1st Edition
Modern Medicine Biomedical Devices, Medical Gases, Radiopharmaceuticals, New Drug Discovery, Volume 2
Modern Medicine: Biomedical Devices, Medical Gases, Radiopharmaceuticals, New Drug Discovery, Volume 2 discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Administration (FDA), the European Medical Agency (EMA), and the Central Drug Standard Control Organization (CDSCO). In the rapidly evolving landscape of modern medicine, groundbreaking innovations have emerged that are reshaping the way we approach healthcare. Modern Medicine delves into the cutting-edge realms of medical devices, medical gases, radiopharmaceuticals, and new drug discovery, offering a comprehensive exploration of these transformative fields that are revolutionizing patient care and medical practices.
- Discover the future of healthcare technology, and uncover the intricate world of biomedical engineering, where state-of-the-art devices seamlessly merge with the human body to monitor, diagnose, and treat ailments
- Dive deep into the utilization of medical gases for respiratory conditions, pain management, and even novel applications in regenerative medicine
- Unravel the mysteries of radiopharmaceuticals, a fusion of molecular imaging and therapy that offers unprecedented insights into the inner workings of the human body
- Embark on a journey through the intricate processes of drug discovery, where groundbreaking research and cutting-edge technologies are yielding therapies that were once deemed impossible
Modern Medicine is a must-read for medical professionals, researchers, students, and anyone intrigued by the remarkable intersection of science, technology, and patient well-being. Join us on a journey to the forefront of medical innovation, where the unimaginable becomes reality, and the future of healthcare takes shape before our eyes. The chapter on regulatory implications for the approval process in this book will be the most useful resource for researchers and students, particularly those with backgrounds in pharma, forensic medicine, regulatory affairs, or those who aspire to succeed in drug research. Additionally, the information contained in this volume of the book could be of great interest to researchers working in the pharmaceutical and health industries.
- New Drug or Investigational New Drug Applications (INDA) Approval Process with the Drugs and Cosmetics Act
- Biomedical Device Rules and Enforcement
- Schedule of Medical Device and Minimum Requirement of Approval
- Approval and Registration Process of a Biomedical Device
- Quality Assurance of Biomedical Devices Central Drugs Standard Control Organization (CDSCO), the United States Food and Drug Administration (US FDA) and the European Union (EU) Regulations
- Regulation in Practising Telemedicine at the Edge of Data Confidentiality and Medical Ethics
- Compressed Medical Gases: Regulations and Quality Control
- Regulation of Radiopharmaceuticals in the Preview of the Drugs and Cosmetics Act, 1940
- Abbreviated New Drug Application (ANDA) or Generic Drug Approval Process
- Biological Licence Application (BLA) Procedures
- Regulatory Approval of Biosimilars Including Nucleic Acid-based Recombinant Products, Recombinant Therapeutic Enzymes, and Protein
- Regulations of Biopharmaceuticals Using Living Microorganisms, Genetically Modified Foods, and Vaccine Development
- Role of Institutional Bio Safety Committee
- Orphan Drugs and Regulatory Approval
- Regulatory Approval Process of In Vitro Diagnostics
Biography
Dr. Pronobesh Chattopadhyay, Ph.D., FNASc., FICS, is a pharmaceutical scientist in the Defence Research Laboratory (DRDO), Tezpur. His working areas are chemical pharmacology, toxicological interaction on expression, chemical target to TRPV, AdipoR1, AdipoR2, c-Jun kinase pathway in lungs and eyes, and these resulted in exploration to development of many defense products. He was instrumental in developing many defense products which are successfully used by India’s armed forces. A notable technology like the "chili grenade" developed from Bhot Jolakia (one of the hottest chilies in the world) has been transferred (transfer of technology) to three industries and is presently used successfully by many law enforcing agencies in India. He also developed protective gear for ultra-violet protection which is stable at −50 C for armed forces deployed in Siachen Glacier; and he has contributed to the development of many products for protecting the armed forces deployed in jungle warfare. He is a Fellow of the National Academy of Sciences India (NASI) and Fellow of Indian Chemical Society (FICS). He has published more than 170 research papers and five book chapters, and filed 15 patents, three of which have been granted. He has received many awards, including the Gandhi Young Technology Innovation Awards under Biotechnology Industry Research Assistance Council (BIRAC), Laboratory Scientist Awards, Technology Awards from DRDO etc. He is a regular reviewer of ethnopharmacology, toxicology, and biochemical pharmacology, and Elsevier publishing house recognized him as a potential reviewer. Twelve Ph.D. degrees and three postdoctoral degrees have been awarded under his supervision, and 25 postgraduate students completed their dissertations.
Dr. Danswrang Goyary, Ph.D., graduated in Biotechnology and completed his M.Sc. and Ph.D. in Biochemistry from North Eastern Hill University (NEHU), Shillong, India. He qualified NET-JRF (UG-CSIR) in 2002 and received a fellowship for his doctoral degree. He started his professional career at Defence Institute of Bio-Energy Research (then Defence Agricultural Research Laboratory), Haldwani (Uttarakhand) as a scientist in the year 2005 and extensively contributed in the fields of life sciences and biopharmaceuticals of defence importance as a biochemist.
Dr. Goyary is presently working in Defence Research Laboratory (DRDO), Tezpur. He is actively involved in studying the mechanism of different kinds of wound healing, haemostasis, and he is associated with the development of defence products such as chili grenades, snake repellent, high SPF sunscreen, impregnated fabrics for disease vector and insect control etc. He has contributed more than 50 publications in peer-reviewed journals, secured two patents, supervised three Ph.D. students, and guided more than 15 postgraduate students. He has received laboratory awards such as Technology Group awards, Science Day oration award, Technology Day oration award etc. He is a member of many committees such as institutional animal ethical committees (IAEC) and institutional biosafety committees (IBSC).
