Download or read book Documentation and Submission of Data Sets written by A. A. Brooks and published by . This book was released on 1972 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Development Research in Practice written by Kristoffer Bjärkefur and published by World Bank Publications. This book was released on 2021-07-16 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Development Research in Practice leads the reader through a complete empirical research project, providing links to continuously updated resources on the DIME Wiki as well as illustrative examples from the Demand for Safe Spaces study. The handbook is intended to train users of development data how to handle data effectively, efficiently, and ethically. “In the DIME Analytics Data Handbook, the DIME team has produced an extraordinary public good: a detailed, comprehensive, yet easy-to-read manual for how to manage a data-oriented research project from beginning to end. It offers everything from big-picture guidance on the determinants of high-quality empirical research, to specific practical guidance on how to implement specific workflows—and includes computer code! I think it will prove durably useful to a broad range of researchers in international development and beyond, and I learned new practices that I plan on adopting in my own research group.†? —Marshall Burke, Associate Professor, Department of Earth System Science, and Deputy Director, Center on Food Security and the Environment, Stanford University “Data are the essential ingredient in any research or evaluation project, yet there has been too little attention to standardized practices to ensure high-quality data collection, handling, documentation, and exchange. Development Research in Practice: The DIME Analytics Data Handbook seeks to fill that gap with practical guidance and tools, grounded in ethics and efficiency, for data management at every stage in a research project. This excellent resource sets a new standard for the field and is an essential reference for all empirical researchers.†? —Ruth E. Levine, PhD, CEO, IDinsight “Development Research in Practice: The DIME Analytics Data Handbook is an important resource and a must-read for all development economists, empirical social scientists, and public policy analysts. Based on decades of pioneering work at the World Bank on data collection, measurement, and analysis, the handbook provides valuable tools to allow research teams to more efficiently and transparently manage their work flows—yielding more credible analytical conclusions as a result.†? —Edward Miguel, Oxfam Professor in Environmental and Resource Economics and Faculty Director of the Center for Effective Global Action, University of California, Berkeley “The DIME Analytics Data Handbook is a must-read for any data-driven researcher looking to create credible research outcomes and policy advice. By meticulously describing detailed steps, from project planning via ethical and responsible code and data practices to the publication of research papers and associated replication packages, the DIME handbook makes the complexities of transparent and credible research easier.†? —Lars Vilhuber, Data Editor, American Economic Association, and Executive Director, Labor Dynamics Institute, Cornell University
Download or read book Guidebook for Drug Regulatory Submissions written by Sandy Weinberg and published by John Wiley & Sons. This book was released on 2009-02-23 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: Destined to become every regulatory director's essential desktop companion Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines. As well, vital information is provided on the most common types of submissions, including: Meeting Requests Orphan Drug Applications Investigatory New Drug Applications (INDAs) New Drug Applications (NDAs) 505(b)2 NDAs Abbreviated New Drug Applications (ANDAs) Annual Report This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia. Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.
Download or read book Official Gazette of the United States Patent and Trademark Office written by and published by . This book was released on 2002 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Arctic Research of the United States written by and published by . This book was released on 2002 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Methods and Applications of Statistics in Clinical Trials Volume 2 written by Narayanaswamy Balakrishnan and published by John Wiley & Sons. This book was released on 2014-06-16 with total page 953 pages. Available in PDF, EPUB and Kindle. Book excerpt: Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods includes updates of established literature from the Wiley Encyclopedia of Clinical Trials as well as original material based on the latest developments in clinical trials. Prepared by a leading expert, the second volume includes numerous contributions from current prominent experts in the field of medical research. In addition, the volume features: • Multiple new articles exploring emerging topics, such as evaluation methods with threshold, empirical likelihood methods, nonparametric ROC analysis, over- and under-dispersed models, and multi-armed bandit problems • Up-to-date research on the Cox proportional hazard model, frailty models, trial reports, intrarater reliability, conditional power, and the kappa index • Key qualitative issues including cost-effectiveness analysis, publication bias, and regulatory issues, which are crucial to the planning and data management of clinical trials
Download or read book Solicitation written by National Institute of Justice (U.S.) and published by . This book was released on 2001 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Document Analysis Systems written by Xiang Bai and published by Springer Nature. This book was released on 2020-08-14 with total page 588 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 14th IAPR International Workshop on Document Analysis Systems, DAS 2020, held in Wuhan, China, in July 2020. The 40 full papers presented in this book were carefully reviewed and selected from 57 submissions. The papers are grouped in the following topical sections: character and text recognition; document image processing; segmentation and layout analysis; word embedding and spotting; text detection; and font design and classification. Due to the Corona pandemic the conference was held as a virtual event .
Download or read book SAS Programming in the Pharmaceutical Industry Second Edition written by Jack Shostak and published by SAS Institute. This book was released on 2014-03-01 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive resource provides on-the-job training for statistical programmers who use SAS in the pharmaceutical industry This one-stop resource offers a complete review of what entry- to intermediate-level statistical programmers need to know in order to help with the analysis and reporting of clinical trial data in the pharmaceutical industry. SAS Programming in the Pharmaceutical Industry, Second Edition begins with an introduction to the pharmaceutical industry and the work environment of a statistical programmer. Then it gives a chronological explanation of what you need to know to do the job. It includes information on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data. This edition has been updated for SAS 9.4, and it features new graphics as well as all new examples using CDISC SDTM or ADaM model data structures. Whether you're a novice seeking an introduction to SAS programming in the pharmaceutical industry or a junior-level programmer exploring new approaches to problem solving, this real-world reference guide offers a wealth of practical suggestions to help you sharpen your skills. This book is part of the SAS Press program.
Download or read book Federal Register written by and published by . This book was released on 2014 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Saving the Right Stuff written by United States. National Archives and Records Administration. Office of Records Administration and published by . This book was released on 1985 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2023-01-12 with total page 996 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.
Download or read book Treatment Episode Data Set TEDS written by and published by . This book was released on 1992 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Manipulating the Mouse Embryo written by Brigid Hogan and published by Cold Spring Harbor Laboratory Press. This book was released on 1986 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Of mouse development -- Setting up a colony for the production of transgenic mice -- Recovery, culture, and transfer of embryos -- Introduction of new genetic information into the developing mouse embryo -- Iolation of pluripotential stem cell lines -- Techhniques for visualizing genes and gene products -- In vitro culture of eggs, embryos, and teratocarcinoma cels -- Chemicals, supplies, and solutions.
Download or read book Democratizing data Environmental data access and its future written by Michael C. Kruk and published by Frontiers Media SA. This book was released on 2023-02-27 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Treatment Episode Data Set TEDS 1992 2001 written by Leigh A. Henderson and published by . This book was released on 2003 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Using DISSPLA at NIH written by National Institutes of Health (U.S.). Division of Computer Research and Technology. Computer Center and published by . This book was released on 1988 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:
