Format:
Online-Ressource (XII, 315 p. 15 illus., 13 illus. in color, digital)
ISBN:
9781461459507
,
1299335608
,
9781299335608
Series Statement:
AAPS Advances in the Pharmaceutical Sciences Series 5
Content:
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the US and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. In Japan, the members are the Ministry of Health, Labour and Welfare (MHLW), and the Japan Pharmaceutical Manufacturers Association (JPMA). In Europe, the members are the EU (Representatives of the European Commission and the European Medicines Agency [EMA]), and the European Federation of Pharmaceutical Industries and Associations (EFPIA). In the United States, the members are the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA). The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) is the secretariat of the ICH. Additional members include Observers from WHO, European Free Trade Association (EFTA), and Canada. The Observers represent non-ICH countries and regions. This volume considers one of ICH’s major categories, Safety, covering topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but in most cases there is a lack of awareness of the many issues that were addressed during the development of the consensus guidances. Further, just as it is important to understand what the guidances state, it is also important to understand the thoughts, debates, and intent of the experts involved, which are not included in the guidance documents. Why has the guideline been written as it is written, why are some topics ignored, and why have some initial guidance proposals have been deleted. These and other related questions and answers are the contents of this book, written by experts who were directly involved in writing the ICH guidances that drive drug development today
Note:
Description based upon print version of record
,
Global Approach in Safety Testing; Copyright; Preface; From European to International Harmonization; Starting the ICH Process; Impressive Results for ICH, So Far; Contents; Contributors; Chapter 1: The International Conference on Harmonisation: History of Safety Guidelines; 1.1 Start of ICH; 1.2 Organization of ICH; 1.3 Contents in ICH; 1.3.1 The Common Technical Dossier; 1.3.2 Reduction, Re fi nement, and Replacement of Animals; 1.3.3 Assessing Toxicity Versus Assuring Safety at Clinical Level; 1.3.4 Regulatory Protocol Approval; 1.4 Restart of Safety Guidelines
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1.4.1 Harmonization of Contents Versus Harmonization in Systems1.4.2 Development of Regulatory Pharmaceutical Toxicological Sciences; 1.5 Final Conclusion; References; Chapter 2: EU Perspective on ICH; 2.1 Introduction; 2.2 Brief History; 2.3 Common Technical Document; 2.4 ICH and the EU Regulatory System; 2.5 The Importance and Tools of Maintenance of Existing Guidelines: Geriatrics and Non-clinical Guidelines; 2.5.1 Geriatrics; 2.5.2 Non-clinical Guidelines; 2.6 ICH Reaching Out to the World Beyond: The Global Cooperation Group
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2.7 The Globalisation of the Pharmaceutical Market and the Regulators' Forum2.8 Outlook; Chapter 3: The Value and Bene fi ts of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health; 3.1 Value and Bene fi ts of the Common Technical Document; 3.2 Shift in Emphasis; U.S. FDA's Implementation of ICH Guidelines; Chapter 4: A Japanese Perspective on Implementation of the Three Rs: Incorporating Best Scientific Practices into Regulatory Process; 4.1 Importance of Three Rs
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4.2 Single-Dose Toxicity Studies and Toxicity Evaluation of Major Metabolites4.2.1 Single-Dose Toxicity Studies; 4.2.2 Toxicity Evaluation of Metabolites; 4.2.2.1 Repeated-Dose Tissue Distribution Studies (ICH-S3B); 4.2.3 Purpose of Tissue Distribution Studies; 4.2.4 Circumstances Under Which Repeated-Dose Tissue Distribution Studies Should Be Considered; References; Chapter 5: Toward More Scienti fi c Relevance in Carcinogenicity Testing*; 5.1 Introduction; 5.2 Development of a Guideline for Dose Selection for Carcinogenicity Studies ICHS1C
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5.2.1 Issues in Achieving a Uni fi ed Dose-Selection Guidance5.2.2 Bridging to a Uniformly Acceptable Guidance; 5.2.3 High Dose Selection; 5.2.3.1 Pharmacodynamic-Based Endpoint; 5.2.3.2 Toxicity-Based Endpoint: MTD Discussion; 5.2.3.3 Pharmacokinetic Endpoints; 5.2.3.4 Pharmacokinetic Endpoint: Saturation of Exposure; 5.2.3.5 Other Endpoints Considered; 5.2.4 Application of Metabolism Data in Carcinogenicity Dose Selection; 5.2.5 Lower Dose-Selection Advice; 5.2.6 Modi fi cations of the Guidance; 5.2.6.1 Addition of Limit Dose De fi nition
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5.2.6.2 Removal of the Restriction for Using the 25-Fold Margin to Nongenotoxic Compounds
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The International Conference on Harmonisation. History of Safety Guidelines -- EU Perspective on ICH -- The Value and Benefits of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities Advancing Harmonization for Better Public Health -- A Japanese Perspective on Implementation of the Three Rs: Incorporating Best Scientific Practices into Regulatory Process -- Towards more Scientific Relevance in Carcinogenicity Testing -- The Evolution, Scientific Reasoning and Use of ICH S2 Guidelines for Genotoxicity Testing of Pharmaceuticals -- Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies , Where are we now; an S3A/S3B update (1995-2011) -- Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B) -- Why and how did Reproduction Toxicity Testing make its early entry into and Rapid Success in ICH? -- ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals -- Safety Pharmacology: Guidelines S7A and S7B -- ICH S8: History and Perspectives -- ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals a Perspective from Regulators on the Development of the Guideline -- Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals ICH M3 and M3(R2).
Additional Edition:
ISBN 9781461459491
Additional Edition:
Buchausg. u.d.T. ISBN 978-1-461-45949-1
Language:
English
DOI:
10.1007/978-1-4614-5950-7
URL:
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