Invaluable guidance to manage nonclinical safety studies This book is a practical reference aiding Study Directors in the design, execution, and reporting of nonclinical studies. Managing the idiosyncrasies inherent in a nonclinical study represents a significant challenge that can only be learned from doing. The editors and authors provide such valuable lessons learned and case studies from their own extensive experience to guide readers. A single-source reference with a broad and holistic overview of nonclinical studies, this book: * Provides a complete overview of nonclinical study…mehr
Invaluable guidance to manage nonclinical safety studies This book is a practical reference aiding Study Directors in the design, execution, and reporting of nonclinical studies. Managing the idiosyncrasies inherent in a nonclinical study represents a significant challenge that can only be learned from doing. The editors and authors provide such valuable lessons learned and case studies from their own extensive experience to guide readers. A single-source reference with a broad and holistic overview of nonclinical studies, this book: * Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study * Covers regulatory and scientific concepts, including multi-site testing and Good Laboratory Practice (GLP) regulations, compliance with testing guidelines, and animal models * Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years * Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry It begins with the basic concepts of regulatory definitions, international testing guidelines and Good Laboratory Practice (GLP) regulations, facility management, and regulatory inspections. The second part then deals with the conduct of a nonclinical study, critical to a successful outcome, and one of the more challenging tasks for a Study Director: developing a protocol. The third section describes specialized studies and the final chapter compiles the case studies and lessons learned from those that have been active participants in nonclinical studies for many years. With such comprehensive coverage across the spectrum of nonclinical testing, the book is applicable to several industries including pharmaceutical, safety science, biotechnology, and regulatory science.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
William J. Brock is the Principal of Brock Scientific Consulting, a Diplomate of ABT and a Fellow of ATS. Dr. Brock has over 30 years of experience with conducting nonclinical studies including genotoxicity, safety pharmacology, developmental and reproductive toxicology, carcinogenicity studies, etc. Barbara Mounho is a Biopharmaceutical Practice Leader at ToxStrategies, Inc., a Diplomate of ABT and a Fellow of ATS. Dr. Mounho has >15 years of experience in the nonclinical safety evaluation of therapeutic biological products. Lijie Fu is the Senior Director and Regulatory Advisor at SNBL. He is a Fellow of ATS with over 30 years' experience in toxicology, holding positions in non-clinical CROs in the US and China. Dr. Fu was retained by WHO as an expert to on Safety Evaluation and GLP Regulations.
Inhaltsangabe
Foreword ix Edwin I. Goldenthal PhD ATS Preface xi Contributors xiii 1 Introduction to the Study Director 1 Mary Ellen Cosenza PhD MS DABT RAC 2 Good Laboratory Practice Regulations: Roles of the Study Director Management and Quality Assurance Unit 7 Barbara Randolph BS MT (ASCP) MBA RQAP (GLP) 3 International Guidelines and Regulations of Nonclinical Studies 27 Bert Haenen PhD ERT Linda Blous Msc and Anne Harman Chappelle PhD DABT 4 Facilities Operations Laboratory Animal Care and Veterinary Services 43 Susan A. MacKenzie VMD PhD DABT Gregory W. Ruppert BA and David G. Serota PhD DABT 5 Regulatory Inspections 73 Russell James Eyre PhD DABT Lijie Fu PhD MPH Fellow ATS and Eric Austin PhD DABT 6 Project Management and the Role of a Study Director 83 Debra Kirchner PhD DABT Parthena Martin PhD DABT and Brenda Frantz BS 7 Managing Multi-site Studies: Roles of the Principal Investigator and the Study Director 95 Suzanne R.T. Wolford PhD DABT 8 Prestudy Preparation the Protocol Data Interpretation and Reporting 107 Carol S. Auletta DABT MBA RAC 9 Study Conduct 131 Lisa Biegel PhD Heather Dale PhD and Mark Morse PhD DABT 10 In Vitro Toxicology Models 145 Gertrude-Emilia Costin PhD MBA and Hans Raabe MS 11 Analytical Chemistry and Toxicology Formulations 171 Eric S. Bodle PhD and Nutan Gangrade PhD 12 Statistical Design and Analysis of Studies 191 John W. Green PhD 13 Clinical Pathology 225 Niraj K. Tripathi BVSc MVSc PhD DACVP Lila Ramaiah BSc DVM PhD DACVP and Nancy E. Everds DVM DACVP 14 Effective Incorporation and Utilization of Biomarkers in Nonclinical Studies 245 Michael R. Bleavins PhD DABT 15 Pathology: Necropsy and Gross Pathology 259 Charles B. Spainhour