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Drug Safety Evaluation
This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
Risk Assessment of Campylobacter Spp. in Broiler Chickens and Vibrio Spp. in Seafood
On cover and title page: WHO food safety consultations.
Machine Learning Algorithms and Applications in Engineering
Machine Learning (ML) is a sub field of artificial intelligence that uses soft computing and algorithms to enable computers to learn on their own and identify patterns in observed data, build models that explain the world, and predict things without having explicit pre-programmed rules and models. This book discusses various applications of ML in engineering fields and the use of ML algorithms in solving challenging engineering problems ranging from biomedical, transport, supply chain and logistics, to manufacturing and industrial. Through numerous case studies, it will assist researchers and practitioners in selecting the correct options and strategies for managing organizational tasks.
Medical Data Analysis and Processing using Explainable Artificial Intelligence
The text presents concepts of explainable artificial intelligence (XAI) in solving real world biomedical and healthcare problems. It will serve as an ideal reference text for graduate students and academic researchers in diverse fields of engineering including electrical, electronics and communication, computer, and biomedical Presents explainable artificial intelligence (XAI) based machine analytics and deep learning in medical science Discusses explainable artificial intelligence (XA)I with the Internet of Medical Things (IoMT) for healthcare applications Covers algorithms, tools, and frameworks for explainable artificial intelligence on medical data Explores the concepts of natural langua...
Primer on Risk Analysis
In every decision context there are things we know and things we do not know. Risk analysis uses science and the best available evidence to assess what we know-and it is intentional in the way it addresses the importance of the things we don't know. Primer on Risk Analysis: Decision Making Under Uncertainty lays out the tasks of risk analysis in a
Principles of Risk Analysis
In every decision context there are things we know and things we do not know. Risk analysis uses science and the best available evidence to assess what we know-and it is intentional in the way it addresses the importance of the things we don't know. Principles of Risk Analysis: Decision Making Under Uncertainty lays out the tasks of risk analysis i
Risk Assessment of Vibrio Vulnificus in Raw Oysters
Vibrio vulnificus is one of three pathogenic Vibrio spp. on which FAO and WHO have undertaken risk assessment work. This pathogen is associated primarily with raw oysters but can occur in a variety of seafood products. As well as causing gastrointestinal illness, V. vulnificus can cause primary septicaemia which is a serious and often fatal disease in individuals with chronic pre-existing conditions. This volume provides an approach for undertaking quantitative risk assessment of V. vulnificus in raw oysters. This risk assessment model was also developed to evaluate the effectiveness of various interventions strategies aimed at reducing V. vulnificus levels in oysters and therefore the associated risk of illness.--Publisher's description.
