Synopsis
Biocompatibility Protocols for Medical Devices and Materials provides comprehensive coverage of the basic science and toxicological testing protocols necessary for the risk assessment and safety analysis of medical devices and materials which are based on the ISO guidelines for body contact and duration of contact. The book begins with device/component selection for toxicological experiments and provides an introduction to topics such as sensitization, irritation tests, material-mediated pyrogenicity, and bacterial-mediated pyrogenicity. Toxicology-related chapters explain the protocols for cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing.
Biocompatibility Protocols for Medical Devices and Materials is a practical guide that provides step-by-step toxicological protocols ranging from materials selection to data interpretation for toxicologists, biomedical researchers, healthcare professionals, product developers, and others working in risk assessment and safety analysis of medical devices.
- Explains the biocompatibility test protocols for medical devices
- Provides an overview about chemical characterization
- Describes toxicokinetic, carcinogenicity, and reproductive toxicity studies
- Discusses the basic points needed to leverage the data from another device
About the Authors
Prakash Srinivasan Timiri Shanmugam, PhD, is currently a Senior Toxicologist at Avanos Medical, Inc. in Alpharetta, Georgia. He was previously contracted as an SME–Biocompatibility at Baxter International, Inc. in Round Lake, IL, United States, and at Johnson & Johnson Medical Device Sector. He has an MSc and a PhD in the specialization of Pharmacology and Toxicology with Chemistry (interdisciplinary) from the University of Madras, Tamil Nadu, and completed his postdoctoral research at Tulane University and LSUHSC-Shreveport, Louisiana. He has authored 5 books, contributed several book chapters, and published research articles in various peer-reviewed international journals and conference proceedings/abstracts.
Thamizharasan Sampath, PhD, PGDCR, is currently Dean of Research and Professor of Pharmacology & Toxicology at the University of Health Sciences (SBIMS), Raipur, CG, India. He has done his MS and PhD specializing in pharmacology under the faculty of medicine from the Post Graduate Institute of Basic Medical Sciences, University of Madras, and also did his Postgraduate diploma in clinical research at State University. He has 17 years of teaching and research experience. His research areas include cancer pharmacology, clinical research, neurotoxicology, nutraceuticals, reproductive toxicology, endocrine pharmacology, phytopharmacology, molecular pharmacology, drug design, and drug discovery. He has published more than 60 research articles in national and international indexed journals and is the author of the book Bamboo - The Golden seed and has also contributed more than 20 book chapters. He has received many awards from various central organizations for his outstanding research and contribution in the field of medicine. He serves as a Chief Editor, Editorial Board Member, and Reviewer in many medical journals. He is a member of Institutional Research Ethics Committee, Animal Ethics Committee, Indian Pharmacological Society, and UNESCO Bioethics Committee.
Indumathy Jagadeeswaran, PhD, is currently working as a Senior Research Associate in the Department of Pediatrics at UT Southwestern Medical Center, Dallas, Texas, United States. She has an MS in Biotechnology with Biochemistry (interdisciplinary) and PhD in Medical Physiology from the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) in Pondicherry, India. She has been working in the field of physiology since 2011 and has completed her postdoctoral training from prestigious institutes including the UT Southwestern Medical Center, Dallas, Texas. She has editorial experience including being an Associate Editor (2014–2017) for a peer-reviewed international journal and is presently a Peer-Review Member of the Scientific Committee and Society. She has contributed book chapters on regulatory standards and has also published research articles in various peer-reviewed international journals.
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