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Chapter-11 Tgn 1412: Lessons for Phase I Trials in India

BOOK TITLE: Drug Discovery and Clinical Research

Author
1. Bhatt Arun
ISBN
9789350252727
DOI
10.5005/jp/books/11216_11
Edition
1/e
Publishing Year
2011
Pages
13
Author Affiliations
1. A-302, Everest Chambers Next to Star TV Office, Marol Naka, Andheri-Kurla Road, Andheri (E), Mumbai, India, Clininvent Research Pvt. Ltd., A-103, Everest Chambers, Marol Naka, Andheri, Kurla Road, Andheri (E), Mumbai, Maharashtra, India
Chapter keywords
TGN-1412 episode, lumbar myalgia, diarrhea, erythema, methylprednisolone, an anti-interleukin-2 receptor, lymphopenia, graft-versus-host disease, hyperalgesia, proinflammatory cytokines, systemic inflammatory response syndrome (SIRS), monocytopenia, type 2 cytokines, multiple cytokine release syndrome, automated external defibrillator (AED), fluid therapy, adrenaline, systemic inflammatory response Syndrome, MHRA GCP Inspection, clinical pharmacology research unit, MHRA GMP Inspection, TGN1412 trial, no observable effect level, no observable adverse effect level, FIH trials, CTEAG review., AED defibrillator, advanced life support, MHRA’s GCP inspections, minimal anticipated biological effect level, Schedule Y 2005, high-risk IMPs

Abstract

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