VMD PhD DABT 16 Histopathology in Toxicity Studies for Study Directors 275 Kevin Keane DVM PhD Fellow IATP 17 Toxicokinetics and Bioanalysis 297 Anthony L. Kiorpes PhD DVM DABT 18 The Planning Conduct and Interpretation of Safety Pharmacology Studies: The Role of the Study Director in Safety Pharmacology Investigations 313 Simon Authier DVM MSc MBA PhD DSP Michael J. Curtis PhD FHEA FBPharmacolS DSP and Michael K. Pugsley PhD FBPharmacolS DSP 19 Genetic Toxicology Studies 333 Robert R. Young MS Mark Powley PhD Timothy E. Lawlor MA and Marilyn J. Aardema PhD 20 Carcinogenicity Studies 355 Reem Elbekai BPharm PhD DABT and Catherine M. Kelly BS 21 Contemporary Practices in Core Developmental Reproductive and Juvenile Toxicity Assessments 371 Ali Said Faqi DVM PhD DABT Fellow ATS 22 Immunotoxicology in Nonclinical Studies 393 Florence G. Burleson PhD and Stefanie C.M. Burleson PhD 23 Nonclinical Safety Assessment of Biotechnology-Derived Products: Considerations and Challenges 405 Barbara Mounho PhD DABT 24 Gene and Cell Therapy Products 427 Peter Working PhD DABT Fellow ATS 25 Vaccines: Preventive and Therapeutic Product Studies 439 Deborah L. Novicki PhD DABT Jayanthi J. Wolf PhD Lisa M. Plitnick PhD and Melanie Hartsough PhD 26 Toxicology Studies Conducted for Pesticides and Commodity Chemicals 465 Elliot Gordon PhD DABT and Linda A. Malley PhD DABT 27 Medical Devices 485 Gregory A. Kopia PhD and John F. Dooley PhD 28 Lessons from the Front Lines 505 Christopher P. Chengelis PhD DABT and C. Steven Godin PhD DABT Index 519
Foreword ix Edwin I. Goldenthal PhD ATS Preface xi Contributors xiii 1 Introduction to the Study Director 1 Mary Ellen Cosenza PhD MS DABT RAC 2 Good Laboratory Practice Regulations: Roles of the Study Director Management and Quality Assurance Unit 7 Barbara Randolph BS MT (ASCP) MBA RQAP (GLP) 3 International Guidelines and Regulations of Nonclinical Studies 27 Bert Haenen PhD ERT Linda Blous Msc and Anne Harman Chappelle PhD DABT 4 Facilities Operations Laboratory Animal Care and Veterinary Services 43 Susan A. MacKenzie VMD PhD DABT Gregory W. Ruppert BA and David G. Serota PhD DABT 5 Regulatory Inspections 73 Russell James Eyre PhD DABT Lijie Fu PhD MPH Fellow ATS and Eric Austin PhD DABT 6 Project Management and the Role of a Study Director 83 Debra Kirchner PhD DABT Parthena Martin PhD DABT and Brenda Frantz BS 7 Managing Multi-site Studies: Roles of the Principal Investigator and the Study Director 95 Suzanne R.T. Wolford PhD DABT 8 Prestudy Preparation the Protocol Data Interpretation and Reporting 107 Carol S. Auletta DABT MBA RAC 9 Study Conduct 131 Lisa Biegel PhD Heather Dale PhD and Mark Morse PhD DABT 10 In Vitro Toxicology Models 145 Gertrude-Emilia Costin PhD MBA and Hans Raabe MS 11 Analytical Chemistry and Toxicology Formulations 171 Eric S. Bodle PhD and Nutan Gangrade PhD 12 Statistical Design and Analysis of Studies 191 John W. Green PhD 13 Clinical Pathology 225 Niraj K. Tripathi BVSc MVSc PhD DACVP Lila Ramaiah BSc DVM PhD DACVP and Nancy E. Everds DVM DACVP 14 Effective Incorporation and Utilization of Biomarkers in Nonclinical Studies 245 Michael R. Bleavins PhD DABT 15 Pathology: Necropsy and Gross Pathology 259 Charles B. Spainhour VMD PhD DABT 16 Histopathology in Toxicity Studies for Study Directors 275 Kevin Keane DVM PhD Fellow IATP 17 Toxicokinetics and Bioanalysis 297 Anthony L. Kiorpes PhD DVM DABT 18 The Planning Conduct and Interpretation of Safety Pharmacology Studies: The Role of the Study Director in Safety Pharmacology Investigations 313 Simon Authier DVM MSc MBA PhD DSP Michael J. Curtis PhD FHEA FBPharmacolS DSP and Michael K. Pugsley PhD FBPharmacolS DSP 19 Genetic Toxicology Studies 333 Robert R. Young MS Mark Powley PhD Timothy E. Lawlor MA and Marilyn J. Aardema PhD 20 Carcinogenicity Studies 355 Reem Elbekai BPharm PhD DABT and Catherine M. Kelly BS 21 Contemporary Practices in Core Developmental Reproductive and Juvenile Toxicity Assessments 371 Ali Said Faqi DVM PhD DABT Fellow ATS 22 Immunotoxicology in Nonclinical Studies 393 Florence G. Burleson PhD and Stefanie C.M. Burleson PhD 23 Nonclinical Safety Assessment of Biotechnology-Derived Products: Considerations and Challenges 405 Barbara Mounho PhD DABT 24 Gene and Cell Therapy Products 427 Peter Working PhD DABT Fellow ATS 25 Vaccines: Preventive and Therapeutic Product Studies 439 Deborah L. Novicki PhD DABT Jayanthi J. Wolf PhD Lisa M. Plitnick PhD and Melanie Hartsough PhD 26 Toxicology Studies Conducted for Pesticides and Commodity Chemicals 465 Elliot Gordon PhD DABT and Linda A. Malley PhD DABT 27 Medical Devices 485 Gregory A. Kopia PhD and John F. Dooley PhD 28 Lessons from the Front Lines 505 Christopher P. Chengelis PhD DABT and C. Steven Godin PhD DABT Index 519
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