Clinical Research - Mittal, Niti; Medhi, Bikash
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· Comprehensive content covering all aspects of clinical research. · Evolving paradigms in clinical research, e.g. modelling and simulation, artificial intelligence, etc. · Milestones in the evolution of drug regulations in India · Drug regulatory framework in India and key ICH countries. · Evolution of drug pricing mechanisms and IPRs in India. · Updated text incorporating the New Drugs and Clinical Trials Rules 2019; Guidelines on BA/BE studies; ICMR National Ethical Guidelines 2017; National Guidelines for Stem Cell Research 2017; Medical Devices Rules 2017. · Latest amendments and…mehr

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Produktbeschreibung
· Comprehensive content covering all aspects of clinical research. · Evolving paradigms in clinical research, e.g. modelling and simulation, artificial intelligence, etc. · Milestones in the evolution of drug regulations in India · Drug regulatory framework in India and key ICH countries. · Evolution of drug pricing mechanisms and IPRs in India. · Updated text incorporating the New Drugs and Clinical Trials Rules 2019; Guidelines on BA/BE studies; ICMR National Ethical Guidelines 2017; National Guidelines for Stem Cell Research 2017; Medical Devices Rules 2017. · Latest amendments and guidelines on ethics committees, informed consent, electronic informed consent, compensation and ICMR Policy on Research Integrity and Publication Ethics 2019. · Templates for various documents like patient information sheet, assent document, case report form, adverse event reporting form etc.
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Autorenporträt
Dr. Niti Mittal (MD, DM) pursued her post-graduation in Pharmacology and DM (Clinical Pharmacology) from the prestigious institute, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh. She graduated from Government Medical College and Hospital, Chandigarh. She is currently working as an Assistant Professor in the Department of Pharmacology, Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, Haryana. During her academic career, she has been actively involved in various research, academic, and pharmacovigilance activities. She holds a sound working knowledge in the field of clinical research and has conducted varied types of research including randomized controlled trials, observational studies, Phase 1 study, meta-analysis etc. She has to her credit more than 40 national and international publications in indexed medical journals. She has contributed chapters in Indian books on clinical research, pharmacology and antibiotics. Her research paper was nominated for U.K. Seth award presentation at a conference organized by Indian Pharmacological Society. She is life member of renowned societies like Indian Pharmacological Society (IPS), Association of Physiologists and Pharmacologists of India (APPI), Indian Society of Rational Pharmacotherapeutics (ISRPT), Society of Pharmacovigilance of India (SOPI)and Indian Society of Clinical Research (ISCR). She is among the peer review panel of various national and international indexed journals.