The Role of the Study Director in Nonclinical Studies (eBook, ePUB)

Pharmaceuticals, Chemicals, Medical Devices, and Pesticides
Redaktion: Brock, William J.; Fu, Lijie; Mounho, Barbara

• Format: ePub

Produktbeschreibung

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The 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 international testing and Good Laboratory Practice (GLP), compliance with 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

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 560
• Erscheinungstermin: 2. Mai 2014
• Englisch
• ISBN-13: 9781118874080
• Artikelnr.: 40882678

Autorenporträt

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