PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-II

Dr. Trilochan Satapathy · Dr. Venkata Suresh Jilakara · Dr Arpan Kumar Tripathi · Ms. Saloni Goyal

JEC PUBLICATION

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244

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A complete handbook on toxicology covers basic principles, regulatory criteria, and sophisticated methods for understanding and assuring the safety of varied chemicals in the following pages. Introduction to toxicology, "Toxicology Fundamentals and Regulatory Guidelines," covers broad overviews, mechanistic toxicology, regulatory frameworks, and descriptive toxicology. Focus is on OECD, ICH, EPA, and Schedule Y regulatory criteria, as well as the history and importance of Good Laboratory Practise (GLP) in drug development. As the book explores "Types of Toxicity Studies and Test Item Characterization," it examines acute, sub-acute, chronic, and particular acute investigations, including oral, cutaneous, and inhalational toxicity studies. Test item characterisation procedures are carefully explained, emphasising their importance in regulatory compliance and toxicity evaluation. This leads to "Advanced Toxicology Studies," which covers reproductive toxicology, genotoxicity, and in vivo carcinogenicity. These investigations provide a thorough view of possible dangers and evaluate drug safety. The book then discusses "IND Enabling Studies and Safety Pharmacology," which covers the necessary research for IND applications. Exploring regulatory settings, corporate views, and safety pharmacology in drug development provides a complete knowledge of experimental substance safety. The third part, "Toxicokinetic and Alternatives to Animal Testing," emphasises toxicokinetic assessment and discusses new methods. Following the evolution of safety assessment practises, these options are investigated for ethical and regulatory consequences. Students, researchers, and professionals traversing toxicology's difficult landscape may find this book invaluable. Its extensive coverage, from basic concepts to sophisticated approaches, makes it an important tool for protecting humans and ecosystems in the dynamic pharmaceuticals and beyond industries.

Perihal pengarang

Dr. Trilochan Satapathy, currently working as Professor and Head, Department of Pharmacology, Columbia Institute of Pharmacy, Vill-Tekari, Near Vidhansabha, Raipur, Chhattisgarh, India. He has a rich experience of 24 years in teaching M. Pharmacy, B. Pharmacy, and D. Pharmacy. He has obtained M.Pharmacy in Pharmacology from K.L.E College of Pharmacy, Belgaum under RGUHS, Bangalore, Karnataka, Ph.D from Utkal University, Vanivihar, Bhubaneswar, Odisha and D.Sc in Pharmacy (Faculty of medical Sciences) from Berhampur University, Odisha. He has guided 05 Ph.D and many M. Pharmacy students for their research. He has more than 120 publications, in various reputed national and international journals.

Dr. Venkata Suresh Jilakara, Professor & Principal at Vathsalya College of Pharmacy, Anatharam, Bhongiri, Telangana. Having 26 + years of teaching & Research experience. He has been serving as National Coordinator, IPA DP NEC since 2014 to 2023. Acted as CoChairman, Registration Committee 68th IPC & received excellence award at 68th Indian Pharmaceutical Congress hosted by IPA in Andhra University, December 16 - 18, 2016. He served as Vice President & Secretary for IPA Local branch Khammam. Education: Completed B. Pharm-1995, M. Pharm - 1997 from Gulbarga University & Ph.D. - 2012 from Andhra University, Visakhapatnam, Andhra Pradesh. Life member of Professional bodies Indian Pharmaceutical Association (IPA), Association of Pharmacy Teachers of India (APTI) & Indian Association of Colleges of Pharmacy (IACP). He has guided PhD. - PG around 72 students and published more than 55 original research articles. Chaired so many AICTE Sponsored scientific sessions as a speaker and chairperson.

Dr. Arpan K Tripathi, currently working as an Associate professor in the Faculty of Pharmaceutical Sciences, Shri Shankaracharya Technical Campus, Junwani, Bhilai, Chhattisgarh, India. He has a rich experience of 12 years in teaching B. Pharmacy, D.Pharmacy, and M.Pharmacy. He has a qualified M.Pharmacy in Pharmacology branch from, SLT Institute of Pharmaceutical Sciences, Guru Ghasidas Central University, and B. Pharmacy from School of Pharmacy, Chouksey Engineering College affiliated to Guru Ghasidas Central University, Bilaspur, Chhattisgarh, India He has guided many students of M. Pharmacy and B. Pharmacy at research level. He has more than 20 publications, one Indian Patent grant two German Patent grants, and 22 design Patents.

Ms. Saloni Goyal, completed her B. Pharm from Kota College of Pharmacy, Rajasthan University of Health and Science, Jaipur, Rajasthan, India. He holds Master degree in Pharmacology from Jaipur National University, Jagatpura, Jaipur, Rajasthan with Gold Medal. She is currently working as Assistant professor at Jaipur National University and has experience in teaching D. Pharm, B. Pharm, M. Pharm, and Pharm D. He is highly professional in Academician and researcher in Pharmacy Field. She is highly professional in Academician and researcher in Pharmacy Field. She is guiding students of M. Pharm and B. Pharm. She has 13 publications in esteemed peer- reviewed National and International Journals. She has two design patent grants. She is a reviewer of esteemed Journal indexed in UGC CARE, Scopus, Web of Science (SCIE). She has been awarded with Young Researcher Award. She is Life member of Society of Pharmaceutical Education & Research (SPER) and Registered Pharmacist.

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