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Textbook on Clinical Research A Guide for Aspiring Professionals and Professionals
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The book provides the basic concepts of clinical research relating to clinical trials, bioavailability and bioequivalence study in a simple language. It covers basically Indian Regulation and Requirements for carrying out clinical research in India. However, looking out the need of global clinical trials, the USFDA, ICH and EMEA guidelines / regulations are included in the accompanying CD. The book has the following chapters: Clinical Research in India (Overview), Drug Development Process (Concept to New Drug Application), Clinical Trials (Study Design, Regulation, Ethics, Good Clinical Practice and Post Marketing Surveillance), Quality Assurance (Standard Operating Procedure, Good Laboratory Practice and Data Management), Bioavailability and Bioequivalence and Appendix containing useful websites, list of Contract Research Organizations in India, Example of Informed Consent Form, Guidance for Industries etc.. Considering the fast growth of Clinical Research Activity in India, the book is developed to be a companion for both clinical research professionals and the aspiring professionals who plan to build a career in clinical research. This can be viewed as text book too for Pharm. D. programmes of the Indian Universities.
Contents: 1. Introduction 2. Clinical Research in India 3. Drug development process 4. Clinical trials 5. Ethical Issues in Clinical Research 6. Good Clinical (Research) Practices (GCP) for Clinical Research in India
7. Quality Assurance in Clinical Research 8. Bioavailability and Bioequivalence Studies
9. Data Management in Clinical Research
About the Author:
Dr. Guru Prasad Mohanta, a former WHO officer, is currently with Annamalai University as Professor of Pharmacy.
He has more than 30 years of teaching, research and administrative experience at various levels with more than 400 articles to his credit. He is a regular columnist for Newspapers and Pharma Magazines. He has authored several popular texts and reference books. With his International Training background he has been advocating the rational use of medicines at various forums. He has completed projects supported by UGC, ICMR, HAI-AP, EPN, CDSCO, and WHO. He was the Coordinator of Peripheral Centre under National Pharmacovigilance Programme supported by World Bank. He is associated with several Indian Universities and Institutions either as member of academic bodies or examiners. He is a member of various National and International Professional Bodies. He has coordinated many continuing professional development programmes for pharmacy teachers and professional pharmacists. He is a trainer in medicine supply chain management, pharmacoeconomics and rational use related areas. He was recipient of the best researcher award of Annamalai University in 2012 and IAPST Pharmaceutical Scientist of the Year 2015 Award.
Contents: 1. Introduction 2. Clinical Research in India 3. Drug development process 4. Clinical trials 5. Ethical Issues in Clinical Research 6. Good Clinical (Research) Practices (GCP) for Clinical Research in India
7. Quality Assurance in Clinical Research 8. Bioavailability and Bioequivalence Studies
9. Data Management in Clinical Research
About the Author:
Dr. Guru Prasad Mohanta, a former WHO officer, is currently with Annamalai University as Professor of Pharmacy.
He has more than 30 years of teaching, research and administrative experience at various levels with more than 400 articles to his credit. He is a regular columnist for Newspapers and Pharma Magazines. He has authored several popular texts and reference books. With his International Training background he has been advocating the rational use of medicines at various forums. He has completed projects supported by UGC, ICMR, HAI-AP, EPN, CDSCO, and WHO. He was the Coordinator of Peripheral Centre under National Pharmacovigilance Programme supported by World Bank. He is associated with several Indian Universities and Institutions either as member of academic bodies or examiners. He is a member of various National and International Professional Bodies. He has coordinated many continuing professional development programmes for pharmacy teachers and professional pharmacists. He is a trainer in medicine supply chain management, pharmacoeconomics and rational use related areas. He was recipient of the best researcher award of Annamalai University in 2012 and IAPST Pharmaceutical Scientist of the Year 2015 Award.
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