Preclinical development handbook ; Toxicology
Author(s)
Bibliographic Information
Preclinical development handbook ; Toxicology
John Wiley & Sons, c2008
- Other Title
-
Toxicology
Available at 4 libraries
  Aomori
  Iwate
  Miyagi
  Akita
  Yamagata
  Fukushima
  Ibaraki
  Tochigi
  Gunma
  Saitama
  Chiba
  Tokyo
  Kanagawa
  Niigata
  Toyama
  Ishikawa
  Fukui
  Yamanashi
  Nagano
  Gifu
  Shizuoka
  Aichi
  Mie
  Shiga
  Kyoto
  Osaka
  Hyogo
  Nara
  Wakayama
  Tottori
  Shimane
  Okayama
  Hiroshima
  Yamaguchi
  Tokushima
  Kagawa
  Ehime
  Kochi
  Fukuoka
  Saga
  Nagasaki
  Kumamoto
  Oita
  Miyazaki
  Kagoshima
  Okinawa
  Korea
  China
  Thailand
  United Kingdom
  Germany
  Switzerland
  France
  Belgium
  Netherlands
  Sweden
  Norway
  United States of America
Note
Includes bibliographical references and index
Description and Table of Contents
Description
A clear, straightforward resource to guide you through preclinical drug development
Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques.
Each chapter was written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Among the key topics covered are:
*
In vitro mammalian cytogenetics tests
*
Phototoxicity
*
Carcinogenicity studies
*
The pharmacogenomics of personalized medicine
*
Bridging studies
*
Toxicogenomics and toxicoproteomics
Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage.
This is a hands-on guide for pharmaceutical scientists involved in preclinical testing,enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.
Table of Contents
Preface. 1 Preclinical Drug Development Planning (Nirmala Bhogal, Robert Combes, and Michael Balls).
2 Use of Project Teams in Preclinical Development (Dorothy M. K. Keefe, Joanne M. Bowen, and Rachel J. Gibson).
3 Relationship between Animal Models and Clinical Research: Using Mucositis as a Practical E xample (Rachel J. Gibson, Joanne M. Bowen, and Dorothy M. K. Keefe).
4 Bacterial Mutation Assay (Premkumar Kumpati).
5 In Vitro Mammalian Cell Mutation Assays (C. Anita H. Bigger, Martha M. Moore, and Robert H. Heflich).
6 In Vitro Mammalian Cytogenetic T ests (R. Julian Preston).
7 In Vivo Genotoxicity Assays (Andreas Hartmann, Krista L. Dobo, and Hans-Jörg Martus).
8 Repeat Dose Toxicity Studies (Shayne Cox Gad).
9 Irritation and Local Tissue Tolerance Studies in Pharmacetical S afety Assessment (Shayne Cox Gad).
10 Safety Assessment Studies: Immunotoxicity (Jacques Descotes).
11 Immunotoxicity Testing: ICH Guideline S8 and Related Aspects (Hans-Gerd Pauels and John Taylor).
12 Reproductive and Developmental Toxicology (Ronald D. Hood and Robert M. Parker).
13 Carcinogenicity Studies (Shayne Cox Gad).
14 Toxicokinetics: An Integral Component of Preclinical Toxicity S tudies (Sonu Sundd Singh).
15 In Vitro Toxicokinetics and Dynamics: Modeling and Interpretation of Toxicity Data (Arie Bruinink).
16 Toxicologic Pathology (Paul B. Tchounwou and José A. Centeno).
17 Secondary Pharmacodynamic Studies and In Vitro Pharmacological Profiling (Duncan Armstrong, Jacques Migeon, Michael G. Rolf, Joanne Bowes, Mark Crawford, and Jean-Pierre Valentin).
18 Current Practices in Safety Pharmacology (Alan S. Bass, Peter K. S. Siegl, Gary A. Gintant, Dennis J. Murphy, and Roger Porsolt).
19 Safety Assessment of Biotechnology-Derived T herapeutics (Mary Ellen Cosenza).
20 Preclinical Development of Protein Pharmaceuticals: An O verview (Dipankar Das and Mavanur R. Suresh).
21 The Pharmacogenomics of Personalized Medicine (Ronald E. Reid).
22 Genomics (Dimitri Semizarov and Eric A. G. Blomme).
23 Proteomics (Juan Casado and J. Ignacio Casal).
24 Toxicogenomics in Preclinical Development (Eric A. G. Blomme, Dimitri Semizarov, and Jeffrey F. Waring).
25 Toxicoproteomics: Preclinical Studies (B. Alex Merrick and Maribel E. Bruno).
26 Regulatory Considerations (Evan B. Siegel and Duane B. Lakings).
27 Regulatory Issues in Preclinical Safety Studies (U.S. FDA) (Kenneth L. Hastings and William J. Brock).
28 Selection and Utilization of CROs for Safety Assessment (Joanne R. Kopplin and Ward R. Richter).
29 Auditing and Inspecting Preclinical Research and Compliance with Good Laboratory Practice (GLP) (N. J. Dent).
30 Drug Impurities and Degradants and Their Safety Qualification (Robin C. Guy).
31 Bridging Studies in Preclinical Pharmaceutical Safety Assessment (Shayne Cox Gad).
Index.
by "Nielsen BookData"