Comparative Evaluation of US Food and Drug Administration and Pharmacologically Guided Approaches to Determine the Maximum Recommended Starting Dose for First-in-Human Clinical Trials in Adult Healthy Men

Journal article

Peer reviewed

Md Tarique Imam, S. P. Venkateshan, Monika Tandon, Nilanjan Saha and K. K. Pillai

Journal of clinical pharmacology, Vol.51(12), pp.1655-1664

Revised version accepted September 21, 2010

12/2011

PMID: 21415286

Abstract

clinical pharmacology

clinical research

clinical trials

pharmacokinetics & drug metabolism

pharmacology

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Title: Comparative Evaluation of US Food and Drug Administration and Pharmacologically Guided Approaches to Determine the Maximum Recommended Starting Dose for First-in-Human Clinical Trials in Adult Healthy Men
Creators - without role: Md Tarique Imam - Jamia Hamdard
S. P. Venkateshan - Clinical Pharmacology Unit, Ranbaxy Laboratories Ltd, India
Monika Tandon - Clinical Pharmacology Unit, Ranbaxy Laboratories Ltd, India
Nilanjan Saha - Clinical Pharmacology Unit, Ranbaxy Laboratories Ltd, India
K. K. Pillai - Jamia Hamdard
Publication Details: Journal of clinical pharmacology, Vol.51(12), pp.1655-1664
Publisher: Blackwell Publishing Ltd
Edition: Revised version accepted September 21, 2010
Number of pages: 10
Identifiers: 9926346908331
Academic Unit: Prince Sattam Bin Abdulaziz University
Language: English
Resource Type: Journal article