This book focuses on the principles, methods, and interpretation involved in establishing the safety, risk, and hazard assessment of small molecules. It presents the regulatory requirements for risk and hazard identification as per the guidelines of the Organization for Economic Cooperation and Development (OECD), Paris, and the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use ICH and Schedule ’Y’, India. It serves as reference material for undergraduate and postgraduate pharmacy degree students as well as senior researchers to learn about the principles, methods, and interpretations of systemic dosage (acute and repeated dose) and genotoxicity (in vitro and in vivo), special toxicological investigations such as reproductive and developmental toxicology, carcinogenicity, and toxicokinetics using animal models or in vitro methods, as applicable. This book is the first of its kind in providing information on the principles and methods of implementation of Good Laboratory Practice based on the guidelines of OECD. It includes detailed chapters about the regulatory requirements and guidelines in pharmaceutical products and agrochemicals. It also describes the infrastructure needed for preclinical studies, including in vivo and in vitro facilities.
Prof Saravana Babu Chidambaram, PhD, has 18 years of research and teaching experience in the field of pharmacology and toxicology. He has obtained his PhD from Tamil Nadu Dr MGR Medical University, Chennai. Currently he is working as a professor in the Department of Pharmacology, JSS College of Pharmacy and is Director of the Centre for Experimental Pharmacology & Toxicology, JSS Academy of Higher Education & Research University, Mysuru, India. He has produced 7 PhD scholars, currently 5 are pursuing, and 12 master’s students and has published more than hundred papers in peer-reviewed journals, authored 12 book chapters, and received grants from Indian Govt bodies, such as DST, DBT, AYUSH, and IBRO, among others, to perform research in field of neuropharmacology and toxicology. He was elected as Fellow of Academy of Science (Animal’s Welfare), Fellow of Indian Chemical Society, and Fellow of Society of Toxicology, India, and executive member of the Society for Neurochemistry,India. He is a recipient of 'Outstanding Researcher in Pharmacology', Venus International Foundation, Chennai (Sep, 2018), and Dr APJ Abdul Kalam Award for Scientific Excellence – 2017, Marina Labs, Chennai (Sep, 2017). He also received appreciation award for being one of the key players in getting GLP certification for Sri Ramachandra University's toxicology centre (Oct, 2014).
Prof Musthafa Mohamed Essa, PhD, is professor of nutrition at Sultan Qaboos University, Oman. He is editor-in-chief of the International Journal of Nutrition, Pharmacology, Neurological Diseases published by Wolters & Kluwer, USA. Prof Essa holds visiting positions at the University of the Pacific, USA, and Macquarie University, Australia. He is the chief editor of a prestigious book series on nutritional neurosciences by Springer. Prof Essa is also acting as editor for BMC Complementary and Alternative Medicine, Frontiers in Neuroscience, and Frontiers inBiosciences. Dr Essa is an expert in the field of nutritional neuroscience/ neuropharmacology and has published more than 170 papers, 60 book chapters, and 14 books. Prof Essa is recipient of many awards from local and international bodies, including Best Book in the World, National Research Award, and Distinguished Researcher, to name few. He has over 15 years of research and teaching experience and till now he was the recipient of many research grants from local and international agencies in the area of neuropharmacology and nutritional neurosciences (approximately 1.64 million USD). Under his guidance, 4 PhD students and 10 master’s students have graduated, and currently he is guiding 2 PhD students in the area of nutritional neuroscience.
M. Walid Qoronfleh, PhD, MBA, is currently the director of healthcare research and policy at Qatar Foundation – WISH. Dr Qoronfleh leads the WISH Doha-based research unit, which is engaged in research areas thatare of immediate global and local healthcare relevance to Qatar. The research areas include autism, mental health, dementia, patient safety, non-communicable diseases (cancer, diabetes, and obesity), precision medicine, and bioethics. Dr Qoronfleh has over 20 years of scientific, technology, business, and commercial experience. He has held several senior management and executive positions with increasing responsibilities at GlaxoSmithKline; Sanofi, USA; and NIH-NCI, to name a few. Dr Qoronfleh is the founder of three biotechnology companies, and he is a co-founder and the managing director of the boutique consulting company Q3CG. Dr Qoronfleh has published more than hundred combined peer-reviewed abstracts and papers. He is also an editor and an ad hoc reviewer for various scientific journals plus a frequent speaker at national and international conferences.
