Screen LibraryGlobal approach in safety testing ICH guidelines explained /
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| Corporate Authors: | |
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| Group Author: | ; |
| Published: |
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| Literature type: | Electronic eBook |
| Language: | English |
| Series: |
AAPS advances in the pharmaceutical sciences series ;
v. 5 |
| Subjects: | |
| Online Access: |
http://dx.doi.org/10.1007/978-1-4614-5950-7 |
| Carrier Form: | 1 online resource (xii, 315 p.) |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: |
9781461459507 (electronic bk.) 1461459508 (electronic bk.) |
| Index Number: | RM301 |
| CLC: | R927 |
| Contents: |
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 / Toward 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) / |