Dose optimization in drug development (Rajesh Krishna)
From: "Krishnaswami, Sriram" Sriram.Krishnaswami@pfizer.com
Subject: [NMusers] Dose optimization in drug development (Rajesh Krishna)
Date: Mon, 8 May 2006 15:53:22 -0400
Dose optimization in drug development (Rajesh Krishna), Drugs and
Pharmaceutical Sciences, Volume 161, Informa healthcare plc, Taylor and
Francis, New York. ISBN: 1574448080, 2006
http://www.crcpress.com/shopping_cart/products/product_detail.asp?sku=DK5184&parent_id=&pc=
With contributions from leading authorities in the field, this source
focuses on two key interfaces in new drug development: transition from
preclinical to Phase I clinical development and transition from Phase IB/IIA
proof-of-concept to Phase IIB/III pivotal efficacy trials promotes
innovative clinical trial designs that may allow for a more optimal strategy
for dose selection, covers procedures and best practices in biomarker
validation and qualification, considers the benefits of novel clinical trial
designs in clinical pharmacology and experimental medicine, and analyzes the
importance of dose optimization during Phase II/III. This reference
provides a concise overview of the key principles in dose selection and
optimization and demonstrates applicability to recent successful new drug
applications. Compiling key issues and current research on safety, efficacy,
and clinical pharmacology, and PK-PD, this volume critically highlights the
multidisciplinary nature of drug development and spans the fields of
pharmacokinetics, clinical pharmacology, biostatistics, and experimental
medicine.
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