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Informationen zum Autor Editors William J. Brock Brock Scientific Consulting, Montgomery Village, USA Kenneth L. Hastings Sanofi, Bethesda, USA Kathy M. McGown FoxKiser, USA Klappentext Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions.It includes:* ICH - the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use* National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia* Repeated dose toxicity studies* Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology* Biotechnology-derived pharmaceuticals* Vaccine development* Phototoxicity and photocarcinogenicity* Degradants, impurities, excipients and metabolitesPrimarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing. Zusammenfassung Providing a comprehensive, international overview of the regulatory requirements for safety assessment for new drug approvals, each chapter in Nonclinical Safety Assessment is written by experts who have direct, firsthand involvement in drug development in the regions where they are located. Inhaltsverzeichnis List of Contributors xvii Preface xix Part I International Regulations and Nonclinical Studies for Pharmaceuticals 1 1 Introduction 3 Kathy M. McGown and William J. Brock 1.1 The Global Pharmaceutical Market 6 1.2 Looking to the Future 9 1.3 Legal and Regulatory Considerations in Drug Development 10 1.4 The Drug Development Process - General Considerations 12 2 ICH: History and Nonclinical Guidances 17 Jan-Willem van der Laan and Kenneth L. Hastings 2.1 Introduction 17 2.2 Organization of the ICH 19 2.3 The ICH Process 20 2.4 Animal Welfare and Alternative Methods 22 2.5 ICH M3 23 2.6 New Initiatives and Topics 24 3 Food and Drug Administration: Nonclinical Program and Pharmaceutical Approval 27 William J. Brock and Kenneth L. Hastings 3.1 Legislative Authority of the FDA 27 3.2 Nonclinical Drug Development and the FDA 31 3.3 Nonclinical Testing: General Conditions and Considerations 34 3.4 Toxicity Testing: Small Molecules and Traditional Pharmaceuticals 34 3.5 Toxicity Testing of Pharmaceuticals - The General Approach 35 3.6 First-in-Human Dosing: Results from Nonclinical Studies 37 4 Nonclinical Pharmaceutical Development in MERCOSUR and Brazil 41 Cristiana Leslie Corr^ea, Giuliana Selmi, and Flavio Ailton Duque Zambrone 4.1 Introduction 41 4.2 MERCOSUR 41 4.3 Brazil 44 5 Nonclinical Safety Assessment: Canada 57 Jamie L. Doran and Mark T. Goldberg 5.1 Introduction 57 5.2 Organization of Health Canada 58 5.3 The Regulatory Framework for Drug Approval in Canada 60 5.4 Nonclinical Assessment in Canada 64
