Nonclinical Safety Assessment

A Guide to International Pharmaceutical Regulations

William J. Brock (Redaktør) ; Kenneth L. Hastings (Redaktør) ; Kathy M. McGown (Redaktør)

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. Les mer
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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. International coverage includes World Health Organization (WHO) principles and regional variations, including EMEA guidance, U.S. FDA, and Asia-Pacific. The text provides insights into the future of nonclinical drug testing and approval and includes a list of resources such as guidelines, guidance, and authoritative non-governmental publications.

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Innholdsfortegnelse

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 5.5 Clinical Trial Applications 70 5.6 Special Regulatory Considerations 74 6 European Pharmaceutical Regulation Nonclinical Testing Requirements 79 Adam Woolley and Jan Willem van der Laan 6.1 Introduction 79 6.2.1 Overview 82 6.3 Nonclinical Testing in the Support of Clinical Trials 86 6.4 Overview 96 7 South Africa 99 Fariza Feraoun and Malik Feraoun 7.1 Introduction 99 7.2 Country Information 100 7.3 The Regulatory Aspects 101 7.4 The Nonclinical Safety Assessment 109 7.5 Conclusion 114 8 Asia Pacific: China 117 Lijie Fu and Qingli Wang 8.1 Introduction 117 8.2 History of Drug Administration 118 8.3 The Provisions for Drug Registration 122 8.4 The SFDA 123 8.5 The SFDA Affiliated Organizations 123 8.6 General Registration Procedures 125 8.7 Pharmaceutical Application 125 8.8 Import Drug Application 127 8.9 Testing Guidelines and Safety Evaluation 129 8.10 GLP Compliance in China 131 8.11 Animal Welfare Requirements 133 9 Pharmaceutical Regulations for Nonclinical Safety Assessment in Japan 135 Kazuichi Nakamura and Osamu Fueki 9.1 History of Regulation for Nonclinical Safety Assessment in Japan 135 9.2 Approval Application of New Drugs in Japan 136 9.3 Current Nonclinical Safety Guidelines Available in Japan 139 9.4 Current Trends of Conduct of Nonclinical Safety Evaluation in Japan 139 9.5 Safety Assessment of Unapproved Drugs 142 9.6 Necessity of 3Rs (Reduction/Refinement/Replacement) of Animal Studies 142 9.7 Attitude of Japanese Pharmaceutical Companies and the Regulatory Agency toward Nonclinical Safety As

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