Main description:

A clear, straightforward resource to guide you throughpreclinical drug development

Following this book′s step–by–step guidance, you cansuccessfully initiate and complete critical phases of preclinicaldrug development. The book serves as a basic,comprehensivereference to prioritizing and optimizing leads, toxicity,pharmacogenomics, modeling, and regulations. This singledefinitive, easy–to–use resource discusses all the issues that needconsideration and provides detailed instructions for currentmethods and techniques.

Each chapter was written by one or more leading experts in thefield. These authors, representing the many disciplines involved inpreclinical toxicology screening and testing, give you the toolsneeded to apply an effective multidisciplinary approach. Theeditor, with more than thirty years′ experience working withpharmaceutical and biotechnology companies, carefully reviewed allthe chapters to ensure that each one is thorough, accurate, andclear.

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 beencountered and their solutions. The authors also set forth thelimitations of various methods and techniques used in determiningthe safety and efficacy of a drug during the preclinical stage.

This is a hands–on guide for pharmaceutical scientists involvedin preclinical testing,enabling them to perform and documentpreclinical safety tests to meet all FDA requirements beforeclinical trials may begin.

Back cover:

A clear, straightforward resource to guide you throughpreclinical drug development

Following this book′s step–by–step guidance, you cansuccessfully initiate and complete critical phases of preclinicaldrug development. The book serves as a basic,comprehensivereference to prioritizing and optimizing leads, toxicity,pharmacogenomics, modeling, and regulations. This singledefinitive, easy–to–use resource discusses all the issues that needconsideration and provides detailed instructions for currentmethods and techniques.

Each chapter was written by one or more leading experts in thefield. These authors, representing the many disciplines involved inpreclinical toxicology screening and testing, give you the toolsneeded to apply an effective multidisciplinary approach. Theeditor, with more than thirty years′ experience working withpharmaceutical and biotechnology companies, carefully reviewed allthe chapters to ensure that each one is thorough, accurate, andclear.

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 beencountered and their solutions. The authors also set forth thelimitations of various methods and techniques used in determiningthe safety and efficacy of a drug during the preclinical stage.

This is a hands–on guide for pharmaceutical scientists involvedin preclinical testing,enabling them to perform and documentpreclinical safety tests to meet all FDA requirements beforeclinical trials may begin.

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. JulianPreston).

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 PharmaceticalS afety Assessment (Shayne Cox Gad).

10 Safety Assessment Studies: Immunotoxicity (JacquesDescotes).

11 Immunotoxicity Testing: ICH Guideline S8 and Related Aspects(Hans–Gerd Pauels and John Taylor).

12 Reproductive and Developmental Toxicology (Ronald D. Hoodand Robert M. Parker).

13 Carcinogenicity Studies (Shayne Cox Gad).

14 Toxicokinetics: An Integral Component of Preclinical ToxicityS tudies (Sonu Sundd Singh).

15 In Vitro Toxicokinetics and Dynamics: Modeling andInterpretation of Toxicity Data (Arie Bruinink).

16 Toxicologic Pathology (Paul B. Tchounwou and José A.Centeno).

17 Secondary Pharmacodynamic Studies and In VitroPharmacological Profiling (Duncan Armstrong, Jacques Migeon,Michael G. Rolf, Joanne Bowes, Mark Crawford, and Jean–PierreValentin).

18 Current Practices in Safety Pharmacology (Alan S. Bass,Peter K. S. Siegl, Gary A. Gintant, Dennis J. Murphy, and RogerPorsolt).

19 Safety Assessment of Biotechnology–Derived T herapeutics(Mary Ellen Cosenza).

20 Preclinical Development of Protein Pharmaceuticals: An Overview (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 andMaribel 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 Compliancewith 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 SafetyAssessment (Shayne Cox Gad).

Index.