 7_9_2016 (IL 40)

description: Acoustic data recorded in an intertidal zone in Wilmington, North Carolina over summer 2016. See attached R script for calibration instructions.<br>
DOI: 10.6084/m9.figshare.4563922.v1
title: IDU_ZNZ.xlsx

description: We used RDS to identify 408 participants, from whom we collected information on demographics, sexual behaviors, and injection practices and obtained samples for biological testing.
DOI: 10.6084/m9.figshare.4563880.v1
title: 7_9_2016 (IL 40)

description: Acoustic data recorded in an intertidal zone in Wilmington, North Carolina over summer 2016. See attached R script for calibration instructions.<br>
DOI: 10.6084/m9.figshare.4563874
title: 7_8_2016 (IL 40)

description: Acoustic data recorded in an intertidal zone in Wilmington, North Carolina over summer 2016. See attached R script for calibration instructions.
DOI: 10.6084/m9.figshare.4563868
title: 7_2_2016 (IL 40)

description: Acoustic data recorded in an intertidal zone in Wilmington, North Carolina over summer 2016. See attached R script for calibration instructions.
DOI: 10.6084/m9.figshare.4563928.v1
title: Model code, data, and output

description: Saved R files containing model outputs for the manuscript "Detecting the impact of temperature on transmission of Zika, dengue and chikungunya using mechanistic models."<br>
DOI: 10.6084/m9.figshare.4563820
title: 7_1_2016 (IL 40)

description: Acoustic data recorded in an intertidal zone in Wilmington, North Carolina over summer 2016. See attached R script for calibration instructions.
DOI: 10.6084/m9.figshare.4563868.v1
title: 7_2_2016 (IL 40)

description: Acoustic data recorded in an intertidal zone in Wilmington, North Carolina over summer 2016. See attached R script for calibration instructions.
DOI: 10.6084/m9.figshare.4563820.v1
title: 7_1_2016 (IL 40)

description: Acoustic data recorded in an intertidal zone in Wilmington, North Carolina over summer 2016. See attached R script for calibration instructions.
DOI: 10.6084/m9.figshare.4563874.v1
title: 7_8_2016 (IL 40)

description: Acoustic data recorded in an intertidal zone in Wilmington, North Carolina over summer 2016. See attached R script for calibration instructions.
DOI: 10.6084/m9.figshare.4563928.v2
title: Model code, data, and output

description: Saved R files containing model outputs for the manuscript "Detecting the impact of temperature on transmission of Zika, dengue and chikungunya using mechanistic models."<br>