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Book
Contract Research and Development Organizations-Their History, Selection, and Utilization
Authors: --- ---
ISBN: 3030430731 3030430723 Year: 2020 Publisher: Cham : Springer International Publishing : Imprint: Springer,

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Abstract

This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolts of study performance. · Electronic reporting requirements – SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). · Consultants and their roles. · An expanded examination of common problems and their solutions. This book boasts complete directories to the global universe of operating labs – where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities – and for auditing studies and projects at such facilities – are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update.


Book
Nonlinear Dimensionality Reduction Techniques
Authors: --- --- ---
ISBN: 9783030810269 Year: 2022 Publisher: Cham Springer International Publishing :Imprint: Springer


Book
Educational Perspectives on Mediality and Subjectivation : Discourse, Power and Analysis
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ISBN: 9783030843434 3030843432 9783030843427 3030843424 Year: 2022 Publisher: Springer Nature

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This book examines the complex relationship between education, media and power. Exploring the entanglement of education media and power structures, the contributions use various examples and case studies to demonstrate how subjectivation processes and digital structures interact with one another. The book asks which modes of subjectivation can be identified with current media cultures, how subjects deal with the challenges and potential of digitality, and how coping and empowerment strategies are developed. By addressing theoretical as well as empirical evidence, the chapters illuminate these connections and the subsequent significance for media education more widely.


Book
Qualitative Research in the Post-Modern Era : Critical Approaches and Selected Methodologies
Authors: ---
ISBN: 3030851249 3030851230 3030851265 Year: 2022 Publisher: Cham : Springer International Publishing : Imprint: Springer,

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This volume describes and discusses some of the intricacies associated with qualitative research in this post-modern era. It is the second of a two-volume set. It strives to define terms, identifies paradigms, methodologies and approaches that are applicable to novice and expert researchers alike. The book pays special attention to the biographies of those individuals who have helped to shape and develop these methodologies or research designs. In addition, consideration is given to historical and political underpinnings that relate to the development of qualitative research methodologies. Each research design is described in detail and the similarities and differences among them are explored. This volume makes use of a contextual approach to research and features interviews with scholars who have assisted in developing such methodologies. Of interest are numerous features such as questions for further study and annotated bibliographies that extend the scope of each of the methodologies described.

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