Preclinical Development Handbook
Toxicology
(Sprache: Englisch)
This book provides drug safety and toxicology scientists with practical guidance for testing and determining the effectiveness and safety of a new drug candidate. It authoritatively covers the important topics within toxicity testing, pharmacogenomics, and...
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Produktinformationen zu „Preclinical Development Handbook “
This book provides drug safety and toxicology scientists with practical guidance for testing and determining the effectiveness and safety of a new drug candidate. It authoritatively covers the important topics within toxicity testing, pharmacogenomics, and regulations for the preclinical safety testing of drug candidates.
Klappentext zu „Preclinical Development Handbook “
A clear, straightforward resource to guide you through preclinical drug developmentFollowing 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.
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.
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.
Inhaltsverzeichnis zu „Preclinical Development Handbook “
- Preface1 Preclinical Drug Development Planning (Nirmala Bhogal, Robert Combes, and Michael Balls)
2 Use of Project T eams 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 T oxicity S tudies (Shayne Cox Gad)
9 Irritation and Local T issue T olerance S tudies in Pharmacetical S afety Assessment (Shayne Cox Gad)
10 Safety Assessment S tudies: Immunotoxicity (Jacques Descotes)
11 Immunotoxicity T esting: ICH Guideline S 8 and Related Aspects (Hans-Gerd Pauels and John Taylor)
12 Reproductive and Developmental T oxicology (Ronald D. Hood and Robert M. Parker)
13 Carcinogenicity S tudies (Shayne Cox Gad)
14 Toxicokinetics: An Integral Component of Preclinical T oxicity S tudies (Sonu Sundd Singh)
15 In Vitro T oxicokinetics and Dynamics: Modeling and Interpretation of Toxicity Data (Arie Bruinink)
16 Toxicologic Pathology (Paul B. Tchounwou and José A. Centeno)
17 Secondary Pharmacodynamic S tudies and In Vitro Pharmacological Profiling (Duncan Armstrong, Jacques Migeon, Michael G. Rolf, Joanne Bowes, Mark Crawford, and Jean-Pierre Valentin)
18 Current Practices in S afety 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
... mehr
(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 S tudies (B. Alex Merrick and Maribel E. Bruno)
26 Regulatory Considerations (Evan B. Siegel and Duane B. Lakings)
27 Regulatory Issues in Preclinical S afety S tudies (U.S. FDA) (Kenneth L. Hastings and William J. Brock)
28 Selection and Utilization of CROs for S afety 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 T heir S afety Qualification (Robin C. Guy)
31 Bridging S tudies in Preclinical Pharmaceutical S afety Assessment (Shayne Cox Gad)
- Index
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 S tudies (B. Alex Merrick and Maribel E. Bruno)
26 Regulatory Considerations (Evan B. Siegel and Duane B. Lakings)
27 Regulatory Issues in Preclinical S afety S tudies (U.S. FDA) (Kenneth L. Hastings and William J. Brock)
28 Selection and Utilization of CROs for S afety 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 T heir S afety Qualification (Robin C. Guy)
31 Bridging S tudies in Preclinical Pharmaceutical S afety Assessment (Shayne Cox Gad)
- Index
... weniger
Autoren-Porträt
Shayne Cox Gad, PHD, DABT, ATS, is the Principal of Gad Consulting Services. Dr. Gad has more than thirty years of experience as a toxicologist, statistical consultant, manager, and general consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of twenty-nine books and numerous papers, presentations, and other publications.
Bibliographische Angaben
- 2008, 1. Auflage, 1032 Seiten, Maße: 25,7 cm, Gebunden, Englisch
- Herausgegeben: Shayne Cox Gad
- Verlag: Wiley & Sons
- ISBN-10: 0470248467
- ISBN-13: 9780470248461
- Erscheinungsdatum: 14.05.2008
Sprache:
Englisch
Pressezitat
"A well referenced desk resource and educational handbook ... .An excellent overview of the principles, methods and application of toxicology in the context of the preclinical drug development process." ( The British Toxicology Newsletter , Winter 2008)
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