eBook A Comprehensive Guide to Toxicology in Nonclinical Drug Development, 2nd Edition

  • Ali S. Faqi
  • Published By:
  • ISBN-10: 0128036214
  • ISBN-13: 9780128036211
  • DDC: 615.704
  • Grade Level Range: College Freshman - College Senior
  • 986 Pages | eBook
  • Original Copyright 2017 | Published/Released June 2017
  • This publication's content originally published in print form: 2017
  • Price:  Sign in for price

About

Overview

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings.

Table of Contents

Front Cover.
Half Title Page.
Dedication.
Title Page.
Copyright Page.
Contents.
List of Contributors.
Foreword.
1: Introduction.
Drug Discovery, Metabolism, And Pharmacokinetics.
2: Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls.
3: ADME in Drug Discovery.
4: Pharmacokinetics and Toxicokinetics.
Toxicological Studies and Ind Application, and First In-Human Clinical Trial.
5: Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development.
6: Genetic Toxicology Testing.
7: Contemporary Practices in Core Safety Pharmacology Assessments.
8: Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-In-Human Clinical Trial.
9: Developmental and Reproductive Toxicology.
10: Immunotoxicology Assessment in Drug Developmental.
11: Juvenile Testing to Support Clinical Trials in Pediatric Population.
12: Preclinical Evaluation of Carcinogenicity Using Standard-Bred and Genetically Engineered Rodent Models.
13: Current Strategies for Abuse Liability Assessment of New Chemical Entities.
Clinical Pathology, Histopathology, and Biomarkers.
14: Clinical Pathology.
15: Best Practice in Toxicological Pathology.
16: Molecular Pathology: Applications in Nonclinical Drug Development.
17: Biomarkers in Nonclinical Drug Development.
Biostatistics, Regulatory Toxicology, and Role of Study Directors.
18: Biostatistics for Toxicologists.
19: Regulatory Toxicology.
20: Role of Study Director and Study Monitor in Drug Development Safety Studies.
Specialty Route of Administration.
21: Infusion Toxicology and Techniques.
22: Photosafety Assessment.
Nonclinical Development of Monoclonal Antibodies, Stem Cells, Oncogenic and Non-Oncogenic Drugs, Oligonucleotides, and Vaccines.
23: Preclinical Development of Monoclonal Antibodies.
24: Nonclinical Safety Assessment of Cell-Based Therapies.
25: Preclinical Development of Nononcogenic Drugs (Small and Large Molecules).
26: Preclinical Development of Oncology Drugs.
27: Preclinical Toxicology of Vaccines1.
28: Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics.
Safety Evaluation of Ocular Drugs, Botanical Products, and Medicinal Devices.
29: Safety Evaluation of Ocular Drugs.
30: Nonclinical Safety Assessment of Botanical Products.
31: Biocompatibility Evaluation of Medical Devices.
Predictive Toxicology, Toxicometabolomics, Toxicogenomics, and Imaging.
32: Application of Evolving Computational and Biological Platforms for Chemical Safety Assessment.
33: Toxicometabolomics Technology and Applications.
34: Toxicogenomics in Preclinical Development.
35: Use of Imaging for Preclinical Evaluation.
Index.