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The present volume-2 of book Title " Book Title: Modern Medicine: Biomedical Device, Medical Gas, 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), EMA, and the CDSCO.
The present volume-2 of book Title "Book Title: Modern Medicine: Biomedical Device, Medical Gas, 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), EMA, and the CDSCO.
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Autorenporträt
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).
Inhaltsangabe
1. New Drug or Investigational New Drug Applications (INDA) Approval Process with the Drugs and Cosmetics Act 2. Biomedical Device Rules and Enforcement 3. Schedule of Medical Device and Minimum Requirement of Approval 4. Approval and Registration Process of a Biomedical Device 5. 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 6. Regulation in Practising Telemedicine at the Edge of Data Confidentiality and Medical Ethics 7. Compressed Medical Gases: Regulations and Quality Control 8. Regulation of Radiopharmaceuticals in the Preview of the Drugs and Cosmetics Act, 1940 9. Abbreviated New Drug Application (ANDA) or Generic Drug Approval Process 10. Biological Licence Application (BLA) Procedures 11. Regulatory Approval of Biosimilars Including Nucleic Acid-based Recombinant Products, Recombinant Therapeutic Enzymes, and Protein 12. Regulations of Biopharmaceuticals Using Living Microorganisms, Genetically Modified Foods, and Vaccine Development 13. Role of Institutional Bio Safety Committee 14. Orphan Drugs and Regulatory Approval 15. Regulatory Approval Process of In Vitro Diagnostics
1. New Drug or Investigational New Drug Applications (INDA) Approval Process with the Drugs and Cosmetics Act 2. Biomedical Device Rules and Enforcement 3. Schedule of Medical Device and Minimum Requirement of Approval 4. Approval and Registration Process of a Biomedical Device 5. 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 6. Regulation in Practising Telemedicine at the Edge of Data Confidentiality and Medical Ethics 7. Compressed Medical Gases: Regulations and Quality Control 8. Regulation of Radiopharmaceuticals in the Preview of the Drugs and Cosmetics Act, 1940 9. Abbreviated New Drug Application (ANDA) or Generic Drug Approval Process 10. Biological Licence Application (BLA) Procedures 11. Regulatory Approval of Biosimilars Including Nucleic Acid-based Recombinant Products, Recombinant Therapeutic Enzymes, and Protein 12. Regulations of Biopharmaceuticals Using Living Microorganisms, Genetically Modified Foods, and Vaccine Development 13. Role of Institutional Bio Safety Committee 14. Orphan Drugs and Regulatory Approval 15. Regulatory Approval Process of In Vitro Diagnostics
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