Development of Biopharmaceutical Drug-Device Products by Feroz Jameel
English | EPUB | 2020 | 888 Pages | ISBN : 3030314146 | 100.30 MB
The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions.

Design, Execution, and Management of Medical Device Clinical Trials By Salah Abdel?Aleem(auth.)
2009 | 282 Pages | ISBN: 0470474262 | PDF | 3 MB
An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.Content: Chapter 1 An Overview of Clinical Study Tasks and Activities (pages 1-13): Chapter 2 Development of Clinical Protocols, Case Report Forms, Clinical Standard Operating Procedures, Informed Consent Form, Study Regulatory Binder, Study Research Agreement, and Other Clinical Materials (pages 15-62): Chapter 3 Qualification/Selection of Study Investigators and Study Monitoring Visits (pages 63-80): Chapter 4 Adverse Events Definitions and Reporting Procedures (pages 81-92): Chapter 5 Statistical Analysis Plan (SAP) and Biostatistics in Clinical Research (pages 93-112): Chapter 6 Final Clinical Study Report (pages 113-125): Chapter 7 Medical Device Regulations, Combination Product, Study Committees, and FDA?Sponsor Meetings (pages 127-194): Chapter 8 Design Issues in Medical Devices Studies (pages 195-219): Chapter 9 Investigator?Initiated Clinical Research (pages 221-227): Chapter 10 Ethical Conduct for Human Research (pages 229-233):

HHD Software Device Monitoring Studio Ultimate 8.45.01.9934 (x64) | 17.8 Mb
Device Monitoring Studio is a high performance non-intrusive software solution for monitoring, logging and analyzing of data coming through PC ports and connections.

HHD Software Device Monitoring Studio Ultimate 8.45.00.9929 (x64) | 17.8 Mb
Device Monitoring Studio is a high performance non-intrusive software solution for monitoring, logging and analyzing of data coming through PC ports and connections.

English | 2022 | ISBN: 1119819237 | 360 pages | True EPUB | 23.96 MB
OPTICAL SWITCHING Comprehensive coverage of optical switching technologies and their applications in optical networks
Optical Switching: Device Technology and Applications in Networks delivers an accessible exploration of the evolution of optical networks with clear explanations of the current state-of-the-art in the field and modern challenges in the development of Internet-of-Things devices. A variety of optical switches—including MEMS-based, magneto, photonic, and SOA-based—are discussed, as is the application of optical switches in networks.

Last updated 1/2021
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Language: English | Size: 2.56 GB | Duration: 5h 25m

English | 2022 | ISBN: 1119819237 | 387 pages | True PDF | 18.87 MB
OPTICAL SWITCHING Comprehensive coverage of optical switching technologies and their applications in optical networks
Optical Switching: Device Technology and Applications in Networks delivers an accessible exploration of the evolution of optical networks with clear explanations of the current state-of-the-art in the field and modern challenges in the development of Internet-of-Things devices. A variety of optical switches—including MEMS-based, magneto, photonic, and SOA-based—are discussed, as is the application of optical switches in networks.

Nandi D Optical Switching Device Technology and App Net 2022 | 18.15 MB
N/A | 373 Pages

Title: Optical Switching
Author: Dalia Nandi, Sandip Nandi, Angsuman Sarkar, and Chandan Kumar Sarkar
Year: N/A

Thermal Reliability of Power Semiconductor Device in the Renewable Energy System
English | 2022 | ISBN: 9811931313 | 310 Pages | PDF EPUB (True) | 54 MB
This book focuses on the thermal reliability of power semiconductor device by looking at the failure mechanism, thermal parameters monitoring, junction temperature estimation, lifetime evaluation, and thermal management. Theoretical analysis and experimental tests are presented to explain existing reliability improvement techniques. This book is a valuable reference for the students and researchers who pay attention to the thermal reliability design of power semiconductor device.

Bringing a Medical Device to the Market: A Scientist's Perspective
English | 2022 | ISBN: 9814968250 | 316 Pages | PDF (True) | 8 MB
Many of us in science have this "Aha!" moment when the mental puzzle is put together and you get a clear picture of a product, which will change the world. Moreover, you have a clear understanding of how it can be a commercial success. So, you decide to start a new company, a startup, and have a clear path to success. However, soon you come face to face with reality, where things are much more complicated. Only a minute fraction of startups survives and becomes successful. This is particularly true in the complex world of medical devices. There are many good books on startups but this book is specifically about startups specializing in medical devices, which are very different from other ones. It is written by a MedDev entrepreneur for first-time MedTech entrepreneurs.